A Study of Heterologous Vaccine Regimen of Adenovirus Serotype 26 Mosaic4 Human Immunodeficiency Virus(Ad26.Mos4.HIV), Adjuvanted Clade C gp140 and Mosaic gp140 to Prevent HIV-1 Infection Among Cis-gender Men and Transgender Individuals Who Have Sex With Cis-gender Men and/or Transgender Individuals

NCT03964415 | Completed Phase 3 Results DMC FDA Drug

• 4 other identifiers: CR1086042018-003666-13VAC89220HPX3002HVTN 706
• Study Type: interventional
• Target: 3,900
• Locations: 9 countries
• Sites: 53

Brief Summary

The purpose of this study is to evaluate the vaccine efficacy (VE) of a heterologous vaccine regimen utilizing Ad26.Mos4.HIV and aluminum phosphate-adjuvanted Clade C gp140 and Mosaic gp140 for the prevention of HIV-1 infection in HIV-1 seronegative cis-gender men and transgender individuals having sex with cis-gender men and/or transgender individuals.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Between the Month 7 and Month 24 Visits (Per-protocol [PP] Set)

  Number of participants with a confirmed HIV-1 infections diagnosed between the Month 7 and Month 24 visits (PP set) was reported. The data represents the cumulative incidence of HIV-1 infections.

  From Month 7 up to Month 24

• Number of Participants With a Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Between the Month 7 and Month 30 Visits (PP Set)

  Number of participants with a confirmed HIV-1 infections diagnosed between the Month 7 and Month 30 visits (PP set) was reported. The data represents the cumulative incidence of HIV-1 infections.

  From Month 7 up to Month 30

Secondary Outcomes (16)

• Number of Participants With Solicited Local Adverse Events (AEs)

  Up to 7 days post each vaccination (dose) on Days 1 (up to Day 8), 84 (up to Day 91), 168 (up to Day 175), and 364 (up to 371)

• Number of Participants With Solicited Systemic Adverse Events (AEs)

  Up to 7 days after each vaccination (dose) on Days 1 (up to Day 8), 84 (up to Day 91), 168 (up to Day 175), and 364 (up to 371)

• Number of Participants With Unsolicited Adverse Events (AEs)

  Up to 28 days after each vaccination (dose) on Days 1 (up to Day 29), 84 (up to Day 112), 168 (up to Day 196), and 364 (up to 392)

• Number of Participants With Adverse Events of Special Interest (AESIs)

  Up to 6 months after the last vaccination (up to Month 18)

• Number of Participants With Medically-attended Adverse Events (MAAEs)

  From Day 1 up to Month 40

Study Arms (2)

Group1:Ad26.Mos4.HIV,Clade C and Mosaic gp140 bivalent vaccine

EXPERIMENTAL

Participants will receive adenovirus serotype 26.Mosaic 4.human immunodeficiency virus (Ad26.Mos4.HIV) via intramuscular (IM) injection into the deltoid muscle at months 0 (Day 1) and 3 (preferably the deltoid of the non-dominant upper arm) and, Ad26.Mos4.HIV together with Clade C and Mosaic gp140 HIV bivalent vaccine IM into the deltoid muscle at Months 6 and 12 (different deltoid for each injection).

Biological: Ad26.Mos4.HIV; Biological: Clade C and Mosaic gp140 HIV bivalent vaccine

Group 2: Placebo

PLACEBO COMPARATOR

Participants will receive placebo into the deltoid muscle on Months 0 (Day 1), 3 (1 injection), 6 and 12 (2 injections).

Biological: Placebo

Interventions

Ad26.Mos4.HIV BIOLOGICAL

Participants will receive Ad26.Mos4.HIV via IM injection into the deltoid muscle at months 0 (Day 1), 3, 6 and 12.

Group1:Ad26.Mos4.HIV,Clade C and Mosaic gp140 bivalent vaccine

Clade C and Mosaic gp140 HIV bivalent vaccine BIOLOGICAL

Participants will receive Clade C and Mosaic gp140 HIV bivalent vaccine as IM injection into the deltoid muscle at Months 6 and 12.

Group1:Ad26.Mos4.HIV,Clade C and Mosaic gp140 bivalent vaccine

Placebo BIOLOGICAL

Participants will receive matching placebo.

