Search / Trial NCT00001096

A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of HIV-1 MN rsgp120 and Bivalent AIDSVAX B/E (HIV-1 MN rgp120/A244 rgp120) in Combination With QS-21 With or Without Alum in Healthy HIV-1 Uninfected Adults

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Trial Information

Current as of December 14, 2024

Completed

Keywords

Vaccines, Synthetic Hiv Antibodies Hiv Antigens Hiv 1 Adjuvants, Immunologic Aids Vaccines T Lymphocytes, Cytotoxic Hiv Seronegativity Hiv Envelope Protein Gp120 Alum Compounds Hiv Preventive Vaccine

ClinConnect Summary

An effective vaccine to prevent HIV-1 infection may need to generate diverse and multifaceted immunologic responses. Required parts of the immune response may include: humoral antibodies, which broadly neutralize non-syncytium-inducing strains of HIV-1; T cell help provided by both CD4 and CD8 positive subsets; and a class I-restricted cytotoxic lymphocyte response. Other effector responses, such as the generation of antibody-dependent cellular cytotoxicity, cytokines, chemokines, or other antiviral factors may also be critical in mounting protective immunity. Given the lack of a surrogate ...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • Volunteers must have:
  • Negative ELISA for HIV within 8 weeks prior to immunization.
  • CD4 count greater than or equal to 400 cells/mm3.
  • Normal history and physical examination. \[Refer to Laboratory values for additional requirements.\]
  • Exclusion Criteria
  • Co-existing Condition:
  • Volunteers with the following conditions or symptoms are excluded:
  • Medical or psychiatric conditions or occupational responsibilities which preclude subject compliance with the protocol.
  • Recent suicidal ideation or psychosis.
  • Active syphilis. NOTE: If the serology is documented to be a false positive or due to a remote (greater than 6 months) treated infection, the volunteer is eligible.
  • Active tuberculosis. NOTE: Volunteers with a positive PPD and a normal chest x-ray showing no evidence of TB and not requiring INH therapy are eligible.
  • Positive for hepatitis B surface antigen.
  • Volunteers with the following prior conditions are excluded:
  • History of immunodeficiency, chronic illness, or autoimmune disease.
  • History of cancer unless there has been surgical excision followed by a sufficient observation period to give a reasonable assurance of cure.
  • History of suicide attempts, recent suicidal ideation, or past or present psychosis.
  • History of anaphylaxis or other serious adverse reactions to vaccines.
  • History of serious allergic reaction to any substance requiring hospitalization or emergency medical care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension).
  • History of reaction to thimerosal.
  • Prior Medication:
  • Excluded:
  • Live attenuated vaccine within 60 days of study. NOTE: Medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) are not exclusionary, but should be given at least 2 weeks away from HIV immunizations.
  • Experimental agents within 30 days prior to study.
  • HIV-1 vaccines or placebo as part of a previous HIV vaccine trial.
  • Prior Treatment:
  • Excluded:
  • Blood products or immunoglobulin in the past 6 months.
  • Experimental agents within 30 days prior to study.
  • Risk Behavior:
  • Excluded:
  • Volunteers with an identifiable higher- or intermediate-risk sexual behavior for HIV infection (i.e., AVEG Risk Groups C or D ).
  • History of intravenous drug use within 12 months prior to enrollment.

Trial Officials

Tom Evans

Study Chair

About National Institute Of Allergy And Infectious Diseases (Niaid)

The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.

Locations

Nashville, Tennessee, United States

Seattle, Washington, United States

Rochester, New York, United States

Baltimore, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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