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VA-006 Vaccinia Vaccine (ACAM2000) for the Production of VIGIV | Clinical Trials | Clareo Health

COMPLETEDPHASE3

VA-006 Vaccinia Vaccine (ACAM2000) for the Production of VIGIV

Vaccinia Vaccine (ACAM2000) for the Production of Vaccinia Immune Globulin Intravenous (VIGIV)

NCT01158157•Emergent BioSolutions

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).

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

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, 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, adrenocorticotropic hormone (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.
+24 more criteria

Locations (1)

Cangene Plasma Resources, Mid-Florida

Altamonte Springs, Florida, United States

Key Dates

Start Date

September 13, 2010

Primary Completion Date

February 14, 2012

Completion Date

February 14, 2012

Last Updated

March 18, 2024

Enrollment

ACTUAL participants

Conditions

Smallpox Vaccine Adverse Reaction

Interventions

ACAM2000

BIOLOGICAL