ClinicalTrials.gov
skipnavHome|Search|Browse|Resources|Help|What's New|About

Development of a New HIV Vaccine

This study is currently recruiting patients.

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
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 Treatment or Intervention Phase
HIV Infections
 Vaccine: PolyEnv1
Phase I

MedlinePlus related topics:  AIDS

Study Type: Interventional
Study Design: Prevention, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety Study

Official Title: Evaluation of the Safety of a Polyvalent Vaccinia Virus HIV-1 Envelope Recombinant Vaccine (PolyEnv1) in Healthy Adults

Further Study Details: 

Expected Total Enrollment:  24

Study start: October 1997

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

Ages Eligible for Study:  18 Years   -   32 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

Exclusion Criteria:


Location and Contact Information

Karen Slobod, MD      901-495-2650    karen.slobod@stjude.org

Tennessee
      St. Jude Children's Research Hospital, Memphis,  Tennessee,  38105,  United States; Recruiting
Nanna M. Howlett, RN  901-495-2846    nanna.howlett@stjude.org 
Karen S. Slobod, MD  901-495-3486    karen.slobod@stjude.org 
Karen S. Slobod, MD,  Principal Investigator
Julia L. Hurwitz, PhD,  Principal Investigator

Study chairs or principal investigators

Karen S. Slobod, MD,  Principal Investigator,  Associate Member   
Julia L. Hurwitz, PhD,  Principal Investigator,  Member   

More Information

Click here for more information about St. Jude Children's Research Hospital.

Click here to learn more about HIV vaccines

Publications

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. No abstract available.

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.

Richmond JF, Mustafa F, Lu S, Santoro JC, Weng J, O'Connell M, Fenyo 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.

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.

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 03.

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.

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.

Study ID Numbers:  P01 AI45142
Record last reviewed:  November 2004
Record first received:  January 17, 2003
ClinicalTrials.gov Identifier:  NCT00051922
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-08
line
U.S. National Library of Medicine, Contact NLM Customer Service
National Institutes of Health, Department of Health & Human Services
Copyright, Privacy, Accessibility, Freedom of Information Act