Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001020
Status:
COMPLETED
Last Update Posted:
2012-05-18
First Post:
1999-11-02
Brief Title:
A Phase I Study of the Safety and Immunogenicity of rgp120HIV-1IIIB Vaccine in Healthy Adult Subjects NOTE Study Extended ONLY for Subjects Who Have Previously Received rgp120HIV-1IIIB or rgp120HIV-1MN on VEU 006 or VEU 006 Rollover Study
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 Study of the Safety and Immunogenicity of rgp120HIV-1IIIB Vaccine in Healthy Adult Subjects NOTE Study Extended ONLY for Subjects Who Have Previously Received rgp120HIV-1IIIB or rgp120HIV-1MN on VEU 006 or VEU 006 Rollover Study
Status:
COMPLETED
Status Verified Date:
2012-05
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:
AMENDED 111793 To determine whether the pattern of response to MN rgp120 vaccine is altered by pre-exposure to IIIB rgp120
ORIGINAL DESIGN To evaluate the safety clinical and immunologic of rgp120HIV-1IIIB vaccine gp120 vaccine immunization in healthy HIV-1 seronegative adult subjects To compare the immune response to 100 mcg gp120 vaccine versus 300 mcg gp120 vaccine To determine whether gp120 vaccine immunization causes a significant immune response as defined by specific parameters eg induction of neutralizing antibodies to the IIIB isolate of HIV-1 gp120 antigen-specific lymphocytic proliferation
Recent evidence suggests that gp120 is the HIV-1 protein with the greatest potential as a vaccine against HIV-1 infection The gp120 envelope protein may be produced by recombinant DNA technology and studies have shown that the vaccine is capable of eliciting neutralizing antibody activity in both rodents and nonhuman primate species
ORIGINAL DESIGN To evaluate the safety clinical and immunologic of rgp120HIV-1IIIB vaccine gp120 vaccine immunization in healthy HIV-1 seronegative adult subjects To compare the immune response to 100 mcg gp120 vaccine versus 300 mcg gp120 vaccine To determine whether gp120 vaccine immunization causes a significant immune response as defined by specific parameters eg induction of neutralizing antibodies to the IIIB isolate of HIV-1 gp120 antigen-specific lymphocytic proliferation
Recent evidence suggests that gp120 is the HIV-1 protein with the greatest potential as a vaccine against HIV-1 infection The gp120 envelope protein may be produced by recombinant DNA technology and studies have shown that the vaccine is capable of eliciting neutralizing antibody activity in both rodents and nonhuman primate species
Detailed Description:
Recent evidence suggests that gp120 is the HIV-1 protein with the greatest potential as a vaccine against HIV-1 infection The gp120 envelope protein may be produced by recombinant DNA technology and studies have shown that the vaccine is capable of eliciting neutralizing antibody activity in both rodents and nonhuman primate species
AMENDED 111793 Selected subjects from VEU 006 or VEU 006 Rollover study will receive two injections of MN rgp120 vaccine administered 28 days apart beginning 10-16 months after their last injection Eight additional clinic visits will be required Subjects are followed for at least 6 months
ORIGINAL DESIGN Twenty-eight subjects will be randomized to receive 100 or 300 mcg rgp120HIV-1IIIB vaccine gp120 vaccine or matching placebo For each dose level 10 subjects will receive vaccine and four subjects will receive matching placebo Injections are given intramuscularly at 0 4 and 32 weeks Each subject receiving treatment at the lower dose level must be monitored for unacceptable toxicity for at least 2 weeks following the initial immunization before his or her second dose is administered and before treatment at the higher dose level begins Subjects are followed for at least 12 months
AMENDED 111793 Selected subjects from VEU 006 or VEU 006 Rollover study will receive two injections of MN rgp120 vaccine administered 28 days apart beginning 10-16 months after their last injection Eight additional clinic visits will be required Subjects are followed for at least 6 months
ORIGINAL DESIGN Twenty-eight subjects will be randomized to receive 100 or 300 mcg rgp120HIV-1IIIB vaccine gp120 vaccine or matching placebo For each dose level 10 subjects will receive vaccine and four subjects will receive matching placebo Injections are given intramuscularly at 0 4 and 32 weeks Each subject receiving treatment at the lower dose level must be monitored for unacceptable toxicity for at least 2 weeks following the initial immunization before his or her second dose is administered and before treatment at the higher dose level begins Subjects are followed for at least 12 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11537 | REGISTRY | DAIDS ES Registry Number | None |
| VEU 006 | None | None | None |
| V0199g | None | None | None |