NCT05828095 is a Phase 1 clinical trial of INO-6160, 2 mg in HIV-1-infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Who is sponsoring NCT05828095?

NCT05828095 is sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

What drugs are being tested in NCT05828095?

Interventions in NCT05828095: INO-6160, 2 mg, Trimer-4571 / 100 mcg 3M-052-AF (5 mcg) + Alum (500 mcg).

What condition does NCT05828095 study?

NCT05828095 studies HIV-1-infection.

Is NCT05828095 still recruiting?

NCT05828095 is currently completed. Last updated 2 September 2025.

Are results published for NCT05828095?

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

Last reviewed 2025-09-02 · How we verify

NCT05828095

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

A Clinical Trial to Evaluate the Safety and Immunogenicity of Synthetic DNAs Encoding a Native-like HIV Env Trimer and Interleukin-12 (INO-6160), Alone or in a Prime-boost Regimen With 3M-052-AF + Alum Adjuvanted VRC HIV Env Trimer 4571 in Adult Participants Without HIV

Completed Phase 1 Results posted Last updated 2 September 2025

What this trial tests

Phase 1 trial testing INO-6160, 2 mg in HIV-1-infection in 20 participants. Completed in 23 January 2025.

Timeline

5 April 2023

Primary endpoint
23 January 2025

23 January 2025

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	none
Primary purpose	prevention
Enrollment	20
Start date	5 April 2023
Primary completion	23 January 2025
Estimated completion	23 January 2025
Sites	3 locations across United States

Drugs / interventions tested

INO-6160, 2 mg — full drug profile →
Trimer-4571 / 100 mcg 3M-052-AF (5 mcg) + Alum (500 mcg) — full drug profile →

Conditions studied

HIV-1-infection — all drugs for HIV-1-infection →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 18 to 55, any sex, with HIV-1-infection. 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 Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness Primary · Measured for 14 days after each injection

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

Group	Value	95% CI
Group T1	4
Group T2	0
Group T1	6
Group T2	7
Group T1	0
Group T2	3
Group T1	0
Group T2	0

Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration Primary · Measured for 14 days after each injection

Erythema/Redness

Group	Value	95% CI
Group T1	4
Group T2	1
Group T1	4
Group T2	5
Group T1	1
Group T2	3
Group T1	1
Group T2	1

Induration/Swelling

Group	Value	95% CI
Group T1	8
Group T2	3
Group T1	1
Group T2	7
Group T1	1
Group T2	0
Group T1	0
Group T2	0

Erythema and/or Induration

Group	Value	95% CI
Group T1	4
Group T2	1
Group T1	4
Group T2	5
Group T1	1
Group T2	3
Group T1	1
Group T2	1

Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms Primary · Measured for 14 days after each injection

Malaise and/or fatigue

Group	Value	95% CI
Group T1	4
Group T2	0
Group T1	5
Group T2	5
Group T1	1
Group T2	4
Group T1	0
Group T2	1

Myalgia

Group	Value	95% CI
Group T1	8
Group T2	2
Group T1	1
Group T2	4
Group T1	1
Group T2	3
Group T1	0
Group T2	1

Headache

Group	Value	95% CI
Group T1	5
Group T2	0
Group T1	4
Group T2	6
Group T1	1
Group T2	4
Group T1	0
Group T2	0

Nausea

Group	Value	95% CI
Group T1	7
Group T2	4
Group T1	3
Group T2	2
Group T1	0
Group T2	4
Group T1	0
Group T2	0

Chills

Group	Value	95% CI
Group T1	9
Group T2	1
Group T1	1
Group T2	8
Group T1	0
Group T2	1
Group T1	0
Group T2	0

Arthralgia

Group	Value	95% CI
Group T1	8
Group T2	5
Group T1	1
Group T2	4
Group T1	1
Group T2	1
Group T1	0
Group T2	0

Max. Systemic Symptoms

Group	Value	95% CI
Group T1	2
Group T2	0
Group T1	7
Group T2	1
Group T1	1
Group T2	8
Group T1	0
Group T2	1

Temperature

Group	Value	95% CI
Group T1	10
Group T2	6
Group T1	0
Group T2	3
Group T1	0
Group T2	1
Group T1	0
Group T2	0

Number of Participants Reporting Unsolicited Adverse Events (AEs) Primary · Measured for 30 days after any receipt of study vaccination.

The number (percentage) of Participants Reporting Unsolicited Adverse Events (AEs) was summarized by arm

Group	Value	95% CI
Group T1	6
Group T2	6

Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation Primary · Measured through Month 6

The number (percentage) of participants with early discontinuation of vaccinations and reason for discontinuation was summarized by arm

Group	Value	95% CI
Group T1	1
Group T2	0
Group T1	0
Group T2	1
Group T1	1
Group T2	2
Group T1	8
Group T2	7

Number of Participants With Early Study Termination and Reason for Early Study Termination Primary · Measured through Month 10

The number (percentage) of participants with early study termination and reason for early study termination was summarized by arm

Group	Value	95% CI
Group T1	1
Group T2	0
Group T1	0
Group T2	1
Group T1	9
Group T2	9

Response Rate of Vaccine-matched IgG Binding Antibody (Ab) Responses as Assessed by Multiplex Assay 2 Weeks Following the Fourth Vaccination Primary · Measured at Months 1.5, 3.5, and 6.5

The Binding Antibody Multiplex Assay (BAMA) assay was used to evaluate binding antibody responses of each serum specimen against BG505 SOSIP (vaccine trimer immunogen) and Trimer 4571 (vaccine matched immunogen). Positivity criteria include (1) the net Mean Fluorescence Intensity (MFI), or MFI - Blank, values are ≥ antigen-specific cutoff at the 1:50 dilution level for IgG (based on the 95th percentile of the baseline visit serum samples and at least 100 MFI minus Blank), (2) the net MFI values are greater than 3 times the baseline (day 0) net MFI, and (3) the MFI values are greater than 3 tim

AB05, 1: 50, M1.5

Group	Value	95% CI
Group T1	1
Group T2	1

AB05, 1: 50, M3.5

Group	Value	95% CI
Group T1	5
Group T2	9

AB05, 1: 50, M6.5

Group	Value	95% CI
Group T1	5
Group T2	6

BG505 MD39.3, 1: 50, M1.5

Group	Value	95% CI
Group T1	7
Group T2	5

BG505 MD39.3, 1: 50, M3.5

Group	Value	95% CI
Group T1	8
Group T2	9

BG505 MD39.3, 1: 50, M6.5

Group	Value	95% CI
Group T1	8
Group T2	6

BG505 MD39.3-BaseKO, 1: 50, M1.5

Group	Value	95% CI
Group T1	1
Group T2	0

BG505 MD39.3-BaseKO, 1: 50, M3.5

Group	Value	95% CI
Group T1	4
Group T2	4

Magnitude of Vaccine-matched IgG Binding Antibody (Ab) Responses as Assessed by Multiplex Assay 2 Weeks Following the Third and Fourth Vaccination Primary · Measured at Months 1.5, 3.5, and 6.5

The Binding Antibody Multiplex Assay (BAMA) assay was used to evaluate binding antibody responses of each serum specimen against BG505 SOSIP (vaccine trimer immunogen) and Trimer 4571 (vaccine matched immunogen). Epitope specificities are assessed via wildtype-mutant pairs. The AB05 antigen was used to assess binding antibody responses to the vaccine-matched trimer INO-6160. The wildtype antigen (BG505 MD39.3) captured both base and non-base specific antibodies, whereas the mutant antigen (BG505 MD39.3-BaseKO), captured only non-base specific antibodies.

AB05, 1: 50, M1.5

Group	Value	95% CI
Group T1	72.2	15.8 – 167.1
Group T2	20.5	5.4 – 126.4

AB05, 1: 50, M3.5

Group	Value	95% CI
Group T1	484.6	188.9 – 1241.4
Group T2	3564.5	1829.2 – 6158.2

AB05, 1: 50, M6.5

Group	Value	95% CI
Group T1	343.9	196.1 – 1039.7
Group T2	22000	22000 – 22000

BG505 MD39.3, 1: 50, M1.5

Group	Value	95% CI
Group T1	9633.4	841.6 – 14037.1
Group T2	2589.8	433.3 – 12484.8

BG505 MD39.3, 1: 50, M3.5

Group	Value	95% CI
Group T1	22000	22000 – 22000
Group T2	22000	22000 – 22000

BG505 MD39.3, 1: 50, M6.5

Group	Value	95% CI
Group T1	22000	12911.1 – 22000
Group T2	22000	22000 – 22000

BG505 MD39.3-BaseKO, 1: 50, M1.5

Group	Value	95% CI
Group T1	342.4	127.3 – 565.6
Group T2	284.5	122.4 – 699.4

BG505 MD39.3-BaseKO, 1: 50, M3.5

Group	Value	95% CI
Group T1	1266.4	462.2 – 2177.6
Group T2	1354.5	501.8 – 3187.5

Response Rate of CD4 + T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination Primary · Measured at Months 3.5 and 6.5

Flow cytometry is employed to examine HIV-1-specific CD4+ and CD8+ T-cell responses using a validated Intracellular Cytokine Staining (ICS) assay. To determine positivity, a one-sided Fisher's exact test is applied to a two-by-two contingency table, testing whether the number of cytokine-producing cells for the stimulated data is equal to that for the negative control data.

