Summary of HIV‑1 vaccine clinical studies conducted by Johnson & Johnson

Study name
Study number
Clinicaltrials.gov identifier
countries
Study name
Mensch
Study number
HIV-V-A002 / IPCAVD006
Clinicaltrials.gov identifier
Countries
USA (single site in Boston)

Study number
HIV-V-A003
Clinicaltrials.gov identifier
Countries
USA (single site in Miami)

Study name
Approach
Study number
HIV-V-A004
Clinicaltrials.gov identifier
Countries
Rwanda
South Africa
Thailand
Uganda
USA

Study number
HPX1002 / IPCAVD010
Clinicaltrials.gov identifier
Countries
USA (single site in Boston)

Study name
Traverse
Study number
HPX2004 / HVTN 117
Clinicaltrials.gov identifier
Countries
Rwanda
USA

Study name
Ascent
Study number
HPX2003 / HVTN 118
Clinicaltrials.gov identifier
Countries
Kenya
Rwanda
USA

Study name
Imbokodo
Study number
HPX2008 / HVTN 705
Clinicaltrials.gov identifier
Countries
Malawi
Mozambique
South Africa
Zambia
Zimbabwe

Study name
Mosaico
Study number
HPX3002 / HVTN 706
Clinicaltrials.gov identifier
Countries
Argentina
Brazil
Italy
Mexico
Peru
Poland
Spain
USA (including Puerto Rico)

Summary of contact information by region/country for VISP HIV testing service for former Johnson & Johnson study participants

Region/Country
Contact

Malawi, Mozambique, South Africa, Zambia, or Zimbabwe

Mexico, Argentina, or Brazil
Please contact the study site (doctor) where your patient was vaccinated


Thailand
Please contact the study site (doctor) where your patient was vaccinated

Uganda, Rwanda, or Kenya
Please contact the study site (doctor) where your patient was vaccinated

More information: Find additional literature to learn more about HIV vaccines and VISP

Name of
first author
Title
Journal
Year
Doi
W. Colón
HIV diagnostics and vaccines: it takes two to tango
J Infect Dis
2024
10.1093/infdis/jiae113

N. Espy
Cross-protocol assessment of induction and durability of VISP/R in HIV preventive vaccine trial participants
PLOS Glob Public Health
2023
10.1371/journal.pgph.0002037

C. Durier
Long-term safety and vaccine-induced seropositivity in healthy volunteers from HIV vaccine trials
AIDS
2019
10.1097/QAD.0000000000002310

M. Couderc
Being “false positive”: an “inconvenience”? Debates and questions regarding the notion of vaccine-induced seropositivity (VISP) in the recruitment of healthy volunteers for a preventive anti-HIV vaccine trial
J Acquir Immune Defic Syndr
2018
10.1097/QAI.0000000000001814

Y. Voronin (VISR Working Group of Global HIV Vaccine Enterprise)
HIV vaccine-induced sero-reactivity: a challenge for trial participants, researchers, and physicians
Vaccine
2015
10.1016/j.vaccine.2014.10.040

E. Van Braeckel
Vaccine-induced HIV seropositivity: a problem on the rise
J Clin Virol
2011
10.1016/j.jcv.2011.01.003

C.J. Cooper
Vaccine-induced HIV seropositivity/reactivity in noninfected HIV vaccine recipients
JAMA
2010
10.1001/jama.2010.926

Glossary

DNA - Deoxyribonucleic acid, a form of genetic material. Once HIV is inside a cell, its RNA is converted into DNA
DNA PCR - Deoxyribonucleic acid polymerase chain reaction, a nucleic acid test that detects small amounts of DNA
EIA - Enzyme-linked immunoassays, a laboratory test that detects antibodies and antigens/proteins, such as those from HIV
HIV - Human immunodeficiency virus
HVTN - HIV Vaccine Trials Network
J&J - Johnson & Johnson
NAAT - Nucleic acid amplification test, a nucleic acid test with “amplification,” which refers to the technology that is necessary to detect very small amounts of the nucleic acid
NAT - Nucleic acid test, an overall term for tests that detect genetic material (nucleic acid like RNA or DNA)
PCR - Polymerase chain reaction, which refers to the technology used to amplify very small amounts of nucleic acid so that it can be detected
RNA - Ribonucleic acid, a form of genetic material. The genetic material (or genome) of HIV is made of RNA
RNA PCR - Ribonucleic acid polymerase chain reaction, a nucleic acid test that detects small amounts of RNA
TNA - Total nucleic acid test, a test that detects both RNA and DNA
VISP - Vaccine-induced seropositivity
VISR - Vaccine-induced seroreactivity
Download Glossary

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Johnson & Johnson does not have an active HIV-1 vaccine development program and only provides this website for information.


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