NCT02915016 is a Phase 1, PHASE2 clinical trial of DNA-HIV-PT123 vaccine in HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Who is sponsoring NCT02915016?

NCT02915016 is sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

What drugs are being tested in NCT02915016?

Interventions in NCT02915016: DNA-HIV-PT123 vaccine, Bivalent Subtype C gp120/MF59 vaccine, Bivalent Subtype C gp120/AS01B vaccine, Placebo.

What condition does NCT02915016 study?

NCT02915016 studies HIV Infections.

Is NCT02915016 still recruiting?

NCT02915016 is currently completed. Last updated 29 April 2022.

Are results published for NCT02915016?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-04-29 · How we verify

NCT02915016

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Evaluating the Safety and Immunogenicity of HIV Clade C DNA Vaccine and MF59- or AS01B-Adjuvanted Clade C Env Protein Vaccines in Various Combinations in Healthy, HIV-Uninfected Adults

Completed Phase 1, PHASE2 Results posted Last updated 29 April 2022

What this trial tests

Phase 1, PHASE2 trial testing DNA-HIV-PT123 vaccine in HIV Infections in 334 participants. Completed in 12 February 2020.

Timeline

7 December 2016

Primary endpoint
7 August 2019

12 February 2020

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	334
Start date	7 December 2016
Primary completion	7 August 2019
Estimated completion	12 February 2020
Sites	17 locations across South Africa, United States

Drugs / interventions tested

DNA-HIV-PT123 vaccine — full drug profile →
Bivalent Subtype C gp120/MF59 vaccine — full drug profile →
Bivalent Subtype C gp120/AS01B vaccine — full drug profile →
Placebo

Conditions studied

HIV Infections — all drugs for HIV Infections →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 18 to 40, any sex, with HIV Infections. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness Primary · Measured through 7 days after each vaccine dose at Month 0, 1, 3, and 6

Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[March 2017\]. The maximum grade observed for each symptom over the time frame is presented.

Pain

Group	Value	95% CI
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	5
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	7
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	6
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	8
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	10
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	5
Group 7: Placebo + Protein/AS01B	4
Group 8: Placebo	10
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	21
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	20
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	27
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	19
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	24
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	18
Group 7: Placebo + Protein/AS01B	24
Group 8: Placebo	13
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	4
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	23
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	17
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	3
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	16
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	27
Group 7: Placebo + Protein/AS01B	22
Group 8: Placebo	1
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	0
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	0
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	0
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	0
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	0
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	0
Group 7: Placebo + Protein/AS01B	0
Group 8: Placebo	0

Tenderness

Group	Value	95% CI
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	4
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	8
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	11
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	5
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	8
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	9
Group 7: Placebo + Protein/AS01B	6
Group 8: Placebo	8
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	20
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	16
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	16
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	21
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	23
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	20
Group 7: Placebo + Protein/AS01B	17
Group 8: Placebo	16
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	6
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	26
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	23
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	4
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	18
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	21
Group 7: Placebo + Protein/AS01B	27
Group 8: Placebo	0
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	0
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	0
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	0
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	0
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	1
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	0
Group 7: Placebo + Protein/AS01B	0
Group 8: Placebo	0

Pain and/or Tenderness

Group	Value	95% CI
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	2
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	6
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	5
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	4
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	8
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	4
Group 7: Placebo + Protein/AS01B	4
Group 8: Placebo	7
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	21
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	16
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	22
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	22
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	21
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	16
Group 7: Placebo + Protein/AS01B	18
Group 8: Placebo	16
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	7
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	28
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	23
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	4
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	20
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	30
Group 7: Placebo + Protein/AS01B	28
Group 8: Placebo	1
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	0
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	0
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	0
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	0
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	1
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	0
Group 7: Placebo + Protein/AS01B	0
Group 8: Placebo	0

Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration Primary · Measured through 7 days after each vaccine dose at Month 0, 1, 3, and 6