Group 2: Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Cis-gender men and transgender individuals who have sex with cis-gender men and/or transgender Individuals.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Individual is either cis-gender man having sex with cis-gender men and/or transgender individuals or transgender woman having sex with cis-gender men and/or transgender individuals or transgender man having sex with cis-gender men and/or transgender women or gender non-conforming individual having receptive or insertive anal and/or vaginal condom-less intercourse and who is considered by the site staff to be at increased risk for HIV-1 infection. The potential participants must in the last 6 months have had any condom-less receptive anal or vaginal sex (not included is condom-less anal sex within a mutually monogamous relationship \>=12 months if the partner is HIV negative or living with HIV and virally suppressed) or rectal or urethral gonorrhea or chlamydia or incident syphilis or any stimulant use or any other drug and/or substance which in the local context may be associated with increased HIV transmission (example, cocaine, amphetamine) or 5 or more sex partners
• Potential participant has a negative test result for HIV-1 and HIV-2 infection less than or equal to (\<=) 28 days prior to first vaccination
• Potential participant must be healthy based on medical history, physical examination, and vital sign measurement performed at screening
• Contraceptive use by participants assigned female at birth and who have not had sexual reassignment surgery should be consistent with local regulations regarding the acceptable methods of contraception for those participating in clinical studies
• All participants of childbearing potential must have a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test at screening and have a negative urine beta-hCG pregnancy test immediately prior to each study vaccine administration

You may not qualify if:

• Potential participants choosing to use PrEP. However, once participants are enrolled and received their first vaccination, and they change their mind regarding PrEP usage, they will be allowed to take PrEP according to the site PrEP plan and will continue to receive further vaccinations. The use of long acting PrEP is disallowed from 24 months prior to Day 1
• Potential participant is a recipient of a HIV-vaccine candidate at any time, or a recipient of other experimental vaccine(s) within the last 12 months prior to Day 1. For participants who received an experimental vaccine (except HIV vaccine) more than 12 months prior to Day 1, documentation of the identity of the experimental vaccine must be provided to the HPX3002/HVTN 706 safety review team, who will determine eligibility on a case by-case basis. Exceptions: participants can be included if the vaccine received (except HIV vaccine) was subsequently licensed or authorized for emergency use (example, Emergency Use Authorization (EUA), Emergency Use Listing (EUL), or similar program). Participants with proof of having received only placebo can also be included. Participants who are currently still in an interventional study of such a licensed/emergency use-authorized vaccine are to be excluded from the current study
• Potential participant has received an HIV-related mAb, whether licensed or investigational, within the last 12 months prior to Day 1. For participants who received an HIV-related mAb more than 12 months prior to Day 1, documentation of the identity of the mAb must be provided to the HPX3002/HVTN 706 safety review team, who will determine eligibility on a case-by-case basis
• Potential participant has known allergy or history of anaphylaxis or other serious adverse reactions to vaccines
• Pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 90 days after the last dose of study vaccination

Sponsors & Collaborators

• Janssen Vaccines & Prevention B.V.: lead

Study Sites (53)

University of Alabama at Birmingham

Birmingham, Alabama, 35222, United States

Location

Bridge HIV

San Francisco, California, 94102, United States

Location

Whitman Walker Health

Washington D.C., District of Columbia, 20816, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Orlando Immunology Center

Orlando, Florida, 32803, United States

Location

Emory University Rollins School of Public Health - Ponce De Leon CRS

Atlanta, Georgia, 30322, United States

Location

The Hope Clinic at Emory University

Decatur, Georgia, 30030, United States

Location

University Of Illinois

Chicago, Illinois, 60612, United States

Location

New Orleans Adolescent Trials Unit CRS

New Orleans, Louisiana, 70112, United States

Location

Dana-Farber/Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Fenway Health

Boston, Massachusetts, 02215, United States

Location

Rutgers, The State University of New Jersey - The University Hospital/ACTG Network

Newark, New Jersey, 07103, United States

Location

Harlem Prevention Center CRS

New York, New York, 10027, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

New York Blood Center

New York, New York, 10065, United States

Location

Strong Memorial Infectious Disease

Rochester, New York, 14642, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Gordon E. Crofoot MD

Houston, Texas, 77098, United States

Location

Seattle Vaccine Trials Unit

Seattle, Washington, 98104, United States

Location

Helios Salud Sa

Buenos Aires, C1141ACG, Argentina

Location

Fundacion Huesped

Ciudad Autonoma de Buenos Aire, C1202ABB, Argentina

Location

Hospital J. M. Ramos Mejía

Ciudad de Buenos Aires, C1221Adc, Argentina

Location

Instituto Caici Srl.

