Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00043511
Status:
COMPLETED
Last Update Posted:
2021-10-14
First Post:
2002-08-09
Brief Title:
Safety of an HIV DNA Vaccine Given to 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 the HIV-1 pGA2JS2 Plasmid DNA Vaccine Given Intramuscularly IM in 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:
The purpose of this study is to see if the experimental HIV vaccine pGA2JS2 is safe and is well tolerated at two different doses Another important purpose of this study is to observe how the immune system responds to the vaccine at different dose levels
Vaccines are given to people to help their bodies fight infection The vaccine being tested in this study is a DNA vaccine The pGA2JS2 plasmid DNA vaccine instructs the body to make some HIV proteins These HIV proteins may trigger an immune response Because only a few of the many proteins HIV needs are made through DNA vaccination there is no risk of getting HIV from the vaccination This and other similar DNA vaccines have been tested for safety in mice rabbits and monkeys The vaccine has been well tolerated at doses to be used in this study
Vaccines are given to people to help their bodies fight infection The vaccine being tested in this study is a DNA vaccine The pGA2JS2 plasmid DNA vaccine instructs the body to make some HIV proteins These HIV proteins may trigger an immune response Because only a few of the many proteins HIV needs are made through DNA vaccination there is no risk of getting HIV from the vaccination This and other similar DNA vaccines have been tested for safety in mice rabbits and monkeys The vaccine has been well tolerated at doses to be used in this study
Detailed Description:
DNA vaccination has induced immune responses in animals to a number of viral bacterial and parasite derived antigens Early clinical experiences with HIV DNA vaccines in humans indicate 1 the tolerability and short-term safety of DNA at doses up to 5000 mcg in humans are excellent and 2 there is potential for immunogenicity
The pGA2JS2 DNA vaccine is part of a planned primeboost regimen of a DNA vaccine prime followed by a modified vaccinia Ankara MVA vaccine boost In studies in monkeys a combination of a DNA vaccine and an MVA vaccine protected the monkeys against disease caused by a monkey virus similar to HIV The current study is an initial investigation of the safety and immunogenicity of the DNA vaccine given alone The pGA2JS2 DNA vaccine expresses gag protease reverse transcriptase env tat vpu and rev
Participants are randomized to 1 of 2 groups People in Group A receive either 2 injections of a lower dose 300 mcg of the DNA plasmid vaccine or the placebo control People in Group B receive either 2 injections of a higher dose 3000 mcg of the DNA plasmid vaccine or the control Group B will be enrolled only if the vaccine is found to be safe and well-tolerated during the initial 2-week evaluation of all participants in Group A Participants receive vaccinations administered at Months 0 and 2 All vaccinations are administered by intramuscular IM injection in an outpatient setting Participants have about 10 clinic visits during this study including the screening and injection visits Participants give blood and urine samples at study visits They are tested for HIV before entering the study and 4 more times during the study Women who can become pregnant may undergo up to 3 pregnancy tests during the study period
The pGA2JS2 DNA vaccine is part of a planned primeboost regimen of a DNA vaccine prime followed by a modified vaccinia Ankara MVA vaccine boost In studies in monkeys a combination of a DNA vaccine and an MVA vaccine protected the monkeys against disease caused by a monkey virus similar to HIV The current study is an initial investigation of the safety and immunogenicity of the DNA vaccine given alone The pGA2JS2 DNA vaccine expresses gag protease reverse transcriptase env tat vpu and rev
Participants are randomized to 1 of 2 groups People in Group A receive either 2 injections of a lower dose 300 mcg of the DNA plasmid vaccine or the placebo control People in Group B receive either 2 injections of a higher dose 3000 mcg of the DNA plasmid vaccine or the control Group B will be enrolled only if the vaccine is found to be safe and well-tolerated during the initial 2-week evaluation of all participants in Group A Participants receive vaccinations administered at Months 0 and 2 All vaccinations are administered by intramuscular IM injection in an outpatient setting Participants have about 10 clinic visits during this study including the screening and injection visits Participants give blood and urine samples at study visits They are tested for HIV before entering the study and 4 more times during the study Women who can become pregnant may undergo up to 3 pregnancy tests during the study period
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 |
|---|---|---|---|
| 10593 | REGISTRY | DAIDS ES Registry Number | None |