MedTrace Logo

A Safety and Immune Response Study of 2 Experimental HIV Vaccines

NCT02404311 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2021-11-05

Study results available
· View outcomes & findings →

Summary

The HIV Vaccine Trials Network (HVTN) is doing a study to test a new HIV vaccine combination. HIV is the virus that causes AIDS.

252 people are taking 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.)

Conditions

  • HIV Infection

Interventions

BIOLOGICAL

ALVAC-HIV

a lyophilized vaccine for injection at a viral titer ≥ 1 × 10E6 cell culture infectious dose (CCID)50 and \< 1 × 10E8 CCID50 (nominal dose of 10E7 CCID50) and is reconstituted with 1mL of sterile sodium chloride solution (NaCl 0.4%) for intramuscular (IM) injection as a single dose.

BIOLOGICAL

Bivalent Subtype C gp120/MF59®

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

BIOLOGICAL

ALVAC-HIV (vCP2438) Placebo

a sterile, lyophilized product that consists of a mixture of virus stabilizer, and freeze drying medium and is reconstituted with 1mL of sterile sodium chloride solution (NaCl 0.4%) for injection as a single dose IM

BIOLOGICAL

Bivalent gp120/MF59® Placebo

Sodium chloride for injection, 0,9% delivered as a 0.5 mL IM injection

Sponsors & Collaborators

  • HIV Vaccine Trials Network

    collaborator NETWORK

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Medical Research Council

    collaborator OTHER_GOV

  • Sanofi Pasteur, a Sanofi Company

    collaborator INDUSTRY

  • GlaxoSmithKline

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Linda-Gail Bekker, MBChB, DTMH, DCH, FCP(SA), PhD · HIV Vaccine Trials Network

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-02-02
Primary Completion
2018-08-07
Completion
2018-08-07
FDA Drug
Yes

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02404311 on ClinicalTrials.gov