Rosario, S2000PBJ, Argentina

Location

Universidade Federal De Minas Gerais - Hospital das Clínicas

Belo Horizonte, 30130-100, Brazil

Location

Centro Medico Sao Francisco

Curitiba, 80810-050, Brazil

Location

Fundacao de Medicina Tropical Doutor Heitor Vieira Dourado - FMT

Manaus, 69040-000, Brazil

Location

Fundacao Oswaldo Cruz

Rio de Janeiro, 21040-900, Brazil

Location

Municipio de Nova Iguacu - Hospital Geral de Nova Iguacu

Rio de Janeiro, 26030-380, Brazil

Location

Instituto de infectologia Emilio Ribas

São Paulo, 01246-900, Brazil

Location

Hospital Das Clinicas Da Faculdade De Medicina Da USP

São Paulo, 01246-903, Brazil

Location

Centro de Referencia E Treinamento Dst/Aids

São Paulo, 02141-000, Brazil

Location

Ospedale San Raffaele

Milan, 20127, Italy

Location

Azienda Ospedaliero-Universitaria Policlinico di Modena

Modena, 41124, Italy

Location

Istituto nazionale malattie infettive 'L. Spallanzani'

Roma, 00149, Italy

Location

Hospital Civil Fray Antonio Alcalde

Guadalajara, 44280, Mexico

Location

Inst. Nal. de Ciencias Med. Y Nutricion Salvador Zubiran

Mexico City, 14000, Mexico

Location

Unidad de Atención Medica e Investigacion en Salud (UNAMIS)

Mérida, 97000, Mexico

Location

Centro de Investigaciones Tecnologicas, Biomedica y medio ambientales (CITBM)

Callao, 07066, Peru

Location

Asociacion Civil Selva Amazonica (ACSA)

Iquitos, 16001, Peru

Location

Asociacion Civil Via Libre

Lima, 15001, Peru

Location

Asociacion Civil Impacta Salud y Educacion - Barranco

Lima - Barranco, Barranco 15063, Peru

Location

Asociacion Civil Impacta Salud y Educacion- San Miguel CRS

Lima - San Miguel, 15088, Peru

Location

Neutrum Lekarze M.Hlebowicz i Partnerzy spolka partnerska

Gdansk, 80-462, Poland

Location

Wroclawskie Centrum Zdrowia SPZOZ, Poradnia Profilaktyczno-Lecznicza

Wroclaw, 50-136, Poland

Location

Clinical Research Puerto Rico Inc

San Juan, 00909, Puerto Rico

Location

University of Puerto Rico

San Juan, 00936-5067, Puerto Rico

Location

Hosp. Univ. Germans Trias I Pujol

Badalona, 08916, Spain

Location

Hosp. Univ. Vall D Hebron

Barcelona, 08001, Spain

Location

Hosp Reina Sofia

Córdoba, 14004, Spain

Location

Hosp Univ Fund Jimenez Diaz

Madrid, 28015, Spain

Location

Hosp. Clinico San Carlos

Madrid, 28040, Spain

Location

Hosp. Gral. Univ. Valencia

Valencia, 46014, Spain

Location

Related Publications (1)

• Buchbinder SP, Spinosa Guzman S, Sanchez J, Willems W, Stieh DJ, van Duijn J, van Rosmalen MGM, Hendriks J, Nijs S, Lavreys L, Paez CA, Grinzstejn B, Hutter J, Mann P, Sierra Madero JG, Cahn P, Castagna A, Truyers C, Roels S, Gilbert PB, Carone M, Luedtke A, Corey L, Pau MG, Tomaka F; HVTN 706/HPX3002/Mosaico Study Team. Efficacy and safety of a mosaic HIV-1 vaccine regimen in men who have sex with men and transgender individuals (HVTN 706/HPX3002/Mosaico): a global, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet HIV. 2025 Dec;12(12):e823-e835. doi: 10.1016/S2352-3018(25)00195-X.

  PMID: 41314741 DERIVED

Results Point of Contact

• Title: Medical Leader
• Organization: Janssen Vaccines & Prevention B.V.

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Vaccines & Prevention B.V. Clinical Trial

  Janssen Vaccines & Prevention B.V.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2019
• First Posted: May 28, 2019
• Study Start: October 31, 2019
• Primary Completion: August 10, 2023
• Study Completion: August 10, 2023
• Last Updated: July 31, 2024
• Results First Posted: July 31, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share

Locations

ES (6); AR (4); US (20); BR (8); PE (5); PL (2); ME (3); PR (2); IT (3)