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

November 2, 1999
May 22, 2012
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Complete list of historical versions of study NCT00000631 on ClinicalTrials.gov Archive Site
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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)
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)

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.

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.

Interventional
Phase 1
Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Prevention
HIV Infections
  • Biological: HIVAC-1e
  • Biological: gp160 Vaccine (MicroGeneSys)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
December 1992
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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.
Male
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00000631
AVEG 002B, 10539
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Study Chair: Corey L
National Institute of Allergy and Infectious Diseases (NIAID)
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP