The products below are in development by IAVI and its partners. Preclinical activities include research and animal studies, early clinical trials are Phase I trials in humans that assess the safety of the candidate, Phase II trials further assess safety as well as assess immunogenicity, and Phase III trials assess the efficacy of the candidate.

 

HIV vaccine candidates

 
Preclinical
Early clinical trials
Efficacy trials

eOD-GT8 60mer mRNA +
Core-g28v2 60mer mRNA
 

Engineered HIV envelope proteins delivered through messenger RNA and designed to target germline B cells and guide their maturation toward the development of neutralizing antibody responses.



Status
IAVI is conducting a Phase I clinical trial (IAVI G002) of these vaccine antigens.


 

Partners 
Bill & Melinda Gates Foundation; Emory University; Fred Hutchinson Cancer Research Center; George Washington University; Moderna; Scripps Research; University of Texas San Antonio

eOD-GT8 60mer mRNA
 

An engineered HIV envelope protein delivered through messenger RNA and designed to target germline B-cell responses to lead to neutralizing antibody development.



Status
IAVI is conducting a Phase I clinical trial (IAVI G003) of this vaccine antigen.


 

Partners 
Aurum Institute (Tembisa, South Africa); Bill & Melinda Gates Foundation; Center for Family Health Research (Kigali, Rwanda); Moderna; Scripps Research; United States Agency for International Development

BG505 GT1.1 gp140, adjuvanted
 

A second-generation, engineered, trimeric HIV Envelope protein.

 

Status
IAVI is conducting a Phase I clinical trial (IAVI C101) of a native-like, trimeric protein immunogen in combination with a GSK adjuvant.


 

Partners 
Amsterdam UMC; Bill & Melinda Gates Foundation; Duke University; Emmes; George Washington University; GSK; Rockefeller University; Scripps Research; United States National Institutes of Health Vaccine Research Center; Vaccine Immunology Statistical Center (FHCRC); Weill Cornell Medical College

BG505 SOSIP.664 gp140, adjuvanted
 

An engineered, native-like, HIV Envelope trimer.

 

Status
IAVI is sponsoring a Phase I clinical trial (IAVI W001) to evaluate this native-like trimeric protein immunogen in combination with a GSK adjuvant.

 

 

Partners 
Amsterdam UMC; Bill & Melinda Gates Foundation (BMGF); BMGF-Collaboration for AIDS Vaccine Discovery-Vaccine Immune Monitoring Consortium; The Dutch Government; Fred Hutchinson Cancer Research Center; GSK; KAVI-Institute of Clinical Research; Massachusetts General Hospital; Ragon Institute of MGH, MIT and Harvard; United States Agency for International Development; Weill Cornell Medical College

rVSVΔG-Env-HIV
 

A vaccine candidate consisting of a replicating vesicular stomatitis virus vector containing an HIV Envelope glycoprotein immunogen.

 

Status
Currently in preclinical development by IAVI.

 

Partners 
CureVac; Government of Japan; Scripps Research Institute; Seattle Children’s Research Institute; United States National Institutes of Health

 

Other IAVI-supported HIV vaccine approaches

 
Preclinical
Early clinical trials
Efficacy trials

HIVconsv
 

A chimeric HIV protein designed to induce T-cell responses against the conserved portions of HIV that is being delivered in a prime boost regimen by a non-replicating chimpanzee adenovirus vector and a non-replicating modified vaccinia Ankara vector.

 

Status
IAVI is supporting a Phase I clinical trial (HIV-CORE 006) led by the Globally Relevant AIDS Vaccine Europe-Africa Trials Partnership (GREAT) that began in Q3 2021.

 

 

Partners 
Center for Family Health Research in Zambia; European and Developing Countries Clinical Trials Partnership; KAVI-Institute of Clinical Research; Kenya Medical Research Institute-Wellcome Trust; Medical Research Council-Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit; The University of Oxford (sponsor)

Ad26.Mos.HIV/gp140 and Ad26.Mos4.HIV/gp140
 

A prime-boost vaccine approach evaluating two different regimens of a priming tetravalent adenovirus serotype 26 vector-based candidate containing a mosaic antigen (one that is computationally derived to provide optimal coverage against all circulating HIV strains), followed by boost with tetravalent Ad26.Mos4.HIV along with either clade C gp140 plus adjuvant or with a combination of Mosaic gp140 and clade C gp140 plus adjuvant. The study will also evaluate a late boost vaccination approximately three years after the final vaccination in the primary vaccination series.

