Search / Trial NCT00000767

A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a Recombinant Vaccinia-HIV-1 IIIB Env/Gag/Pol Vaccine (TBC-3B)

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

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Trial Information

Current as of December 27, 2024

Completed

Keywords

Vaccines, Synthetic Vaccinia Virus Viral Vaccines Smallpox Vaccine Hiv 1 Aids Vaccines Hiv Seronegativity Hiv Preventive Vaccine

ClinConnect Summary

Antigenic drift, defined as the genetic variation of the HIV-1 envelope gene that results in antigenic variation during natural infection, may confound attempts to achieve protective immunity using a vaccine based solely on HIV-1 envelope proteins. Inclusion of conserved core and polymerase proteins along with envelope protein in a candidate vaccine may address some of the problems with antigenic variability. A prime-boost immunization approach using a novel priming immunogen expressing env, gag, and pol genes of the HIV-1 IIIB strain will be attempted in this study.

In Part I, vaccinia-im...

Gender

ALL

Eligibility criteria

  • • Inclusion Criteria
  • Subjects must have:
  • • Negative ELISA and Western blot for HIV-1 within 6 weeks prior to immunization.
  • • Normal history and physical exam.
  • • History of smallpox vaccination at least 5 years prior to study entry (Part I) OR no prior smallpox vaccination (Part II).
  • • Absolute CD4 count \>= 400 cells/mm3.
  • • Normal urinalysis.
  • NOTE:
  • • No more than 10 percent of volunteers in both Parts I and II may be over 50 years of age.
  • • 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.
  • • Occupational responsibilities that preclude 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.
  • • Eczema.
  • * Household contact with persons meeting any of the following criteria:
  • • pregnancy, less than 12 months of age, eczema, immunodeficiency disease, or use of immunosuppressive medications.
  • 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.
  • • Eczema within the past year.
  • • History of serious allergic reaction to any substance, requiring hospitalization or emergent medical care (e.g., Steven-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:
  • • Prior HIV vaccines.
  • • Live attenuated vaccines within the past 60 days. NOTE: Medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) do not exclude but should be administered at least 2 weeks prior to HIV immunizations.
  • • Experimental agents within the past 30 days.
  • Prior Treatment:
  • Excluded:
  • • Receipt of blood products or immunoglobulins within the past 6 months. It is STRONGLY RECOMMENDED that any activity that might expose subject to HIV (unprotected sex or needle sharing) be avoided.

Trial Officials

Keefer M

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

Pittsburgh, Pennsylvania, United States

Saint Louis, Missouri, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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