Erythema

Group	Value	95% CI
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	26
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	35
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	38
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	23
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	34
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	36
Group 7: Placebo + Protein/AS01B	31
Group 8: Placebo	21
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	3
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	4
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	4
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	3
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	3
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	4
Group 7: Placebo + Protein/AS01B	5
Group 8: Placebo	2
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	0
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	0
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	2
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	0
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	0
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	2
Group 7: Placebo + Protein/AS01B	0
Group 8: Placebo	0
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	1
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	2
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	2
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	0
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	3
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	2
Group 7: Placebo + Protein/AS01B	3
Group 8: Placebo	0

Induration

Group	Value	95% CI
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	28
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	35
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	37
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	23
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	33
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	38
Group 7: Placebo + Protein/AS01B	36
Group 8: Placebo	24
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	1
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	6
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	7
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	2
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	4
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	2
Group 7: Placebo + Protein/AS01B	4
Group 8: Placebo	0
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	0
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	0
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	1
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	0
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	2
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	1
Group 7: Placebo + Protein/AS01B	0
Group 8: Placebo	0
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	0
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	2
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	2
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	2
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	5
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	3
Group 7: Placebo + Protein/AS01B	6
Group 8: Placebo	0

Erythema and/or Induration

Group	Value	95% CI
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	25
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	31
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	34
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	22
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	31
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	35
Group 7: Placebo + Protein/AS01B	30
Group 8: Placebo	21
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	3
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	7
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	7
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	2
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	4
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	4
Group 7: Placebo + Protein/AS01B	4
Group 8: Placebo	2
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	0
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	0
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	2
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	0
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	1
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	2
Group 7: Placebo + Protein/AS01B	0
Group 8: Placebo	0
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	1
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	3
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	3
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	2
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	4
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	3
Group 7: Placebo + Protein/AS01B	5
Group 8: Placebo	0

Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Primary · Measured through 7 days after each vaccination at Month 0, 1, 3, and 6

Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[March 2017\]. The following symptoms are considered as systemic reactogenicity if the onset date was within the periods of assessment specified in the protocol: malaise and/or fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia, and body temperature. The item Max. Systemic Reaction is the maximum of the individual systemic variables for a participant. It does not include temperature.

Malaise and/or fatigue

Group	Value	95% CI
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	14
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	20
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	18
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	18
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	16
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	11
Group 7: Placebo + Protein/AS01B	16
Group 8: Placebo	15
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	11
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	21
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	15
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	10
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	18
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	14
Group 7: Placebo + Protein/AS01B	10
Group 8: Placebo	5
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	4
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	8
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	14
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	1
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	13
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	21
Group 7: Placebo + Protein/AS01B	23
Group 8: Placebo	4
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	1
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	1
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	3
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	1
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	3
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	4
Group 7: Placebo + Protein/AS01B	1
Group 8: Placebo	0

Myalgia

Group	Value	95% CI
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	17
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	24
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	20
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	16
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	23
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	15
Group 7: Placebo + Protein/AS01B	17
Group 8: Placebo	18
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	9
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	16
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	15
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	11
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	11
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	11
Group 7: Placebo + Protein/AS01B	12
Group 8: Placebo	4
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	4
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	10
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	15
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	3
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	14
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	22
Group 7: Placebo + Protein/AS01B	20
Group 8: Placebo	2
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	0
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	0
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	0
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	0
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	2
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	2
Group 7: Placebo + Protein/AS01B	1
Group 8: Placebo	0

Headache

Group	Value	95% CI
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	20
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	21
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	15
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	14
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	18
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	14
Group 7: Placebo + Protein/AS01B	13
Group 8: Placebo	13
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	7
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	21
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	21
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	11
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	18
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	14
Group 7: Placebo + Protein/AS01B	17
Group 8: Placebo	8
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	3
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	7
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	14
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	4
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	11
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	21
Group 7: Placebo + Protein/AS01B	20
Group 8: Placebo	2
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	0
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	1
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	0
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	1
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	3
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	1
Group 7: Placebo + Protein/AS01B	0
Group 8: Placebo	1