 

Status
IAVI clinical research center partner Center for Family Health Research in Kigali, Rwanda, is participating in the long-term extension and late boosting of Phase I/II study HPX2003.

Partners 
Beth Israel Deaconess Medical Center; Bill & Melinda Gates Foundation; HIV Vaccine Trials Network; Janssen; National Institute of Allergy and Infectious Diseases; Ragon Institute of MGH, MIT and Harvard; United States Military HIV Research Program

PrEPVacc
 

A Phase IIb trial of DNA and MVA with an adjuvanted Env protein compared to just DNA with a different adjuvanted Env protein, both regimens tested in combination with orapre-exposure prophylaxis (PrEP).

 

Status
IAVI is supporting an efficacy trial (PV1) that began in Q4 2020.


 

Partners 
European and Developing Countries Clinical Trials Partnership; Imperial College London and Uganda Virus Research Institute-London School of Hygiene and Tropical Medicine, with other partners from Germany, South Africa, Sweden, Switzerland, Tanzania, the U.K., and U.S.

 

Passive immunization against HIV via broadly neutralizing antibodies

 
Preclinical
Early clinical trials
Efficacy trials

Enhanced bnAbs for HIV prevention
 

IAVI and partners are planning a first-in-human Phase I clinical trial with broadly neutralizing antibodies engineered to improve potency and half-life: ePGT121v1, ePGDM1400v9, and VRC01.23LS.

 

Status
Currently in development by IAVI and partners.

 

 

Partners 
Scripps Research; Serum Institute of India; United States Agency for International Development; United States National Institutes of Health and its clinical trial networks

bnAbs PGT121, VRC07-523LS, and PGDM1400
 

IAVI is sponsoring a Phase I/IIa trial (T003) to assess the safety, pharmacokinetics, and antiviral activity of the monoclonal antibodies PGT121 and VRC07-523LS in combination for both treatment and prevention of HIV infection.

 

Status
Phase I/IIa


 

Partners 
Beth Israel Deaconess Medical Center; U.S. National Institutes of Health; Vaccine Research Center at the U.S. National Institute of Allergy and Infectious Diseases

bnAbs 3BNC117-LS-J and 10-1074-LS-J
 

IAVI is sponsoring a trial (IAVI C100) through the VxPDC to assess these bnAbs alone or in combination, as well as an enhanced version of these antibodies, in HIV-infected and uninfected volunteers for either treatment or prevention of HIV infection.

 

Status
Phase I/II


 

Partners 
Bill & Melinda Gates Foundation; Brigham and Women's Hospital; Center for Family Health Research; Fred Hutchinson Cancer Research Center - Seattle HIV Vaccine Trials Unit; Infectious Diseases Institute; KAVI-Institute of Clinical Research; Partners in Health Research and Development – Center for Clinical Research-KEMRI; Rockefeller University; Uganda Virus Research Institute; University of Washington; Wits Reproductive Health Institute

 

Long-acting antiretrovirals for HIV prevention

 
Preclinical
Early clinical trials
Efficacy trials

Cabotegravir
 

A long-acting, injectable antiretroviral for HIV prevention.

 

Status
The Uganda Virus Research Institute/IAVI HIV vaccine program, an IAVI clinical research partner, is participating in an ongoing Phase III efficacy trial (HPTN 084) to compare long-acting cabotegravir to daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) for pre-exposure prophylaxis in HIV-uninfected cisgender women in Africa (study now in open label phase).

Partners 
Bill & Melinda Gates Foundation; HIV Prevention Trials Network; National Institute of Allergy and Infectious Diseases; ViiV Healthcare

 

Emerging infectious diseases vaccine candidates

 
Preclinical
Early clinical trials
Efficacy trials

rVSVΔG-LASV-GPC
 

A vaccine candidate for Lassa fever prevention, consisting of replicating vesicular stomatitis vector containing a Lassa virus glycoprotein immunogen.

 

Status
IAVI is conducting a Phase I clinical trial and planning a Phase II trial.


