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Trial record 3 of 8 for:    acam2000 | Smallpox | Phase 3

VA-006 Vaccinia Vaccine (ACAM2000) for the Production of 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01158157
Recruitment Status : Completed
First Posted : July 8, 2010
Results First Posted : March 26, 2019
Last Update Posted : March 18, 2020
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Emergent BioSolutions

Brief 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).

Condition or disease Intervention/treatment Phase
Smallpox Vaccine Adverse Reaction Biological: ACAM2000 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Vaccinia Vaccine (ACAM2000) for the Production of Vaccinia Immune Globulin Intravenous (VIGIV)
Actual Study Start Date : September 13, 2010
Actual Primary Completion Date : February 14, 2012
Actual Study Completion Date : February 14, 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smallpox

Arm Intervention/treatment
Vaccination
This study was a single arm study. All eligible subjects received ACAM2000.
Biological: ACAM2000
Percutaneous administration of a droplet (2.5µg) of ACAM2000 using a bifurcated needle.




Primary Outcome Measures :
  1. Percent of Participants With Adverse Events Related to ACAM2000 Vaccine Administration [ Time Frame: Days 0 to 90 post-vaccination ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
    • 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:

    • Arrhythmia
    • Syncope
    • Previous myocardial infarction
    • Angina
    • Coronary artery disease
    • Congestive heart failure
    • Cardiomyopathy
    • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01158157


Locations
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United States, Florida
Cangene Plasma Resources, Mid-Florida
Altamonte Springs, Florida, United States, 32701
Sponsors and Collaborators
Emergent BioSolutions
Centers for Disease Control and Prevention
Investigators
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Principal Investigator: Ronald Brown, MD Cangene Plasma Resources, Mid-Florida
Additional Information:
Publications:
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Responsible Party: Emergent BioSolutions
ClinicalTrials.gov Identifier: NCT01158157    
Other Study ID Numbers: VA-006
First Posted: July 8, 2010    Key Record Dates
Results First Posted: March 26, 2019
Last Update Posted: March 18, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vaccinia
Smallpox
Poxviridae Infections
DNA Virus Infections
Virus Diseases
Infections