Search / Trial NCT00000832

A Randomized, Placebo-Controlled, Double-Blinded Phase I Safety and Immunogenicity Trial of Recombinant Envelope Protein, HIV-1 SF-2 rgp120 (BIOCINE), Combined With MF59 in HIV-1 Uninfected Adult Volunteers

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

Trial Information

Current as of December 26, 2024

Completed

Keywords

Vaccines, Synthetic Hiv 1 Adjuvants, Immunologic Hiv Envelope Protein Gp120 Aids Vaccines Hiv Seronegativity Hiv Preventive Vaccine

ClinConnect Summary

One approach to improve the immunogenicity of an HIV-1 subunit protein vaccine is to combine the immunogen with an adjuvant.

Healthy volunteers receive intramuscular injections of rgp120/HIV-1SF2 with MF59 adjuvant emulsion or MF59 alone at months 0, 1, 6, 9, 10 and 12 (was months 0, 1, 6 and 10, amended 12/19/96).

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • Volunteers must have:
  • Normal history and physical exam.
  • HIV negativity.
  • Absolute CD4 count \>= 400 cells/mm3.
  • Normal urine dipstick with esterase and nitrite.
  • Lower risk sexual behavior.
  • Exclusion Criteria
  • Co-existing Condition:
  • Subjects with the following symptoms or conditions are excluded:
  • Positive hepatitis B surface antigen.
  • Medical or psychiatric condition (such as recent suicidal ideation or present psychosis) that precludes compliance.
  • Active syphilis. NOTE: Subjects with serology documented to be a false positive or due to a remote (\> 6 months) treated infection are eligible.
  • Active tuberculosis. NOTE: Subjects with a positive PPD and a normal chest x-ray showing no evidence of TB and not requiring isoniazid therapy are eligible.
  • Subjects with the following prior conditions are excluded:
  • History of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications.
  • 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 psychiatric condition (such as history of suicide attempts or past psychosis) that precludes compliance.
  • History of cancer unless there has been surgical excision that is considered to have achieved cure.
  • Prior Medication:
  • Excluded:
  • Live attenuated vaccines within 60 days prior to study entry. NOTE: Medically indicated killed or subunit vaccines (e.g., influenza, pneumococcal) do not exclude if administered at least 2 weeks from HIV immunizations.
  • Experimental agents within 30 days prior to study entry.
  • Prior HIV vaccines.
  • Prior Treatment:
  • Excluded:
  • Blood products or immunoglobulin within the past 6 months.
  • Identifiable high-risk behavior for HIV infection, including:
  • History of injection drug use within past 12 months.
  • Higher risk sexual behavior.

Trial Officials

Corey L

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

Rochester, New York, United States

Pittsburgh, Pennsylvania, United States

Saint Louis, Missouri, United States

Birmingham, Alabama, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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