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

NCT ID: NCT03964415

Last Updated: 2024-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 3900 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-31
• Study Completion Date: 2023-08-10

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.

Detailed Description

Human immunodeficiency virus type 1 (HIV-1) is a retrovirus that, if left untreated, can progress to acquired immunodeficiency syndrome (AIDS), a condition in which the immune system is severely compromised, leading to life-threatening conditions. Ad26.Mos4.HIV is a tetravalent vaccine composed of Ad26.Mos1.Gag-Pol, Ad26.Mos2.Gag-Pol, Ad26.Mos1.Env, and Ad26.Mos2S.Env. Clade C and Mosaic gp140 HIV bivalent vaccine contains: Clade C gp140, HIV-1 Env gp140 of Clade C, Mosaic gp140, HIV-1 Env gp140, and aluminum phosphate adjuvant. Evidences showed that a combination of vaccination with Ad26.Mos.HIV followed by Ad26.Mos.HIV together with Clade C gp140 protein in aluminum phosphate adjuvant led to highest level of protection observed so far with this vaccine concept. Study comprises of a screening period of 45 days, a 12-month vaccination period and a follow-up period of at least 18 months after fourth vaccination (until Month 30) in participants who remain HIV-1 negative or up to 6 months after diagnosis of HIV-1 infection in participants who become HIV-1 infected. Participants who completed their Month 30 visit will be followed for HIV infection, medically-attended adverse event (MAAEs) and serious adverse events until the end of study (Month 30). Primary analysis of vaccine efficacy will evaluate the number of HIV-1 infections in the vaccine group compared to number of HIV-1 infections in the placebo group between Month 7 and Month X (with 24<=X<=30) in per-protocol population.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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

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).

Group Type: EXPERIMENTAL

Ad26.Mos4.HIV

Intervention Type: BIOLOGICAL

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

Clade C and Mosaic gp140 HIV bivalent vaccine

Intervention Type: BIOLOGICAL

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

Group 2: Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Participants will receive matching placebo.

Interventions

Ad26.Mos4.HIV

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

Intervention Type: BIOLOGICAL

Clade C and Mosaic gp140 HIV bivalent vaccine

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

Intervention Type: BIOLOGICAL

Placebo

Participants will receive matching placebo.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Vaccines & Prevention B.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Vaccines & Prevention B.V. Clinical Trial

Role: STUDY_DIRECTOR

Janssen Vaccines & Prevention B.V.

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Bridge HIV

San Francisco, California, United States

Whitman Walker Health

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

University of Miami

Miami, Florida, United States

Orlando Immunology Center

Orlando, Florida, United States

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

Atlanta, Georgia, United States

The Hope Clinic at Emory University

Decatur, Georgia, United States

University Of Illinois

Chicago, Illinois, United States

New Orleans Adolescent Trials Unit CRS

New Orleans, Louisiana, United States

Dana-Farber/Brigham and Women's Hospital

Boston, Massachusetts, United States

Fenway Health

Boston, Massachusetts, United States

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

Newark, New Jersey, United States

Harlem Prevention Center CRS

New York, New York, United States

Columbia University Medical Center

New York, New York, United States

New York Blood Center

New York, New York, United States

Strong Memorial Infectious Disease

Rochester, New York, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Gordon E. Crofoot MD

Houston, Texas, United States

Seattle Vaccine Trials Unit

Seattle, Washington, United States

Helios Salud Sa

Buenos Aires, , Argentina

Fundacion Huesped

Ciudad Autonoma de Buenos Aire, , Argentina

Hospital J. M. Ramos Mejía

Ciudad de Buenos Aires, , Argentina

Instituto Caici Srl.

Rosario, , Argentina

Universidade Federal De Minas Gerais - Hospital das Clínicas

Belo Horizonte, , Brazil

Centro Medico Sao Francisco

Curitiba, , Brazil

Fundacao de Medicina Tropical Doutor Heitor Vieira Dourado - FMT

Manaus, , Brazil

Fundacao Oswaldo Cruz

Rio de Janeiro, , Brazil

Municipio de Nova Iguacu - Hospital Geral de Nova Iguacu

Rio de Janeiro, , Brazil

Instituto de infectologia Emilio Ribas

São Paulo, , Brazil

Hospital Das Clinicas Da Faculdade De Medicina Da USP

São Paulo, , Brazil

Centro de Referencia E Treinamento Dst/Aids

São Paulo, , Brazil

Ospedale San Raffaele

Milan, , Italy

Azienda Ospedaliero-Universitaria Policlinico di Modena

Modena, , Italy

Istituto nazionale malattie infettive 'L. Spallanzani'

Roma, , Italy

Hospital Civil Fray Antonio Alcalde

Guadalajara, , Mexico

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

Mexico City, , Mexico

Unidad de Atención Medica e Investigacion en Salud (UNAMIS)

Mérida, , Mexico

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

Callao, , Peru

Asociacion Civil Selva Amazonica (ACSA)

Iquitos, , Peru

Asociacion Civil Via Libre

Lima, , Peru

Asociacion Civil Impacta Salud y Educacion - Barranco

Lima - Barranco, , Peru

Asociacion Civil Impacta Salud y Educacion- San Miguel CRS

Lima - San Miguel, , Peru

Neutrum Lekarze M.Hlebowicz i Partnerzy spolka partnerska

Gdansk, , Poland

Wroclawskie Centrum Zdrowia SPZOZ, Poradnia Profilaktyczno-Lecznicza

Wroclaw, , Poland

Clinical Research Puerto Rico Inc

San Juan, , Puerto Rico

University of Puerto Rico

San Juan, , Puerto Rico

Hosp. Univ. Germans Trias I Pujol

Badalona, , Spain

Hosp. Univ. Vall D Hebron

Barcelona, , Spain

Hosp Reina Sofia

Córdoba, , Spain

Hosp Univ Fund Jimenez Diaz

Madrid, , Spain

Hosp. Clinico San Carlos

Madrid, , Spain

Hosp. Gral. Univ. Valencia

Valencia, , Spain

Countries

United States; Argentina; Brazil; Italy; Mexico; Peru; Poland; Puerto Rico; Spain

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2018-003666-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

VAC89220HPX3002

Identifier Type: OTHER

Identifier Source: secondary_id

HVTN 706

Identifier Type: OTHER

Identifier Source: secondary_id

CR108604

Identifier Type: -

Identifier Source: org_study_id