NCT00063778

Brief Summary

The purpose of this study is to see if different doses of an experimental HIV vaccine are safe and to study how the immune system responds to the vaccine. The vaccine will be tested in healthy, HIV uninfected volunteers. AVX101 contains only one of the many substances that HIV needs to make more copies of itself; therefore, the vaccine cannot cause HIV or AIDS.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P50-P75 for phase_1 hiv-infections

Timeline
Completed

Started Jul 2003

Geographic Reach
2 countries

7 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

July 1, 2003

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 7, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 8, 2003

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
Last Updated

July 2, 2012

Status Verified

June 1, 2012

Enrollment Period

2 years

First QC Date

July 7, 2003

Last Update Submit

June 27, 2012

Conditions

HIV Infections

Keywords

HIV SeronegativityHIV Preventive VaccineAIDS VaccinesGene Products, gagHIV-1Dose-Response Relationship, ImmunologicInjections, Subcutaneous

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 (3)

1 x 10^4 IU dose

EXPERIMENTAL

Vaccine dose of 1 x 10\^4 IU per injection

Biological: AVX101

1 x 10^5 IU dose

EXPERIMENTAL

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

Biological: AVX101

Placebo

PLACEBO COMPARATOR
Other: placebo

Interventions

AVX101BIOLOGICAL

Alphavirus replicon particle vaccine expressing HIV Gag antigen

1 x 10^4 IU dose1 x 10^5 IU dose
placeboOTHER

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

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • HIV negative
  • 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
  • Access to participating site and available for follow-up during the 12 month study

You may not qualify if:

  • HIV vaccines or placebos in prior HIV vaccine trial
  • Measurable anti-VEE antibody
  • High risk for HIV infection according to HVTN Risk Criteria
  • 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
  • Current tuberculosis prophylaxis or therapy
  • Active syphilis
  • Serious adverse reaction to vaccines. A person who had an adverse reaction to pertussis vaccine as a child is not excluded.
  • Autoimmune disease or immunodeficiency
  • Unstable asthma
  • Type 1 or Type 2 Diabetes Mellitus
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Johns Hopkins University

Baltimore, Maryland, 21205-1901, United States

Location

Columbia University

New York, New York, 10032, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642-0002, United States

Location

New York Blood Ctr- Union Square

The Bronx, New York, 10456, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

SAAVI Vaccine Research Unit

Durban, South Africa

Location

Chris Hani Baragwanath Hospital

Soweto, South Africa

Location

Related Publications (5)

  • Pushko P, Parker M, Ludwig GV, Davis NL, Johnston RE, Smith JF. Replicon-helper systems from attenuated Venezuelan equine encephalitis virus: expression of heterologous genes in vitro and immunization against heterologous pathogens in vivo. Virology. 1997 Dec 22;239(2):389-401. doi: 10.1006/viro.1997.8878.

    PMID: 9434729BACKGROUND

  • Pushko P, Bray M, Ludwig GV, Parker M, Schmaljohn A, Sanchez A, Jahrling PB, Smith JF. Recombinant RNA replicons derived from attenuated Venezuelan equine encephalitis virus protect guinea pigs and mice from Ebola hemorrhagic fever virus. Vaccine. 2000 Aug 15;19(1):142-53. doi: 10.1016/s0264-410x(00)00113-4.

    PMID: 10924796BACKGROUND

  • Davis NL, Caley IJ, Brown KW, Betts MR, Irlbeck DM, McGrath KM, Connell MJ, Montefiori DC, Frelinger JA, Swanstrom R, Johnson PR, Johnston RE. Vaccination of macaques against pathogenic simian immunodeficiency virus with Venezuelan equine encephalitis virus replicon particles. J Virol. 2000 Jan;74(1):371-8. doi: 10.1128/jvi.74.1.371-378.2000.

    PMID: 10590126BACKGROUND

  • Strauss JH, Strauss EG. The alphaviruses: gene expression, replication, and evolution. Microbiol Rev. 1994 Sep;58(3):491-562. doi: 10.1128/mr.58.3.491-562.1994.

    PMID: 7968923BACKGROUND

  • 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 Burke, MD

    Johns Hopkins University

    STUDY CHAIR

  • Salim Abdool Karim, MD, PhD

    University of Natal, Durban, South Africa

    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

July 7, 2003

First Posted

July 8, 2003

Study Start

July 1, 2003

Primary Completion

July 1, 2005

Study Completion

July 1, 2005

Last Updated

July 2, 2012

Record last verified: 2012-06

Locations

US(5)ZA(2)