Search / Trial NCT00000631

A Phase I Randomized Trial to Evaluate the Safety and Immunogenicity of Vaccinia-HIV Envelope Recombinant Vaccine (HIVAC-1e) in Combination With Soluble Recombinant Envelope Vaccine (VaxSyn)

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

Trial Information

Current as of December 05, 2024

Completed

Keywords

Vaccines, Synthetic Vaccinia Virus Viral Envelope Proteins Viral Vaccines Aids Vaccines Hiv Seronegativity Hiv Preventive Vaccine

ClinConnect Summary

Recent Phase I trials conducted at the AIDS Vaccine Units have shown that antibodies have persisted in most recipients for 6 months after boosting, and responses seem significantly higher and more persistent than responses achieved by just two doses of soluble protein vaccine alone or two doses of HIVAC-1e alone. This study tests in a previously recruited cohort of volunteers whether additional boosting with soluble recombinant gp160 results in increased immunogenicity of longer duration.

Twelve volunteers who have previously received two doses of HIVAC-1e (or DryVax) and two doses of gp16...

Gender

MALE

Eligibility criteria

  • Inclusion Criteria
  • Patients must have:
  • Normal history and physical exam.
  • Negative ELISA for HIV.
  • Negative HIV p24 antigen test.
  • Normal urinalysis.
  • Prior Medication: Required:
  • Two prior doses of HIVAC-1e (or DryVax) and two prior doses of gp160 vaccine.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms and conditions are excluded:
  • Risk factors for HIV infection including active intravenous drug use and more than 2 sexual partners.
  • History of immunodeficiency or chronic illness.
  • Hypersensitivity to insects.
  • Medical or psychiatric condition that makes it unlikely the patient will comply with the protocol.
  • Patients with the following prior conditions are excluded:
  • History of immunodeficiency or chronic illness.
  • Prior Medication:
  • Excluded:
  • Immunosuppressive medications.
  • Prior Treatment:
  • Excluded:
  • Blood or blood product transfusion within the past 6 months.
  • Risk Behavior: Excluded:
  • Intravenous drug use.
  • More than 2 sexual partners.

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

Seattle, Washington, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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