Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001044
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 rgp120HIV-1MN 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 rgp120HIV-1MN 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:
PRIMARY To examine the safety and potential improvement in immune responses elicited by combining rsgp120HIV-1MN with the adjuvant QS-21 SECONDARY To examine the role of alum in the vaccineadjuvant formulation to determine the optimal dose ratio of vaccine to adjuvant and to obtain initial information on the optimal schedule of administration AS PER AMENDMENT 070297 To determine the ability of immunization with rsgp120HV-1MN in combination with QS21 with or without alum to induce an HIV-1 envelope-specific delayed-type hypersensitivity DTH response in volunteers who undergo rsgp120MN skin testing
Immune responses in HIV-uninfected individuals receiving subunit envelope vaccines formulated with alum adjuvant suggest that functional antibodies capable of neutralizing HIV-1 in vitro may be induced but the titers are relatively low in comparison to those measured in individuals with natural HIV-1 infection These limitations might be overcome by the addition or substitution of a more suitable adjuvant such as QS-21
Immune responses in HIV-uninfected individuals receiving subunit envelope vaccines formulated with alum adjuvant suggest that functional antibodies capable of neutralizing HIV-1 in vitro may be induced but the titers are relatively low in comparison to those measured in individuals with natural HIV-1 infection These limitations might be overcome by the addition or substitution of a more suitable adjuvant such as QS-21
Detailed Description:
Immune responses in HIV-uninfected individuals receiving subunit envelope vaccines formulated with alum adjuvant suggest that functional antibodies capable of neutralizing HIV-1 in vitro may be induced but the titers are relatively low in comparison to those measured in individuals with natural HIV-1 infection These limitations might be overcome by the addition or substitution of a more suitable adjuvant such as QS-21
Volunteers are randomized to 20 treatment arms containing four patients each rsgp120HIV-1MN is administered at four dose levels 0 100 300 and 600 mcg and QS-21 adjuvant is administered at three dose levels 0 50 and 100 mcg Some subject cohorts receive alum in the vaccine formulation Sixty volunteers receive injections at months 0 1 and 10 and 20 volunteers receive injections at months 0 1 and 6 AS PER AMENDMENT 070297 All consenting volunteers who have received three immunizations will be tested for DTH response to HIV-1 envelope with use of intradermal MN rsgp120 Follow-up is extended to 56 days after administration of the intradermal injections
Volunteers are randomized to 20 treatment arms containing four patients each rsgp120HIV-1MN is administered at four dose levels 0 100 300 and 600 mcg and QS-21 adjuvant is administered at three dose levels 0 50 and 100 mcg Some subject cohorts receive alum in the vaccine formulation Sixty volunteers receive injections at months 0 1 and 10 and 20 volunteers receive injections at months 0 1 and 6 AS PER AMENDMENT 070297 All consenting volunteers who have received three immunizations will be tested for DTH response to HIV-1 envelope with use of intradermal MN rsgp120 Follow-up is 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 |
|---|---|---|---|
| 10564 | REGISTRY | DAIDS ES Registry Number | None |