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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Cangene Corporation
ClinicalTrials.gov Identifier:
NCT01158157
First received: July 5, 2010
Last updated: February 28, 2012
Last verified: February 2012
  Purpose

The purpose of this study is to vaccinate plasma donors with ACAM2000(TM) smallpox vaccine for collection of plasma to be used in the manufacture of Vaccinia Immune Globulin Intravenous (VIGIV).


Condition Intervention Phase
Smallpox Vaccination
Biological: ACAM2000
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Vaccinia Vaccine (ACAM2000) for the Production of Vaccinia Immune Globulin Intravenous

Resource links provided by NLM:


Further study details as provided by Cangene Corporation:

Primary Outcome Measures:
  • Plasma collection [ Time Frame: Up to 3 months ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Safety [ Time Frame: Up to 3 months ] [ Designated as safety issue: Yes ]
    To collect safety data for the use of ACAM2000™ smallpox vaccine in plasma donors who have previously been vaccinated with smallpox vaccine


Enrollment: 25
Study Start Date: August 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: ACAM2000
    Percutaneous administration of a droplet (2.5µg) of ACAM2000 using a bifurcated needle.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
    • 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 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, 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01158157

Locations
United States, Florida
Cangene Plasma Resources, Mid-Florida
Altamonte Springs, Florida, United States, 32701
Sponsors and Collaborators
Cangene Corporation
Investigators
Principal Investigator: Ronald Brown, MD Cangene Plasma Resources, Mid-Florida
  More Information

No publications provided

Responsible Party: Cangene Corporation
ClinicalTrials.gov Identifier: NCT01158157     History of Changes
Other Study ID Numbers: VA-006
Study First Received: July 5, 2010
Last Updated: February 28, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Smallpox
Vaccinia
Poxviridae Infections
DNA Virus Infections
Virus Diseases
Antibodies
Immunoglobulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 25, 2014