NCT00097838

Brief Summary

The purpose of this study is to evaluate the safety of and immune response to an alphavirus replicon, HIV-1 subtype C gag vaccine, AVX101, in HIV uninfected adults in the United States, South Africa, and Botswana.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P75+ for phase_1 hiv-infections

Timeline
Completed

Started Oct 2004

Longer than P75 for phase_1 hiv-infections

Geographic Reach
3 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 1, 2004

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

July 2, 2012

Status Verified

June 1, 2012

Enrollment Period

4.9 years

First QC Date

November 30, 2004

Last Update Submit

June 27, 2012

Conditions

HIV Infections

Keywords

HIV SeronegativityHIV Preventive Vaccine

Outcome Measures

Primary Outcomes (1)

  • Grade IV adverse events

    The sample size at each vaccine dose level was selected such that the stopping rule for not escalating the dose (2 or more vaccine-related Grade IV adverse experiences) would be met with high probability if the true toxicity rate was above 15-20%, and such that dose escalation would occur with high probability if the true toxicity rate was less than 5%.

    1 year

Secondary Outcomes (7)

  • Local and systemic adverse events

    7 days after each dose

  • Binding antibodies by ELISA

    1 year

  • Chromium release CTL assay

    3 months

  • IFN-gamma ELISpot assay

    3 months

  • Antibodies to VEE virus

    1 year

  • +2 more secondary outcomes

Study Arms (5)

1 x 10^5 IU dose

EXPERIMENTAL

Vaccine dose of 1 x 10\^5 IU per injection

Biological: AVX101

1 x 10^6 IU dose

EXPERIMENTAL

Vaccine dose of 1 x 10\^6 IU per injection

Biological: AVX101

1 x 10^7 IU dose

EXPERIMENTAL

Vaccine dose of 1 x 10\^7 IU per injection

Biological: AVX101

1 x 10^8 IU dose

EXPERIMENTAL

Vaccine dose of 1 x 10\^8 IU per injection

Biological: AVX101

Placebo

PLACEBO COMPARATOR

phosphate buffered saline, pH 7.2, HSA, sodium gluconate, and sucrose

Other: placebo

Interventions

AVX101BIOLOGICAL

Alphavirus replicon particle vaccine expressing HIV Gag antigen

1 x 10^5 IU dose1 x 10^6 IU dose1 x 10^7 IU dose1 x 10^8 IU dose
placeboOTHER

phosphate buffered saline, pH 7.2, HSA, sodium gluconate, and sucrose

Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • HIV uninfected
  • At low risk for HIV infection
  • Willing to receive HIV test results
  • Good general health
  • Acceptable methods of contraception for females of reproductive potential
  • Hepatitis B surface antigen negative
  • Anti-hepatitis C virus antibody (anti-HCV) negative or negative HCV PCR if anti-HCV is positive
  • Meets educational requirements of the study

You may not qualify if:

  • HIV vaccines or placebos in prior HIV vaccine trial
  • Immunosuppressive medications within 168 days prior to first study vaccine administration
  • Blood products within 120 days prior to first study vaccine administration
  • Immunoglobulin within 60 days prior to first study vaccine administration
  • Live attenuated vaccines within 30 days prior to first study vaccine administration
  • Investigational research agents within 30 days prior to first study vaccine administration
  • Subunit or killed vaccines within 14 days prior to first study vaccine administration
  • Allergy treatment with antigen injections within 30 days prior to first vaccine administration
  • Current tuberculosis prophylaxis or therapy
  • Serious adverse reaction to a vaccine. A person who had an adverse reaction to pertussis vaccine as a child is not excluded.
  • Autoimmune disease or immunodeficiency
  • Active syphilis
  • Unstable asthma
  • Type 1 or type 2 diabetes mellitus
  • Thyroid disease requiring treatment in the past 12 months
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Johns Hopkins University

Baltimore, Maryland, 21205-1901, United States

Location

New York Blood Center - Union Square

New York, New York, 10003, United States

Location

Columbia University

New York, New York, 10032, United States

Location

University of Rochester

Rochester, New York, 14642-0001, United States

Location

New York Blood Center - Bronx

The Bronx, New York, 10456, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Botswana HIV Vaccine Clinical Eval. Ctr, Princess

Gaborone, Botswana

Location

Perinatal HIV Research Unit, Chris Hani Baragwanat

Bertsham, 2013, South Africa

Location

Related Publications (5)

  • Davis NL, West A, Reap E, MacDonald G, Collier M, Dryga S, Maughan M, Connell M, Walker C, McGrath K, Cecil C, Ping LH, Frelinger J, Olmsted R, Keith P, Swanstrom R, Williamson C, Johnson P, Montefiori D, Johnston RE. Alphavirus replicon particles as candidate HIV vaccines. IUBMB Life. 2002 Apr-May;53(4-5):209-11. doi: 10.1080/15216540212657.

    PMID: 12120997BACKGROUND

  • Williamson AL. The development of HIV-1 subtype C vaccines for Southern Africa. IUBMB Life. 2002 Apr-May;53(4-5):207-8. doi: 10.1080/15216540212648.

    PMID: 12120996BACKGROUND

  • Williamson C, Morris L, Maughan MF, Ping LH, Dryga SA, Thomas R, Reap EA, Cilliers T, van Harmelen J, Pascual A, Ramjee G, Gray G, Johnston R, Karim SA, Swanstrom R. Characterization and selection of HIV-1 subtype C isolates for use in vaccine development. AIDS Res Hum Retroviruses. 2003 Feb;19(2):133-44. doi: 10.1089/088922203762688649.

    PMID: 12639249BACKGROUND

  • Schlesinger S. Alphavirus vectors: development and potential therapeutic applications. Expert Opin Biol Ther. 2001 Mar;1(2):177-91. doi: 10.1517/14712598.1.2.177.

    PMID: 11727528BACKGROUND

  • Wecker M, Gilbert P, Russell N, Hural J, Allen M, Pensiero M, Chulay J, Chiu YL, Abdool Karim SS, Burke DS; HVTN 040/059 Protocol Team; NIAID HIV Vaccine Trials Network. Phase I safety and immunogenicity evaluations of an alphavirus replicon HIV-1 subtype C gag vaccine in healthy HIV-1-uninfected adults. Clin Vaccine Immunol. 2012 Oct;19(10):1651-60. doi: 10.1128/CVI.00258-12. Epub 2012 Aug 22.

    PMID: 22914365DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Donald S. Burke, MD

    Center for Immunization Research, Johns Hopkins School of Public Health

    STUDY CHAIR

  • Salim Abdool Karim, MD, PhD

    University of KwaZulu

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2004

First Posted

December 1, 2004

Study Start

October 1, 2004

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

July 2, 2012

Record last verified: 2012-06

Locations

BO(1)US(6)ZA(1)