NCT03409276

Evaluating the Safety and Immunogenicity of Env (A,B,C,A/E)/Gag (C) DNA and gp120 (A,B,C,A/E) Protein/GLA-SE HIV Vaccines, Given Individually or Co-administered, in Healthy, HIV-1-Uninfected Adults

Completed Phase 1 Results posted Last updated 25 April 2022

What this trial tests

Phase 1 trial testing env (A,B,C,A/E)/gag (C) DNA Vaccine in HIV Infections in 60 participants. Completed in 22 October 2020.

Timeline

16 March 2018

Primary endpoint
11 May 2020

22 October 2020

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	60
Start date	16 March 2018
Primary completion	11 May 2020
Estimated completion	22 October 2020
Sites	6 locations across United States

Drugs / interventions tested

• env (A,B,C,A/E)/gag (C) DNA Vaccine — full drug profile →
• gp120 (A,B,C,A/E) Protein Vaccine — full drug profile →
• Placebo
• GLA-SE adjuvant — full drug profile →

Conditions studied

• HIV Infections — all drugs for HIV Infections →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 18 to 50, 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 Primary · Measured through 3 days after participants' each vaccination at Months 0, 2 for part A and Months 0, 1, 3, 6, 8 for part B

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

Pain

Group	Value	95% CI
Part A: Placebo	2
Part A: Vaccine	5
Part B: Placebo	5
Part B: Vaccine 1	3
Part B: Vaccine 2	1
Part A: Placebo	0
Part A: Vaccine	4
Part B: Placebo	1
Part B: Vaccine 1	12
Part B: Vaccine 2	15
Part A: Placebo	0
Part A: Vaccine	1
Part B: Placebo	0
Part B: Vaccine 1	5
Part B: Vaccine 2	4
Part A: Placebo	0
Part A: Vaccine	0
Part B: Placebo	0
Part B: Vaccine 1	1
Part B: Vaccine 2	1

Tenderness

Group	Value	95% CI
Part A: Placebo	2
Part A: Vaccine	3
Part B: Placebo	4
Part B: Vaccine 1	1
Part B: Vaccine 2	0
Part A: Placebo	0
Part A: Vaccine	6
Part B: Placebo	2
Part B: Vaccine 1	15
Part B: Vaccine 2	17
Part A: Placebo	0
Part A: Vaccine	1
Part B: Placebo	0
Part B: Vaccine 1	4
Part B: Vaccine 2	3
Part A: Placebo	0
Part A: Vaccine	0
Part B: Placebo	0
Part B: Vaccine 1	1
Part B: Vaccine 2	1

Pain and/or Tenderness

Group	Value	95% CI
Part A: Placebo	2
Part A: Vaccine	3
Part B: Placebo	4
Part B: Vaccine 1	1
Part B: Vaccine 2	0
Part A: Placebo	0
Part A: Vaccine	6
Part B: Placebo	2
Part B: Vaccine 1	13
Part B: Vaccine 2	15
Part A: Placebo	0
Part A: Vaccine	1
Part B: Placebo	0
Part B: Vaccine 1	6
Part B: Vaccine 2	5
Part A: Placebo	0
Part A: Vaccine	0
Part B: Placebo	0
Part B: Vaccine 1	1
Part B: Vaccine 2	1

Erythema

Group	Value	95% CI
Part A: Placebo	2
Part A: Vaccine	10
Part B: Placebo	6
Part B: Vaccine 1	14
Part B: Vaccine 2	13
Part A: Placebo	0
Part A: Vaccine	0
Part B: Placebo	0
Part B: Vaccine 1	0
Part B: Vaccine 2	2
Part A: Placebo	0
Part A: Vaccine	0
Part B: Placebo	0
Part B: Vaccine 1	2
Part B: Vaccine 2	4
Part A: Placebo	0
Part A: Vaccine	0
Part B: Placebo	0
Part B: Vaccine 1	5
Part B: Vaccine 2	2

Induration

Group	Value	95% CI
Part A: Placebo	2
Part A: Vaccine	10
Part B: Placebo	6
Part B: Vaccine 1	16
Part B: Vaccine 2	14
Part A: Placebo	0
Part A: Vaccine	0
Part B: Placebo	0
Part B: Vaccine 1	1
Part B: Vaccine 2	3
Part A: Placebo	0
Part A: Vaccine	0
Part B: Placebo	0
Part B: Vaccine 1	0
Part B: Vaccine 2	2
Part A: Placebo	0
Part A: Vaccine	0
Part B: Placebo	0
Part B: Vaccine 1	4
Part B: Vaccine 2	2

