Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001052
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Phase I Multicenter Randomized Double-Blind Placebo-Controlled HIV-1 Vaccine Trial to Evaluate the Safety and Immunogenicity of MN Recombinant Soluble gp120HIV-1 rsgp120HIV-1 Genentech in Combination With QS21 Adjuvant andor Alum 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 I Multicenter Randomized Double-Blind Placebo-Controlled HIV-1 Vaccine Trial to Evaluate the Safety and Immunogenicity of MN Recombinant Soluble gp120HIV-1 rsgp120HIV-1 Genentech in Combination With QS21 Adjuvant andor Alum 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 extend the evaluation of safety and immunogenicity of MN recombinant soluble gp120HIV-1 MN rsgp120HIV-1 in combination with QS21 with or without alum and on two different vaccination schedules
Recent animal studies indicate that immunizing with MN rsgp120HIV-1 in combination with QS21 on a 0 1 2 month schedule results in a more rapid rise in binding and neutralizing antibody response than on a 0 1 6 month schedule Such an effect may be particularly desirable in vaccine delivery This study compares these two delivery schedules using the unadjuvanted vaccine formulation rsgp120HIV-1 with or without addition of alum
Recent animal studies indicate that immunizing with MN rsgp120HIV-1 in combination with QS21 on a 0 1 2 month schedule results in a more rapid rise in binding and neutralizing antibody response than on a 0 1 6 month schedule Such an effect may be particularly desirable in vaccine delivery This study compares these two delivery schedules using the unadjuvanted vaccine formulation rsgp120HIV-1 with or without addition of alum
Detailed Description:
Recent animal studies indicate that immunizing with MN rsgp120HIV-1 in combination with QS21 on a 0 1 2 month schedule results in a more rapid rise in binding and neutralizing antibody response than on a 0 1 6 month schedule Such an effect may be particularly desirable in vaccine delivery This study compares these two delivery schedules using the unadjuvanted vaccine formulation rsgp120HIV-1 with or without addition of alum
Healthy volunteers 20 per group receive MN rsgp120HIV-1 300 or 0 mcg in combination with QS21 100 mcg either with or without alum at 0 1 and 2 months or 0 1 and 6 months For both vaccination schedules an additional five volunteers receive only vehicle with alum The 0 mcg antigen groups are included primarily as negative controls Subjects may be contacted for follow-up on health status once or twice yearly for at least 5 years
Healthy volunteers 20 per group receive MN rsgp120HIV-1 300 or 0 mcg in combination with QS21 100 mcg either with or without alum at 0 1 and 2 months or 0 1 and 6 months For both vaccination schedules an additional five volunteers receive only vehicle with alum The 0 mcg antigen groups are included primarily as negative controls Subjects may be contacted for follow-up on health status once or twice yearly for at least 5 years
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 |
|---|---|---|---|
| 10565 | REGISTRY | DAIDS ES Registry Number | None |