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
  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)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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.

Resource links provided by NLM:


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: 35 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 581
Study Start Date: June 2006
Study Completion Date: October 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1: Healthy subjects
Healthy control group with (n=9) and without (n=88) a history of previous smallpox vaccination
Biological: IMVAMUNE (MVA-BN)
2 immunizations, four weeks apart: 1 x 10E8_TCID50, SC
Experimental: Group 2: HIV-infected, CD4 200 -750/µl, vaccinia-naive
HIV-infected subjects without a history of previous smallpox vaccination (n=351)
Biological: IMVAMUNE (MVA-BN)
2 immunizations, four weeks apart: 1 x 10E8_TCID50, SC
Experimental: Group 3: HIV-infected, CD4 200 - 750/µl, vaccinia-experienced
HIV-infected subjects with a history of previous smallpox vaccination; n = 100
Biological: IMVAMUNE (MVA-BN)
2 immunizations, four weeks apart: 1 x 10E8_TCID50, SC

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00316589

  Show 36 Study Locations
Sponsors and Collaborators
Bavarian Nordic
Investigators
Principal Investigator: Edgar Turner Overton, MD Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Bavarian Nordic
ClinicalTrials.gov Identifier: NCT00316589     History of Changes
Other Study ID Numbers: POX-MVA-011
Study First Received: April 19, 2006
Last Updated: October 4, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on October 02, 2014