Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000746
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Phase I Multicenter Randomized Trial to Evaluate the Safety and Immunogenicity of a Recombinant Vaccinia-HIV Envelope Vaccine HIVAC-1e in Combination With a Panel of Subunit Recombinant HIV Envelope Vaccines
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 Trial to Evaluate the Safety and Immunogenicity of a Recombinant Vaccinia-HIV Envelope Vaccine HIVAC-1e in Combination With a Panel of Subunit Recombinant HIV Envelope Vaccines
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 determine in healthy volunteers whether priming with a vaccinia HIV-1 gp160 envelope gene recombinant vaccine HIVAC-1e followed by boosting with one of two subunit recombinant HIV-1 envelope vaccines Env 2-3 and gp120 provides enhanced immunogenicity compared to vaccination with the gp120 subunit vaccine alone Per 100192 amendment boosts with VaxSyn gp160 were eliminated To evaluate the immunogenicity of one versus two priming doses of HIVAC-1e prior to a boost with gp120 To compare the relative immunogenicity of the three subunit vaccines when administered as boosters
Secondary To examine the safety of administering the individual subunit vaccines in combination with HIVAC-1e and the safety of administering the gp120 subunit vaccine alone
In a previous study of candidate HIV vaccines the evidence suggested that administration of a booster vaccination with a different vaccine preparation may produce a better immune response than administration of HIVAC-1e vaccine alone
Secondary To examine the safety of administering the individual subunit vaccines in combination with HIVAC-1e and the safety of administering the gp120 subunit vaccine alone
In a previous study of candidate HIV vaccines the evidence suggested that administration of a booster vaccination with a different vaccine preparation may produce a better immune response than administration of HIVAC-1e vaccine alone
Detailed Description:
In a previous study of candidate HIV vaccines the evidence suggested that administration of a booster vaccination with a different vaccine preparation may produce a better immune response than administration of HIVAC-1e vaccine alone
Seventy healthy volunteers are randomized to one of four groups Groups A and D receive one initial immunization with HIVAC-1e followed by two boosts with subunit gp120 and Env 2-3 respectively at months 8 and 12 Group B receives two immunizations with HIVAC-1e at months 0 and 8 followed by a single boost with subunit gp120 at month 12 Group C receives three doses of subunit gp120 only at months 0 8 and 12 Per 100192 amendment boosts with VaxSyn gp160 have been eliminated Subjects are followed for 18 months
Seventy healthy volunteers are randomized to one of four groups Groups A and D receive one initial immunization with HIVAC-1e followed by two boosts with subunit gp120 and Env 2-3 respectively at months 8 and 12 Group B receives two immunizations with HIVAC-1e at months 0 and 8 followed by a single boost with subunit gp120 at month 12 Group C receives three doses of subunit gp120 only at months 0 8 and 12 Per 100192 amendment boosts with VaxSyn gp160 have been eliminated Subjects are followed for 18 months
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 |
|---|---|---|---|
| 10553 | REGISTRY | DAIDS ES Registry Number | None |
| AVEG Protocol 008 | None | None | None |