A-AB05, IFN-g and/or IL-2, M3.5

Group	Value	95% CI
Group T1	7
Group T2	7

A-AB05, IFN-g and/or IL-2, M6.5

Group	Value	95% CI
Group T1	8
Group T2	5

A-AB05, IL-21, M3.5

Group	Value	95% CI
Group T1	2
Group T2	2

A-AB05, IL-21, M6.5

Group	Value	95% CI
Group T1	0
Group T2	1

A-AB05, IL-4 or IL-5 or IL-13 and CD40L, M3.5

Group	Value	95% CI
Group T1	0
Group T2	0

A-AB05, IL-4 or IL-5 or IL-13 and CD40L, M6.5

Group	Value	95% CI
Group T1	0
Group T2	0

BG505 A-AB05-gp120, IFN-g and/or IL-2, M3.5

Group	Value	95% CI
Group T1	8
Group T2	9

BG505 A-AB05-gp120, IFN-g and/or IL-2, M6.5

Group	Value	95% CI
Group T1	8
Group T2	6

Magnitude of CD4 + T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination Primary · Measured at Months 3.5 and 6.5

Flow cytometry is employed to examine HIV-1-specific CD4+ and CD8+ T-cell responses using a validated ICS assay

A-AB05, IFN-g and/or IL-2, M3.5

Group	Value	95% CI
Group T1	0.05	0.04 – 0.07
Group T2	0.04	0.02 – 0.08

A-AB05, IFN-g and/or IL-2, M6.5

Group	Value	95% CI
Group T1	0.04	0.04 – 0.06
Group T2	0.06	0.03 – 0.08

A-AB05, IL-21, M3.5

Group	Value	95% CI
Group T1	0	0 – 0.02
Group T2	0.01	0 – 0.01

A-AB05, IL-21, M6.5

Group	Value	95% CI
Group T1	0	0 – 0.01
Group T2	0	0 – 0.01

A-AB05, IL-4 or IL-5 or IL-13 and CD40L, M3.5

Group	Value	95% CI
Group T1	0	0 – 0
Group T2	0	0 – 0

A-AB05, IL-4 or IL-5 or IL-13 and CD40L, M6.5

Group	Value	95% CI
Group T1	0	0 – 0
Group T2	0	0 – 0

BG505 A-AB05-gp120, IFN-g and/or IL-2, M3.5

Group	Value	95% CI
Group T1	0.14	0.09 – 0.23
Group T2	0.2	0.14 – 0.21

BG505 A-AB05-gp120, IFN-g and/or IL-2, M6.5

Group	Value	95% CI
Group T1	0.15	0.11 – 0.18
Group T2	0.16	0.15 – 0.17

Response Rate of CD8+ T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination Primary · Measured at Months 3.5 and 6.5

A-AB05, IFN-g and/or IL-2, M3.5

Group	Value	95% CI
Group T1	1
Group T2	0

A-AB05, IFN-g and/or IL-2, M6.5

Group	Value	95% CI
Group T1	1
Group T2	0

BG505 A-AB05-gp120, IFN-g and/or IL-2, M3.5

Group	Value	95% CI
Group T1	5
Group T2	3

BG505 A-AB05-gp120, IFN-g and/or IL-2, M6.5

Group	Value	95% CI
Group T1	5
Group T2	3

BG505 A-AB05-gp41, IFN-g and/or IL-2, M3.5

Group	Value	95% CI
Group T1	1
Group T2	0

BG505 A-AB05-gp41, IFN-g and/or IL-2, M6.5

Group	Value	95% CI
Group T1	1
Group T2	0

Total Env, IFN-g and/or IL-2, M3.5

Group	Value	95% CI
Group T1	6
Group T2	3

Total Env, IFN-g and/or IL-2, M6.5

Group	Value	95% CI
Group T1	6
Group T2	3

Magnitude of CD8+ T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination Primary · Measured at Months 3.5 and 6.5

Flow cytometry is employed to examine HIV-1-specific CD4+ and CD8+ T-cell responses using a validated ICS assay