Erythema and/or Induration

Group	Value	95% CI
Part A: Placebo	2
Part A: Vaccine	10
Part B: Placebo	6
Part B: Vaccine 1	14
Part B: Vaccine 2	12
Part A: Placebo	0
Part A: Vaccine	0
Part B: Placebo	0
Part B: Vaccine 1	0
Part B: Vaccine 2	3
Part A: Placebo	0
Part A: Vaccine	0
Part B: Placebo	0
Part B: Vaccine 1	2
Part B: Vaccine 2	4
Part A: Placebo	0
Part A: Vaccine	0
Part B: Placebo	0
Part B: Vaccine 1	5
Part B: Vaccine 2	2

Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Primary · Measured through 3 days after participants' each vaccination at Months 0, 2 for part A and Months 0, 1, 3, 6, 8 for part B

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

Malaise and/or fatigue

Group	Value	95% CI
Part A: Placebo	1
Part A: Vaccine	5
Part B: Placebo	2
Part B: Vaccine 1	4
Part B: Vaccine 2	6
Part A: Placebo	1
Part A: Vaccine	5
Part B: Placebo	1
Part B: Vaccine 1	8
Part B: Vaccine 2	8
Part A: Placebo	0
Part A: Vaccine	0
Part B: Placebo	2
Part B: Vaccine 1	7
Part B: Vaccine 2	6
Part A: Placebo	0
Part A: Vaccine	0
Part B: Placebo	1
Part B: Vaccine 1	2
Part B: Vaccine 2	1

Myalgia

Group	Value	95% CI
Part A: Placebo	1
Part A: Vaccine	6
Part B: Placebo	4
Part B: Vaccine 1	8
Part B: Vaccine 2	11
Part A: Placebo	1
Part A: Vaccine	4
Part B: Placebo	2
Part B: Vaccine 1	9
Part B: Vaccine 2	7
Part A: Placebo	0
Part A: Vaccine	0
Part B: Placebo	0
Part B: Vaccine 1	2
Part B: Vaccine 2	1
Part A: Placebo	0
Part A: Vaccine	0
Part B: Placebo	0
Part B: Vaccine 1	2
Part B: Vaccine 2	2

Headache

Group	Value	95% CI
Part A: Placebo	1
Part A: Vaccine	5
Part B: Placebo	2
Part B: Vaccine 1	3
Part B: Vaccine 2	9
Part A: Placebo	1
Part A: Vaccine	5
Part B: Placebo	3
Part B: Vaccine 1	10
Part B: Vaccine 2	8
Part A: Placebo	0
Part A: Vaccine	0
Part B: Placebo	1
Part B: Vaccine 1	8
Part B: Vaccine 2	2
Part A: Placebo	0
Part A: Vaccine	0
Part B: Placebo	0
Part B: Vaccine 1	0
Part B: Vaccine 2	2

Nausea

Group	Value	95% CI
Part A: Placebo	1
Part A: Vaccine	8
Part B: Placebo	4
Part B: Vaccine 1	12
Part B: Vaccine 2	15
Part A: Placebo	1
Part A: Vaccine	2
Part B: Placebo	1
Part B: Vaccine 1	6
Part B: Vaccine 2	4
Part A: Placebo	0
Part A: Vaccine	0
Part B: Placebo	1
Part B: Vaccine 1	3
Part B: Vaccine 2	2
Part A: Placebo	0
Part A: Vaccine	0
Part B: Placebo	0
Part B: Vaccine 1	0
Part B: Vaccine 2	0

Vomiting

Group	Value	95% CI
Part A: Placebo	2
Part A: Vaccine	10
Part B: Placebo	6
Part B: Vaccine 1	17
Part B: Vaccine 2	18
Part A: Placebo	0
Part A: Vaccine	0
Part B: Placebo	0
Part B: Vaccine 1	3
Part B: Vaccine 2	1
Part A: Placebo	0
Part A: Vaccine	0
Part B: Placebo	0
Part B: Vaccine 1	1
Part B: Vaccine 2	2
Part A: Placebo	0
Part A: Vaccine	0
Part B: Placebo	0
Part B: Vaccine 1	0
Part B: Vaccine 2	0

Chills

Group	Value	95% CI
Part A: Placebo	2
Part A: Vaccine	10
Part B: Placebo	6
Part B: Vaccine 1	11
Part B: Vaccine 2	15
Part A: Placebo	0
Part A: Vaccine	0
Part B: Placebo	0
Part B: Vaccine 1	4
Part B: Vaccine 2	4
Part A: Placebo	0
Part A: Vaccine	0
Part B: Placebo	0
Part B: Vaccine 1	4
Part B: Vaccine 2	0
Part A: Placebo	0
Part A: Vaccine	0
Part B: Placebo	0
Part B: Vaccine 1	2
Part B: Vaccine 2	2

Arthralgia

Group	Value	95% CI
Part A: Placebo	2
Part A: Vaccine	8
Part B: Placebo	6
Part B: Vaccine 1	10
Part B: Vaccine 2	17
Part A: Placebo	0
Part A: Vaccine	1
Part B: Placebo	0
Part B: Vaccine 1	8
Part B: Vaccine 2	2
Part A: Placebo	0
Part A: Vaccine	1
Part B: Placebo	0
Part B: Vaccine 1	1
Part B: Vaccine 2	1
Part A: Placebo	0
Part A: Vaccine	0
Part B: Placebo	0
Part B: Vaccine 1	2
Part B: Vaccine 2	1

Max. Systemic Symptoms

Group	Value	95% CI
Part A: Placebo	1
Part A: Vaccine	3
Part B: Placebo	2
Part B: Vaccine 1	3
Part B: Vaccine 2	5
Part A: Placebo	1
Part A: Vaccine	6
Part B: Placebo	0
Part B: Vaccine 1	8
Part B: Vaccine 2	8
Part A: Placebo	0
Part A: Vaccine	1
Part B: Placebo	3
Part B: Vaccine 1	8
Part B: Vaccine 2	6
Part A: Placebo	0
Part A: Vaccine	0
Part B: Placebo	1
Part B: Vaccine 1	2
Part B: Vaccine 2	2

Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product Primary · Measured through 30 days after each vaccine dose at Months 0, 2 for part A and Months 0, 1, 3, 6, 8 for part B

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

Group	Value	95% CI
Part A: Placebo	0
Part A: Vaccine	0
Part B: Placebo	0
Part B: Vaccine 1	5
Part B: Vaccine 2	2
Part A: Placebo	2
Part A: Vaccine	6
Part B: Placebo	5
Part B: Vaccine 1	14
Part B: Vaccine 2	16
Part A: Placebo	0
Part A: Vaccine	4
Part B: Placebo	1
Part B: Vaccine 1	2
Part B: Vaccine 2	3

Number of Participants Reporting Adverse Events (AEs), by Severity Grade Primary · Measured through 30 days after each vaccine dose at Months 0, 2 for part A and Months 0, 1, 3, 6, 8 for part B

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

Group	Value	95% CI
Part A: Placebo	0
Part A: Vaccine	2
Part B: Placebo	1
Part B: Vaccine 1	0
Part B: Vaccine 2	2
Part A: Placebo	2
Part A: Vaccine	4
Part B: Placebo	4
Part B: Vaccine 1	18
Part B: Vaccine 2	14
Part A: Placebo	0
Part A: Vaccine	0
Part B: Placebo	0
Part B: Vaccine 1	1
Part B: Vaccine 2	2
Part A: Placebo	0
Part A: Vaccine	4
Part B: Placebo	1
Part B: Vaccine 1	2
Part B: Vaccine 2	3

Number of Participants Reporting Serious Adverse Events (SAEs) Primary · Measured through Month 8 for part A and Month 14 for part B

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
Part A: Placebo	0
Part A: Vaccine	0
Part B: Placebo	0
Part B: Vaccine 1	0
Part B: Vaccine 2	0

Number of Participants Reporting Adverse Events of Special Interest (AESIs) Primary · Measured through Month 8 for part A and Month 14 for part B

Adverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases. There were no adverse events of special interest reported by any participant.

