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
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.
Partners
Bill & Melinda Gates Foundation; Collaboration for AIDS Vaccine Discovery Vaccine Immunology Statistical Center; Duke University; Emory University; Fred Hutchinson Cancer Center; George Washington University; Moderna; Scripps Research; United States Institutes of Health Vaccine Research Center; 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.
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
(AS01B)
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
(3M-052 AF + alum)
(3M-052 AF + alum)
An engineered, native-like, HIV Envelope trimer.
Status
IAVI is conducting Phase I clinical trials (IAVI C107, IAVI C110) of a native-like, trimeric protein immunogen in combination with 3M-052-AF + Alum adjuvants
Partners
Amsterdam UMC; Bill & Melinda Gates Foundation; CRODA/UVAX Bio and Polymun Scientific GmbH; Duke University; Emmes; George Washington University; Rockefeller University; Scripps Research; 3M Company/3M Innovative Properties Company and AAHI; United States National Institutes of Health Vaccine Research Center Division of AIDS; United States National Institutes of Health Vaccine Research Center; Vaccine Immunology Statistical Center (FHCRC); Weill Cornell Medical College
BG505 SOSIP.664 gp140, adjuvanted (AS01B)
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; Dutch Government; Fred Hutchinson Cancer 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
Government of Japan
Other IAVI-supported HIV vaccine approaches
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 oral pre-exposure prophylaxis (PrEP).
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
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; United States Agency for International Development; United States National Institutes of Health and its clinical trial networks; University of Oslo
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 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
Emerging infectious diseases vaccine candidates
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 Phase II and Phase III trials.
Partners
Batavia Biosciences; Brigham and Women’s Hospital; Charles River Laboratories; Coalition for Epidemic Preparedness; East West Medical Research Institute; EpiCentre; European & Developing Countries Clinical Trials Partnership; Imperial College London; IQVIA; La Jolla Institute for Immunology; Kenema Government Hospital; Merck Advisory Group; NeoGenomics Laboratories; Noguchi Memorial Institute for Medical Research, Ghana; PREVAIL (Redemption Hospital); Public Health Agency of Canada; Seattle Children's Research Institute; The George Washington University; Tulane University; Walter Reed Army Institute of Research, Nigeria
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; 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.
Partners
Batavia Biosciences; Biomedical Advanced Research and Development Authority (BARDA); BioReliance; Boston University’s National Emerging Infectious Diseases Laboratories; Charles River Laboratories; Imperial College London; IQVIA; La Jolla Institute for Immunology; Merck Advisory Group; NeoGenomics Laboratories; Public Health Agency of Canada; 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; Charles River Laboratories; Defense Threat Reduction Agency; Government of Japan; Imperial College London; Merck Advisory Group; Neogenomics Laboratories; PATH; Public Health Agency of Canada; University of North Carolina at Chapel Hill
Mini-protein for COVID-19 prophylaxis
IPD-52520
A small protein designed to prevent infection with SARS-CoV-2.
Status
Currently in preclinical development.
Partners
Bill & Melinda Gates Foundation; Institute for Protein Design at The University of Washington
Tuberculosis (TB) vaccine candidates
MTBVAC
Biofabri’s MTBVAC is the only live-attenuated tuberculosis vaccine derived from Mycobacterium tuberculosis. 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
mRNA-encoded TB antigens
Under the support of a grant from the U.S. National Institutes of Health, IAVI is working with Moderna to explore the potential for using mRNA vaccine technology to develop vaccines against tuberculosis.
Status
Currently, IAVI/Moderna mRNA TB vaccine constructs are undergoing preclinical evaluation.
Partners
Moderna; Tufts University; U.S. National Institute of Allergy and Infectious Diseases; U.S. National Institutes of Health; University of Georgia
