Vaccinia Vaccine (ACAM2000) for the Production of Vaccinia Immune Globulin Intravenous(VIGIV)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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Plasma will be collected from a sufficient number of subjects vaccinated with ACAM2000 to produce approximately 60 L of plasma needed to manufacture VIGIV which will be compared to VIGIV previously collected from subjects vaccinated with Dryvax.
Secondary Outcome Measures :
Safety [ Time Frame: Up to 3 months ]
To collect safety data for the use of ACAM2000™ smallpox vaccine in plasma donors who have previously been vaccinated with smallpox vaccine
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Ages Eligible for Study:
18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Signed written informed consent.
Age 18 - 65 years.
Normal and healthy as determined by medical history, physical exam, vital signs and clinical laboratory tests at screening visit.
Subject must meet all required subject suitability criteria that pertain to normal Source Plasma donors.
Subject must have been previously immunized for smallpox, at ≥1 year prior to commencement of screening assessments for the VA-006 trial, and vaccination history must be confirmed by oral or written history AND the presence of a visible pathognomonic smallpox vaccination scar.
Female subjects of childbearing potential must use at least one of the following means of birth control documented by a physician's letter:
Hormonal (oral/injectable/implant) for at least 30 days prior to vaccination
IUD inserted at least 7 days prior to vaccination.
Female subjects who are not using one of the methods of birth control listed above must be documented as postmenopausal, which is defined as not having a menstrual period for longer than 12 months and having a serum FSH level ≥ 40 mIU/mL.
History of severe adverse event(s) from previous participation in the VA-001 or VA-005 trials or any other smallpox vaccination program/study.
Subject, household contact, or other close/intimate contact:
with eczema, history of eczema, exfoliative skin conditions, wounds, burns, or other skin conditions at the Investigator's discretion.
with a history of immunodeficiencies (see section 7.1.2 of the protocol).
who received radiotherapy or chemotherapy, ACTH, corticosteroids, or immunosuppressive drugs.
with eye disease treated with topical steroids.
with known or suspected disorders of immunoglobulin synthesis.
with leukemia, lymphomas of any type, melanoma, or other malignant neoplasms affecting the bone marrow or lymphatic systems.
with a history of adverse reactions to smallpox (vaccinia) vaccine.
has recently been diagnosed with cancer and who will be undergoing chemotherapy or radiation therapy during the vaccination healing time.
is a transplant recipient (except for corneal transplant).
is pregnant, planning pregnancy or breast feeding (female subjects must have negative serum pregnancy test at screening and negative urine pregnancy test prior to vaccination).
Household or other close/intimate contact(s) under the age of 12 months.
History of allergies to latex, phenol, any of the antibiotics listed in the vaccine content, or any other component of ACAM2000 or its diluent
Severely or morbidly obese or higher obesity classification (BMI ≥ 35).
Subjects with abnormal EKG and/or cardiac Troponin levels at screening.
Subjects with cancer or kidney disease (except kidney stones).
Subject has 3 or more of the following risk factors:
High blood pressure diagnosed by a doctor
High blood cholesterol diagnosed by a doctor
Diabetes or high blood sugar diagnosed by a doctor
A first degree relative (for example, mother, father, brother, sister) who had a heart condition before the age of 50
Currently smokes cigarettes
Cardiovascular disease or heart condition diagnosed by a doctor at any time in the past, with or without symptoms, including:
Previous myocardial infarction
Coronary artery disease
Congestive heart failure
Stroke or transient ischemic attack
Chest pain or shortness of breath with activity (such as walking up stairs)
Other heart conditions being treated by a physician.