Status:
COMPLETED
Safety and Immunogenicity of IMVAMUNE® (MVA-BN®) Smallpox Vaccine in HIV Infected Patients
Lead Sponsor:
Bavarian Nordic
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
HIV Infections
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to gather information on the safety and immunogenicity of an investigational smallpox vaccine in HIV infected populations. Subjects will receive two vaccinations
Eligibility Criteria
Inclusion
- Genders eligible for Study: Both
- Age: between 18 and 55 years
- Healthy volunteers are accepted
- Subjects tested positive for HIV-1 infection (HIV-infected subjects).
- Subjects that are tested negative for HIV (Healthy subjects).
- Either on stable antiretroviral therapy or not on antiretroviral therapy.
- CD4 cells \> = 200 - 750/µl.
- Subjects must be in good general health except for HIV infection.
- Women must not be pregnant and use an acceptable method of contraception.
Exclusion
- Impairment of immunologic function (other than HIV infection).
- History of coronary heart disease, myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure.
- Uncontrolled serious infection.
- History of or active autoimmune disease.
- History or clinical manifestation of clinically significant and severe hematological, renal, hepatic, pulmonary, central nervous, cardiovascular or gastrointestinal disorders.
- History of an immediate family member (father, mother, brother, or sister) who has had onset of ischemic heart disease before the age of 50 years.
- High risk of developing a myocardial infarction or coronary death.
- History of intravenous drug abuse (within the last 12 months).
- Known allergy to egg or aminoglycoside (gentamicin).
- History of anaphylaxis or severe allergic reaction.
- Subjects undergoing treatment for tuberculosis infection or disease.
- Chronic administration of systemic immuno-suppressants.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
581 Patients enrolled
Trial Details
Trial ID
NCT00316589
Start Date
June 1 2006
End Date
October 1 2009
Last Update
January 3 2019
Active Locations (36)
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1
Alabama Vaccine Research Clinic; University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-2050
2
Health for Life Clinic, PLLC
Little Rock, Arkansas, United States, 72207
3
Providence Clinical Research
Burbank, California, United States, 91505
4
Northern California Research
Carmichael, California, United States, 95608