Bavarian
Nordic
POX-MVA-011
A
Multicenter, Open-Label, Controlled Phase II Study
to Evaluate Safety and Immunogenicity of MVA-BN®
(IMVAMUNETM) Smallpox Vaccine in 18-55 Year Old Naive
and Previously Vaccinated HIV Infected Subjects With
CD4 Counts > 200 – 500/µl.
Purpose of this Study: To gather
information on the safety and immunogenicity of an
investigational smallpox vaccine in HIV infected populations.
Subjects will receive two vaccinations.
Requirements to Enter Study:
- Genders eligible for Study: Both
- Age: between 18 and 55 years
- Healthy volunteers are accepted
Inclusion Criteria:
- Subjects with tested positive HIV-1 infection.
- Subjects that are tested negative for HIV.
- Either on stable antiretroviral therapy or not
on antiretroviral therapy.
- CD4 cells > = 200 – 500/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 Criteria:
- 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.
Treatment: MVA-BN® (IMVAMUNETM)
Smallpox Vaccine
Duration of Study: Each subject
will be required to visit the study site for 7 scheduled
visits up to a duration of 39 weeks.
For
more information contact:
Study
Contacts
Randee
Silverman, RN (215) 615-0122
