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 test the safety of the candidate, and efficacy trials are Phase II and III trials in humans that test the immunogenicity and safety of the candidate.

 

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 in combination with a GSK adjuvant.


 

Partners 
Amsterdam Medical Center, Bill & Melinda Gates Foundation (BMGF), BMGF-Collaboration for AIDS Vaccine Discovery-Vaccine Immune Monitoring Consortium, 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 (BMGF), BMGF-Collaboration for AIDS Vaccine Discovery-Vaccine Immune Monitoring Consortium, 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.664 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 (BMGF), BMGF-Collaboration for AIDS Vaccine Discovery-Vaccine Immune Monitoring Consortium, 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 and 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 UVRI-IAVI, in Entebbe, Uganda, is participating in the long-term extension of HIV-V-A004, and Projet San Francisco in Kigali, Rwanda, is participating in the long-term extension of Phase I/II studies HIV-V-A004, HPX2004, and HPX2003.

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 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/II clinical trial (HIV-CORE 006) planned to start in 2020.

 

 

Partners 
European and Developing Countries Clinical Trials Partnership, Kenya AIDS Vaccine Initiative-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), 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 (HVTN 705) 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, United States National Institutes of Health

bNAbs PGT121, PGDM1400, and/or VRC07 523LS
 

IAVI is sponsoring or supporting trials through the VxPDC to assess these bNAbs alone or in combination (T001 and T002) 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 (BMGF), BMGF-Collaboration for AIDS Vaccine Discovery-Vaccine Immune Monitoring Consortium

bNAbs 3BNC117 and 10-1074
 

IAVI is supporting and will be sponsoring 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. See clincialtrials.gov for more information.

 

Status
Phase I


 

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

bNAbs PGT121, VRC07-523LS, and PGDM1400
 

IAVI is sponsoring a Phase I/II 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/II


 

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

 

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 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 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
IAVI is conducting a Phase IIa dose-defining safety and immunogenicity study (A-050) involving adults in South Africa.

 

 

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

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
IAVI is conducting a Phase IIb trial in Kenya, South Africa, and Zambia (TB018).

*The GSK proprietary AS01 adjuvant system contains QS-21 Stimulon® adjuvant licensed from Antigenics LLC, a wholly owned subsidiary of Agenus Inc. (NASDAQ: AGEN), MPL and liposomes.

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) is conducting a Phase II trial (A055) in South Africa and Tanzania.

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