A Multicenter, Open-label Phase I/II Study to Evaluate Safety and Immunogenicity of MVA-BN® Smallpox Vaccine in HIV Infected Subjects (CD4 Counts >350 / µl) and Healthy Subjects With and Without Previous Smallpox Vaccination

Bavarian Nordic5 sites in 1 country151 target enrollmentJuly 2005

ConditionsHIV Infections

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: HIV Infections
Sponsor: Bavarian Nordic
Enrollment: 151
Locations: 5
Primary Endpoint: Occurrence, relationship and intensity of any serious and/or unexpected adverse reaction at any time during the study
Status: Completed
Last Updated: 13 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.

Registry

clinicaltrials.gov

Start Date

July 2005

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bavarian Nordic

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male subjects between 18 and 49 years of age or female subjects between 18 and 55 years of age who provided informed consent.
•Women with negative pregnancy test.
•Women of childbearing potential must use an acceptable method of contraception.
•Cardiac enzymes within ULN.
•White blood cells ≥ 2500/mm3 and \< 11,000/ mm
•Absolute neutrophil count ≥ 1000/mm
•Adequate renal function.
•Adequate hepatic function.
•Negative hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc).
•Negative antibody test to hepatitis C virus (HCV).

Exclusion Criteria

•Pregnant or breast-feeding women.
•Uncontrolled serious infection i.e. not responding to antimicrobial therapy.
•History of any serious medical condition (other than HIV infection).
•History of or active autoimmune disease.
•Known or suspected impairment of immunologic function (other than HIV infection).
•History of malignancy.
•History or clinical manifestation of clinically significant and severe haematological, renal, hepatic, pulmonary, central nervous, cardiovascular or gastrointestinal disorders.
•Clinically significant mental disorder not adequately controlled by medical treatment.
•Any condition which might interfere with study objectives.
•History of coronary heart disease, myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure, or any other heart condition under the care of a doctor.

Outcomes

Primary Outcomes

Occurrence, relationship and intensity of any serious and/or unexpected adverse reaction at any time during the study

Secondary Outcomes

Neutralisation assay specific seroconversion rates and geometric mean titres (at all blood sampling time points)
ELISA specific seroconversion rates and geometric mean titres (at all blood sampling time points)