Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of HIV-1 Chimp Adenovirus Vaccines Expressing Clade C gp140 & CH505TF gp120 Protein Boost in HIV-uninfected Adult.

NCT05182125 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: HVTN 139UM1AI068614
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this study is to evaluate the safety and immunogenicity of HIV-1 vaccines based on chimpanzee serotypes of adenovirus expressing clade C gp140 and a CH505TF gp120 protein boost in healthy, HIV- uninfected adult participants.

Conditions

HIV Infections

Keywords

HIV

Outcome Measures

Primary Outcomes (7)

• Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Pain and/or Tenderness

  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.

  Measured through 7 days after each study product administration at Study Day 0 (Month 0) for Part A (T1, T2, and C3) and at Study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).

• Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration

  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.

  Measured through 7 days after each study product administration at Study Day 0 (Month 0) for Part A (T1, T2, and C3) and at Study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).

• Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms

  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.

  Measured through 7 days after each study product administration at Study Day 0 (Month 0) for Part A (T1, T2, and C3) and at Study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).

• Numbers of Participant With Early Study Termination Associated With Reactogenicity, AE, or Death During Main Study and AESI Visits.

  From the termination and adverse event forms that were collected during main study clinical visits period and AESI contact visits. Counts are tabulated by treatment arm.

  Early study termination reason was collected through 7 days for reactogenicity, 30 days for AEs and 12 months for deaths following any receipt of study product (up to 18 months).

• Number of Participants Reporting Serious Adverse Events (SAEs)

  From adverse event (AE) forms, counts are tabulated by treatment arm. AE forms were collected during main study clinical visits and AESI contact visits

  Measured through 12 months following any receipt of study product(up to 18 months). Study products were given at Study Day 0 (Month 0) for Part A (T1, T2, and C3) and at Study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).

• Number of Participants Reporting Medically Attended Adverse Events (MAAEs)

  From adverse event (AE) forms, counts are tabulated by treatment arm. AE forms were collected during main study clinical visits and AESI contact visits

  Measured through 12 months following any receipt of study product(up to 18 months). Study products were given at Study Day 0 (Month 0) for Part A (T1, T2, and C3) and at Study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).

• Number of Participants Reporting Adverse Event of Special Interests (AESIs)

  From adverse event (AE) forms, counts are tabulated by treatment arm. AE forms were collected during main study clinical visits and AESI contact visits

  Measured through 12 months following any receipt of study product(up to 18 months). Study products were given at Study Day 0 (Month 0) for Part A (T1, T2, and C3) and at Study Days 0 (Month 0), 84 (Month 3) and 168 (Month 6) for Part B (T4, T5, and C6).

Secondary Outcomes (21)

• Response Rate of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)

  Measured at Month 1 for both Part A and Part B

• Magnitude of HIV-specific Serum IgG Binding Antibodies Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)

  Measured at Month 1 for both Part A and Part B

• HIV-specific Serum IgG Binding Antibodies Magnitude Breadth of AUC (AUC--MB) by Panel and Treatment Arm Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)

  Measured at Month 1 for both Part A and Part B

• Response Rate of HIV-specific CD4+ and CD8+ T-cell Responses Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)

  Measured at Month 1 for both Part A and Part B

• Magnitude of HIV-specific CD4+ and CD8+ T-cell by Cytokine, T-cell Subset, Antigen and Treatment Group Assessed 4 Weeks After a Single Vaccination (Part A) or the First Vaccination (Part B)

  Measured at Month 1 for both Part A and Part B

Study Arms (6)

Part A, Group 1: AdC6-HIVgp140

EXPERIMENTAL

Participants will receive 1 x 10\^10 vp AdC6-HIVgp140 to be administered as two separate 1 mL IM injections into the deltoid of the non-dominant arm unless medically contraindicated at month 0.

