Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-27 @ 11:11 PM
Study NCT ID:
NCT01571960
Status:
COMPLETED
Last Update Posted:
2021-10-15
First Post:
2012-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Safety and Immune Response of a Prime-Boost HIV Vaccine Regimen in Healthy, HIV-Uninfected, Vaccinia-Naive Adults
Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Organization:
Study Overview
Official Title:
A Phase 1 Placebo Controlled Clinical Trial to Evaluate the Safety and Immunogenicity of a Prime-Boost Vaccine Regimen of GEO-D03 DNA and MVA/HIV62B Vaccines in Healthy, HIV-1-Uninfected Vaccinia Naive Adult Participants
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:
This study will test the safety and immune responses of a prime-boost regimen of two HIV vaccines- a DNA vaccine followed by a modified vaccinia Ankara (MVA) vaccine- in healthy, HIV-uninfected, vaccinia-naive adults.
Detailed Description:
Although multiple candidate HIV vaccines are being studied, there is not yet an effective preventive HIV vaccine. This study will test the safety and immune responses of prime-boost regimens of two HIV vaccines: two injections of GEO-D03 DNA priming vaccine followed by either two or three boosting injections of MVA/HIV62B (MVA62B) vaccine.
This study will enroll 48 healthy, HIV-1-uninfected, vaccinia-naive adults into 1 of 3 groups. Participants within each group will be randomly assigned to receive either the study vaccine regimen (40 total participants) or placebo vaccine regimen (8 total participants).
The total study duration will be approximately 45 months. Participants in Group 1 will attend clinic visits for 14 months followed by annual health contacts, for a total of 3 years after initial study injection. Participants in Group 2 will attend clinic visits for 22 months followed by annual health contacts, for a total of 3 years after initial study injection. Participants in Group 3 will attend clinic visits for 20 months followed by annual health contacts, for a total of 3 years after initial study injection. Participants in Group 1 will have 17 study visits, participants in Group 2 will have 23 visits, and participants in Group 3 will have 21 visits.
At the screening visit, participants will give a medical history and undergo a complete physical exam, electrocardiogram (ECG), urine collection, blood collection, interview, HIV test, and pregnancy test (for participants who were born female). Participants will receive an intramuscular (IM) vaccination (study vaccine or placebo) into the deltoid on the schedule assigned to their group. The vaccination schedule is as follows: Group 1 participants will receive an injection on Days 0, 56, 112, 168, and 224; Group 2 participants will receive an injection on Days 0, 56, 112, 168, and 303; Group 3 participants will receive an injection on Days 0, 56, 112, and 224. On vaccination visits, participants will also undergo an abbreviated physical exam, a pregnancy test (for participants who were born female), risk-reduction counseling, and blood collection. Immediately following vaccination, participants will remain in the clinic for observation for 30 minutes; participants will be given a post-vaccination symptom log and instructed on how to complete it. Follow-up visits will consist of a brief physical exam, blood collection, and interview; some follow-up visits may also consist of a urine collection, HIV test, or ECG.
The last clinic visit will be at Day 425 for participants in Group 1, Day 667 for participants in Group 2, and Day 607 for participants in Group 3; after this visit, participants will be contacted for annual health follow-up consisting of confirming vital status, collecting safety information, and reporting a new HIV diagnosis or a pregnancy. A clinic visit will only be required if HIV confirmatory testing is necessary.
This study will enroll 48 healthy, HIV-1-uninfected, vaccinia-naive adults into 1 of 3 groups. Participants within each group will be randomly assigned to receive either the study vaccine regimen (40 total participants) or placebo vaccine regimen (8 total participants).
The total study duration will be approximately 45 months. Participants in Group 1 will attend clinic visits for 14 months followed by annual health contacts, for a total of 3 years after initial study injection. Participants in Group 2 will attend clinic visits for 22 months followed by annual health contacts, for a total of 3 years after initial study injection. Participants in Group 3 will attend clinic visits for 20 months followed by annual health contacts, for a total of 3 years after initial study injection. Participants in Group 1 will have 17 study visits, participants in Group 2 will have 23 visits, and participants in Group 3 will have 21 visits.
At the screening visit, participants will give a medical history and undergo a complete physical exam, electrocardiogram (ECG), urine collection, blood collection, interview, HIV test, and pregnancy test (for participants who were born female). Participants will receive an intramuscular (IM) vaccination (study vaccine or placebo) into the deltoid on the schedule assigned to their group. The vaccination schedule is as follows: Group 1 participants will receive an injection on Days 0, 56, 112, 168, and 224; Group 2 participants will receive an injection on Days 0, 56, 112, 168, and 303; Group 3 participants will receive an injection on Days 0, 56, 112, and 224. On vaccination visits, participants will also undergo an abbreviated physical exam, a pregnancy test (for participants who were born female), risk-reduction counseling, and blood collection. Immediately following vaccination, participants will remain in the clinic for observation for 30 minutes; participants will be given a post-vaccination symptom log and instructed on how to complete it. Follow-up visits will consist of a brief physical exam, blood collection, and interview; some follow-up visits may also consist of a urine collection, HIV test, or ECG.
The last clinic visit will be at Day 425 for participants in Group 1, Day 667 for participants in Group 2, and Day 607 for participants in Group 3; after this visit, participants will be contacted for annual health follow-up consisting of confirming vital status, collecting safety information, and reporting a new HIV diagnosis or a pregnancy. A clinic visit will only be required if HIV confirmatory testing is necessary.
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 11827 | REGISTRY | DAIDS ES | View |