Safety of and Immune Response to an HIV-1 Subtype C Vaccine (AVX101) in HIV Uninfected Adults

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00097838
• Date of registration: 30/11/2004
• Prospective Registration: No
• Primary sponsor: AlphaVax, Inc.
• Public title: Safety of and Immune Response to an HIV-1 Subtype C Vaccine (AVX101) in HIV Uninfected Adults
• Scientific title: A Phase I, Dose Escalation, Safety, and Immunogenicity Trial of an Alphavirus Replicon HIV-1 Subtype C Gag Vaccine (AVX101) in Healthy HIV-1 Uninfected Adult Participants
• Date of first enrolment: October 2004
• Target sample size: 96
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00097838
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
• Phase: Phase 1

Countries of recruitment

Botswana, South Africa, United States

Contacts

• Name: Donald S. Burke, MD
• Affiliation: Center for Immunization Research, Johns Hopkins School of Public Health

• Name: Salim Abdool Karim, MD, PhD
• Affiliation: University of KwaZulu

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- Serious angioedema within the past 3 years

- Uncontrolled hypertension

- Bleeding disorder

- Malignancy unless it has been surgically removed and, in the opinion of the
investigator, is not likely to recur during the study period

- Seizure disorder requiring medication within the past 3 years

- Asplenia

- Mental illness that would interfere with compliance with the protocol

- Other conditions that, in the judgment of the investigator, would interfere with the
study

- Pregnant or breastfeeding



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Both

Health Condition(s) or Problem(s) studied

HIV Infections

Intervention(s)

Biological: AVX101

Other: placebo

Primary Outcome(s)

Grade IV adverse events [Time Frame: 1 year]

Secondary Outcome(s)

Chromium release CTL assay [Time Frame: 3 months]

Replication-competent viral vector viremia [Time Frame: 2 weeks after each vaccine dose]

Antibodies to VEE virus [Time Frame: 1 year]

Binding antibodies by ELISA [Time Frame: 1 year]

IFN-gamma ELISpot assay [Time Frame: 3 months]

Local and systemic adverse events [Time Frame: 7 days after each dose]

Intracellular cytokine staining (ICS) assay [Time Frame: 3 months]

Secondary ID(s)

HVTN 059

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

HIV Vaccine Trials Network

National Institute of Allergy and Infectious Diseases (NIAID)