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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000631
First received: November 2, 1999
Last updated: May 22, 2012
Last verified: May 2012
  Purpose

Primary: To determine whether additional boosting with soluble recombinant gp160 vaccine (VaxSyn) after priming with a vaccinia-HIV envelope recombinant (HIVAC-1e) provides a significant advantage in the degree and duration of immunogenicity. Secondary: To learn more about the safety of the combination use of the two HIV envelope vaccines in the study (VaxSyn and HIVAC-1e).

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.


Condition Intervention Phase
HIV Infections
Biological: HIVAC-1e
Biological: gp160 Vaccine (MicroGeneSys)
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 13
Study Completion Date: December 1992
Detailed Description:

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 gp160 receive an additional boost of gp160 at 12-20 months after the last boost and an additional dose of HIVAC-1e at least 9 months after the final gp160 boost.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000631

Locations
United States, Washington
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, United States, 981050371
Sponsors and Collaborators
Investigators
Study Chair: Corey L
  More Information

Publications:
McElrath J, Peterson E, Dragavon J, Berger D, Hoffman M, Klucking S, Greenberg P, Corey L. Combination prime-boost approach to HIV vaccination in seronegative individuals: enhanced immunity with additional subunit gp160 protein boosting. Int Conf AIDS. 1992 Jul 19-24;8(1):Mo9 (abstract no MoB 0027)

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000631     History of Changes
Other Study ID Numbers: AVEG 002B, 10539
Study First Received: November 2, 1999
Last Updated: May 22, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Vaccines, Synthetic
Vaccinia Virus
Viral Envelope Proteins
Viral Vaccines
AIDS Vaccines
HIV Seronegativity
HIV Preventive Vaccine

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Vaccinia
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Poxviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on August 26, 2014