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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. Identifier: NCT01158157
Recruitment Status : Completed
First Posted : July 8, 2010
Results First Posted : March 26, 2019
Last Update Posted : March 18, 2020
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Emergent BioSolutions

Tracking Information
First Submitted Date  ICMJE July 5, 2010
First Posted Date  ICMJE July 8, 2010
Results First Submitted Date  ICMJE June 7, 2017
Results First Posted Date  ICMJE March 26, 2019
Last Update Posted Date March 18, 2020
Actual Study Start Date  ICMJE September 13, 2010
Actual Primary Completion Date February 14, 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 1, 2019)
Percent of Participants With Adverse Events Related to ACAM2000 Vaccine Administration [ Time Frame: Days 0 to 90 post-vaccination ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 6, 2010)
Plasma collection [ Time Frame: Up to 3 months ]
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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2010)
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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE VA-006 Vaccinia Vaccine (ACAM2000) for the Production of VIGIV
Official Title  ICMJE Vaccinia Vaccine (ACAM2000) for the Production of Vaccinia Immune Globulin Intravenous (VIGIV)
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Smallpox Vaccine Adverse Reaction
Intervention  ICMJE Biological: ACAM2000
Percutaneous administration of a droplet (2.5µg) of ACAM2000 using a bifurcated needle.
Study Arms  ICMJE Vaccination
This study was a single arm study. All eligible subjects received ACAM2000.
Intervention: Biological: ACAM2000
Publications * Russell PK. Vaccines in civilian defense against bioterrorism. Emerg Infect Dis. 1999 Jul-Aug;5(4):531-3.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 28, 2012)
Original Estimated Enrollment  ICMJE
 (submitted: July 6, 2010)
Actual Study Completion Date  ICMJE February 14, 2012
Actual Primary Completion Date February 14, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01158157
Other Study ID Numbers  ICMJE VA-006
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Emergent BioSolutions
Study Sponsor  ICMJE Emergent BioSolutions
Collaborators  ICMJE Centers for Disease Control and Prevention
Investigators  ICMJE
Principal Investigator: Ronald Brown, MD Cangene Plasma Resources, Mid-Florida
PRS Account Emergent BioSolutions
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP