Safety and Immunogenicity of IMVAMUNE® (MVA-BN®) Smallpox Vaccine in HIV Infected Patients
- Conditions
- HIV Infections
- Interventions
- Biological: IMVAMUNE (MVA-BN)
- Registration Number
- NCT00316589
- Lead Sponsor
- Bavarian Nordic
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 581
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HIV-infected, vaccinia-experienced IMVAMUNE (MVA-BN) Subjects with a history of previous smallpox vaccination, IMVAMUNE (MVA-BN) HIV-infected, vaccinia-naive IMVAMUNE (MVA-BN) Subjects without a history of previous smallpox vaccination, IMVAMUNE (MVA-BN) Healthy subjects IMVAMUNE (MVA-BN) Control group with and without a history of previous smallpox vaccination IMVAMUNE (MVA-BN)
- Primary Outcome Measures
Name Time Method Serious Adverse Events within 32 weeks Incidence, relationship and intensity of any Serious Adverse Event (SAE)
- Secondary Outcome Measures
Name Time Method Unsolicited Adverse Events: Incidence within 29 days after any vaccination Incidence of any unsolicited adverse events
Unsolicited Adverse Events: Intensity within 29 days after any vaccination Occurrence of unsolicited adverse events by Intensity
Unsolicited Adverse Events: Relationship to Vaccination within 29 days after any vaccination Occurrence of unsolicited adverse events by relationship to study vaccine
CD4+ T-cell Counts within 32 weeks Median CD4+ T-cell counts over time
CD8+ T-cell Counts within 32 weeks Median CD8+ T-cell counts over time
Viral Load within 32 weeks Viral load (HIV-1 RNA levels) over time
Related Grade >=3 Adverse Events within 29 days after any vaccination Incidence of any Grade 3 or higher adverse drug reaction (missing, unknown, not evaluable, possibly, probably, or definitely related) to the study vaccine
Solicited Local Adverse Events within 8 days after any vaccination Incidence and intensity of solicited local AEs (pain, erythema, swelling). Percentages based on subjects with at least one completed diary card.
Solicited General Adverse Events within 8 days after any vaccination Incidence of solicited general AEs (increased body temperature, headache, myalgia, chills, nausea, and fatigue): Intensity and relationship to vaccination. Percentages based on subjects with at least one completed diary card.
PRNT Seroconversion Rate within 32 weeks Seroconversion rate based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (6) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
PRNT GMT within 32 weeks Geometric Mean Titers (GMT) based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Titers below the detection limit are included with a value of '1'.
ELISA Seroconversion Rate within 32 weeks Seroconversion rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
ELISA GMT within 32 weeks Geometric Mean Titers (GMT) based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Titers below the detection limit are included with a value of '1'.
ELISPOT IFN-γ: Response Rate within 32 weeks Response rate based on number of subjects with response in an interferon gamma (IFN-γ) ELISPOT assay. Response is defined as the appearance of a signal in subjects that had no signal at Baseline or a relative increase by a factor of ≥1.7 compared to Baseline in subjects that had a signal at Baseline. Percentages based on number of subjects with data available.
ELISPOT IFN-γ: SFU within 32 weeks Median number of interferon gamma (IFN-γ) secreting peripheral blood mononuclear cells (PBMC) in response to stimulation with MVA-BN detected by ELISPOT assay.
Trial Locations
- Locations (36)
AltaMed Health Services
🇺🇸Los Angeles, California, United States
The CORE Center
🇺🇸Chicago, Illinois, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Clinical Trials Research Services
🇺🇸Pittsburgh, Pennsylvania, United States
University of South Carolina
🇺🇸Columbia, South Carolina, United States
Valley AIDS Council
🇺🇸Harlingen, Texas, United States
Benchmark Clinical Research
🇺🇸San Francisco, California, United States
Alabama Vaccine Research Clinic; University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Health for Life Clinic, PLLC
🇺🇸Little Rock, Arkansas, United States
University of Iowa, Division of Infectious Diseases
🇺🇸Iowa City, Iowa, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
The Kinder Medical Group
🇺🇸Miami, Florida, United States
Consultive Medicine
🇺🇸Daytona Beach, Florida, United States
CSI Clinical Trials, Inc.
🇺🇸Fountain Valley, California, United States
Atlanta ID Group
🇺🇸Atlanta, Georgia, United States
Northern California Research
🇺🇸Carmichael, California, United States
Clinical Research of West Florida
🇺🇸Clearwater, Florida, United States
Northpoint Medical, PA
🇺🇸Fort Lauderdale, Florida, United States
Infectious Diseases of NW Florida
🇺🇸Pensacola, Florida, United States
Palm Beach Center
🇺🇸West Palm Beach, Florida, United States
Indiana University School of Medicine; Division of Infectious Disease
🇺🇸Indianapolis, Indiana, United States
St. Louis University, Center for Vaccine Dev.
🇺🇸Saint Louis, Missouri, United States
Northstar Medical Center
🇺🇸Chicago, Illinois, United States
Diversified Medical Practices
🇺🇸Houston, Texas, United States
Nemechek Health Renewal
🇺🇸Kansas City, Missouri, United States
Vanderbilt University, AIDS Clinical Trials Center
🇺🇸Nashville, Tennessee, United States
Universtity of Rochester School of Medicine
🇺🇸Rochester, New York, United States
Nicholaos C. Bellos, MD PA
🇺🇸Dallas, Texas, United States
Brown Medical School
🇺🇸Providence, Rhode Island, United States
Maternal Infant Studies Center (CEMI)
🇵🇷San Juan, Puerto Rico
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
University of Oklahoma
🇺🇸Oklahoma City, Oklahoma, United States
Alta Bates Summit Medical Center, East Bay AIDS Center
🇺🇸Oakland, California, United States
Providence Clinical Research
🇺🇸Burbank, California, United States
Clinical Research P.R., Inc.
🇵🇷San Juan, Puerto Rico
Immuniodeficiency Clinic, ECMC
🇺🇸Buffalo, New York, United States