Safety of and Immune Response to Two HIV Vaccine Formulations (rMVA-HIV and rFPV-HIV) Alone or in Combination in HIV Uninfected Adults

Completed · Phase 1

Conditions studied: HIV Infections

In brief

The purpose of this study is to evaluate the safety of and immune response to two HIV vaccine formulations, rMVA-HIV and rFPV-HIV, alone and in combination, in HIV uninfected adults.

Key facts

Study ID

NCT00083603

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

150

Starts

2004-09-01

Expected to finish

2007-08-01

Last updated by the study team

2021-10-14

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• HIV uninfected within 8 weeks prior to first vaccination
• Blood pressure 140/90 or less upon enrollment
• Good general health
• Willing to receive HIV test results
• Understand the vaccination procedure
• Negative for hepatitis B surface antigen
• Negative for anti-hepatitis C virus antibodies (anti-HCV) or negative for HCV PCR if anti-HCV is positive
• Willing to use acceptable forms of contraception
• Willing to be followed for the duration of the study
• Have access to a participating HIV vaccine trial site

You may not qualify if…

• HIV vaccines or placebos in prior HIV vaccine trial
• Previously received Avipox vaccine
• Previously received Vaccinia vaccine
• Immunosuppressive medications within 168 days prior to first vaccination
• Blood products within 120 days prior to first vaccination
• Immunoglobulin within 60 days prior to first vaccination
• Live attenuated vaccines within 30 days prior to first vaccination
• Investigational research agents within 30 days prior to first vaccination
• Medically indicated subunit or killed vaccines within 14 days prior to first study vaccine administration or allergy treatment with antigen injections within 30 days prior to first vaccination
• Current tuberculosis prophylaxis or therapy
• Hypersensitivity to egg products
• Past or present cardiac disease
• Two or more of the following cardiac risk factors: history of fasting LDL greater than 160 mg/dl; first degree relative who had heart condition, excluding hypertension; cigarette smoking
• ECG with clinically significant findings (e.g., conduction disturbance, repolarization abnormality, significant atrial or ventricular arrhythmia, frequent atrial or ventricular ectopy, ST elevation consistent with ischemia, evidence of past or evolving myocardial infarction)
• 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
• Diabetes mellitus type 1 or 2
• Thyroid disease requiring treatment
• Serious angioedema within the last 3 years
• 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
• Absence of the spleen
• Mental illness that would interfere with the study

Where it is running

• Alabama Vaccine CRS — Birmingham, Alabama, United States
• Saint Louis Univ. School of Medicine, HVTU — St Louis, Missouri, United States
• Univ. of Rochester HVTN CRS — Rochester, New York, United States
• FHCRC/UW Vaccine CRS — Seattle, Washington, United States
• Projeto Praça Onze/Hesfa Crs — Rio de Janeiro, Brazil
• Sao Paulo HVTU - CRT DST/AIDS CRS — São Paulo, Brazil

Full record on ClinicalTrials.gov

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