Evaluating the Safety and Immune Response of an Adenovirus-Based HIV Vaccine in HIV-Uninfected Adults
|HIV Infections||Biological: Ad26.ENVA.01 (rAd26) Biological: Placebo Vaccine||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||A Phase 1 Randomized, Double-Blind, Placebo Controlled Clinical Trial to Evaluate the Safety, Mucosal Immunogenicity and Innate Immune Responses of Recombinant Adenovirus Serotype 26 HIV-1 Vaccine (Ad26.ENVA.01) in Healthy, HIV-1 Uninfected Adults (Ad26.ENVA.01 (rAd26) HIV-1 Mucosal/IPCAVD-003 Vaccine Study)|
- Local and systemic reactions to vaccine [ Time Frame: Measured through the 18-month follow-up visit ]
- Adverse and serious adverse experiences [ Time Frame: Measured through the 18-month follow-up visit ]
- Innate immune responses, including cytokine levels and natural killer (NK) cell populations [ Time Frame: Measured through the 18-month follow-up visit ]
- Humoral immune responses, including neutralizing antibodies against HIV and Ad26 and binding antibodies [ Time Frame: Measured through the 18-month follow-up visit ]
- Cell mediated immunity, including T-cell gamma interferon responses by enzyme-linked immunosorbent spot (ELISPOT) and T-cell responses by flow cytometry [ Time Frame: Measured through the 18-month follow-up visit ]
- Mucosal immune responses, including histopathology and T-cell responses by flow cytometry [ Time Frame: Measured through the 18-month follow-up visit ]
- Genotyping [ Time Frame: Measured through the 18-month follow-up visit ]
|Study Start Date:||July 2010|
|Study Completion Date:||May 2016|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Experimental: Ad26.ENVA.01 (rAd26)
Participants will receive the Ad26.ENVA.01 (rAd26) vaccine at baseline.
Biological: Ad26.ENVA.01 (rAd26)
5 x 10^10 virus particles (VP) vaccine delivered intramuscularly (IM)
Placebo Comparator: Placebo Vaccine
Participants will receive the placebo vaccine at baseline.
Biological: Placebo Vaccine
Placebo vaccine delivered IM
Other Name: FFB, final formula buffer
Control of the global HIV pandemic will require the development of a safe and effective vaccine. Many HIV preventive vaccines that are in development use a recombinant adenovirus serotype 5 (rAd5) vector as a way of delivering the vaccine into cells. However, the majority of people, particularly in the developing world, have immunity against the Ad5 vector, which means the vaccine will not be effective at preventing HIV infection. This study will use a rAd26 vector as part of a HIV vaccine, as research has shown that relatively few people have immunity against this vector. The purpose of this study is to evaluate the safety and immunogenicity of a rAd26 vector preventive HIV-1 vaccine.
This study will enroll healthy, HIV-uninfected people. Participants will be randomly assigned to receive either the rAd26 vaccine or a placebo vaccine. All vaccines will be injected into the upper arm. At the vaccination study visit, participants will undergo a medical and medication history review, physical examination, and a rectal sampling procedure. They will then receive their assigned vaccine. After receiving the vaccine, participants will remain in the clinic for at least 30 minutes for observation and monitoring of side effects. Participants will receive counseling on HIV risk reduction and pregnancy prevention. For 7 days after the vaccination, participants will monitor their temperature and side effects. Additional study visits will occur at Days 1, 3, 7, 14, 28, 61, 168, and 365. At these visits, participants will undergo a medical history review, physical examination, counseling, and blood collection. At the Day 14 and 168 visits, a rectal sampling procedure will be performed. Participants will attend a study visit or be contacted by study researchers by telephone or e-mail 18 months after receiving the vaccine for follow-up health and safety monitoring. Participants may elect to attend optional follow-up visits for blood collection at Years 2, 3, 4, and 5.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01103687
|United States, Massachusetts|
|Brigham and Women's Hosp. Novel Adenoviral Vector Prophylactic HIV Vaccine Non-Network CRS|
|Boston, Massachusetts, United States, 02115-6110|
|Study Chair:||Lindsey Baden||Brigham and Women's Hospital|