Group	Value	95% CI
Part A: Placebo	0
Part A: Vaccine	0
Part B: Placebo	0
Part B: Vaccine 1	0
Part B: Vaccine 2	0

Numbers of Participants With Grade 1 or Higher Local Laboratory Results Primary · Measured during Screening, Day 14, Day 70, Day140 for part A and visits Screening, Day 14, Day 42, Day 98, Day 182, Day 238 and Day 334 for part B

The number (percentage) of participants with local laboratory values recorded as meeting Grade 1 AE criteria or above as specified in the DAIDS AE Grading Table were tabulated by treatment arm for each post-vaccination time point. Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown.

AST (U/L)- Day42

Group	Value	95% CI
Part B: Placebo	0
Part B: Vaccine 1	1
Part B: Vaccine 2	0

AST (U/L)- Day98

Group	Value	95% CI
Part B: Placebo	0
Part B: Vaccine 1	0
Part B: Vaccine 2	1

AST (U/L)- Day140

Group	Value	95% CI
Part A: Placebo	0
Part A: Vaccine	1

ALT (SGPT) (U/L)- Day42

Group	Value	95% CI
Part B: Placebo	0
Part B: Vaccine 1	1
Part B: Vaccine 2	0

Hemoglobin (g/dL)- Day182

Group	Value	95% CI
Part B: Placebo	0
Part B: Vaccine 1	2
Part B: Vaccine 2	0

Hemoglobin (g/dL)- Day238

Group	Value	95% CI
Part B: Placebo	0
Part B: Vaccine 1	1
Part B: Vaccine 2	0

Hemoglobin (g/dL)- Day334

Group	Value	95% CI
Part B: Placebo	0
Part B: Vaccine 1	1
Part B: Vaccine 2	0

Creatinine (g/dL)- Day14

Group	Value	95% CI
Part A: Placebo	0
Part A: Vaccine	2
Part B: Placebo	0
Part B: Vaccine 1	0
Part B: Vaccine 2	0

Alk Phos, AST, ALT in UL Primary · Measured through Screening, Day 14, Day 70, Day140 for part A and visits Screening, Day 14, Day 42, Day 98, Day 182, Day 238 and Day 334 for part B

Laboratory results are summarized by analyte and timepoint.

Alkaline Phosphatase (U/L)- Screening

Group	Value	95% CI
Part A: Placebo	61	58 – 64
Part A: Vaccine	59.5	46 – 69
Part B: Placebo	54.5	51 – 60
Part B: Vaccine 1	61	56 – 74
Part B: Vaccine 2	59	52 – 78

Alkaline Phosphatase (U/L)- Day14

Group	Value	95% CI
Part A: Placebo	57.5	46 – 69
Part A: Vaccine	56	43 – 81
Part B: Placebo	53	49 – 56
Part B: Vaccine 1	62	56 – 71
Part B: Vaccine 2	60	51 – 65.5

Alkaline Phosphatase (U/L)- Day42

Group	Value	95% CI
Part B: Placebo	56	53 – 59
Part B: Vaccine 1	69	58 – 73
Part B: Vaccine 2	57	51 – 68

Alkaline Phosphatase (U/L)- Day70

Group	Value	95% CI
Part A: Placebo	54	51 – 57
Part A: Vaccine	55	50 – 76

Alkaline Phosphatase (U/L)- Day98

Group	Value	95% CI
Part B: Placebo	54	51 – 57
Part B: Vaccine 1	64	54 – 77
Part B: Vaccine 2	61	50 – 72

Alkaline Phosphatase (U/L)- Day140

Group	Value	95% CI
Part A: Placebo	57.5	50 – 65
Part A: Vaccine	59	50 – 68

Alkaline Phosphatase (U/L)- Day182

Group	Value	95% CI
Part B: Placebo	59.5	52 – 61
Part B: Vaccine 1	63	56 – 72
Part B: Vaccine 2	60.5	44 – 68

Alkaline Phosphatase (U/L)- Day238

Group	Value	95% CI
Part B: Placebo	52	50 – 73
Part B: Vaccine 1	61.5	52 – 72
Part B: Vaccine 2	58.5	49 – 69

Hemoglobin, Creatinine in g/dL Primary · Measured through Screening, Day 14, Day 70, Day140 for part A and visits Screening, Day 14, Day 42, Day 98, Day 182, Day 238 and Day 334 for part B

Laboratory results are summarized by analyte and timepoint.

