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)
NCT ID: NCT00000631
Last Updated: 2021-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
13 participants
INTERVENTIONAL
1992-12-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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PREVENTION
NONE
Interventions
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HIVAC-1e
gp160 Vaccine (MicroGeneSys)
Eligibility Criteria
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Inclusion Criteria
* 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
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.
18 Years
60 Years
MALE
Yes
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Corey L
Role: STUDY_CHAIR
Locations
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Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, United States
Countries
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References
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McElrath MJ, Corey L, Greenberg PD. Evaluation of cytotoxic T cell responses to candidate HIV-1 vaccines in HIV-1-uninfected individuals. AIDS Res Hum Retroviruses. 1994;10 Suppl 2:S69-72.
Kent SJ, Greenberg PD, Hoffman MC, Akridge RE, McElrath MJ. Antagonism of vaccine-induced HIV-1-specific CD4+ T cells by primary HIV-1 infection: potential mechanism of vaccine failure. J Immunol. 1997 Jan 15;158(2):807-15.
Mosier DE, Gulizia RJ, MacIsaac PD, Corey L, Greenberg PD. Resistance to human immunodeficiency virus 1 infection of SCID mice reconstituted with peripheral blood leukocytes from donors vaccinated with vaccinia gp160 and recombinant gp160. Proc Natl Acad Sci U S A. 1993 Mar 15;90(6):2443-7. doi: 10.1073/pnas.90.6.2443.
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)
McElrath MJ, Rabin M, Hoffman M, Klucking S, Garcia JV, Greenberg PD. Evaluation of human immunodeficiency virus type 1 (HIV-1)-specific cytotoxic T-lymphocyte responses utilizing B-lymphoblastoid cell lines transduced with the CD4 gene and infected with HIV-1. J Virol. 1994 Aug;68(8):5074-83. doi: 10.1128/JVI.68.8.5074-5083.1994.
McElrath MJ, Corey L, Greenberg PD, Matthews TJ, Montefiori DC, Rowen L, Hood L, Mullins JI. Human immunodeficiency virus type 1 infection despite prior immunization with a recombinant envelope vaccine regimen. Proc Natl Acad Sci U S A. 1996 Apr 30;93(9):3972-7. doi: 10.1073/pnas.93.9.3972.
Cooney EL, McElrath MJ, Corey L, Hu SL, Collier AC, Arditti D, Hoffman M, Coombs RW, Smith GE, Greenberg PD. Enhanced immunity to human immunodeficiency virus (HIV) envelope elicited by a combined vaccine regimen consisting of priming with a vaccinia recombinant expressing HIV envelope and boosting with gp160 protein. Proc Natl Acad Sci U S A. 1993 Mar 1;90(5):1882-6. doi: 10.1073/pnas.90.5.1882.
Other Identifiers
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10539
Identifier Type: REGISTRY
Identifier Source: secondary_id
AVEG 002B
Identifier Type: -
Identifier Source: org_study_id