A Multicenter, Open-label, Controlled Phase II Study to Evaluate Safety and Immunogenicity of MVA-BN® (IMVAMUNE) Smallpox Vaccine in 18-55 Year Old Naive and Previously Vaccinated HIV Infected Subjects With CD4 Counts >200 - 750/µl.

Bavarian Nordic36 sites in 2 countries581 target enrollmentJune 2006

ConditionsHIV Infections

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: HIV Infections
Sponsor: Bavarian Nordic
Enrollment: 581
Locations: 36
Primary Endpoint: Serious Adverse Events
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

June 2006

End Date

October 2009

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bavarian Nordic

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Serious Adverse Events

Time Frame: within 32 weeks

Incidence, relationship and intensity of any Serious Adverse Event (SAE)

Secondary Outcomes

Viral Load(within 32 weeks)
CD8+ T-cell Counts(within 32 weeks)
Unsolicited Adverse Events: Incidence(within 29 days after any vaccination)
Unsolicited Adverse Events: Intensity(within 29 days after any vaccination)
Unsolicited Adverse Events: Relationship to Vaccination(within 29 days after any vaccination)
CD4+ T-cell Counts(within 32 weeks)
Related Grade >=3 Adverse Events(within 29 days after any vaccination)
Solicited Local Adverse Events(within 8 days after any vaccination)
Solicited General Adverse Events(within 8 days after any vaccination)
PRNT Seroconversion Rate(within 32 weeks)
PRNT GMT(within 32 weeks)
ELISA Seroconversion Rate(within 32 weeks)
ELISA GMT(within 32 weeks)
ELISPOT IFN-γ: Response Rate(within 32 weeks)
ELISPOT IFN-γ: SFU(within 32 weeks)