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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)

National Institute of Allergy and Infectious Diseases (NIAID) logo

National Institute of Allergy and Infectious Diseases (NIAID)

Status and phase

Completed
Phase 1

Conditions

HIV Infections

Treatments

Biological: HIVAC-1e
Biological: gp160 Vaccine (MicroGeneSys)

Study type

Interventional

Funder types

NIH

Identifiers

NCT00000631
10539 (Registry Identifier)
AVEG 002B

Details and patient eligibility

About

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.

Full 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.

Sex

Male

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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 contacts and locations

1

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Data sourced from clinicaltrials.gov

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