Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001031
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Phase II Clinical Trial to Evaluate the Immunogenicity and Reactogenicity of the Recombinant HIV-1 Envelope Vaccines SF-2 rgp120 CHO Chiron Vaccines in MF59 Adjuvant and MN rgp120HIV-1 VaxGen in Alum Adjuvant 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 II Clinical Trial to Evaluate the Immunogenicity and Reactogenicity of the Recombinant HIV-1 Envelope Vaccines SF-2 rgp120 CHO Chiron Vaccines in MF59 Adjuvant and MN rgp120HIV-1 VaxGen in Alum Adjuvant in Healthy 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:
To evaluate the safety and immunogenicity of SF-2 rgp120 vaccine in MF59 versus MN rgp120 vaccine in alum in volunteers who are seronegative for HIV-1 AS PER AMENDMENT 070297 To determine the ability of immunization with MN rgp120HIV-1 in combination with alum or SF-2 rgp120 in combination with MF59 to induce an HIV-1 envelope-specific delayed-type hypersensitivity DTH response in volunteers who receive rsgp120MN skin testing
The amino acid sequence of HIV-1 gp120 can vary as much as 40 percent from isolate to isolate Thus the identification of an immunogen that can elicit broadly neutralizing antibodies to HIV-1 is a major challenge in AIDS vaccine development Two candidate vaccines recombinant envelope subunit proteins from the SF-2 and MN isolates of HIV-1 have shown immunogenicity and good tolerance in healthy immunocompetent adults This study will expand testing into a larger population base particularly targeting individuals at high risk for HIV infection
The amino acid sequence of HIV-1 gp120 can vary as much as 40 percent from isolate to isolate Thus the identification of an immunogen that can elicit broadly neutralizing antibodies to HIV-1 is a major challenge in AIDS vaccine development Two candidate vaccines recombinant envelope subunit proteins from the SF-2 and MN isolates of HIV-1 have shown immunogenicity and good tolerance in healthy immunocompetent adults This study will expand testing into a larger population base particularly targeting individuals at high risk for HIV infection
Detailed Description:
The amino acid sequence of HIV-1 gp120 can vary as much as 40 percent from isolate to isolate Thus the identification of an immunogen that can elicit broadly neutralizing antibodies to HIV-1 is a major challenge in AIDS vaccine development Two candidate vaccines recombinant envelope subunit proteins from the SF-2 and MN isolates of HIV-1 have shown immunogenicity and good tolerance in healthy immunocompetent adults This study will expand testing into a larger population base particularly targeting individuals at high risk for HIV infection
HIV-seronegative volunteers including four populations at higher risk for HIV infection and two populations at lower risk receive one of four regimens Two treatment groups receive 50 mcg SF-2 rgp 120 BIOCINE in MF59 adjuvant or 600 mcg MN rgp120 Genentech in alum Two control groups receive vehicle placebo in MF59 adjuvant alone or alum adjuvant alone Immunizations are given at months 0 1 and 6 AS PER AMENDMENT 1093 patients enrolled by June 15 1993 receive a fourth immunization at month 12 or 18 50 percent of patients for each schedule Patients are followed until 2 years after the first injection AS PER AMENDMENT 051094 a special study of vaccine acceptability and HIV-related risk behavior will be conducted at some time between months 12 and 18 AS PER AMENDMENT 070297 a special DTH study will be conducted in consenting volunteers who have received three or four immunizations The injections will be given at the end of the study on or after day 1 56 Followup is extended to 56 days after administration of the intradermal injection
HIV-seronegative volunteers including four populations at higher risk for HIV infection and two populations at lower risk receive one of four regimens Two treatment groups receive 50 mcg SF-2 rgp 120 BIOCINE in MF59 adjuvant or 600 mcg MN rgp120 Genentech in alum Two control groups receive vehicle placebo in MF59 adjuvant alone or alum adjuvant alone Immunizations are given at months 0 1 and 6 AS PER AMENDMENT 1093 patients enrolled by June 15 1993 receive a fourth immunization at month 12 or 18 50 percent of patients for each schedule Patients are followed until 2 years after the first injection AS PER AMENDMENT 051094 a special study of vaccine acceptability and HIV-related risk behavior will be conducted at some time between months 12 and 18 AS PER AMENDMENT 070297 a special DTH study will be conducted in consenting volunteers who have received three or four immunizations The injections will be given at the end of the study on or after day 1 56 Followup is extended to 56 days after administration of the intradermal injection
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 |
|---|---|---|---|
| 10588 | REGISTRY | DAIDS ES Registry Number | None |