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.
1 other identifier
interventional
581
2 countries
36
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. Subjects will receive two vaccinations
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 hiv-infections
Started Jun 2006
Typical duration for phase_2 hiv-infections
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2006
CompletedFirst Posted
Study publicly available on registry
April 21, 2006
CompletedStudy Start
First participant enrolled
June 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedResults Posted
Study results publicly available
January 3, 2019
CompletedJanuary 3, 2019
December 1, 2018
2.8 years
April 19, 2006
December 7, 2018
December 7, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Serious Adverse Events
Incidence, relationship and intensity of any Serious Adverse Event (SAE)
within 32 weeks
Secondary Outcomes (15)
Related Grade >=3 Adverse Events
within 29 days after any vaccination
Solicited Local Adverse Events
within 8 days after any vaccination
Solicited General Adverse Events
within 8 days after any vaccination
Unsolicited Adverse Events: Incidence
within 29 days after any vaccination
Unsolicited Adverse Events: Intensity
within 29 days after any vaccination
- +10 more secondary outcomes
Study Arms (3)
Healthy subjects
EXPERIMENTALControl group with and without a history of previous smallpox vaccination IMVAMUNE (MVA-BN)
HIV-infected, vaccinia-naive
EXPERIMENTALSubjects without a history of previous smallpox vaccination, IMVAMUNE (MVA-BN)
HIV-infected, vaccinia-experienced
EXPERIMENTALSubjects with a history of previous smallpox vaccination, IMVAMUNE (MVA-BN)
Interventions
2 immunizations, four weeks apart: 1 x 10E8 TCID50, subcutaneous
Eligibility Criteria
You may qualify if:
- Subjects tested positive for HIV-1 infection (HIV-infected subjects).
- Subjects that are tested negative for HIV (Healthy subjects).
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bavarian Nordiclead
- National Institutes of Health (NIH)collaborator
Study Sites (36)
Alabama Vaccine Research Clinic; University of Alabama at Birmingham
Birmingham, Alabama, 35294-2050, United States
Health for Life Clinic, PLLC
Little Rock, Arkansas, 72207, United States
Providence Clinical Research
Burbank, California, 91505, United States
Northern California Research
Carmichael, California, 95608, United States
CSI Clinical Trials, Inc.
Fountain Valley, California, 92708, United States
AltaMed Health Services
Los Angeles, California, 90022, United States
Alta Bates Summit Medical Center, East Bay AIDS Center
Oakland, California, 94609, United States
Benchmark Clinical Research
San Francisco, California, 94102, United States
Clinical Research of West Florida
Clearwater, Florida, 33765, United States
Consultive Medicine
Daytona Beach, Florida, 32117, United States
Northpoint Medical, PA
Fort Lauderdale, Florida, 33308, United States
The Kinder Medical Group
Miami, Florida, 33133, United States
Infectious Diseases of NW Florida
Pensacola, Florida, 32504, United States
Palm Beach Center
West Palm Beach, Florida, 33409, United States
Atlanta ID Group
Atlanta, Georgia, 30309, United States
The CORE Center
Chicago, Illinois, 60612, United States
Northstar Medical Center
Chicago, Illinois, 60657, United States
Indiana University School of Medicine; Division of Infectious Disease
Indianapolis, Indiana, 46202-2859, United States
University of Iowa, Division of Infectious Diseases
Iowa City, Iowa, 52242, United States
Nemechek Health Renewal
Kansas City, Missouri, 64111, United States
St. Louis University, Center for Vaccine Dev.
St Louis, Missouri, 63104, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-5130, United States
Immuniodeficiency Clinic, ECMC
Buffalo, New York, 14260, United States
Universtity of Rochester School of Medicine
Rochester, New York, 14642, United States
University of Oklahoma
Oklahoma City, Oklahoma, 73104, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104-6073, United States
Clinical Trials Research Services
Pittsburgh, Pennsylvania, 15206, United States
Brown Medical School
Providence, Rhode Island, 02906, United States
University of South Carolina
Columbia, South Carolina, 29203, United States
Vanderbilt University, AIDS Clinical Trials Center
Nashville, Tennessee, 37203, United States
Nicholaos C. Bellos, MD PA
Dallas, Texas, 75204, United States
Valley AIDS Council
Harlingen, Texas, 78550, United States
Diversified Medical Practices
Houston, Texas, 77027, United States
Clinical Research P.R., Inc.
San Juan, 00909, Puerto Rico
Maternal Infant Studies Center (CEMI)
San Juan, 00936-5067, Puerto Rico
Related Publications (1)
Overton ET, Stapleton J, Frank I, Hassler S, Goepfert PA, Barker D, Wagner E, von Krempelhuber A, Virgin G, Meyer TP, Muller J, Badeker N, Grunert R, Young P, Rosch S, Maclennan J, Arndtz-Wiedemann N, Chaplin P. Safety and Immunogenicity of Modified Vaccinia Ankara-Bavarian Nordic Smallpox Vaccine in Vaccinia-Naive and Experienced Human Immunodeficiency Virus-Infected Individuals: An Open-Label, Controlled Clinical Phase II Trial. Open Forum Infect Dis. 2015 May 5;2(2):ofv040. doi: 10.1093/ofid/ofv040. eCollection 2015 Apr.
PMID: 26380340RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Program Lead, Clinical Operations
- Organization
- Bavarian Nordic A/S
Study Officials
- PRINCIPAL INVESTIGATOR
Edgar Turner Overton, MD
Washington University School of Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2006
First Posted
April 21, 2006
Study Start
June 1, 2006
Primary Completion
March 1, 2009
Study Completion
October 1, 2009
Last Updated
January 3, 2019
Results First Posted
January 3, 2019
Record last verified: 2018-12