Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-01-08 @ 4:54 PM
Study NCT ID:
NCT00618605
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2008-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of and Immune Response to an Adenoviral HIV-1 Vaccine in Healthy Adults
Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Organization:
Study Overview
Official Title:
A Phase 1 Randomized, Double-Blind, Placebo Controlled Dose Escalation Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Adenovirus Serotype 26 HIV-1 Vaccine (Ad26.ENVA.01) in Healthy, HIV-1 Uninfected Adults
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Successful control of the HIV epidemic will require a safe and effective vaccine to be developed. A successful vaccine will need to stimulate a widespread immune response. The purpose of this study is to determine the safety of and immune response to an adenovirus serotype HIV vaccine in HIV uninfected adults.
Detailed Description:
HIV infection continues to spread at pandemic levels throughout the world. Control of this pandemic can only be achieved with the development of a safe and effective preventive HIV vaccine. A vaccine that will prevent HIV infection will elicit a strong immune response from both CD4 and CD8 cells. Recombinant adenovirus serotype vectors have been shown to elicit just such a response. The purpose of this study is to determine the safety and immunogenicity of the recombinant adenovirus serotype 26 preventive HIV-1 vaccine.
This study will last 12 months. Participants will be randomly assigned to one of four arms that will receive different doses of the vaccine or placebo administered via intermuscular injection. Participants in Arms 1, 2, and 3 will all receive 3 injections. Each injection will contain the same dose of vaccine. Arm 4 will receive 2 injections of a dose of vaccine that will be determined by the safety data from Arms 1, 2, and 3. Participants will be enrolled sequentially, from lowest to highest dose of vaccine, into Arms 1, 2, and 3. Arms will begin enrollment only following review of safety data from the previous group. After the Day 42 safety data from Arms 1, 2, and 3 have been reviewed, the dose for Arm 4 will be determined, and enrollment into that arm will begin.
There will be 10 study visits in this study, occurring at baseline and after 0.5, 1, 1.5, 2, 6, 6.5, 7, and 12 months. Participants in Arms 1, 2, and 3 will receive injections on Days 0, 28, and 168. Participants in Arm 4 will receive injections on Days 0 and 168. Participants will be asked to record their temperature and other side effects in a symptom log for 7 days after each injection. Risk reduction/pregnancy prevention counseling will occur at visits 1 through 9, and physical exams and assessments of illness or adverse events will occur at all visits. At most visits, blood, urine, and oral swab collection will occur. At some visits, HIV testing and pregnancy testing will occur.
Once a year for 5 years following study entry, participants will attend a study visit or will be contacted by study staff by telephone or e-mail for follow-up safety and health monitoring. Some participants will also undergo a blood collection at these visits.
This study will last 12 months. Participants will be randomly assigned to one of four arms that will receive different doses of the vaccine or placebo administered via intermuscular injection. Participants in Arms 1, 2, and 3 will all receive 3 injections. Each injection will contain the same dose of vaccine. Arm 4 will receive 2 injections of a dose of vaccine that will be determined by the safety data from Arms 1, 2, and 3. Participants will be enrolled sequentially, from lowest to highest dose of vaccine, into Arms 1, 2, and 3. Arms will begin enrollment only following review of safety data from the previous group. After the Day 42 safety data from Arms 1, 2, and 3 have been reviewed, the dose for Arm 4 will be determined, and enrollment into that arm will begin.
There will be 10 study visits in this study, occurring at baseline and after 0.5, 1, 1.5, 2, 6, 6.5, 7, and 12 months. Participants in Arms 1, 2, and 3 will receive injections on Days 0, 28, and 168. Participants in Arm 4 will receive injections on Days 0 and 168. Participants will be asked to record their temperature and other side effects in a symptom log for 7 days after each injection. Risk reduction/pregnancy prevention counseling will occur at visits 1 through 9, and physical exams and assessments of illness or adverse events will occur at all visits. At most visits, blood, urine, and oral swab collection will occur. At some visits, HIV testing and pregnancy testing will occur.
Once a year for 5 years following study entry, participants will attend a study visit or will be contacted by study staff by telephone or e-mail for follow-up safety and health monitoring. Some participants will also undergo a blood collection at these visits.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: