IAVI T001

IAVI T001

Phase:
I
Status:
Ongoing
Strategies:
Passive Immunization
Candidates:
PGT121
Countries:
USA
Volunteers:              63
Partners:
Beth Israel Deaconess Medical Center, Ragon Institute of MGH, MIT and Harvard
 
This is a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics and anti-viral efficacy of the PGT121 monoclonal antibody for HIV prevention and therapy. PGT121 mAb is a recombinant human IgG1 monoclonal antibody that targets a V3 glycan-dependent epitope region of the HIV envelope protein. PGT121 mAb was chosen for this study because it is potent, neutralizes a wide array of HIV viruses, and can prevent and treat simian-human immunodeficiency virus (SHIV) in rhesus monkeys.
ClinicalTrials.gov Identifier: NCT02960581

IPCAVD009

Safety, Tolerability, and Immunogenicity Study of Homologous Ad26 Mosaic Vector Vaccine Regimens or Heterologous Ad26 Mosaic and MVA Mosaic Vector Vaccine Regimens With Glycoprotein 140 (gp140) for Human Immunodeficiency Virus (HIV) Prevention
 
Sponsor: Crucell Holland BV
Collaborators: U.S. National Institute of Allergy and Infectious Diseases Division of AIDS, U.S. Military HIV Research Program, Beth Israel Deaconess Medical Center, International AIDS Vaccine Initiative
 
 
ClinicalTrials.gov Identifier: NCT02315703
 
USA; Rwanda; South Africa; Thailand; Uganda
 
Estimated  Enrollment: 400
Study Start Date:

December 2014

 

IDEA EV06

Phase:
I
Status:
Completed
Strategies:
DNA, Protein
Candidates:
DNA-HIV-PT123, AIDSVAX B/E
Countries:
Uganda
Volunteers:
72
Partners:
IAVI; EuroVacc Foundation
 

A phase I double blind placebo-controlled clinical trial to evaluate the safety and immunogenicity of the combination of DNA-HIV-PT123 and AIDSVAX ® B/E in HIV-1-uninfected adult participants with or without underlying Schistosoma mansoni (S. mansoni) infection.

ClinicalTrials.gov Identifier: NCT02376582

IAVI R001

Phase:
I
Status:
Completed
Candidates:
rcAd26.MOS1.HIVEnv
Countries:
United States
Volunteers:
24
Partners:

University of Rochester; Beth Israel Deaconess Medical Center

Phase 1 Trial of the Safety and Immunogenicity of an Oral, Replicating Ad26 Vectored HIV-1 Vaccine

ClinicalTrials.gov Identifier: NCT02366013

N004 (HIVCORE 004)

Phase:
I/IIA
Status:
Completed
Strategies:
DNA, Viral Vector - Pox, Viral Vector-Adeno
Candidates:
Ad35-GRIN, MVA.HIVconsv, pSG2.HIVconsvDNA
Countries:
Kenya
Volunteers:
72
Partners:
IAVI; University of Oxford; European and Developing Countries Clinical Trials Partnership (EDCTP); Karolinska Institutet; University of Nairobi Ichor Medical Systems Incorporated
 
A Phase I/IIa Clinical Trial of HIV-1 Vaccines pSG2.HIVconsv DNA, MVA.HIVconsv and Ad35-GRIN in Combined Regimens in Healthy HIV-1/2-negative Adults in Nairobi
 
The study is part of a long-term aim to develop an effective HIV-1 vaccine and will evaluate safety and immunogenicity of vaccines focusing T cell responses on  the conserved region of the HIV-1 proteome. The vaccines used are pSG2.HIVconsv DNA (D), MVA.HIVconsv (M) and Ad35-GRIN (A), delivered in regimens AM, DDDAM and DeDeDeAM, where e indicates electroporation. ClinicalTrials.gov Identifier: NCT02099994