Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001042
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Phase I Randomized Double-Blind Placebo-Controlled Clinical Trial to Compare the Safety and Immunogenicity of Recombinant Envelope Protein rgp120HIV-1SF2 BIOCINE Combined With Seven Adjuvants in Healthy HIV-1 Uninfected Individuals
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 Randomized Double-Blind Placebo-Controlled Clinical Trial to Compare the Safety and Immunogenicity of Recombinant Envelope Protein rgp120HIV-1SF2 BIOCINE Combined With Seven Adjuvants in Healthy HIV-1 Uninfected Individuals
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 in healthy HIV-negative volunteers the safety and immunogenicity of rgp120HIV-1SF2 BIOCINE formulated with each of seven adjuvants
PER AMENDMENT 3696 Purpose of the extension study - To determine the ability of immunization with rgp 120SF-2 to induce an HIV-1 envelope-specific delayed-type hypersensitivity DTH response in volunteers who receive rsgp 120MN skin testing
One approach to improve the immunogenicity of an HIV-1 subunit protein vaccine is to combine the immunogen with an adjuvant Adjuvants may augment vaccine immunogenicity by several mechanisms and as a result induce a more favorable antibody response with high titers which appear earlier in the course of immunization and persist over time
PER AMENDMENT 3696 Purpose of the extension study - To determine the ability of immunization with rgp 120SF-2 to induce an HIV-1 envelope-specific delayed-type hypersensitivity DTH response in volunteers who receive rsgp 120MN skin testing
One approach to improve the immunogenicity of an HIV-1 subunit protein vaccine is to combine the immunogen with an adjuvant Adjuvants may augment vaccine immunogenicity by several mechanisms and as a result induce a more favorable antibody response with high titers which appear earlier in the course of immunization and persist over time
Detailed Description:
One approach to improve the immunogenicity of an HIV-1 subunit protein vaccine is to combine the immunogen with an adjuvant Adjuvants may augment vaccine immunogenicity by several mechanisms and as a result induce a more favorable antibody response with high titers which appear earlier in the course of immunization and persist over time
Volunteers are randomized to receive 50 mcg rgp120HIV-1SF2 in combination with one of seven different adjuvants aluminum hydroxide alum monophosphoryl lipid A liposome-encapsulated monophosphoryl lipid A MF59 MTP-PEMF59 Syntex adjuvant formulation SAF2 and SAF2 plus threonyl muramyl dipeptide threonyl MDP An additional placebo control arm of volunteers receive alum only Doses are administered at 0 2 and 6 months Volunteers are followed for 1 year after the last immunization Per 8594 amendment eligible volunteers except those who received monophosphoryl lipid A for the first three immunizations may receive a fourth dose at month 15
PER AMENDMENT 3696 Extension Study- Protocol 015 has been modified to add a special DTH study At the end of the study on day 784 intradermal injections of MN rsgp 120 will be administered to consenting volunteers who have received 4 immunizations as part of protocol 015 Follow up will be extended to 56 days after administration of the intradermal injections
Volunteers are randomized to receive 50 mcg rgp120HIV-1SF2 in combination with one of seven different adjuvants aluminum hydroxide alum monophosphoryl lipid A liposome-encapsulated monophosphoryl lipid A MF59 MTP-PEMF59 Syntex adjuvant formulation SAF2 and SAF2 plus threonyl muramyl dipeptide threonyl MDP An additional placebo control arm of volunteers receive alum only Doses are administered at 0 2 and 6 months Volunteers are followed for 1 year after the last immunization Per 8594 amendment eligible volunteers except those who received monophosphoryl lipid A for the first three immunizations may receive a fourth dose at month 15
PER AMENDMENT 3696 Extension Study- Protocol 015 has been modified to add a special DTH study At the end of the study on day 784 intradermal injections of MN rsgp 120 will be administered to consenting volunteers who have received 4 immunizations as part of protocol 015 Follow up will be extended to 56 days after administration of the intradermal injections
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 |
|---|---|---|---|
| 10563 | REGISTRY | DAIDS ES Registry Number | None |