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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
  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

  Hide Study Locations
Locations
United States, Alabama
Alabama Vaccine Research Clinic; University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-2050
United States, Arkansas
Health for Life Clinic, PLLC
Little Rock, Arkansas, United States, 72207
United States, California
Providence Clinical Research
Burbank, California, United States, 91505
Northern California Research
Carmichael, California, United States, 95608
CSI Clinical Trials, Inc.
Fountain Valley, California, United States, 92708
AltaMed Health Services
Los Angeles, California, United States, 90022
Alta Bates Summit Medical Center, East Bay AIDS Center
Oakland, California, United States, 94609
Benchmark Clinical Research
San Francisco, California, United States, 94102
United States, Florida
Clinical Research of West Florida
Clearwater, Florida, United States, 33765
Consultive Medicine
Daytona Beach, Florida, United States, 32117
Northpoint Medical, PA
Ft. Lauderdale, Florida, United States, 33308
The Kinder Medical Group
Miami, Florida, United States, 33133
Infectious Diseases of NW Florida
Pensacola, Florida, United States, 32504
Palm Beach Center
West Palm Beach, Florida, United States, 33409
United States, Georgia
Atlanta ID Group
Atlanta, Georgia, United States, 30309
United States, Illinois
Northstar Medical Center
Chicago, Illinois, United States, 60657
The CORE Center
Chicago, Illinois, United States, 60612
United States, Indiana
Indiana University School of Medicine; Division of Infectious Disease
Indianapolis, Indiana, United States, 46202-2859
United States, Iowa
University of Iowa, Division of Infectious Diseases
Iowa City, Iowa, United States, 52242
United States, Missouri
Nemechek Health Renewal
Kansas City, Missouri, United States, 64111
St. Louis University, Center for Vaccine Dev.
St. Louis, Missouri, United States, 63104
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-5130
United States, New York
Immuniodeficiency Clinic, ECMC
Buffalo, New York, United States
Universtity of Rochester School of Medicine
Rochester, New York, United States, 14642
United States, Oklahoma
University of Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-6073
Clinical Trials Research Services
Pittsburgh, Pennsylvania, United States, 15206
United States, Rhode Island
Brown Medical School
Providence, Rhode Island, United States, 02906
United States, South Carolina
University of South Carolina
Columbia, South Carolina, United States, 29203
United States, Tennessee
Vanderbilt University, AIDS Clinical Trials Center
Nashville, Tennessee, United States, 37203
United States, Texas
Nicholaos C. Bellos, MD PA
Dallas, Texas, United States, 75204
Valley AIDS Council
Harlingen, Texas, United States, 78550
Diversified Medical Practices
Houston, Texas, United States, 77027
Puerto Rico
Clinical Research P.R., Inc.
San Juan, Puerto Rico, 00909
Maternal Infant Studies Center (CEMI)
San Juan, Puerto Rico, 00936-5067
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:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 25, 2014