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)
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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) |
| Estimated Enrollment: | 13 |
| Study Completion Date: | December 1992 |
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 |
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 More Information
Publications:
| 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 March 14, 2013