Biological: AdC6-HIVgp140

Part A, Group 2: AdC7-HIVgp140

EXPERIMENTAL

Participants will receive 1 x 10\^10 vp AdC7-HIVgp140 to be administered as two separate 1 mL IM injections into the deltoid of the non-dominant arm unless medically contraindicated at month 0.

Biological: AdC7-HIVgp140

Part A, Group 3: Placebo

PLACEBO COMPARATOR

Participants will receive placebo for AdC6-HIVgp140 or AdC7-HIVgp140 (labeled as Sodium Chloride for Injection, 0.9%) to be administered as two separate 1 mL IM injections into the deltoid of the non-dominant arm unless medically contraindicated at month 0.

Biological: Placebo

Part B, Group 4: AdC6-HIVgp140 + AdC7-HIVgp140 + 400 mcg CH505TF gp120/GLA-SE

EXPERIMENTAL

Participants will receive 5 x 10\^10 vp AdC6-HIVgp140 to be administered as two separate 1 mL IM injections into the deltoid of the non-dominant arm unless medically contraindicated at month 0. Then 5 x 10\^10 vp AdC7-HIVgp140 to be administered as two separate 1 mL IM injections into the deltoid of the non-dominant arm unless medically contraindicated at month 3. Then 400 mcg CH505TF gp120 admixed with 10 mcg GLA-SE administered as a 1mL IM injection into either thigh unless medically contraindicated at month 6.

Biological: AdC6-HIVgp140; Biological: AdC7-HIVgp140; Biological: CH505TF gp120; Biological: GLA-SE (glucopyranosyl lipid A - stable emulsion; [labeled as AP 10-201])

Part B, Group 5: AdC7-HIVgp140 + AdC6-HIVgp140 + 400 mcg CH505TF gp120/GLA-SE

EXPERIMENTAL

Participants will receive 5 x 10\^10 vp AdC7-HIVgp140 to be administered as two separate 1 mL IM injections into the deltoid of the non-dominant arm unless medically contraindicated at month 0. Then 5 x 10\^10 vp AdC6-HIVgp140 to be administered as two separate 1 mL IM injections into the deltoid of the non-dominant arm unless medically contraindicated at month 3. Then 400 mcg CH505TF gp120 admixed with 10 mcg GLA-SE administered as a 1mL IM injection into either thigh unless medically contraindicated at month 6.

Biological: AdC6-HIVgp140; Biological: AdC7-HIVgp140; Biological: CH505TF gp120; Biological: GLA-SE (glucopyranosyl lipid A - stable emulsion; [labeled as AP 10-201])

Part B, Group 6: Placebo + Placebo + Placebo

PLACEBO COMPARATOR

Participants will receive placebo for AdC6-HIVgp140and AdC7-HIVgp140 (labeled as Sodium Chloride for Injection, 0.9%) to be administered as two separate 1 mL IM injections into the deltoid of the non-dominant arm unless medically contraindicated at month 0 and 3. Placebo for CH505TF/GLA-SE (labeled as Sodium Chloride for Injection, 0.9% ) to be administered as 1 mL IM injection into either thigh at month 6.

Biological: Placebo

Interventions

CH505TF gp120 BIOLOGICAL

CH505TF gp120 is formulated in 20 mM sodium phosphate, 150 mM NaCl, 0.02% polysorbate 80 (PS80), pH 6.5, supplied as a frozen liquid in 2 mL glass vials. Each 2 mL vial contains 0.75 mL of formulated gp120 at a concentration of 0.8 mg/mL and is stored at ≤ -65°C. The study product is described in further detail in the IB.

Part B, Group 4: AdC6-HIVgp140 + AdC7-HIVgp140 + 400 mcg CH505TF gp120/GLA-SE; Part B, Group 5: AdC7-HIVgp140 + AdC6-HIVgp140 + 400 mcg CH505TF gp120/GLA-SE

GLA-SE (glucopyranosyl lipid A - stable emulsion; [labeled as AP 10-201]) BIOLOGICAL

The GLA-SE adjuvant will be provided as vials containing 20 mcg/mL GLA in a 4% oil-in-water emulsion. Each sterile, single use vial contains 0.4 mL of product. Product appears as a milky-white liquid. GLA-SE must be stored at 2° to 8°C and must not be frozen. The study product is described in further detail within the IB.