Hemoglobin (g/dL)- Screening

Group	Value	95% CI
Part A: Placebo	14.7	13.7 – 15.7
Part A: Vaccine	13.75	12.7 – 15.2
Part B: Placebo	13.85	13.2 – 14.6
Part B: Vaccine 1	14.7	13.2 – 15
Part B: Vaccine 2	14.8	13.4 – 15.4

Hemoglobin (g/dL)- Day14

Group	Value	95% CI
Part A: Placebo	14.65	14.4 – 14.9
Part A: Vaccine	13.45	12.8 – 14.3
Part B: Placebo	13.5	12.3 – 14.4
Part B: Vaccine 1	13.5	12.5 – 14.8
Part B: Vaccine 2	13.95	12.75 – 14.7

Hemoglobin (g/dL)- Day42

Group	Value	95% CI
Part B: Placebo	13.9	12.5 – 14.4
Part B: Vaccine 1	13.8	13.1 – 14.5
Part B: Vaccine 2	13.8	13.3 – 15.1

Hemoglobin (g/dL)- Day70

Group	Value	95% CI
Part A: Placebo	13.25	12.5 – 14
Part A: Vaccine	14.1	13 – 14.5

Hemoglobin (g/dL)- Day98

Group	Value	95% CI
Part B: Placebo	13.2	12.7 – 14.6
Part B: Vaccine 1	14	12.9 – 14.7
Part B: Vaccine 2	14.8	13.4 – 15.3

Hemoglobin (g/dL)- Day140

Group	Value	95% CI
Part A: Placebo	14.35	13 – 15.7
Part A: Vaccine	13.65	12.3 – 14.6

Hemoglobin (g/dL)- Day182

Group	Value	95% CI
Part B: Placebo	13.6	12.2 – 14
Part B: Vaccine 1	13.4	11.6 – 14.2
Part B: Vaccine 2	14	13.2 – 14.8

Hemoglobin (g/dL)- Day238

Group	Value	95% CI
Part B: Placebo	13.5	11.2 – 14.4
Part B: Vaccine 1	13.2	12.2 – 14
Part B: Vaccine 2	14	12.8 – 15.1

WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm Primary · Measured through Screening, Day 14, Day 70, Day140 for part A and visits Screening, Day 14, Day 42, Day 98, Day 182, Day 238 and Day 334 for part B

Laboratory results are summarized by analyte and timepoint.

WBC (1000/cubic mm)- Screening

Group	Value	95% CI
Part A: Placebo	5.1	4.4 – 5.8
Part A: Vaccine	6.305	4.8 – 7.3
Part B: Placebo	5.9	5.3 – 6.2
Part B: Vaccine 1	5.7	5.2 – 7.1
Part B: Vaccine 2	6.4	5.5 – 7.4

WBC (1000/cubic mm)- Day14

Group	Value	95% CI
Part A: Placebo	4.35	3.4 – 5.3
Part A: Vaccine	5.62	4.4 – 7.5
Part B: Placebo	5.65	4.8 – 6.6
Part B: Vaccine 1	6	5.6 – 6.8
Part B: Vaccine 2	6.4	5.185 – 6.85

WBC (1000/cubic mm)- Day42

Group	Value	95% CI
Part B: Placebo	6.45	5.4 – 8.3
Part B: Vaccine 1	6.2	5.1 – 7.1
Part B: Vaccine 2	6.3	5.3 – 6.9

WBC (1000/cubic mm)- Day70

Group	Value	95% CI
Part A: Placebo	5.8	3.6 – 8
Part A: Vaccine	6.12	5.6 – 7.3

WBC (1000/cubic mm)- Day98

Group	Value	95% CI
Part B: Placebo	5.8	5.6 – 6
Part B: Vaccine 1	6.11	5.3 – 7.1
Part B: Vaccine 2	5.7	4.8 – 6.7

WBC (1000/cubic mm)- Day140

Group	Value	95% CI
Part A: Placebo	4.15	4.1 – 4.2
Part A: Vaccine	6.26	4.9 – 9.1

WBC (1000/cubic mm)- Day182

Group	Value	95% CI
Part B: Placebo	6	5.4 – 6.6
Part B: Vaccine 1	5.6	5.1 – 7.1
Part B: Vaccine 2	6.25	5 – 7

