Status:
WITHDRAWN
A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Safety and Immunogenicity of an HIV-1 Pseudovirion Vaccine
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18-60 years
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 t...
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 envel...
Eligibility Criteria
Inclusion Criteria
Patients must have:
- Negative ELISA for HIV-1 antibody within 8 weeks of initial immunization.
- CD4 count >= 400 cells/mm3.
- Negative Hepatitis B surface antigen.
- Normal history and physical examination.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions and symptoms are excluded:
- Medical or psychiatric condition or occupational responsibilities preclude compliance with the protocol.
- Present psychosis.
- Active syphilis (eligible if serology documented to be a false positive or due to remote, i.e., > 6 months treated infection).
- Active tuberculosis (eligible if positive purified protein derivative test and normal chest x-ray showing no evidence of TB and not requiring isoniazid therapy).
- Hepatitis B antigenemia.
Concurrent Medication:
Excluded:
Immunosuppressive medications.
Patients with the following prior conditions are excluded:
- History of immunodeficiency, chronic illness, malignancy, or autoimmune disease.
- History of cancer unless there has been surgical excision followed by sufficient observation period to give a reasonable assurance of cure.
- History of suicide attempts, recent suicidal ideation or who have past psychosis.
- History of anaphylaxis or other serious adverse reactions to vaccines.
- History of serious allergic reaction to any substance, requiring hospitalization or emergent medical care (e.g. Stevens-Johnson syndrome, bronchospasm, or hypotension).
Prior Medication:
Excluded:
- Prior receipt of HIV-1 vaccines or placebo recipient in a previous HIV vaccine trial.
- Use of experimental agents within 30 days prior to study.
- Live attenuated vaccines within 60 days of study.
- Medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) within 2 weeks prior to study.
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:
- History of injection drug use within the last 12 months prior to enrollment.
- Higher or intermediate risk sexual behavior as defined by the AVEG ( i.e., meeting the criteria for AVEG Risk Group C or D).
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:
- Only those volunteers meeting the criteria for AVEG Risk Groups A and B will be enrolled in this study.
Key Trial Info
Start Date :
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00000835
Last Update
October 29 2021
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