Products in development by IAVI and its partners

 

Candidates designed to induce broadly neutralizing antibodies

 
Preclinical
Early clinical trials
Efficacy trials

BG505 GT1.1 gp140
 

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

 

Status
IAVI is supporting preclinical development for this germline-targeting, native-like, trimeric protein immunogen.


 

Partners 
Amsterdam Medical Center, Bill & Melinda Gates Foundation, GSK, United States National Institutes of Health Vaccine Research Center, Rockefeller University, Weill Cornell Medical College

mRNA
 

Messenger RNA, which plays a critical role in directing protein synthesis in the body, is being explored as a potential delivery system for vaccine immunogens designed to induce bNAbs.



Status
IAVI is conducting preclinical studies to evaluate mRNA to deliver vaccine immunogens.


 


eOD-GT8 60mer
 

An engineered HIV envelope protein expressed as a nanoparticle and designed to target germline responses to lead to neutralizing antibody development.


Status
IAVI is conducting a Phase I clinical trial (IAVI G001) of this vaccine candidate in combination with a GSK adjuvant.


 

Partners 
Bill & Melinda Gates Foundation, Fred Hutchinson Cancer Research Center, George Washington University, GSK, United States National Institutes of Health (NIH) Center for HIV/AIDS Vaccine Immunology and Immunogen Discovery, NIH Vaccine Research Center, Scripps Research

BG505 SOSIP gp140
 

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 Medical Center, Bill & Melinda Gates Foundation, The Dutch Government, Fred Hutchinson Cancer Research Center, GSK, Kenya AIDS Vaccine Initiative-Institute of Clinical Research, Ragon Institute, United States Agency for International Development, Weill Cornell Medical College

 

Replicating viral vector-based candidates

 
Preclinical
Early clinical trials
Efficacy trials

VSVΔG-Env.BG505
 

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 
Bill & Melinda Gates Foundation, United States National Institutes of Health, United States Agency for International Development, World Bank

VSVΔG-Lassa
 

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

 

Status
Currently in preclinical development by IAVI.


 

Partners 
Batavia, Center for Infectious Disease Research, Coalition for Epidemic Preparedness, Imperial College London, Public Health Agency of Canada, Ragon Institute of MGH, MIT and Harvard, Scripps Research, Tulane University, University of Kansas, University of Texas Medical Branch, Viral Hemorrhagic Fever Consortium

 

Other vaccine approaches

 
Preclinical
Early clinical trials
Efficacy trials

Ad26.Mos.HIV/gp140 or Ad26.Mos4.HIV/gp140
 

A prime-boost vaccine regimen combining either a trivalent or 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), combined with an HIV gp140 Envelope protein and an adjuvant.

 

Status
IAVI clinical research center partner Projet San Francisco in Kigali, Rwanda, is participating in an ongoing Phase I study (HPX2004).

Partners 
Beth Israel Deaconess Medical Center, HIV Vaccine Trials Network, Janssen, National Institute of Allergy and Infectious Diseases, Ragon Institute, United States Military HIV Research Program

HIVconsv
 

A chimeric HIV protein designed to induce T-cell responses against the conserved portions of HIV that is being delivered by either 1) a non-replicating chimpanzee adenovirus vector, or 2) a non-replicating modified vaccinia Ankara vector.

 

Status
IAVI is supporting a clinical trial (HIV-CORE 006) planned to start in 2019.

 

Partners 
European and Developing Countries Clinical Trials Partnership, Kenya AIDS Vaccine Initiative-Institute of Clinical Research, Oxford University, Uganda Virus Research Institute-London School of Hygiene and Tropical Medicine, Wellcome Trust-Kenya Medical Research Institute, Zambia Emory HIV Research Project

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 planned to start in 2019


 

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, Mozambique, South Africa, Sweden, Switzerland, Tanzania, the U.K., and U.S.

Ad26.Mos4.HIV/gp140
 

A prime-boost vaccine regimen combining a tetravalent adenovirus serotype 26 vector-based candidate containing a mosaic antigen with an HIV Envelope protein and an adjuvant.


Status

The Zambia-Emory HIV Research Project, an IAVI clinical research partner, is participating in an ongoing Phase IIb trial (HVTN705/HPX2003) testing this prime-boost vaccine regimen.


 

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

 

Alternative approaches to deliver bNAbs/immunoprophylaxis

 
Preclinical
Early clinical trials
Efficacy trials

Enhanced bNAbs for HIV prevention
 

IAVI and partners are engineering broadly neutralizing antibodies to improve potency and half-life in an effort to make passive administration more feasible and affordable on a global scale.

 

Status
Currently in preclinical development by IAVI

 

Partners 
Institute of Protein Innovation, Scripps Research, Serum Institute of India, United States Agency for International Development

bNAbs PGT121 and PGDM1400
 

IAVI is sponsoring or supporting trials through the VxPDC to assess these bNAbs alone or in combination in HIV-infected and uninfected volunteers for either treatment or prevention of HIV infection.

 

Status
Phase I


 

Partners 
Beth Israel Deaconess Medical Center, Bill & Melinda Gates Foundation

bNAbs 3BNC117 and 10-1074
 

IAVI is sponsoring or supporting trials 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


 

Partners 
Bill & Melinda Gates Foundation, Rockefeller University (sponsor)

 

Long-acting antiretrovirals

 
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 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 women in Africa.

 

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

 

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 is considered a strong approach to deliver the durable T-cell responses thought to be required for long-term protection against TB.

 

Status
Aeras Global TB Vaccine Foundation NPC (the South Africa affiliate of IAVI) is conducting a Phase IIa dose-defining safety and immunogenicity study involving adults in South Africa.

 

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

M72/AS01E
 

GSK’s M72 TB protein vaccine candidate, administered with the company’s AS01E adjuvant, is being tested for its ability to prevent TB disease among adult volunteers.

 

Status
Aeras Global TB Vaccine Foundation NPC (the South Africa affiliate of IAVI) is conducting a Phase IIb trial in Kenya, South Africa, and Zambia.

 

Partners 
GSK (sponsor)

H56/IC31
 

Statens Serum Institut’s H56 TB protein vaccine candidate in combination with the IC31® adjuvant, developed by Valneva, will be 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.

 

Status
Aeras Global TB Vaccine Foundation NPC (the South Africa affiliate of IAVI) will conduct a Phase II trial in South Africa and Tanzania, planned for Q4 2018.

 

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