WBC (1000/cubic mm)- Day238

Group	Value	95% CI
Part B: Placebo	6	4.8 – 6.2
Part B: Vaccine 1	6	5 – 7
Part B: Vaccine 2	6.15	5.57 – 6.75

Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation Primary · Measured through study completion, up to 31 months

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

Group	Value	95% CI
Part A: Placebo	0
Part A: Vaccine	0
Part B: Placebo	0
Part B: Vaccine 1	0
Part B: Vaccine 2	1
Part A: Placebo	0
Part A: Vaccine	0
Part B: Placebo	0
Part B: Vaccine 1	1
Part B: Vaccine 2	0
Part A: Placebo	0
Part A: Vaccine	0
Part B: Placebo	0
Part B: Vaccine 1	0
Part B: Vaccine 2	5
Part A: Placebo	0
Part A: Vaccine	0
Part B: Placebo	0
Part B: Vaccine 1	1
Part B: Vaccine 2	1

Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination Secondary · Measured at Month 2.5 for part A and 8.5 for part B

Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Samples from post-enrollment visits have positive responses if they meet three criteria: (1) net MFI greater than or equal to an antigen-specific response threshold (def

254008_D11gp120.avi/293F

Group	Value	95% CI
Part A: Placebo	0
Part A: Vaccine	8
Part B: Placebo	0
Part B: Vaccine 1	18
Part B: Vaccine 2	13

51802_D11gp120.avi/293F

Group	Value	95% CI
Part A: Placebo	0
Part A: Vaccine	9
Part B: Placebo	0
Part B: Vaccine 1	18
Part B: Vaccine 2	13

A244 D11gp120_avi

Group	Value	95% CI
Part A: Placebo	0
Part A: Vaccine	8
Part B: Placebo	0
Part B: Vaccine 1	18
Part B: Vaccine 2	13

B.6240_D11gp120/293F

Group	Value	95% CI
Part A: Placebo	0
Part A: Vaccine	9
Part B: Placebo	0
Part B: Vaccine 1	17
Part B: Vaccine 2	13

BJOX002_D11gp120.avi/293F

Group	Value	95% CI
Part A: Placebo	0
Part A: Vaccine	9
Part B: Placebo	0
Part B: Vaccine 1	16
Part B: Vaccine 2	12

BORI_D11gp120.avi/293F

Group	Value	95% CI
Part A: Placebo	0
Part A: Vaccine	9
Part B: Placebo	0
Part B: Vaccine 1	15
Part B: Vaccine 2	11

CNE20_D11gp120.avi/293F

Group	Value	95% CI
Part A: Placebo	0
Part A: Vaccine	8
Part B: Placebo	0
Part B: Vaccine 1	18
Part B: Vaccine 2	13

TT31P.2792_D11gp120.avi/293F

Group	Value	95% CI
Part A: Placebo	0
Part A: Vaccine	8
Part B: Placebo	0
Part B: Vaccine 1	18
Part B: Vaccine 2	13

Adverse events — posted to ClinicalTrials.gov

Time frame: Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part A: Placebo

Serious: 0/2 (0%)

Deaths: 0/2

Part A: Vaccine

Serious: 0/10 (0%)

Deaths: 0/10

Part B: Placebo

Serious: 0/6 (0%)

Deaths: 0/6

Part B: Vaccine 1

Serious: 0/21 (0%)

Deaths: 0/21

Part B: Vaccine 2

Serious: 0/21 (0%)

Deaths: 0/21

Other adverse events (101 terms — click to expand)

