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VA-008 ACAM2000® Vaccination of Plasma Donors 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02443623
Recruitment Status : Recruiting
First Posted : May 14, 2015
Last Update Posted : March 18, 2020
Sponsor:
Information provided by (Responsible Party):
Emergent BioSolutions

Brief Summary:

Objectives:

  • To vaccinate plasma donors with the ACAM2000 smallpox vaccine thereby inducing an immune response resulting in high anti-vaccinia antibody titers. The collection of donor plasma will be used in the manufacturing of Vaccinia Immune Globulin Intravenous (VIGIV).
  • To ensure the safety of plasma donors vaccinated with ACAM2000 through the implementation of risk factor screening procedures and the collection of post-vaccination safety data.

Condition or disease Intervention/treatment Phase
Smallpox Vaccine Adverse Reaction Biological: Vaccination with ACAM2000 Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Vaccinia Vaccination (ACAM2000®) of Plasma Donors for the Production of Vaccinia Immune Globulin Intravenous (VIGIV)
Study Start Date : September 2015
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smallpox

Arm Intervention/treatment
Experimental: Single Arm Vaccinated with ACAM2000
  • To vaccinate plasma donors with the ACAM2000 smallpox vaccine thereby inducing an immune response resulting in high anti-vaccinia antibody titers. The collection of donor plasma will be used in the manufacturing of Vaccinia Immune Globulin Intravenous (VIGIV).
  • To ensure the safety of plasma donors vaccinated with ACAM2000 through the implementation of risk factor screening procedures and the collection of post-vaccination safety data.
Biological: Vaccination with ACAM2000
In this study (VA-008), healthy adult male and female volunteers who meet the requirements for source plasma donors and study entry criteria will be vaccinated with the ACAM2000 smallpox vaccine for collection of plasma to be used in the manufacture of VIGIV. There are possible risks associated with ACAM2000 vaccination. To ensure the safety of plasma donors, risk factor screening procedures and the collection of post-vaccination safety data will be assessed throughout the study.




Primary Outcome Measures :
  1. Safety as measured by the nature, date and time of onset, intensity, duration, causality, and outcome of the event post-ACAM2000 vaccination. [ Time Frame: Approximately 750 to 3000 donors will be enrolled in this study. The outcomes measures will be assessed up to 3 months post-vaccination. ]
    A final safety assessment at Day 90 post-vaccination. All related AEs (serious and non-serious) will be followed to resolution or stabilization as applicable (may extend beyond Day 90 post-vaccination).



Information from the National Library of Medicine

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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 to 65.
  • Normal and healthy (immune competent) as determined by medical history, physical exam, vital signs and clinical laboratory tests during the screening period.
  • If all lab results for quantitative IgA immunoglobulin level are lower than 15% below normal range, the subject may not proceed further in the screening process.
  • Subject must meet all required subject suitability criteria that pertain to normal source plasma donors.
  • Negative HIV serology during screening period.
  • Subject must have been previously immunized for smallpox, at ≥3 years prior to commencement of screening assessments, 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 agree to use highly effective birth control methods.

Exclusion Criteria:

  • History of severe related adverse event(s) from previous participation in VA-001 or VA-006 trials or to any smallpox vaccination.
  • The subject, or a household contact or other close/intimate contact of the subject has ANY of the following:

    • Eczema, history of eczema, exfoliative skin conditions, wounds, burns, or other skin conditions at the investigator's discretion.
    • A history of immunodeficiency.
    • Currently or has recently received radiotherapy or chemotherapy, adrenocorticotropic hormone (ACTH), corticosteroids, or immunosuppressive drugs.
    • Eye disease treated with topical steroids.
    • Known or suspected disorders of immunoglobulin synthesis.
    • Leukemia, lymphomas of any type, melanoma, or other malignant neoplasms affecting the bone marrow or lymphatic systems.
    • Has 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 of childbearing potential must have negative pregnancy test prior to vaccination).
  • Household or other close/intimate contact(s) under the age of 12 months.
  • History of allergies to phenol, any of the antibiotics listed in the vaccine content, or any other component of ACAM2000 or its diluents.
  • Subjects with kidney disease (except kidney stones).
  • Subjects with abnormal EKG at screening (if applicable). To mitigate the risk of enrolling at risk subjects and potentially jeopardizing subject safety an EKG will be performed prior to vaccination with ACAM2000 smallpox vaccine in all potential subjects ≥50 years old and for all potential subjects <50 with two cardiac risk factors as listed immediately below including; severely or morbidly obese or higher obesity classification (BMI ≥36); high blood pressure; high blood cholesterol; diabetes or high blood sugar; a first degree relative who had a heart condition before the age of 50; and current tobacco smokers.
  • Subject has three or more of the following risk factors:

    • Severely or morbidly obese or higher obesity classification (BMI ≥36)
    • 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 tobacco (cigarettes)
  • Cardiovascular disease or heart condition diagnosed by a doctor at any time in the past, with or without symptoms, including:

    • Arrhythmia
    • Syncope related to cardiac disease
    • Previous myocardial infarction
    • Angina
    • Coronary artery disease
    • Congestive heart failure
    • Cardiomyopathy
    • Stroke or transient ischemic attack
    • Myocarditis
    • Pericarditis
    • Chest pain or shortness of breath with activity (such as climbing stairs), peripheral edema, heart palpitations, dry cough, irregular heartbeat, excessive fatigue, unexplained syncope
    • 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): NCT02443623


Contacts
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Contact: Hugo Astacio, MD 204 275-4441 hastacio@ebsi.com

Locations
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Canada, Manitoba
Bio Products Laboratory Ltd (plasma vendor of Cangene Corporation) Recruiting
Winnipeg, Manitoba, Canada, R3T 5Y3
Contact: Noreen Allsopp    204-275-4305    nallsopp@ebsi.com   
Sponsors and Collaborators
Emergent BioSolutions
Investigators
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Study Director: Christine Hall, PhD Cangene Corporation
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Responsible Party: Emergent BioSolutions
ClinicalTrials.gov Identifier: NCT02443623    
Other Study ID Numbers: VA-008
First Posted: May 14, 2015    Key Record Dates
Last Update Posted: March 18, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Smallpox
Poxviridae Infections
DNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs