Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000835
Status:
WITHDRAWN
Last Update Posted:
2021-10-29
First Post:
1999-11-02
Brief Title:
A Multicenter Randomized Placebo-Controlled Double-Blind Trial to Evaluate the Safety and Immunogenicity of an HIV-1 Pseudovirion Vaccine
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Multicenter Randomized Placebo-Controlled Double-Blind Trial to Evaluate the Safety and Immunogenicity of an HIV-1 Pseudovirion Vaccine
Status:
WITHDRAWN
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:
The purpose of this trial is to determine the safety and immunogenicity of an HIV-1 pseudovirion vaccine given at one antigen dose alone and in combination with each of two different adjuvants using two immunization schedules
The pseudovirions are virus-like particles generated by in vitro production of HIV-1 viral proteins which are capable of assembly into particles The presence of gag gene products in addition to envelope glycoprotein should assist in humoral and cellular immunologic responses to internal HIV-1 viral proteins The pseudovirion vaccine has been tested in preclinical trials in mice guinea pigs rabbits and nonhuman primates with good safety and immunogenicity profile
The pseudovirions are virus-like particles generated by in vitro production of HIV-1 viral proteins which are capable of assembly into particles The presence of gag gene products in addition to envelope glycoprotein should assist in humoral and cellular immunologic responses to internal HIV-1 viral proteins The pseudovirion vaccine has been tested in preclinical trials in mice guinea pigs rabbits and nonhuman primates with good safety and immunogenicity profile
Detailed Description:
The pseudovirions are virus-like particles generated by in vitro production of HIV-1 viral proteins which are capable of assembly into particles The presence of gag gene products in addition to envelope glycoprotein should assist in humoral and cellular immunologic responses to internal HIV-1 viral proteins The pseudovirion vaccine has been tested in preclinical trials in mice guinea pigs rabbits and nonhuman primates with good safety and immunogenicity profile
A total of 78 volunteers will be recruited and randomly assigned to receive pseudovirion vaccine andor the placeboadjuvant All volunteers will receive injections intramuscularly at 0 1 3 6 and 12 months
Group I 30 volunteers pseudovirion vaccine wadjuvant or wo adjuvant Group II 30 volunteers pseudovirion vaccine wadjuvant or wo adjuvant Group III 18 volunteers adjuvant QS21 or alum or saline placebo NOTE Group I will receive appropriate adjuvant or saline placebo at Month 3 without pseudovirion vaccine
A total of 78 volunteers will be recruited and randomly assigned to receive pseudovirion vaccine andor the placeboadjuvant All volunteers will receive injections intramuscularly at 0 1 3 6 and 12 months
Group I 30 volunteers pseudovirion vaccine wadjuvant or wo adjuvant Group II 30 volunteers pseudovirion vaccine wadjuvant or wo adjuvant Group III 18 volunteers adjuvant QS21 or alum or saline placebo NOTE Group I will receive appropriate adjuvant or saline placebo at Month 3 without pseudovirion vaccine
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 |
|---|---|---|---|
| 11541 | REGISTRY | DAIDS ES Registry Number | None |