Development of a New HIV Vaccine

NCT00051922 | Completed Phase 1

• 1 other identifier: P01AI045142
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Infections

Keywords

HIV Preventive Vaccine; HIV Seronegativity

Outcome Measures

Primary Outcomes (1)

• Tolerability and safety of the PolyEnv1 vaccine

  Throughout study

Study Arms (1)

1

EXPERIMENTAL

Participants will receive vaccine and will be followed for 1 year

Biological: PolyEnv1

Interventions

PolyEnv1 BIOLOGICAL

Recombinant vaccinia virus vaccine

1

Eligibility Criteria

• Age: 18 Years - 32 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Publications (11)

• 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. doi: 10.4049/jimmunol.171.8.4140.

  PMID: 14530336 BACKGROUND

• 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. doi: 10.1016/s0264-410x(98)00355-7.

  PMID: 10195794 BACKGROUND

• 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. doi: 10.1385/IR:21:1:7.

  PMID: 10803879 BACKGROUND

• 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. doi: 10.1016/s0264-410x(96)00185-5.

  PMID: 9139484 BACKGROUND

• 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. doi: 10.1089/aid.1995.11.1131. No abstract available.

  PMID: 8554911 BACKGROUND

• 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. doi: 10.1006/viro.1997.8478.

  PMID: 9143282 BACKGROUND

• 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. doi: 10.1586/14760584.4.3.305.

  PMID: 16026246 BACKGROUND

• 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. doi: 10.1186/1742-6405-2-3.

  PMID: 15860130 BACKGROUND

• 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. doi: 10.1073/pnas.071063898. Epub 2001 Apr 3.

  PMID: 11287644 BACKGROUND

• 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. doi: 10.1128/jvi.77.7.4231-4236.2003.

  PMID: 12634380 BACKGROUND

• 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. doi: 10.1007/s10096-003-1075-3. Epub 2004 Jan 20.

  PMID: 14735404 RESULT

Related Links

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

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Patricia Flynn, MD

  Associate Member

  PRINCIPAL INVESTIGATOR

• Julia L. Hurwitz, PhD

  Member

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH

Study Record Dates

• First Submitted: January 17, 2003
• First Posted: January 22, 2003
• Study Start: October 1, 1997
• Primary Completion: July 1, 2006
• Study Completion: June 1, 2009
• Last Updated: June 8, 2011

Record last verified: 2011-06

Locations

US (1)