 

Partners 
Batavia Biosciences; Brigham and Women’s Hospital; Coalition for Epidemic Preparedness; East West Medical Research Institute; Imperial College London; Kenema Government Hospital; La Jolla Institute for Immunology; Merck Advisory Group; PREVAIL (Redemption Hospital); Public Health Agency of Canada; Ragon Institute of MGH, MIT and Harvard; Seattle Children’s Research Institute; The George Washington University; Tulane University; University of Kansas; University of Texas Medical Branch at Galveston; Viral Hemorrhagic Fever Consortium

rVSV∆G-MARV-GP
 

A vaccine candidate for Marburg virus disease prevention, consisting of replicating vesicular stomatitis vector containing a Marburg virus glycoprotein immunogen.

 

Status
Currently in preclinical development by IAVI.


 

Partners 
Batavia Biosciences; Charles River Laboratories; Defense Threat Reduction Agency; Imperial College London; IQVIA; La Jolla Institute for Immunology; Merck Advisory Group; Public Health Agency of Canada; Ragon Institute of MGH, MIT and Harvard; Seattle Children’s Research Institute; Texas Biomedical Research Institute; University of Texas Medical Branch at Galveston; Viral Hemorrhagic Fever Consortium

rVSV∆G-SUDV-GP
 

A vaccine candidate for Sudan ebolavirus disease prevention, consisting of replicating vesicular stomatitis vector containing a Sudan ebolavirus glycoprotein immunogen.

 

Status
Currently in preclinical development by IAVI.


 

Partners 
Batavia Biosciences; Biomedical Advanced Research and Development Authority (BARDA); BioReliance; Boston University’s National Emerging Infectious Diseases Laboratories (NEIDL); Charles River Laboratories; Imperial College London; IQVIA; La Jolla Institute for Immunology; Merck Advisory Group; Neogenomics; Public Health Agency of Canada; Ragon Institute of MGH, MIT and Harvard; Seattle Children’s Research Institute; Tulane University; University of Texas Medical Branch at Galveston; Viral Hemorrhagic Fever Consortium

rVSV∆G-SARS-CoV-2
 

A vaccine candidate for coronavirus disease (COVID-19) prevention, consisting of replicating vesicular stomatitis vector containing the coronavirus spike glycoprotein immunogen.

 

Status
Currently in preclinical development.


 

Partners 
Batavia Biosciences; Boston University’s National Emerging Infectious Diseases Laboratory (NEIDL); Charles River Laboratories; Defense Threat Reduction Agency; Government of Japan; Imperial College London; Merck Advisory Group; New Iberia Research Center; Public Health Agency of Canada; University of North Carolina at Chapel Hill

 

Tuberculosis (TB) vaccine candidates

 
Preclinical
Early clinical trials
Efficacy trials

MTBVAC
 

Biofabri’s MTBVAC is the only live-attenuated Mycobacterium tuberculosis vaccine. This class of vaccines represents a promising strategy to generate durable T-cell responses likely to be required for long-term protection against TB.

 

Status
IAVI has concluded a Phase Ib/IIa dose-defining safety and immunogenicity study (A-050) involving adults in South Africa. A safety/immunogenicity study of MTBVAC in people with HIV infection is planned to begin in 2023, in anticipation of a subsequent efficacy study in adults. Additionally, Biofabri is sponsoring an ongoing Phase III trial (MTBVACN3) of MTBVAC in newborns.

 

 

Partners 
Biofabri S.L.; South African Tuberculosis Vaccine Initiative; Tuberculosis Vaccine Initiative; United States Department of Defense; United States National Institutes of Health; Universidad de Zaragoza

H56/IC31
 

Statens Serum Institut’s H56 TB protein vaccine candidate in combination with the IC31® adjuvant, developed by Valneva, is being evaluated in a trial sponsored by Statens Serum Institut and Aeras Global TB Vaccine Foundation NPC (the South Africa affiliate of IAVI) to see if it can reduce the rate of recurrent TB disease in HIV-uninfected adults already successfully treated for pulmonary TB disease. The study will conclude in Q1 2023; data will be available in Q3 2023.

 

Status
Aeras Global TB Vaccine Foundation NPC (the South Africa affiliate of IAVI) is conducting a Phase II trial (A-055) in South Africa and Tanzania.

Partners 
European and Developing Countries Clinical Trials Partnership; Statens Serum Institut