A Phase I, Multicenter, Randomized Trial to Evaluate the Safety and Immunogenicity of a Recombinant Vaccinia-HIV Envelope Vaccine (HIVAC-1e) in Combination With a Panel of Subunit Recombinant HIV Envelope Vaccines
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
![](https://webarchive.library.unt.edu/web/20130315212038im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Primary: To determine in healthy volunteers whether priming with a vaccinia HIV-1 gp160 envelope gene recombinant vaccine (HIVAC-1e) followed by boosting with one of two subunit recombinant HIV-1 envelope vaccines (Env 2-3 and gp120) provides enhanced immunogenicity compared to vaccination with the gp120 subunit vaccine alone. (Per 10/01/92 amendment, boosts with VaxSyn (gp160) were eliminated.) To evaluate the immunogenicity of one versus two priming doses of HIVAC-1e prior to a boost with gp120. To compare the relative immunogenicity of the three subunit vaccines when administered as boosters.
Secondary: To examine the safety of administering the individual subunit vaccines in combination with HIVAC-1e and the safety of administering the gp120 subunit vaccine alone.
In a previous study of candidate HIV vaccines, the evidence suggested that administration of a booster vaccination with a different vaccine preparation may produce a better immune response than administration of HIVAC-1e vaccine alone.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Biological: rgp120/HIV-1 SF-2 Biological: Env 2-3 Biological: HIVAC-1e Biological: gp160 Vaccine (MicroGeneSys) |
Phase 1 |
Study Type: | Interventional |
Study Design: | Endpoint Classification: Safety Study Primary Purpose: Prevention |
Official Title: | A Phase I, Multicenter, Randomized Trial to Evaluate the Safety and Immunogenicity of a Recombinant Vaccinia-HIV Envelope Vaccine (HIVAC-1e) in Combination With a Panel of Subunit Recombinant HIV Envelope Vaccines |
Estimated Enrollment: | 56 |
Study Completion Date: | July 1994 |
In a previous study of candidate HIV vaccines, the evidence suggested that administration of a booster vaccination with a different vaccine preparation may produce a better immune response than administration of HIVAC-1e vaccine alone.
Seventy healthy volunteers are randomized to one of four groups. Groups A and D receive one initial immunization with HIVAC-1e followed by two boosts with subunit gp120 and Env 2-3, respectively, at months 8 and 12. Group B receives two immunizations with HIVAC-1e at months 0 and 8 followed by a single boost with subunit gp120 at month 12. Group C receives three doses of subunit gp120 only at months 0, 8 and 12. (Per 10/01/92 amendment, boosts with VaxSyn (gp160) have been eliminated.) Subjects are followed for 18 months.
![](https://webarchive.library.unt.edu/web/20130315212038im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Subjects must have:
- Normal history and physical exam.
- Negative HIV screening by ELISA, Western blot, and p24 antigen (PBMC HIV culture or HIV-specific PCR can be substituted for Western blot and p24 antigen).
- History of smallpox vaccination more than 5 years prior to enrollment.
- Normal urinalysis.
- Absolute CD4 count = or > 500 cells/mm3.
Prior Medication: Required:
- Vaccinia (smallpox) vaccination more than 5 years prior to study enrollment. Identifiable high-risk behavior for HIV infection as determined by screening questionnaire/interview.
Exclusion Criteria
Co-existing Condition:
Subjects with the following symptoms or conditions are excluded:
- Household contacts who are pregnant, < 12 months of age, have eczema, or have immunodeficiency disease or who use immunosuppressive medications.
- Hepatitis B surface antigenemia.
- Medical or psychiatric condition or occupational responsibilities that preclude compliance.
Subjects with the following prior conditions are excluded:
- History of immunodeficiency or chronic illness.
- Eczema within the past year.
Prior Medication:
Excluded:
- Prior experimental HIV vaccine.
- Immunoglobulin administration or use of experimental agent within the past 2 months.
- History of immunosuppressive medications.
Prior Treatment:
Excluded:
- Blood or blood product transfusion within the previous 6 months.
![](https://webarchive.library.unt.edu/web/20130315212038im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
![](https://webarchive.library.unt.edu/web/20130315212038im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Publications:
Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000746 History of Changes |
Other Study ID Numbers: | AVEG 008, AVEG Protocol 008, 10553 |
Study First Received: | November 2, 1999 |
Last Updated: | May 23, 2012 |
Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Vaccines, Synthetic Vaccinia Virus Viral Vaccines HIV-1 HIV Envelope Protein gp160 |
HIV Envelope Protein gp120 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