Part B, Group 4: AdC6-HIVgp140 + AdC7-HIVgp140 + 400 mcg CH505TF gp120/GLA-SE; Part B, Group 5: AdC7-HIVgp140 + AdC6-HIVgp140 + 400 mcg CH505TF gp120/GLA-SE

Placebo BIOLOGICAL

Placebo will be Sodium Chloride for Injection, 0.9%, will be used as the placebo. It must be stored as recommended by the manufacturer.

Part A, Group 3: Placebo; Part B, Group 6: Placebo + Placebo + Placebo

AdC6-HIVgp140 BIOLOGICAL

The product is diluted in 2.5% Glycerol/25 mM NaCl/20 mM TRIS \[tris(hydroxymethyl)aminomethane\], pH 8.0 formulation buffer to a concentration of 1.2 x 10\^11 vp/mL and filled at 0.3 mL for AdC6-HIVgp140 into a 2 mL Type 1 glass vial and stoppered with a gray chlorobutyl rubber stopper. The product is clear to slightly cloudy liquid, essentially free of visible particles. AdC6-HIVgp140 should be stored at ≤ -65°C prior to use/preparation. The study product is described in further detail in the Investigator's Brochure (IB).

Part A, Group 1: AdC6-HIVgp140; Part B, Group 4: AdC6-HIVgp140 + AdC7-HIVgp140 + 400 mcg CH505TF gp120/GLA-SE; Part B, Group 5: AdC7-HIVgp140 + AdC6-HIVgp140 + 400 mcg CH505TF gp120/GLA-SE

AdC7-HIVgp140 BIOLOGICAL

The products is diluted in 2.5% Glycerol/25 mM NaCl/20 mM TRIS \[tris(hydroxymethyl)aminomethane\], pH 8.0 formulation buffer to a concentration of 1.2 x 10\^11 vp/mL and filled at 0.6 mL for AdC7-HIVgp140 into a 2 mL Type 1 glass vial and stoppered with a gray chlorobutyl rubber stopper. The product is clear to slightly cloudy liquid, essentially free of visible particles. AdC7-HIVgp140 should be stored at ≤ -65°C prior to use/preparation. The study product is described in further detail in the IB.

Part A, Group 2: AdC7-HIVgp140; Part B, Group 4: AdC6-HIVgp140 + AdC7-HIVgp140 + 400 mcg CH505TF gp120/GLA-SE; Part B, Group 5: AdC7-HIVgp140 + AdC6-HIVgp140 + 400 mcg CH505TF gp120/GLA-SE

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• General and Demographic Criteria
• Age of 18 through 50 years.
• Access to a participating HVTN CRS and willingness to be followed for the planned duration of the study.
• Ability and willingness to provide informed consent.
• Assessment of understanding: volunteer demonstrates understanding of this study and that in a previous trial with an adenovirus type 5 (Ad5) vector there was an association of increased HIV acquisition with receipt of that study product; completes a questionnaire prior to first vaccination with verbal demonstration of understanding of all questionnaire items answered incorrectly.
• Willing to be contacted annually after completion of scheduled clinic visits for a total of 3 years following initial study injection.
• Agrees not to enroll in another study of an investigational research agent until the last scheduled clinic visit.
• Good general health as shown by medical history, physical exam, and screening laboratory tests.
• HIV-Related Criteria
• Willingness to receive HIV test results.
• Willingness to discuss HIV infection risks and amenable to HIV risk reduction counseling.
• Assessed as "low risk" for HIV acquisition per low risk guidelines (see Appendix M), agrees to discuss HIV infection risks, agrees to risk reduction counseling, and agrees to avoid behavior associated with high risk of HIV exposure through the final study visit. Low risk may include persons stably taking PrEP as prescribed for 6 months or longer.
• Hemogram/Complete blood count (CBC)
• Hemoglobin
• g/dL for volunteers who were assigned female sex at birth