A-AB05, IFN-g and/or IL-2, M3.5

Group	Value	95% CI
Group T1	0	0 – 0
Group T2	0	0 – 0

A-AB05, IFN-g and/or IL-2, M6.5

Group	Value	95% CI
Group T1	0	0 – 0.01
Group T2	0	0 – 0.01

BG505 A-AB05-gp120, IFN-g and/or IL-2, M3.5

Group	Value	95% CI
Group T1	0.06	0.01 – 0.15
Group T2	0.02	0.01 – 0.05

BG505 A-AB05-gp120, IFN-g and/or IL-2, M6.5

Group	Value	95% CI
Group T1	0.06	0.02 – 0.19
Group T2	0.06	0.01 – 0.12

BG505 A-AB05-gp41, IFN-g and/or IL-2, M3.5

Group	Value	95% CI
Group T1	0.01	0 – 0.01
Group T2	0.01	0 – 0.02

BG505 A-AB05-gp41, IFN-g and/or IL-2, M6.5

Group	Value	95% CI
Group T1	0.01	0 – 0.01
Group T2	0.01	0 – 0.02

Total Env, IFN-g and/or IL-2, M3.5

Group	Value	95% CI
Group T1	0.11	0.04 – 0.19
Group T2	0.03	0.02 – 0.06

Total Env, IFN-g and/or IL-2, M6.5

Group	Value	95% CI
Group T1	0.13	0.05 – 0.24
Group T2	0.08	0.02 – 0.14

Adverse events — posted to ClinicalTrials.gov

Time frame: Unsolicited AEs will be collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Group T1

Serious: 0/10 (0%)

Deaths: 0/10

Group T2

Serious: 0/10 (0%)

Deaths: 0/10

Other adverse events (27 terms — click to expand)

Reaction	System	Group T1	Group T2
Fatigue (Solicited)	General disorders	—	—
Injection site pain (Solicited)	General disorders	—	—
Headache (Solicited)	Nervous system disorders	—	—
Chills (Solicited)	General disorders	—	—
Injection site erythema (Solicited)	General disorders	—	—
Myalgia (Solicited)	Musculoskeletal and connective tissue disorders	—	—
Injection site swelling (Solicited)	General disorders	—	—
Nausea (Solicited)	Gastrointestinal disorders	—	—
Arthralgia (Solicited)	Musculoskeletal and connective tissue disorders	—	—
Body temperature increased (Solicited)	Investigations	—	—
Injection site vesicles	General disorders	—	—
COVID-19	Infections and infestations	—	—
Lymphadenopathy	Blood and lymphatic system disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Anal chlamydia infection	Infections and infestations	—	—
Chlamydial infection	Infections and infestations	—	—
Herpes zoster	Infections and infestations	—	—
Nasopharyngitis	Infections and infestations	—	—
Pharyngitis streptococcal	Infections and infestations	—	—
Respiratory syncytial virus infection	Infections and infestations	—	—
Sinusitis	Infections and infestations	—	—
Alanine aminotransferase increased	Investigations	—	—
Blood creatinine increased	Investigations	—	—
Haemoglobin decreased	Investigations	—	—
Syncope	Nervous system disorders	—	—
Vulvovaginal ulceration	Reproductive system and breast disorders	—	—
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	—	—

Data from ClinicalTrials.gov NCT05828095 adverse events section.

Sponsor's own description

This is a randomized open-label trial to examine the safety and immunogenicity of INO-6160 (synthetic DNAs encoding a native-like HIV Env Trimer and Interleukin-12), alone or in a prime-boost regimen with VRC HIV Env Trimer 4571 adjuvanted with 3M-052-AF + Alum. The primary hypothesis is that the vaccine regimen will elicit HIV-1 envelope protein-specific binding antibody (Ab) and T-cell responses

Publications & conference data

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

Harnessing innate immune pathways for therapeutic advancement in cancer.
Hu A, Sun L, Lin H, Liao Y, et al · · 2024 · cited 150× · PMID 38523155 · DOI 10.1038/s41392-024-01765-9
Exploring synergies between B- and T-cell vaccine approaches to optimize immune responses against HIV-workshop report.
Maciel M, Amara RR, Bar KJ, Crotty S, et al · · 2024 · cited 12× · PMID 38383616 · DOI 10.1038/s41541-024-00818-y
Guiding HIV-1 vaccine development with preclinical nonhuman primate research.
Counts JA, Saunders KO. · · 2023 · cited 5× · PMID 37712825 · DOI 10.1097/coh.0000000000000819
Recent advances in HIV-1 envelope-based vaccine designs for guiding broadly neutralizing antibody response.
Singh S, Kumar S, Luthra K. · · 2026 · PMID 42012184 · DOI 10.1128/jvi.02202-25
DNA electroporation of HIV Env elicits robust T cell responses and memory B cell responses with muted serum antibody levels that can be boosted with recombinant protein.
De Rosa SC, Gravett RM, Hahn WO, Villaran M, et al · · 2026 · PMID 41865485 · DOI 10.1016/j.vaccine.2026.128487

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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 NCT05828095 (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: 2 September 2025

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/NCT05828095.

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

NCT05828095

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for HIV-1-infection

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

Verify against primary sources