NCT00961883

Safety of and Immune Response to Prime/Boost Vaccine Regimens in Healthy, HIV-1 Uninfected, Ad5 Seronegative Adults

A Phase 1b Clinical Trial to Evaluate the Safety and Immunogenicity of Heterologous Prime/Boost Vaccine Regimens (NYVAC-B/rAd5 vs. rAd5/NYVAC-B) in Healthy, HIV-1 Uninfected, Ad5 Seronegative Adult Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: HIV Vaccine Trials Network · Network
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Investigators will examine the safety of and immune responses to two vaccines expressing synthetic HIV proteins: NYVAC-B (a poxvirus), and rAd5 (an adenovirus). The study will compare responses in participants receiving NYVAC-B first, and rAd5 later, to those who receive rAd5 first, and NYVAC-B later. A different dose of rAd5 will be tested in each group.

Detailed description

In order to halt the HIV pandemic an effective vaccine must be developed. In this study, investigators will examine the safety and immune response to a prime-boost strategy using two different vaccine regimens, NYVAC-B and rAd5. Eighty participants will be recruited to this study. Participants will be randomly assigned to one of four different groups (study arms). Each group will receive both study vaccines and placebo but at different times. All NYVAC-B vaccine doses will be the same, but the doses of the rAD5 vaccine will differ from group to group. Some participants in each group will receive only placebo. Participants will visit the study clinic about 13 times over the course of 12 months and be contacted for follow-up for 4 years. All study injections will be given in the same upper arm area. There will be a total of four injections during the course of the study. After each injection, participants will need to stay in the clinic for at least 25 minutes to check for any adverse reactions. Additionally, participants will need to monitor their own health on the evening after the injection and for the next three evenings, by taking their temperature and making notes of any noticed side effects. Tools will be provided to accomplish both of these tasks. During these few days following the injection, study investigators will need to maintain contact with participants (the participant will specify the best mode of contact). Certain clinical procedures will be performed during the course of this study including regular HIV testing and counseling, physical exams, collection of blood and urine, pregnancy tests if applicable, questions about health and medications, questions about HIV risk and sexual behaviors, and any personal problems or benefits participants may have experienced from participating in the study.

Conditions

• HIV Infections

Interventions

Type	Name	Description
BIOLOGICAL	NYVAC-B	New York Vaccinia (NYVAC) vector for HIV-1, delivered intramuscularly by injection at a dose of 1 x 10 \^7 PFU
BIOLOGICAL	Placebo	Sodium Chloride for injection, delivered intramuscularly
BIOLOGICAL	rAd5	Recombinant adenoviral serotype 5 (rAd5) vector vaccine, delivered by injection intramuscularly at a dose of 1 x 10\^10 PFU
BIOLOGICAL	rAd5	Recombinant adenoviral serotype 5 (rAd5) vector vaccine, delivered by injection intramuscularly at a dose of 1 x 10\^9 PFU
BIOLOGICAL	rAd5	Recombinant adenoviral serotype 5 (rAd5) vector vaccine, delivered by injection intramuscularly at a dose of 1 x 10\^8 PFU

Timeline

• Start date: 2009-08-01
• Primary completion: 2013-01-01
• First posted: 2009-08-19
• Last updated: 2013-09-06

Locations

2 sites across 1 country: Switzerland