Reaction	System	Part A: Placebo	Part A: Vaccine	Part B: Placebo	Part B: Vaccine 1	Part B: Vaccine 2
Any Event in SOC	Infections and infestations	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—
Any Event in SOC	Gastrointestinal disorders	—	—	—	—	—
Any Event in SOC	Investigations	—	—	—	—	—
Any Event in SOC	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Any Event in SOC	Skin and subcutaneous tissue disorders	—	—	—	—	—
Any Event in SOC	General disorders	—	—	—	—	—
Blood creatinine increased	Investigations	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—
Injection site pruritus	General disorders	—	—	—	—	—
Any Event in SOC	Injury, poisoning and procedural complications	—	—	—	—	—
Any Event in SOC	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Any Event in SOC	Blood and lymphatic system disorders	—	—	—	—	—
Gastroenteritis viral	Infections and infestations	—	—	—	—	—
Influenza	Infections and infestations	—	—	—	—	—
Any Event in SOC	Nervous system disorders	—	—	—	—	—
Any Event in SOC	Psychiatric disorders	—	—	—	—	—
Any Event in SOC	Renal and urinary disorders	—	—	—	—	—
Proteinuria	Renal and urinary disorders	—	—	—	—	—
Dermatitis contact	Skin and subcutaneous tissue disorders	—	—	—	—	—
Iron deficiency anaemia	Blood and lymphatic system disorders	—	—	—	—	—
Lymph node pain	Blood and lymphatic system disorders	—	—	—	—	—
Any Event in SOC	Ear and labyrinth disorders	—	—	—	—	—
Eustachian tube dysfunction	Ear and labyrinth disorders	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—
Anal fissure	Gastrointestinal disorders	—	—	—	—	—
Anal fissure haemorrhage	Gastrointestinal disorders	—	—	—	—	—
Cannabinoid hyperemesis syndrome	Gastrointestinal disorders	—	—	—	—	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—	—	—	—	—
Haematemesis	Gastrointestinal disorders	—	—	—	—	—
Tongue ulceration	Gastrointestinal disorders	—	—	—	—	—
Chest pain	General disorders	—	—	—	—	—
Cyst	General disorders	—	—	—	—	—
Influenza like illness	General disorders	—	—	—	—	—
Any Event in SOC	Hepatobiliary disorders	—	—	—	—	—
Hepatic cyst	Hepatobiliary disorders	—	—	—	—	—
Abscess limb	Infections and infestations	—	—	—	—	—
Body tinea	Infections and infestations	—	—	—	—	—
Bronchitis viral	Infections and infestations	—	—	—	—	—
Cellulitis	Infections and infestations	—	—	—	—	—

Data from ClinicalTrials.gov NCT03409276 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of env (A,B,C,A/E)/gag (C) DNA and gp120 (A,B,C,A/E) protein/GLA-SE HIV-1 vaccines (PDPHV-201401) as a prime-boost regimen or co-administered in repeated doses, in healthy, HIV-1-uninfected adults.

Publications & conference data

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

1. HIV vaccinology: 2021 update.
   Lee JH, Crotty S. · · 2021 · cited 46× · PMID 34272086 · DOI 10.1016/j.smim.2021.101470
2. 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
3. Safety and immunogenicity of a polyvalent DNA-protein HIV vaccine with matched Env immunogens delivered as a prime-boost regimen or coadministered in HIV-uninfected adults in the USA (HVTN 124): a phase 1, placebo-controlled, double-blind randomised controlled trial.
   Frank I, Li SS, Grunenberg N, Overton ET, et al · · 2024 · cited 10× · PMID 38692824 · DOI 10.1016/s2352-3018(24)00036-5
4. Antibody and cellular responses to HIV vaccine regimens with DNA plasmid as compared with ALVAC priming: An analysis of two randomized controlled trials.
   Moodie Z, Walsh SR, Laher F, Maganga L, et al · · 2020 · cited 10× · PMID 32442195 · DOI 10.1371/journal.pmed.1003117
5. Biotech's role in advancing HIV vaccine development.
   Tatoud R, Brander C, Hwang C, Kennelly J, et al · · 2024 · cited 2× · PMID 39042015 · DOI 10.1080/22221751.2024.2384460
6. Nucleic Acid Vaccines Encoding Proteins and Virus-like Particles for HIV Prevention.
   Tarrés-Freixas F, Clotet B, Carrillo J, Blanco J. · · 2024 · cited 2× · PMID 38543932 · DOI 10.3390/vaccines12030298
7. A polyvalent DNA prime with matched polyvalent protein/GLA-SE boost regimen elicited the most robust and broad IgG and IgG3 V1V2 binding antibody and CD4+ T cell responses among 13 HIV vaccine trials.
   Moodie Z, Li SS, Giorgi EE, Williams LD, et al · · 2025 · cited 1× · PMID 40190112 · DOI 10.1080/22221751.2025.2485317
8. Glycan-reactive antibodies isolated from human HIV-1 vaccine trial participants show broad pathogen cross-reactivity.
   Jamieson PJ, Shen X, Abu-Shmais AA, Wasdin PT, et al · · 2025 · PMID 41212034 · DOI 10.1128/jvi.01256-25