VA-006 Vaccinia Vaccine (ACAM2000) for the Production of VIGIV (NCT01158157) | Clinical Trial Compass
CompletedPhase 3
VA-006 Vaccinia Vaccine (ACAM2000) for the Production of VIGIV
United States25 participantsStarted 2010-09-13
Plain-language summary
The purpose of this study is to vaccinate plasma donors with ACAM2000 smallpox vaccine for collection of plasma to be used in the manufacturing of Vaccinia Immune Globulin Intravenous (VIGIV).
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* 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:
* Surgical sterilization
* Hormonal (oral/injectable/implant) for at least 30 days prior to vaccination
* Intrauterine device (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 follicle-stimulating hormone (FSH) level ≥ 40 mIU/mL.
Exclusion Criteria:
* 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, …
What they're measuring
1
Percent of Participants With Adverse Events Related to ACAM2000 Vaccine Administration