Nausea

Group	Value	95% CI
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	21
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	37
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	34
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	22
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	38
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	30
Group 7: Placebo + Protein/AS01B	30
Group 8: Placebo	20
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	7
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	12
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	11
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	6
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	8
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	13
Group 7: Placebo + Protein/AS01B	10
Group 8: Placebo	3
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	2
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	1
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	5
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	2
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	4
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	7
Group 7: Placebo + Protein/AS01B	10
Group 8: Placebo	1
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	0
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	0
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	0
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	0
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	0
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	0
Group 7: Placebo + Protein/AS01B	0
Group 8: Placebo	0

Vomiting

Group	Value	95% CI
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	29
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	46
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	47
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	29
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	45
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	45
Group 7: Placebo + Protein/AS01B	42
Group 8: Placebo	20
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	1
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	3
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	2
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	1
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	5
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	5
Group 7: Placebo + Protein/AS01B	4
Group 8: Placebo	3
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	0
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	1
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	1
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	0
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	0
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	0
Group 7: Placebo + Protein/AS01B	4
Group 8: Placebo	1
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	0
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	0
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	0
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	0
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	0
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	0
Group 7: Placebo + Protein/AS01B	0
Group 8: Placebo	0

Chills

Group	Value	95% CI
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	27
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	34
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	32
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	25
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	25
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	22
Group 7: Placebo + Protein/AS01B	23
Group 8: Placebo	21
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	3
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	9
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	8
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	5
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	12
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	8
Group 7: Placebo + Protein/AS01B	6
Group 8: Placebo	3
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	0
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	6
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	9
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	0
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	11
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	19
Group 7: Placebo + Protein/AS01B	17
Group 8: Placebo	0
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	0
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	1
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	1
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	0
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	2
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	1
Group 7: Placebo + Protein/AS01B	4
Group 8: Placebo	0

Arthralgia

Group	Value	95% CI
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	25
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	38
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	33
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	26
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	29
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	26
Group 7: Placebo + Protein/AS01B	24
Group 8: Placebo	20
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	5
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	9
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	12
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	4
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	15
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	10
Group 7: Placebo + Protein/AS01B	10
Group 8: Placebo	4
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	0
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	3
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	5
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	0
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	5
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	12
Group 7: Placebo + Protein/AS01B	15
Group 8: Placebo	0
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	0
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	0
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	0
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	0
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	1
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	2
Group 7: Placebo + Protein/AS01B	1
Group 8: Placebo	0

Max. Systemic Symptoms

Group	Value	95% CI
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	12
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	13
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	8
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	8
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	11
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	3
Group 7: Placebo + Protein/AS01B	8
Group 8: Placebo	9
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	10
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	19
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	19
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	13
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	16
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	12
Group 7: Placebo + Protein/AS01B	15
Group 8: Placebo	10
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	7
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	17
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	19
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	7
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	19
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	31
Group 7: Placebo + Protein/AS01B	22
Group 8: Placebo	4
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	1
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	1
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	4
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	2
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	4
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	4
Group 7: Placebo + Protein/AS01B	5
Group 8: Placebo	1

Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product Primary · Measured through 30 days after each vaccination at Month 0, 1, 3, and 6

For participants reporting multiple AEs over the time frame, the maximum relationship is counted.

Group	Value	95% CI
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	3
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	2
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	1
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	5
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	4
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	4
Group 7: Placebo + Protein/AS01B	2
Group 8: Placebo	1
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	21
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	32
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	33
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	15
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	35
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	27
Group 7: Placebo + Protein/AS01B	25
Group 8: Placebo	12
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	6
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	16
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	16
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	10
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	11
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	19
Group 7: Placebo + Protein/AS01B	23
Group 8: Placebo	11

Number of Participants Reporting Adverse Events (AEs), by Severity Grade Primary · Measured through 30 days after each vaccination at Month 0, 1, 3, and 6

For participants reporting multiple AEs over the time frame, the maximum severity grade is counted.

