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HVTN 100

Status
Completed
Phase
I/II
Principal Investigator(s)
Linda-Gail Bekker, MBChB, DTMH, DCH, FCP(SA), PhD
Objective

About 252 people will take part in this study at multiple sites. The US National Institutes of Health (NIH) is paying for the study.

The investigators are doing this study to answer several questions.

  • Are the study vaccines safe to give to people?
  • Are people able to take the study vaccines without becoming too uncomfortable?
  • How do people's immune systems respond to the study vaccines? (Your immune system protects you from disease.)

*Interim results from HVTN 100, presented July, 2016 at the AIDS 2016 in Durban, provided the green light for a Phase III efficacy trial (HVTN 702) on the modified RV144 regimen*

 

*Trial is in follow-up*

 

Last updated March 31, 2021

Prevention Option(s)
HIV Vaccine
Study Design
Controlled
Randomized
Double-blind
Arms and Assigned Interventions
Description
2 recombinant monomeric proteins, each at a dose of 100 mcg, mixed with MF59® adjuvant (an oil-in-water emulsion) delivered as a 0.5 mL IM injection
Mode of Delivery
Intramuscular
Products
ALVAC
gp120
ARMs
Experimental
Clade
C
Description
Sodium chloride for injection, 0,9% delivered as a 0.5 mL IM injection
Mode of Delivery
Intramuscular
ARMs
Placebo Comparator
Results
Subtype C ALVAC-HIV and bivalent subtype C gp120/MF59 HIV-1 vaccine in low-risk, HIV-uninfected, South African adults: a phase 1/2 trial.
Official Code
NCT02404311
Related Publications
Safety and immune responses after a 12-month booster in healthy HIV-uninfected adults in HVTN 100 in South Africa: A randomized double-blind placebo-controlled trial of ALVAC-HIV (vCP2438) and bivalen
Landscapes of binding antibody and T-cell responses to pox-protein HIV vaccines in Thais and South Africans
Trial Sponsors
National Institute of Allergy and Infectious Diseases (NIAID), HIV Vaccine Trials Network Bill and Melinda Gates Foundation, Medical Research Council Sanofi Pasteur, a Sanofi Company, Novartis Vaccines
January 2015
August 2018
Enrollment
252
18
Years
40
Population
Men
Women
Sites

CAPRISA eThekwini Clinical Research Site

Durban, KwaZulu-Natal
South Africa

Isipingo CRS

Westville, KwaZulu-Natal
South Africa

Emavundleni Desmond Tutu HIV Centre CRS

Cape Town
South Africa

Aurum Institute

Klerksdorp
South Africa

Perinatal HIV Research Unit

Soweto
South Africa

Soshanguve

South Africa