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WITHDRAWN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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