Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001096
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Phase I Multicenter Randomized Double-Blind Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of HIV-1 MN rsgp120 and Bivalent AIDSVAX BE HIV-1 MN rgp120A244 rgp120 in Combination With QS-21 With or Without Alum in Healthy HIV-1 Uninfected 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 I Multicenter Randomized Double-Blind Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of HIV-1 MN rsgp120 and Bivalent AIDSVAX BE HIV-1 MN rgp120A244 rgp120 in Combination With QS-21 With or Without Alum in Healthy HIV-1 Uninfected 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 assess the safety and immune response to two experimental vaccines when formulated with QS-21 or QS-21 plus alum To determine whether the new preparation of QS-21 in polysorbate 80 is less reactogenic than the QS-21 formulation used in AVEG Protocols 016 016A and 016B To examine whether QS-21 is immunologically equivalent to that used in 16B To determine if QS-21 when given with low doses of antigen induces measurable HIV-1-specific CTL activity To evaluate if the QS-21 dose-sparing effect extends to an antigen dose of 05 micrograms To determine if the bivalent vaccine gives responses equivalent to the monovalent product or if a broadening of the HIV-1-specific binding and neutralizing antibody responses occurs
An effective vaccine to prevent HIV-1 infection may need to generate diverse and multifaceted immunologic responses Required parts of the immune response may include humoral antibodies which broadly neutralize non-syncytium-inducing strains of HIV-1 T cell help provided by both CD4 and CD8 positive subsets and a class I-restricted cytotoxic lymphocyte response Other effector responses such as the generation of antibody-dependent cellular cytotoxicity cytokines chemokines or other antiviral factors may also be critical in mounting protective immunity Given the lack of a surrogate immunologic marker the most practical approach for possible efficacy trials would be to evaluate a candidate vaccine that elicits as many of these responses as possible
An effective vaccine to prevent HIV-1 infection may need to generate diverse and multifaceted immunologic responses Required parts of the immune response may include humoral antibodies which broadly neutralize non-syncytium-inducing strains of HIV-1 T cell help provided by both CD4 and CD8 positive subsets and a class I-restricted cytotoxic lymphocyte response Other effector responses such as the generation of antibody-dependent cellular cytotoxicity cytokines chemokines or other antiviral factors may also be critical in mounting protective immunity Given the lack of a surrogate immunologic marker the most practical approach for possible efficacy trials would be to evaluate a candidate vaccine that elicits as many of these responses as possible
Detailed Description:
An effective vaccine to prevent HIV-1 infection may need to generate diverse and multifaceted immunologic responses Required parts of the immune response may include humoral antibodies which broadly neutralize non-syncytium-inducing strains of HIV-1 T cell help provided by both CD4 and CD8 positive subsets and a class I-restricted cytotoxic lymphocyte response Other effector responses such as the generation of antibody-dependent cellular cytotoxicity cytokines chemokines or other antiviral factors may also be critical in mounting protective immunity Given the lack of a surrogate immunologic marker the most practical approach for possible efficacy trials would be to evaluate a candidate vaccine that elicits as many of these responses as possible
Volunteers in each of 5 groups receive vaccine or placebo by intramuscular injection at Months 0 1 and 6 All patients receive one of two doses of QS-21 along with vaccine or placebo and some groups receive alum as follows
Group 1 low-dose MN rsgp120HIV-1 plus QS-21 13 volunteers Group 2 high-dose MN rsgp120HIV-1 plus QS-21 13 volunteers Group 3 AIDSVAX BE injection contains each of the two vaccine components HIV-1 MN rgp120 and A244 rgp120HIV-1 plus QS-21 plus alum 13 volunteers
Group 4 high-dose MN rgp120HIV-1 plus QS-21 plus alum 13 volunteers Group 5 placebo plus QS-21 8 volunteers Volunteers will be closely monitored after each immunization and followed for a minimum of 12 months after the initial immunization
Volunteers in each of 5 groups receive vaccine or placebo by intramuscular injection at Months 0 1 and 6 All patients receive one of two doses of QS-21 along with vaccine or placebo and some groups receive alum as follows
Group 1 low-dose MN rsgp120HIV-1 plus QS-21 13 volunteers Group 2 high-dose MN rsgp120HIV-1 plus QS-21 13 volunteers Group 3 AIDSVAX BE injection contains each of the two vaccine components HIV-1 MN rgp120 and A244 rgp120HIV-1 plus QS-21 plus alum 13 volunteers
Group 4 high-dose MN rgp120HIV-1 plus QS-21 plus alum 13 volunteers Group 5 placebo plus QS-21 8 volunteers Volunteers will be closely monitored after each immunization and followed for a minimum of 12 months after the initial immunization
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 |
|---|---|---|---|
| 10585 | REGISTRY | DAIDS ES Registry Number | None |