Group	Value	95% CI
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	11
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	13
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	10
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	6
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	19
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	8
Group 7: Placebo + Protein/AS01B	9
Group 8: Placebo	3
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	12
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	19
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	22
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	10
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	16
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	22
Group 7: Placebo + Protein/AS01B	16
Group 8: Placebo	10
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	1
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	2
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	2
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	4
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	3
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	1
Group 7: Placebo + Protein/AS01B	2
Group 8: Placebo	0
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	0
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	0
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	0
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	0
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	1
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	0
Group 7: Placebo + Protein/AS01B	0
Group 8: Placebo	0

Number of Participants Reporting Serious Adverse Events (SAEs) Primary · Measured through Month 12

Measured as outlined in Version 2.0 (January 2010) of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual)

Group	Value	95% CI
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	0
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	1
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	0
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	1
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	1
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	1
Group 7: Placebo + Protein/AS01B	0
Group 8: Placebo	0

Number of Participants Reporting Adverse Events of Special Interest (AESIs) Primary · Measured through Month 18

There were no adverse events of special interest reported by any participant.

Group	Value	95% CI
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	0
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	0
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	0
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	0
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	0
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	0
Group 7: Placebo + Protein/AS01B	0
Group 8: Placebo	0

Number of Participants Reporting New Chronic Conditions (Requiring Medical Intervention for ≥ 30 Days) Primary · Measured through Month 12

There were no new chronic conditions (requiring medical intervention for ≥ 30 days) reported by any participant.

Group	Value	95% CI
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	0
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	0
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	0
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	0
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	0
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	0
Group 7: Placebo + Protein/AS01B	0
Group 8: Placebo	0

Number of Participants With Early Study Termination Associated With an AE or Reactogenicity Primary · Measured through Month 12

There were no early study terminations associated with an AE or reactogenicity reported by any participant.

Group	Value	95% CI
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	0
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	0
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	0
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	0
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	0
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	0
Group 7: Placebo + Protein/AS01B	0
Group 8: Placebo	0

Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity Primary · Measured through Month 6.5

From the study product discontinuation form, study product administration reasons are tabulated by treatment arm.

Group	Value	95% CI
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	1
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	0
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	0
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	0
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	0
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	0
Group 7: Placebo + Protein/AS01B	0
Group 8: Placebo	0
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	0
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	0
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	0
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	1
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	2
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	3
Group 7: Placebo + Protein/AS01B	6
Group 8: Placebo	0
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	3
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	2
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	2
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	1
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	1
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	4
Group 7: Placebo + Protein/AS01B	1
Group 8: Placebo	3
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	26
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	48
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	48
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	28
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	47
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	43
Group 7: Placebo + Protein/AS01B	43
Group 8: Placebo	21

Chemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase. Primary · Measured during screening, and 2 weeks after each vaccination at Month 0, 1, 3, and 6

For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.

ALT (SGPT) (U/L)-Screening

Group	Value	95% CI
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	15	12 – 18
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	14.5	12 – 20
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	15	11 – 18
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	13.5	11 – 20
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	16.5	13 – 25
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	16	11 – 23
Group 7: Placebo + Protein/AS01B	15	12 – 21
Group 8: Placebo	17	12 – 20

ALT (SGPT) (U/L)-Day 14

Group	Value	95% CI
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	14	12.5 – 16.5
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	16	11 – 19
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	16	12 – 21
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	13	10 – 19
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	17.5	13 – 24
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	16	11 – 23.5
Group 7: Placebo + Protein/AS01B	15.5	10 – 19.5
Group 8: Placebo	16	11 – 20.5

ALT (SGPT) (U/L)-Day 42

Group	Value	95% CI
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	14	12 – 17
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	14	11 – 19
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	14	11 – 22
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	13	10 – 17
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	16	12 – 25
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	16	10 – 20
Group 7: Placebo + Protein/AS01B	15	11 – 20
Group 8: Placebo	14	10 – 19

