Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000630
Status:
COMPLETED
Last Update Posted:
2021-10-27
First Post:
1999-11-02
Brief Title:
Phase I Safety and Immunogenicity Trial of Vaccinia-HIV Envelope Recombinant Vaccine HIVAC-1e in Combination With Soluble Recombinant Envelope Vaccine gp160 VaxSyn
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Phase I Safety and Immunogenicity Trial of Vaccinia-HIV Envelope Recombinant Vaccine HIVAC-1e in Combination With Soluble Recombinant Envelope Vaccine gp160 VaxSyn
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 if priming giving the first vaccination with a vaccinia recombinant HIVAC-1e provides a significant advantage in immunogenicity production of antibodies compared to priming with a soluble recombinant protein gp160 to learn more about the safety of the combination use of the two HIV envelope vaccines utilized in the study
Recent studies at the AIDS vaccine units have shown the safety of two candidate HIV vaccines HIVAC-1e and gp160 Specific questions to be addressed in this part of the study include Does combination vaccination result in a synergistic added response not predicted by just the addition of a second vaccination and does this synergism depend on the unique priming effect of a vaccinia recombinant or will any combination do
Recent studies at the AIDS vaccine units have shown the safety of two candidate HIV vaccines HIVAC-1e and gp160 Specific questions to be addressed in this part of the study include Does combination vaccination result in a synergistic added response not predicted by just the addition of a second vaccination and does this synergism depend on the unique priming effect of a vaccinia recombinant or will any combination do
Detailed Description:
Recent studies at the AIDS vaccine units have shown the safety of two candidate HIV vaccines HIVAC-1e and gp160 Specific questions to be addressed in this part of the study include Does combination vaccination result in a synergistic added response not predicted by just the addition of a second vaccination and does this synergism depend on the unique priming effect of a vaccinia recombinant or will any combination do
Volunteers will be randomized to one of four groups Group A 20 volunteers will receive gp160 VaxSyn followed two months later by a repeat dose Group B 20 volunteers will receive VaxSyn followed two months later by HIVAC-1e Group C 20 volunteers will receive HIVAC-1e followed two months later by VaxSyn Group D 10 volunteers will receive HIVAC-1e followed two months later by HIVAC-1e For volunteers in Groups A B and C who do not react to the initial vaccination a second attempt to obtain a reaction may be made 7 or more days following the initial inoculation Per addendum two additional booster inoculations are given one at 6 months or later post initial inoculation Groups A C and D receive VaxSyn and Group B receives HIVAC-1e and another at 12 months or later all Groups receive VaxSyn
Volunteers will be randomized to one of four groups Group A 20 volunteers will receive gp160 VaxSyn followed two months later by a repeat dose Group B 20 volunteers will receive VaxSyn followed two months later by HIVAC-1e Group C 20 volunteers will receive HIVAC-1e followed two months later by VaxSyn Group D 10 volunteers will receive HIVAC-1e followed two months later by HIVAC-1e For volunteers in Groups A B and C who do not react to the initial vaccination a second attempt to obtain a reaction may be made 7 or more days following the initial inoculation Per addendum two additional booster inoculations are given one at 6 months or later post initial inoculation Groups A C and D receive VaxSyn and Group B receives HIVAC-1e and another at 12 months or later all Groups receive VaxSyn
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 |
|---|---|---|---|
| 10538 | REGISTRY | DAIDS ES Registry Number | None |