Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00301184
Status:
COMPLETED
Last Update Posted:
2022-08-08
First Post:
2006-03-08
Brief Title:
Safety of and Immune Response to a DNA HIV Vaccine pGA2JS7 Boosted With a Modified Vaccinia HIV Vaccine MVAHIV62 in Healthy 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 Clinical Trial to Evaluate the Safety and Immunogenicity of pGA2JS7 DNA Vaccine and Recombinant Modified Vaccinia AnkaraHIV62 Vaccine in Healthy HIV-1-Uninfected Adult Participants
Status:
COMPLETED
Status Verified Date:
2022-08
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 determine the safety of and immune response to a DNA HIV vaccine pGA2JS7 followed by a modified vaccinia smallpox HIV vaccine MVAHIV62 in HIV uninfected adults
Detailed Description:
The worldwide HIVAIDS epidemic may only be controlled through a safe and effective vaccine that will prevent HIV infection DNA vaccines are inexpensive to construct easily produced in large quantities and stable for long periods of time Recombinant modified vaccinia Ankara vaccines have been shown to be safe in humans and immunogenicity after administration of both vaccines has been encouraging When used together a more robust immunologic response was associated with DNA HIV vaccine administration followed by modified vaccinia vaccine administration compared to using either DNA or vaccinia vaccine alone This study will evaluate the safety and immunogenicity of an experimental DNA HIV vaccine prime pGAJS7 followed by a similarly structured modified vaccinia boost MVAHIV62 in HIV uninfected adults Participants in this study will be recruited only in the United States
This study will be divided into 2 parts Each participant will be involved with their part of study for 1 year Participants in Part 1 will be randomly assigned to one of two different vaccination groups Group 1A participants will be randomly assigned to receive either placebo or 2 lower doses of the DNA HIV vaccine DNA at study entry and Month 2 followed by 2 lower doses of the modified vaccinia vaccine MVA at Months 4 and 6 Group 1B will not enroll until safety and immunogenicity data from Group 1A have been evaluated Group 1B participants will receive either placebo or two higher doses of DNA at study entry and Month 2 followed by two higher doses of MVA at Months 4 and 6
Enrollment into Part 2 will begin only after safety data from Part 1 are reviewed In Part 2 participants will be randomly assigned to one of two different vaccination groups Within each group participants will be randomly assigned to receive some series of vaccines or placebo Group 2A participants will receive either placebo or the maximum tolerated dose MTD from Part 1 of DNA at study entry and MTD of MVA at Months 2 and 6 Group 2B participants will receive MTD of MVA at study entry and Months 2 and 6
There will be 12 study visits over 12 months for Groups 1 and 2 There will be 11 study visits over 12 months for Groups 3 and 4 Medication history a physical exam an interview HIV and pregnancy prevention counseling and adverse events reporting will occur at all visits Blood and urine collection and an electrocardiogram ECG will occur at selected visits
This study will be divided into 2 parts Each participant will be involved with their part of study for 1 year Participants in Part 1 will be randomly assigned to one of two different vaccination groups Group 1A participants will be randomly assigned to receive either placebo or 2 lower doses of the DNA HIV vaccine DNA at study entry and Month 2 followed by 2 lower doses of the modified vaccinia vaccine MVA at Months 4 and 6 Group 1B will not enroll until safety and immunogenicity data from Group 1A have been evaluated Group 1B participants will receive either placebo or two higher doses of DNA at study entry and Month 2 followed by two higher doses of MVA at Months 4 and 6
Enrollment into Part 2 will begin only after safety data from Part 1 are reviewed In Part 2 participants will be randomly assigned to one of two different vaccination groups Within each group participants will be randomly assigned to receive some series of vaccines or placebo Group 2A participants will receive either placebo or the maximum tolerated dose MTD from Part 1 of DNA at study entry and MTD of MVA at Months 2 and 6 Group 2B participants will receive MTD of MVA at study entry and Months 2 and 6
There will be 12 study visits over 12 months for Groups 1 and 2 There will be 11 study visits over 12 months for Groups 3 and 4 Medication history a physical exam an interview HIV and pregnancy prevention counseling and adverse events reporting will occur at all visits Blood and urine collection and an electrocardiogram ECG will occur at selected visits
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 |
|---|---|---|---|
| 5P01AI049364-05 | NIH | DAIDS ES Registry Number | httpsreporternihgovquickSearch5P01AI049364-05 |
| 10140 | REGISTRY | None | None |