ALT (SGPT) (U/L)-Day 98

Group	Value	95% CI
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	15	12 – 17.5
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	15	12 – 20
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	14.5	10 – 20
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	14	10 – 20
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	18	13 – 26
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	17	12 – 23
Group 7: Placebo + Protein/AS01B	15	12 – 18
Group 8: Placebo	16	12 – 23

ALT (SGPT) (U/L)-Day 182

Group	Value	95% CI
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	15	13 – 18
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	17	13 – 22
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	14	11 – 21
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	16	11 – 20
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	16	13 – 23.5
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	19.5	10 – 27
Group 7: Placebo + Protein/AS01B	16	11 – 22
Group 8: Placebo	20	11 – 27

AST (U/L)-Screening

Group	Value	95% CI
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	20	17 – 22
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	18.5	16 – 23
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	19	16 – 23
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	19	16 – 24
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	20	17 – 22
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	19	16 – 24
Group 7: Placebo + Protein/AS01B	19.5	16 – 23
Group 8: Placebo	20	16.5 – 22.5

AST (U/L)-Day 14

Group	Value	95% CI
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	18	16.5 – 21
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	18	15 – 22
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	19	16 – 25
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	18	15 – 21
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	19.5	16 – 23
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	19.5	15 – 25
Group 7: Placebo + Protein/AS01B	19	15 – 22
Group 8: Placebo	19	17 – 21.5

AST (U/L)-Day 42

Group	Value	95% CI
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	19.5	17 – 21
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	19	16 – 22
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	18	15 – 22
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	16.5	14 – 20.5
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	19	16 – 25
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	19	15 – 23
Group 7: Placebo + Protein/AS01B	19	18 – 22
Group 8: Placebo	19	15 – 23

Chemistry and Hematology Laboratory Measures - Creatinine. Primary · Measured during screening, and 2 weeks after each vaccination at Month 0, 1, 3, and 6

For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.

Creatinine (mg/dL)-Screening

Group	Value	95% CI
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	0.795	0.7 – 0.92
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	0.8	0.7 – 0.91
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	0.8	0.7 – 0.89
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	0.79	0.7 – 0.91
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	0.77	0.67 – 0.87
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	0.715	0.62 – 0.87
Group 7: Placebo + Protein/AS01B	0.8	0.7 – 0.9
Group 8: Placebo	0.8	0.7 – 0.9

Creatinine (mg/dL)-Day 14

Group	Value	95% CI
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	0.785	0.685 – 0.97
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	0.84	0.65 – 0.95
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	0.8	0.7 – 0.87
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	0.88	0.77 – 0.95
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	0.78	0.65 – 0.9
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	0.79	0.7 – 0.88
Group 7: Placebo + Protein/AS01B	0.8	0.7 – 0.915
Group 8: Placebo	0.805	0.7 – 0.895

Creatinine (mg/dL)-Day 42

Group	Value	95% CI
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	0.83	0.71 – 0.92
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	0.83	0.7 – 0.95
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	0.805	0.7 – 0.9
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	0.81	0.77 – 0.9
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	0.8	0.7 – 0.89
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	0.79	0.63 – 0.9
Group 7: Placebo + Protein/AS01B	0.8	0.7 – 0.93
Group 8: Placebo	0.84	0.72 – 0.94

Creatinine (mg/dL)-Day 98

Group	Value	95% CI
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	0.815	0.72 – 0.905
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	0.8	0.695 – 0.945
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	0.8	0.7 – 0.94
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	0.81	0.72 – 0.91
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	0.78	0.7 – 0.9
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	0.79	0.7 – 0.81
Group 7: Placebo + Protein/AS01B	0.83	0.7 – 0.95
Group 8: Placebo	0.9	0.75 – 0.94

