Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00083603
Status:
COMPLETED
Last Update Posted:
2021-10-14
First Post:
2004-05-26
Brief Title:
Safety of and Immune Response to Two HIV Vaccine Formulations rMVA-HIV and rFPV-HIV Alone or in Combination in HIV Uninfected Adults
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase I Trial to Evaluate the Safety and Immunogenicity of rMVA-HIV rMVA-HIV EnvGag rMVA-HIV TatRevNef-RT and rFPV-HIV rFPV-HIV EnvGag rFPV-HIV TatRevNef-RT Vaccines Alone or in Combination in Healthy Vaccinia Naive HIV-1 Negative 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:
The purpose of this study is to evaluate the safety of and immune response to two HIV vaccine formulations rMVA-HIV and rFPV-HIV alone and in combination in HIV uninfected adults
Detailed Description:
Pox viruses are used for investigational vaccines in humans because they can accommodate large amounts of foreign DNA can infect mammalian cells and can access the cytotoxic T-cell responses believed to be important in the control of HIV infection and disease Two pairs of matching recombinant HIV vaccines have been developed for use in this study One pair uses a modified vaccinia Ankara MVA vector and the other pair uses a fowlpox vector FPV Each vaccine pair consists of one vaccine containing envgag sequences and one vaccine containing modified tatrevnef-RT sequences The HIV sequences are identical and are from a vertically transmitted pediatric primary isolate The controls in this study are MVA vectors and FPVs without the HIV genes The study will evaluate the safety and immunogenicity of the vaccine pairs
There are two parts to this study Participants in Part A will be randomly assigned to one of five different vaccination groups Within each group participants will be randomly assigned to receive either vaccine or control injections Group 1 participants will receive the FPV vaccine pair or FPV control at each vaccine visit Groups 2 3 and 4 will receive one of three different doses of the MVA vaccine pair or MVA control at study entry and Month 1 then a fixed dose of the FPV vaccine pair or FPV control at Months 3 5 and 7 Group 5 participants will receive the MVA vaccine pair or MVA control at maximum tolerated dose MTD at each vaccine visit Groups 1 and 2 will enroll simultaneously Groups 3 4 and 5 will enroll as safety data from the previous groups become available
In Part B participants will be randomly assigned to receive study vaccine or control vaccine in one of three vaccination groups Group 6 participants will receive the FPV vaccine pair or FPV control at each vaccine visit Group 7 participants will receive the MVA vaccine pair or MVA control at study entry and Month 1 then a fixed dose of the FPV vaccine pair or FPV control at Months 3 5 and 7 Group 8 participants will receive the MVA vaccine pair at MTD or MVA control at each vaccine visit Enrollment into Groups 6 7 and 8 will begin simultaneously after the completion of the safety data evaluation of Groups 1 and 2
Study vaccinations will be given at study entry and at Months 1 3 5 and 7 Tests for cardiac injury will be performed at screening and at each 2-week follow-up visit after vaccination Participants will have an electrocardiogram ECG at screening and 2 weeks after the first and last vaccinations Study visits will occur at screening study entry and at 11 visits over 13 months Study visits will consist of a physical exam risk reductionpregnancy prevention counseling cardiac symptom assessment and blood and urine collection Women will have pregnancy tests at study entry and Months 1 3 5 7 and 13
There are two parts to this study Participants in Part A will be randomly assigned to one of five different vaccination groups Within each group participants will be randomly assigned to receive either vaccine or control injections Group 1 participants will receive the FPV vaccine pair or FPV control at each vaccine visit Groups 2 3 and 4 will receive one of three different doses of the MVA vaccine pair or MVA control at study entry and Month 1 then a fixed dose of the FPV vaccine pair or FPV control at Months 3 5 and 7 Group 5 participants will receive the MVA vaccine pair or MVA control at maximum tolerated dose MTD at each vaccine visit Groups 1 and 2 will enroll simultaneously Groups 3 4 and 5 will enroll as safety data from the previous groups become available
In Part B participants will be randomly assigned to receive study vaccine or control vaccine in one of three vaccination groups Group 6 participants will receive the FPV vaccine pair or FPV control at each vaccine visit Group 7 participants will receive the MVA vaccine pair or MVA control at study entry and Month 1 then a fixed dose of the FPV vaccine pair or FPV control at Months 3 5 and 7 Group 8 participants will receive the MVA vaccine pair at MTD or MVA control at each vaccine visit Enrollment into Groups 6 7 and 8 will begin simultaneously after the completion of the safety data evaluation of Groups 1 and 2
Study vaccinations will be given at study entry and at Months 1 3 5 and 7 Tests for cardiac injury will be performed at screening and at each 2-week follow-up visit after vaccination Participants will have an electrocardiogram ECG at screening and 2 weeks after the first and last vaccinations Study visits will occur at screening study entry and at 11 visits over 13 months Study visits will consist of a physical exam risk reductionpregnancy prevention counseling cardiac symptom assessment and blood and urine collection Women will have pregnancy tests at study entry and Months 1 3 5 7 and 13
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 10056 | REGISTRY | DAIDS ES Registry Number | None |