Safety and Immunogenicity of IMVAMUNE® (MVA-BN®) Smallpox Vaccine in HIV Infected Patients

Bavarian Nordic

Status and phase: Completed; Phase 2

Conditions: HIV Infections

Treatments: Biological: IMVAMUNE (MVA-BN)

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT00316589

POX-MVA-011

Details and patient eligibility

About

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

Enrollment: 581 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

• Genders eligible for Study: Both
• Age: between 18 and 55 years
• Healthy volunteers are accepted

Inclusion Criteria:

• 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 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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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581 participants in 3 patient groups

Healthy subjects

Experimental group

Description:

Control group with and without a history of previous smallpox vaccination IMVAMUNE (MVA-BN)

Treatment:

Biological: IMVAMUNE (MVA-BN)

HIV-infected, vaccinia-naive

Experimental group

Description:

Subjects without a history of previous smallpox vaccination, IMVAMUNE (MVA-BN)

Treatment:

Biological: IMVAMUNE (MVA-BN)

HIV-infected, vaccinia-experienced

Experimental group

Description:

Subjects with a history of previous smallpox vaccination, IMVAMUNE (MVA-BN)

Treatment:

Biological: IMVAMUNE (MVA-BN)