Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-25 @ 4:10 AM
NCT ID:
NCT00079820
Eligibility Criteria:
Inclusion Criteria:
Subjects must meet the following to be eligible for the study:
* adult males or females who provided informed consent for the study.
* adults 18 and 31 years (inclusive).
* good general health,
* female subjects must not be pregnant or lactating and be on appropriate contraception or be a female unable to bear children.
* subjects be available for participation during the entire study.
Exclusion Criteria:
Any of the following exclusion criteria are met, the subject is NOT eligible.
* military service prior to 1989 or after December 13th, 2002.
* history of previous smallpox vaccination
* known/suspected history of immunodeficiency, or with current radiation treatment or use of immunosuppressive or anti-neoplastic drugs.
* subjects with a household member or intimate contact with the same conditions listed above.
* known or suspected impairment of other immunologic function.
* malignancy, including squamous cell or basal cell skin cancer at vaccination site
* active autoimmune disease.
* subjects with known eye diseases or other conditions that require the use of corticosteroid eye drops.
* known/history of cardiac disease.
* subjects who have been diagnosed with 3 or more of the following risk factors for ischemic coronary disease: a) high blood pressure b) elevated blood cholesterol levels c) diabetes or high blood sugar d) first degree relative (for example, mother, father, brother, or sister) who had a heart condition before the age of 50 e) smoke cigarettes
* subjects with a history of palpitations or abnormalities of cardiac rhythm.
* subjects with odd ECG patterns
* subjects with a ten percent or greater risk of developing a myocardial infarction or coronary death within the next 10 years.
* positive or elevated creatinine kinase, CK-MB, or Troponin I laboratory test levels.
* abnormalities of clinical laboratory assessments.
* past history or current diagnosis of chronic renal disease, adverse reactions to drugs characterized by renal impairment, a serum creatinine \> 1.5 mg/dL, or presence of 1+ protein in urinalysis at screening and a calculated creatinine clearance of not less than 80 mL/min.
* current diagnosis or past history of eczema.
* subjects with a household member or intimate contact with the same conditions listed above.
* presence of acute, chronic, or exfoliative skin conditions, open wounds, or burns.
* history of keloid formation.
* known allergies to MVA or to any known components (Neomycin, Gentamycin) of the vaccine.
* known allergy to eggs or egg products.
* known allergies to any component of the Dryvax® vaccine. Antibiotics in Dryvax® include neomycin, streptomycin, chlortetracycline, and polymixin B.
* known allergies to any known component of the Dryvax® diluent (i.e., glycerin and phenol).
* known allergies to any known component of VIG, (i.e., thimerosal or previous allergic reaction to immunoglobulins).
* known allergies to cidofovir or sulphur containing drugs, including probenecid, trimethoprim, and sulfonamide antibiotics.
* transfusion of blood or treatment with any blood product, including intramuscular or intravenous serum globulin within 6 months of the screening visit.
* positive serology result for HIV, hepatitis B surface antigen, or hepatitis C.
* current diagnosis or history within six months of the screening visit of drug or alcohol abuse disorders.
* significant acute or chronic psychiatric illness.
* female subjects with a positive serum pregnancy test result
* subjects with a household member or direct contact with someone who is pregnant or lactating.
* temperature or acute illness within 3 days prior to vaccination
* inoculation with an inactivated vaccine with 14 days of Day 0 or with a live attenuated vaccine within 30 days of Day 0.
* subjects who have participated in another investigational drug or vaccine trial within 30 days of Day 0.
* subjects who are planning on donating blood or organs within 30 days of vaccination.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
31 Years
Study:
NCT00079820
Study Brief:
Protocol Section:
NCT00079820