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Home > "S" Clinical Trials Conditions > Safety and Immunogenicity of Smallpox Vaccine MVA-BN  Safety and Immunogenicity of Smallpox Vaccine MVA-BN
Safety and Immunogenicity of Smallpox Vaccine MVA-BN
For Condition: Smallpox
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The overall goals of this study are to expand the available data on the safety and immunogenicity of MVA-BN in vaccinia-naive adults and to determine the optimum dose of MVA-BN to induce immune responses and attenuate Dryvax take reactions. The primary objective of the study is to assess the safety and tolerability of MVA-BN vaccine. The secondary objectives are to evaluate the ability of different doses of MVA-BN to induce humoral and cellular immune responses; to compare the humoral and cellular immune responses induced after two doses of MVA-BN given via s.c. or i.m. routes of injection; to determine the effect of two injections of various doses of MVA-BN on subsequent administration of Dryvax; and to compare the long-term immune response to MVA-BN and Dryvax.
Details: The development of safer vaccines against smallpox is an ongoing United States public health priority. Live replicating vaccinia virus vaccines were used in the worldwide eradication campaign in the 1960's and 70s. Adverse events and the safety profile of those vaccines have led to the search for safer vaccines against smallpox. Modified Vaccinia Ankara (MVA) vaccine from Bavarian Nordic is one candidate vaccine that will be tested. This study will assess the safety and preliminary immunogenicity of MVA-BN in healthy volunteers who have never received a smallpox vaccination. The proposed trial will evaluate a dose response effect following subcutaneous administration of MVA-BN or placebo followed by an immunization with Dryvax (the established smallpox vaccine). Volunteers will be randomized to receive one of six dose regimens of MVA (or placebo) followed by Dryvax (or placebo). All participants will be followed for safety and the development of immune responses to vaccinia.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Parallel Assignment
Minimum Age/Maximum Age: 18 Years/32 Years
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: - 18-32 years of age (Children are excluded due to reasons of safety. A pediatric study of vaccinia is planned to evaluate safety). - Never received a smallpox vaccination. - No typical vaccinia scar. - Willing to sign informed consent. - Availability for follow-up for the planned duration of the study 2 years after vaccination. - Acceptable medical history by screening evaluation and brief clinical assessment. - For women, negative serum pregnancy test at screening and negative urine or serum pregnancy test within 24 hours prior to vaccination. - Negative ELISA for HIV. - Negative hepatitis B surface antigen and negative antibody to hepatitis C virus - If the volunteer is female and of childbearing potential, she agrees to use acceptable contraception and not become pregnant for at least 56 days after the last vaccination. A woman is considered of childbearing potential unless post-menopausal or surgically sterilized. (Acceptable contraception methods are restricted to effective intrauterine devices (IUDs) or licensed hormonal products/pill/patch/injection or with use of method for a minimum of 30 days prior to vaccination). Women who are not sexually active must agree to use one of the acceptable contraception methods if they are of childbearing potential. - ECG without clinical significance (complete left or right bundle branch block, or sustained ventricular arrythmia, or 2 PVCs in a row, or ST elevation consistent with ischemia). - CBC: Hemoglobin > 11 g/dl; White blood cells greater than 2500 and less than 11000/mm(3); Platelets greater than or equal to 140000/mm(3). - ALT less than 1.25 times institutional upper limit of normal - Adequate renal function defined as a serum creatinine <1.2 mg/dL; urine protein < 30mg/dL or non or trace proteinuria (by urinalysis or dip stick); and a calculated creatinine clearance > or equal to 80 mL/min based on the following formulas: Males [(140-age in years) X weight in kg]/72 X serum creatinine); Females: 0.85X [(140-age in years) X weight in kg]/72 X serum creatinine). - Negative urine glucose by dipstick or urinalysis. EXCLUSION CRITERIA: - History of immunodeficiency. - Known or suspected impairment of immunologic function including, but not limited to, clinically significant liver disease; diabetes mellitus; moderate to severe kidney impairment. - Malignancy, including squamous cell skin cancer or basal cell skin cancer at vaccination site or history of skin cancer at the vaccination site. - Known or suspected history of smallpox vaccination. - Use of immunosuppressive medication. Corticosteroid nasal sprays are permissible. Persons who have used topical steroid can be enrolled after their therapy is completed. - Medical or psychiatric condition or occupational responsibilities which preclude volunteer compliance with the protocol. - Any history of illegal injection drug use. - Receipt of inactivated vaccine 14 days prior to vaccination. - Receipt of live attenuated vaccines within 30 days of vaccination. - Use of experimental agents within 30 days prior to study. - Receipt of blood products or immunoglobulin in the past 6 months prior to vaccination. - Acute febrile illness (> 100.5 degrees F) on the day of vaccination. - Pregnant or lactating women. - Eczema of any degree or history of eczema. - Military service prior to 1989 or after January 2003. - People with atopic dermatitis, Varicella zoster, chronic exfoliative skin disorders/conditions or any acute skin disorders of large magnitude, e.g., laceration requiring sutures, burn greater than 2 x 2 cm. - Household contacts/sexual contacts with, or occupational exposure to (other than minimal contact), people with any of the following: - pregnancy - <12 months of age - eczema or history of eczema - any of the above skin disorders/conditions - immunodeficiency disease or use of immunosuppressive medications. - Any condition that, in the opinion of the investigator, might interfere with study objectives. - Known allergies to any component of the Dryvax vaccine (e.g., polymyxin B sulfate, dihyrostreptomycin sulfate, chlorotetracycline hydrochloride, neomycin sulfate). - Known allergies to any known component of the Dryvax diluent (i.e., glycerin and phenol). - Known allergies to any known component of Vaccine immune globulin (VIG), i.e., thimerosal or previous allergic reaction to immunoglobulins. - Known allergies to cidofovir or probenecid. - Active autoimmune disease. Persons with vitiligo or thyroid disease on thyroid replacement are not excluded. - History of keloid formation. - Known allergy to egg or aminoglycoside. - History of myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, or other heart condition under the care of a doctor. - History of an immediate family member (father, mother, brother or sister) who has had onset of ischemic heart disease before the age 50 years. - Ten percent or greater risk of developing a myocardial infarction or coronary death within the next 10 years using the National Cholesterol Education Program's Risk Assessment Tool for Estimating Your 10-year Risk of Having a Heart Attack, located at the following ULL: http://hin.nhlbi.nih.gov/atpiii/calculator.asp. NOTE: This criterion applies only to volunteers 20 years of age and older. - Typical vaccinia scar. - Known allergies to, or any component of, MVA or MVA-BN vaccine (e.g. tris(hydroxymethyl)-amino methane, sodium chloride, sucrose, dextran, L-Glutamic acid monopotassium, chicken embryo fibroblast proteins, gentamycin). - Study personnel.
Total Enrollment: 90
Location and Contact Information:
University of Massachusetts Med Sch Worcester *Recruiting*
Worcester, Massachusetts, 01655
United States
Recruiting
Additional Information:
Study ID Numbers: 02-017;
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00082446
Other Smallpox Studies:
1. A Study of Dryvax Vaccine Against Smallpox in Previously Unvaccinated Adults
2. Study of Reactogenicity, Safety, Immunogenicity, and Pock Lesion Formation of a Cell-Cultured Smallpox Vaccine Compared to Dryvax®
3. Dose On Safety, Tolerability, and Immunogenicity of ACAM2000 Smallpox Vaccine in Adults With Previous Smallpox Vaccination
4. Human Immune Response to Smallpox Vaccine
5. Dressing Preparation Comparison for Smallpox Vaccination Sites
Related Studies:
Other Smallpox Clinical Trials
Other Massachusetts Clinical Trials
Other Worcester Clinical Trials
Safety and Immunogenicity of Smallpox Vaccine MVA-BN
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