Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000832
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Randomized Placebo-Controlled Double-Blinded Phase I Safety and Immunogenicity Trial of Recombinant Envelope Protein HIV-1 SF-2 rgp120 BIOCINE Combined With MF59 in HIV-1 Uninfected Adult Volunteers
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Placebo-Controlled Double-Blinded Phase I Safety and Immunogenicity Trial of Recombinant Envelope Protein HIV-1 SF-2 rgp120 BIOCINE Combined With MF59 in HIV-1 Uninfected Adult Volunteers
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:
To determine the safety and immunogenicity of rgp120HIV-1SF2 combined with MF59 adjuvant emulsion versus MF59 alone in HIV-negative volunteers
One approach to improve the immunogenicity of an HIV-1 subunit protein vaccine is to combine the immunogen with an adjuvant
One approach to improve the immunogenicity of an HIV-1 subunit protein vaccine is to combine the immunogen with an adjuvant
Detailed Description:
One approach to improve the immunogenicity of an HIV-1 subunit protein vaccine is to combine the immunogen with an adjuvant
Healthy volunteers receive intramuscular injections of rgp120HIV-1SF2 with MF59 adjuvant emulsion or MF59 alone at months 0 1 6 9 10 and 12 was months 0 1 6 and 10 amended 121996
Healthy volunteers receive intramuscular injections of rgp120HIV-1SF2 with MF59 adjuvant emulsion or MF59 alone at months 0 1 6 9 10 and 12 was months 0 1 6 and 10 amended 121996
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 |
|---|---|---|---|
| 10575 | REGISTRY | DAIDS ES Registry Number | None |