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Safety and Immunogenicity of IMVAMUNE® (MVA-BN®) Smallpox Vaccine in HIV Infected Patients
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Bavarian Nordic
National Institutes of Health (NIH)
Information provided by: Bavarian Nordic
ClinicalTrials.gov Identifier: NCT00316589
  Purpose

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


Condition Intervention Phase
HIV Infections
Biological: IMVAMUNE (MVA-BN)
Biological: IMVAMUNE
Phase II

MedlinePlus related topics: AIDS Smallpox
Drug Information available for: PANVAC-V
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: 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.

Further study details as provided by Bavarian Nordic:

Primary Outcome Measures:
  • Occurrence, relationship and intensity of any serious and/or unexpected adverse reaction at any time during the study [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Neutralisation assay specific seroconversion rates and geometric mean titres (at all blood sampling time points); [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  • ELISA specific seroconversion rates and geometric mean titres (at all blood sampling time points) [ Time Frame: 30 months ] [ Designated as safety issue: No ]

Enrollment: 581
Study Start Date: June 2006
Estimated Study Completion Date: April 2009
Estimated Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Biological: IMVAMUNE (MVA-BN)
2 immunizations: 1 x 10E8_TCID50, healthy subjects
2: Experimental Biological: IMVAMUNE
2 immunizations: 1 x 10E8_TCID50, HIV infected subjects (200-750 CD4 cts/µl, vaccinia naive)
3: Experimental Biological: IMVAMUNE
2 immunizations: 1 x 10E8_TCID50, HIV infected subjects (200-750 CD4 cts/µl, vaccinia experienced)

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • 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 - 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00316589

  Show 37 Study Locations
Sponsors and Collaborators
Bavarian Nordic
Investigators
Principal Investigator: Edgar Turner Overton, MD Washington University, St. Louis
  More Information

Responsible Party: Bavarian Nordic ( Monika Fluer )
Study ID Numbers: POX-MVA-011
Study First Received: April 19, 2006
Last Updated: January 12, 2009
ClinicalTrials.gov Identifier: NCT00316589  
Health Authority: United States: Food and Drug Administration

Keywords provided by Bavarian Nordic:
HIV
treatment experienced
treatment vaccinia naive

Study placed in the following topic categories:
Virus Diseases
Smallpox
Sexually Transmitted Diseases, Viral
Vaccinia
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 16, 2009