|
|
|
|
|
|
Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000835 |
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.
Condition |
HIV Infections |
MedlinePlus related topics: | AIDS |
Study Type: | Observational |
Study Design: | Natural History |
Official Title: | A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Safety and Immunogenicity of an HIV-1 Pseudovirion Vaccine |
Estimated Enrollment: | 78 |
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 and/or the placebo/adjuvant. All volunteers will receive injections intramuscularly at 0, 1, 3, 6, and 12 months.
Group I (30 volunteers): pseudovirion vaccine w/adjuvant or w/o adjuvant. Group II (30 volunteers): pseudovirion vaccine w/adjuvant or w/o 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.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions and symptoms are excluded:
Concurrent Medication:
Excluded:
Immunosuppressive medications.
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
Receipt of blood products or immunoglobulin in the past 6 months.
Risk Behavior:
Excluded:
Volunteers having identifiable higher risk behavior for HIV infection as determined by screening questions designed to identify risk factors for HIV infection, specifically:
Volunteers risk behavior for HIV infection will be determined upon information obtained from a questionnaire and from the AIDS Vaccine Evaluation Group (AVEG) risk behavior guidelines.
NOTE:
Study ID Numbers: | AVEG 025 |
First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00000835 |
Health Authority: | United States: Federal Government |
|
|
|