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Development of a New HIV Vaccine

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00051922
First Posted: January 22, 2003
Last Update Posted: June 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
  Purpose
The purpose of the study is to determine the safety of a new HIV vaccine and to evaluate the immune response to the vaccine. Only some HIV genes are used to make the vaccine and therefore the vaccine cannot itself cause HIV or AIDS.

Condition Intervention Phase
HIV Infections Biological: PolyEnv1 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of the Safety of a Polyvalent Vaccinia Virus HIV-1 Envelope Recombinant Vaccine (PolyEnv1) in Healthy Adults

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Tolerability and safety of the PolyEnv1 vaccine [ Time Frame: Throughout study ]

Enrollment: 24
Study Start Date: October 1997
Study Completion Date: June 2009
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will receive vaccine and will be followed for 1 year
Biological: PolyEnv1
Recombinant vaccinia virus vaccine

Detailed Description:

HIV-1 presents several challenges to vaccine design, including: 1) high mutation rates resulting in tremendous diversity of virus envelope, the target of neutralizing antibody, such that antibody elicited to one envelope may not protect from virus with a distinct envelope; 2) envelope from infected persons differs from envelopes obtained from T-cell line cultures, the usual source of envelope for vaccines; and 3) envelope glycoprotein exists as oligomers on the virion surface, not as the monomers used in previous vaccines. This study will test a new vaccine that has been designed to meet these challenges by delivering diverse, patient-derived, oligomeric envelopes to induce multiple type-specific responses capable of recognizing native envelope on natural variants. The vaccine vector used in this vaccine trial is recombinant vaccinia virus based on the NYCDH vaccinia isolate.

Participants in this study will receive the PolyEnv1 HIV vaccine and will be followed for one year. Laboratory tests will be performed at 10 study visits to monitor the participants' immunologic response and assess the safety of the vaccine. Patients will also have numerous HIV tests throughout the study period.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 32 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • HIV-1 negative
  • Availability for one year of follow-up
  • No evidence of previous smallpox vaccination
  • Acceptable methods of contraception

Exclusion Criteria:

  • Immunosuppressive or chronic illness
  • Medical or psychological conditions which could affect compliance
  • High risk for HIV infection
  • Live attenuated vaccines within 60 days
  • Experimental agents within 30 days
  • Blood products within past 6 months
  • Eczema
  • Pregnant or lactating women
  • Household contact with immunodeficient person, pregnant woman, or child less than 12 months of age
  • Allergy to gentamicin
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00051922


Locations
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Patricia Flynn, MD Associate Member
Principal Investigator: Julia L. Hurwitz, PhD Member
  More Information

Additional Information:
Publications:
Slobod KS, Lockey TD, Howlett N, Srinivas RV, Rencher SD, Freiden PJ, Doherty PC, Hurwitz JL. Subcutaneous administration of a recombinant vaccinia virus vaccine expressing multiple envelopes of HIV-1. Eur J Clin Microbiol Infect Dis. 2004 Feb;23(2):106-10. Epub 2004 Jan 20.
Brown SA, Stambas J, Zhan X, Slobod KS, Coleclough C, Zirkel A, Surman S, White SW, Doherty PC, Hurwitz JL. Clustering of Th cell epitopes on exposed regions of HIV envelope despite defects in antibody activity. J Immunol. 2003 Oct 15;171(8):4140-8.
Caver TE, Lockey TD, Srinivas RV, Webster RG, Hurwitz JL. A novel vaccine regimen utilizing DNA, vaccinia virus and protein immunizations for HIV-1 envelope presentation. Vaccine. 1999 Mar 17;17(11-12):1567-72.
Lockey TD, Slobod KS, Caver TE, D'Costa S, Owens RJ, McClure HM, Compans RW, Hurwitz JL. Multi-envelope HIV vaccine safety and immunogenicity in small animals and chimpanzees. Immunol Res. 2000;21(1):7-21.
Rencher SD, Lockey TD, Srinivas RV, Owens RJ, Hurwitz JL. Eliciting HIV-1 envelope-specific antibodies with mixed vaccinia virus recombinants. Vaccine. 1997 Feb;15(3):265-72. Erratum in: Vaccine 2000 Mar 17;18(18):1969. Vaccine. 2010 Apr 26;28(19):3507.
Rencher SD, Slobod KS, Dawson DH, Lockey TD, Hurwitz JL. Does the key to a successful HIV type 1 vaccine lie among the envelope sequences of infected individuals? AIDS Res Hum Retroviruses. 1995 Sep;11(9):1131-3.
Richmond JF, Mustafa F, Lu S, Santoro JC, Weng J, O'Connell M, Fenyö EM, Hurwitz JL, Montefiori DC, Robinson HL. Screening of HIV-1 Env glycoproteins for the ability to raise neutralizing antibody using DNA immunization and recombinant vaccinia virus boosting. Virology. 1997 Apr 14;230(2):265-74.
Slobod KS, Bonsignori M, Brown SA, Zhan X, Stambas J, Hurwitz JL. HIV vaccines: brief review and discussion of future directions. Expert Rev Vaccines. 2005 Jun;4(3):305-13. Review.
Slobod KS, Coleclough C, Brown SA, Stambas J, Zhan X, Surman S, Jones BG, Zirkel A, Freiden PJ, Brown B, Sealy R, Bonsignori M, Hurwitz JL. Clade, Country and Region-specific HIV-1 Vaccines: Are they necessary? AIDS Res Ther. 2005 Apr 28;2(1):3.
Surman S, Lockey TD, Slobod KS, Jones B, Riberdy JM, White SW, Doherty PC, Hurwitz JL. Localization of CD4+ T cell epitope hotspots to exposed strands of HIV envelope glycoprotein suggests structural influences on antigen processing. Proc Natl Acad Sci U S A. 2001 Apr 10;98(8):4587-92. Epub 2001 Apr 3.
Zhan X, Slobod KS, Surman S, Brown SA, Lockey TD, Coleclough C, Doherty PC, Hurwitz JL. Limited breadth of a T-helper cell response to a human immunodeficiency virus envelope protein. J Virol. 2003 Apr;77(7):4231-6.

Responsible Party: Patricia Flynn, MD, St. Jude's Children's Hospital
ClinicalTrials.gov Identifier: NCT00051922     History of Changes
Other Study ID Numbers: P01AI045142 ( U.S. NIH Grant/Contract )
First Submitted: January 17, 2003
First Posted: January 22, 2003
Last Update Posted: June 8, 2011
Last Verified: June 2011

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
HIV Preventive Vaccine
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs


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