NCT02404311

A Safety and Immune Response Study of 2 Experimental HIV Vaccines

A Phase 1-2 Randomized, Double-blind, Placebo-controlled Clinical Trial of Clade C ALVAC-HIV (vCP2438) and Bivalent Subtype C gp120/MF59® in HIV-uninfected Adults at Low Risk of HIV Infection

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 252 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.)

Detailed description

The HIV Vaccine Trials Network (HVTN) is doing a study to test a new HIV vaccine combination. HIV is the virus that causes AIDS. 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.) The study uses 2 different vaccines: ALVAC-HIV (vCP2438) and bivalent gp120/MF59. These are experimental HIV vaccines -- the investigators do not know whether the vaccines will be safe to use in people, or whether they will work to prevent HIV infection. These vaccines are used only in research studies. The ALVAC vaccine is made out of canarypox virus, which infects birds but cannot grow in human cells. This virus has small bits of man-made DNA inserted into it. DNA is a natural substance found in all living things, including people and some viruses. The canarypox virus helps get the DNA into the body's cells. The DNA then tells those cells to make small amounts of proteins that look like some of the ones found in HIV. A study in South Africa, HVTN 097, gave a similar ALVAC vaccine to about 80 participants. So far, no one has had serious health problems. The Protein vaccine has man-made pieces of a protein found on the outside of HIV. These protein pieces are mixed with an adjuvant called MF59. An adjuvant is something added to the vaccine to help the immune system respond better. MF59 has been included with other vaccines that have been given to over 50,000 people in clinical trials without causing any serious health problems. This combination of study vaccines has not been given to people before. However, similar ALVAC and protein vaccines have been given to more than 10,000 people in clinical trials without causing any serious health problems. Also, over 300 people have received a similar combination of ALVAC and protein vaccines with the MF59 adjuvant in clinical trials without having any serious health problems. The study is in 2 parts, Part A and Part B. Part B continues the study in order to learn how well boosting the study vaccines improves immune responses. 252 people took part in Part A of this study at multiple sites. Those who continue to meet eligibility requirements are invited to continue in Part B. The US National Institutes of Health (NIH) is paying for the study. For people who continue to Part B, the study requires about 23 clinic visits in 4 years.

Conditions

• HIV Infection

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-02-02
• Primary completion: 2018-08-07
• Completion: 2018-08-07
• First posted: 2015-03-31
• Last updated: 2021-11-05
• Results posted: 2020-10-19

Locations

5 sites across 1 country: South Africa

Regulatory

• FDA-regulated drug study