Creatinine (mg/dL)-Day 182

Group	Value	95% CI
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59	0.81	0.7 – 0.93
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B	0.855	0.72 – 0.98
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B	0.8	0.7 – 0.93
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59	0.84	0.76 – 0.98
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B	0.8	0.7 – 0.9
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B	0.785	0.7 – 0.9
Group 7: Placebo + Protein/AS01B	0.84	0.7 – 1
Group 8: Placebo	0.87	0.8 – 0.93

Adverse events — posted to ClinicalTrials.gov

Time frame: Serious adverse events and new chronic conditions requiring medical intervention of more than 30 days were collected through the month 12 timepoint. Adverse events of special interest were collected through month 18. All other AEs were collected through 30 days after each vaccination.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59

Serious: 0/30 (0%)

Deaths: 0/30

Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B

Serious: 1/50 (2%)

Deaths: 0/50

Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B

Serious: 0/50 (0%)

Deaths: 0/50

Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59

Serious: 1/30 (3%)

Deaths: 0/30

Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B

Serious: 1/50 (2%)

Deaths: 0/50

Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B

Serious: 1/50 (2%)

Deaths: 0/50

Group 7: Placebo + Protein/AS01B

Serious: 0/50 (0%)

Deaths: 0/50

Group 8: Placebo

Serious: 0/24 (0%)

Deaths: 0/24

Serious adverse events (10 terms)

Reaction	System	Group 1: DNA-HIV-PT123 + P…	Group 2: DNA-HIV-PT123 + P…	Group 3: DNA-HIV-PT123 + P…	Group 4: DNA-HIV-PT123 + P…	Group 5: DNA-HIV-PT123 + P…	Group 6: DNA-HIV-PT123 + P…	Group 7: Placebo + Protein…	Group 8: Placebo
Any SOC	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Obstructive pancreatitis	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Pancreatitis acute	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Any SOC	Infections and infestations	—	—	—	—	—	—	—	—
Lower respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—
Any SOC	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—
Facial bones fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—
Any SOC	Reproductive system and breast disorders	—	—	—	—	—	—	—	—
Dysfunctional uterine bleeding	Reproductive system and breast disorders	—	—	—	—	—	—	—	—

Other adverse events (172 terms — click to expand)

Reaction	System	Group 1: DNA-HIV-PT123 + P…	Group 2: DNA-HIV-PT123 + P…	Group 3: DNA-HIV-PT123 + P…	Group 4: DNA-HIV-PT123 + P…	Group 5: DNA-HIV-PT123 + P…	Group 6: DNA-HIV-PT123 + P…	Group 7: Placebo + Protein…	Group 8: Placebo
Any SOC	Infections and infestations	—	—	—	—	—	—	—	—
Any SOC	Investigations	—	—	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—	—	—
Blood creatinine increased	Investigations	—	—	—	—	—	—	—	—
Any SOC	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—
Any SOC	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Any SOC	General disorders	—	—	—	—	—	—	—	—
Any SOC	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—
Injection site pruritus	General disorders	—	—	—	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—	—	—	—
Any SOC	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—
Any SOC	Renal and urinary disorders	—	—	—	—	—	—	—	—
Proteinuria	Renal and urinary disorders	—	—	—	—	—	—	—	—
Any SOC	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—
Lymphadenopathy	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—
Genitourinary chlamydia infection	Infections and infestations	—	—	—	—	—	—	—	—
Any SOC	Nervous system disorders	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—
Any SOC	Reproductive system and breast disorders	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Influenza like illness	General disorders	—	—	—	—	—	—	—	—
Bacterial vaginosis	Infections and infestations	—	—	—	—	—	—	—	—
Furuncle	Infections and infestations	—	—	—	—	—	—	—	—
Sexually transmitted disease	Infections and infestations	—	—	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—	—	—
Viral infection	Infections and infestations	—	—	—	—	—	—	—	—
Muscle strain	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—
Platelet count decreased	Investigations	—	—	—	—	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—
Any SOC	Psychiatric disorders	—	—	—	—	—	—	—	—
Haematuria	Renal and urinary disorders	—	—	—	—	—	—	—	—
Vulvovaginal pruritus	Reproductive system and breast disorders	—	—	—	—	—	—	—	—
Any SOC	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—
Rash pruritic	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—
Iron deficiency anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—
Lymph node pain	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—
Any SOC	Ear and labyrinth disorders	—	—	—	—	—	—	—	—
Vertigo	Ear and labyrinth disorders	—	—	—	—	—	—	—	—
Any SOC	Eye disorders	—	—	—	—	—	—	—	—