You may not qualify if:

• Blood products received within 120 days before first vaccination.
• Investigational research agents received within 30 days before first vaccination.
• Body mass index (BMI) ≥ 40; or BMI ≥ 35 with 2 or more of the following: age \> 45, systolic blood pressure \> 140 mm Hg, diastolic blood pressure \> 90 mm Hg, current tobacco smoker, known hyperlipidemia.
• Intent to participate in another study of an investigational research agent or any other study that requires non-HVTN HIV antibody testing during the planned duration of the HVTN 139 study.
• Pregnant or breastfeeding.
• Active duty and reserve US military personnel.
• Vaccines and other Injections
• HIV vaccine(s) received in a prior HIV vaccine trial. For volunteers who have received control/placebo in an HIV vaccine trial, the HVTN 139 PSRT will determine eligibility on a case-by-case basis.
• Previous receipt of monoclonal antibodies (mAbs), whether licensed or investigational. Exceptions may be made by the HVTN 139 PSRT on a case-by-case basis.
• Non-HIV experimental vaccine(s) received within the last 1 year in a prior vaccine trial. Exceptions may be made by the HVTN 139 PSRT for vaccines that have subsequently undergone licensure by the FDA. For volunteers who have received control/placebo in an experimental vaccine trial, the HVTN 139 PSRT will determine eligibility on a case-by-case basis. For volunteers who have received an experimental vaccine(s) greater than 1 years ago, eligibility for enrollment will be determined by the HVTN 139 PSRT on a case-by-case basis.
• Live attenuated vaccines received within 30 days before first vaccination or scheduled within 28 days after injection (eg, measles, mumps, and rubella \[MMR\]; oral polio vaccine \[OPV\]; varicella; yellow fever; live attenuated influenza vaccine).
• Any vaccines that are not live attenuated vaccines and were received within 14 days prior to first vaccination (eg, tetanus, pneumococcal, Hepatitis A or B).
• Allergy treatment with antigen injections within 30 days before first vaccination or that are scheduled within 14 days after first vaccination.
• Immune System
• Serious adverse reactions to vaccines or to vaccine components such as glycerol, sodium chloride, tris (hydroxymethyl)aminomethane including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain. (Not excluded from participation: a volunteer who had a nonanaphylactic adverse reaction to pertussis vaccine as a child).

Sponsors & Collaborators

• HIV Vaccine Trials Network: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• National Institutes of Health (NIH): collaborator
• Department of Health and Human Services: collaborator

Study Sites (6)

Emavundleni CRS

Cape Town, South Africa

Location

CAPRISA eThekwini CRS

Durban, South Africa

Location

Isipingo CRS

Isipingo, South Africa

Location

Soweto HVTN CRS

Johannesburg, South Africa

Location

Aurum Institute Klerksdorp CRS

Klerksdorp, South Africa

Location

Setshaba Research Centre CRS

Soshanguve, South Africa

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Product Labeling

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Product Packaging; Industry; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Jessica Andriesen, PhD, Associate Director of HVTN SDMC Operations
• Organization: Fred Hutchinson Cancer Center

hvtn.covpn.sdmc@hvtn.org

206-667-5812

Study Officials

• Ameena Goga

  HIV Prevention Research Unit, South African Medical Research Council

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: January 10, 2022
• Study Start: November 25, 2021
• Primary Completion: August 21, 2023
• Study Completion: May 14, 2025
• Last Updated: December 24, 2025
• Results First Posted: November 27, 2024

Record last verified: 2025-12

Locations

ZA (6)