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) - Full Text View

Sponsor:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00000631

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 I

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)

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: PANVAC-V

U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment:

13

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000631

Locations

United States, Washington
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, United States, 981050371

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Study Chair:

Corey L

More Information

Publications:

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.

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.

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.

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.

ClinicalTrials.gov Identifier:	NCT00000631 History of Changes
Other Study ID Numbers:	AVEG 002B
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
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 February 12, 2012