Most-reported serious reactions: Any SOC, Obstructive pancreatitis, Pancreatitis acute, Any SOC, Lower respiratory tract infection, Pneumonia, Any SOC, Facial bones fracture.

Data from ClinicalTrials.gov NCT02915016 adverse events section.

Sponsor's own description

This study will evaluate the safety and immune response to the DNA-HIV-PT123 vaccine used in combination with one of two protein vaccines (Bivalent Subtype C gp120/MF59 or Bivalent Subtype C gp120/AS01B) in healthy, HIV-uninfected adults.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Recent Advances in the Development of Toll-like Receptor Agonist-Based Vaccine Adjuvants for Infectious Diseases.
Yang JX, Tseng JC, Yu GY, Luo Y, et al · · 2022 · cited 81× · PMID 35214155 · DOI 10.3390/pharmaceutics14020423
DNA priming and gp120 boosting induces HIV-specific antibodies in a randomized clinical trial.
Rouphael NG, Morgan C, Li SS, Jensen R, et al · · 2019 · cited 33× · PMID 31566579 · DOI 10.1172/jci128699
Post-Immune Antibodies in HIV-1 Infection in the Context of Vaccine Development: A Variety of Biological Functions and Catalytic Activities.
Timofeeva A, Sedykh S, Nevinsky G. · · 2022 · cited 12× · PMID 35335016 · DOI 10.3390/vaccines10030384
The potential and challenges of circular RNA in the development of vaccines and drugs for emerging infectious diseases.
Chen K, Xu Y, Li J, Gu S, et al · · 2025 · cited 10× · PMID 40951762 · DOI 10.1016/j.omtn.2025.102687
Multi-Envelope HIV-1 Vaccine Development: Two Targeted Immune Pathways, One Desired Protective Outcome.
Hurwitz JL, Bonsignori M. · · 2018 · cited 6× · PMID 29315059 · DOI 10.1089/vim.2017.0144
Safety and Immunogenicity of a DNA Vaccine With Subtype C gp120 Protein Adjuvanted With MF59 or AS01B: A Phase 1/2a HIV-1 Vaccine Trial.
Garrett N, Garrett N, Dintwe O, Monaco CL, et al · · 2024 · cited 5× · PMID 38916429 · DOI 10.1097/qai.0000000000003438
Cross-protocol assessment of induction and durability of VISP/R in HIV preventive vaccine trial participants.
Espy N, Han X, Grant S, Kwara E, et al · · 2023 · cited 5× · PMID 37289667 · DOI 10.1371/journal.pgph.0002037
Participants' characteristics and motivations to screen for HIV vaccine and monoclonal antibody trials in KwaZulu-Natal, South Africa.
Hanass-Hancock J, Carpenter B, Reddy T, Nzuza A, et al · · 2021 · cited 5× · PMID 34895272 · DOI 10.1186/s13063-021-05792-7

Verify or expand the search:

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Other National Institute of Allergy and Infectious Diseases (NIAID) trials

Trials by the same sponsor.

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NCT07342491 — Dasatinib for HIV-1 Reservoir Reduction · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02915016 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID)
Last refreshed: 29 April 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02915016.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT02915016

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (10 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of DNA-HIV-PT123 vaccine

Other recruiting trials for HIV Infections

Other National Institute of Allergy and Infectious Diseases (NIAID) trials

Verify against primary sources