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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Bavarian Nordic
ClinicalTrials.gov Identifier:
NCT00316589
First received: April 19, 2006
Last updated: October 4, 2012
Last verified: October 2012

April 19, 2006
October 4, 2012
June 2006
March 2009   (final data collection date for primary outcome measure)
Occurrence, relationship and intensity of any serious and/or unexpected adverse reaction at any time during the study [ Time Frame: 35 weeks ] [ Designated as safety issue: Yes ]
Occurrence, relationship and intensity of any serious and/or unexpected adverse reaction at any time during the study
Complete list of historical versions of study NCT00316589 on ClinicalTrials.gov Archive Site
  • Occurrence of any Grade 3 or higher adverse reaction (missing, unknown, not evaluable, possibly, probably, or definitely related) to the study vaccine [ Time Frame: 28 days after each vaccination ] [ Designated as safety issue: Yes ]
  • Occurrence, intensity and duration of solicited local adverse events (erythema, swelling and pain) within one week after each vaccination [ Time Frame: 8 days ] [ Designated as safety issue: Yes ]
  • Occurrence, intensity and duration of systemic adverse events (pyrexia, headache, myalgia, nausea, fatigue and chills) within 1 week after each vaccination. Relationship to vaccination [ Time Frame: 8 days ] [ Designated as safety issue: Yes ]
  • Occurrence, intensity and duration of all unsolicited adverse events (i.e. serious + non-serious) within 4 weeks after each vaccination. Relationship to vaccination [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Plaque Reduction Neutralization Test (PRNT) specific seroconversion rates and geometric mean titers (GMTs) (at all blood sampling time points). [ Time Frame: up to 35 weeks ] [ Designated as safety issue: No ]
  • ELISA specific seroconversion rates and geometric mean titers (at all blood sampling time points). [ Time Frame: up to 35 weeks ] [ Designated as safety issue: No ]
  • Interferon (IFN) gamma producing T-cells in response to stimulation with MVA-BN (IMVAMUNE) detected by Enzyme-Linked Immunospot (ELISPOT) (only for the 165 subjects in the main study). [ Time Frame: up to 35 weeks ] [ Designated as safety issue: No ]
  • Change in CD4+ and CD8+ T-cell counts in HIV-infected subjects [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • 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)
Not Provided
Not Provided
 
Safety and Immunogenicity of IMVAMUNE® (MVA-BN®) Smallpox Vaccine in HIV Infected Patients
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.

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

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV Infections
Biological: IMVAMUNE (MVA-BN)
2 immunizations, four weeks apart: 1 x 10E8_TCID50, SC
  • Experimental: Group 1: Healthy subjects
    Healthy control group with (n=9) and without (n=88) a history of previous smallpox vaccination
    Intervention: Biological: IMVAMUNE (MVA-BN)
  • Experimental: Group 2: HIV-infected, CD4 200 -750/µl, vaccinia-naive
    HIV-infected subjects without a history of previous smallpox vaccination (n=351)
    Intervention: Biological: IMVAMUNE (MVA-BN)
  • Experimental: Group 3: HIV-infected, CD4 200 - 750/µl, vaccinia-experienced
    HIV-infected subjects with a history of previous smallpox vaccination; n = 100
    Intervention: Biological: IMVAMUNE (MVA-BN)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
581
October 2009
March 2009   (final data collection date for primary outcome measure)
  • 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.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00316589
POX-MVA-011
Yes
Bavarian Nordic
Bavarian Nordic
National Institutes of Health (NIH)
Principal Investigator: Edgar Turner Overton, MD Washington University School of Medicine
Bavarian Nordic
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP