Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001538
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Phase I Study of APL 400-003 a Candidate HIV Vaccine in HIV-Negative Volunteers
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Phase I Study of APL 400-003 a Candidate HIV Vaccine in HIV-Negative Volunteers
Status:
COMPLETED
Status Verified Date:
2000-02
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 is a randomized double blind study of the safety and immunogenicity of APL 400-003 a plasmid DNA vaccine encoding the env and rev genes of HIV-1 in HIV-negative volunteers Three doses of vaccine are being tested 100 300 and 1000 micro g 8 volunteers per dose will be randomized 6 to plasmid vaccine and 2 to a vehicle control Immunizations will be administered at day 0 and weeks 4 and 8 with a booster immunization administered at week 24 An additional 5 volunteers may be included in an open manner at the dose likely to be used in subsequent studies The primary aims of the study are to determine 1 the safety of APL 400-003 as evaluated by clinical and laboratory safety parameters and 2 the immunogenicity of APL 400-003 as determined by a broad range of laboratory assays Up to 33 patients allowing for drop-outs will be enrolled in the study and volunteers will be followed for one year after immunization
Detailed Description:
This is a randomized double blind study of the safety and immunogenicity of APL 400-003 a plasmid DNA vaccine encoding the env and rev genes of HIV-1 in HIV-negative volunteers Four doses of vaccine are being tested 100 300 1000 and 3000 micrograms 8 volunteers per dose will be randomized 6 to plasmid vaccine and 2 to a vehicle control Immunizations will be administered at day 0 and weeks 4 and 8 with a booster immunization administered at week 24 An additional 5 volunteers may be included in an open manner at the dose likely to be used in subsequent studies The primary aims of the study are to determine 1 the safety of APL 400-003 as evaluated by clinical and laboratory safety parameters and 2 the immunogenicity of APL 400-003 as determined by a broad range of laboratory assays Up to 41 patients allowing for drop-outs will be enrolled in the study and volunteers will be followed for one year after immunization
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 |
|---|---|---|---|
| 96-I-0050 | None | None | None |