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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02443623
Recruitment Status : Completed
First Posted : May 14, 2015
Last Update Posted : August 18, 2021
Sponsor:
Information provided by (Responsible Party):
Emergent BioSolutions

Tracking Information
First Submitted Date  ICMJE May 6, 2015
First Posted Date  ICMJE May 14, 2015
Last Update Posted Date August 18, 2021
Study Start Date  ICMJE September 2015
Actual Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2015)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE VA-008 ACAM2000® Vaccination of Plasma Donors for the Production of VIGIV
Official Title  ICMJE Vaccinia Vaccination (ACAM2000®) of Plasma Donors for the Production of Vaccinia Immune Globulin Intravenous (VIGIV)
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.
Detailed Description

This protocol is being conducted 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). The objective of this protocol is 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.

Participants will be followed for the duration of the study, an expected average of 90 days as described below in the planned study assessments.

Screening [complete within 14 days before Baseline (Day 0)]:

  • Informed consent obtained from prospective donors
  • Post-consent information including medical history, smallpox vaccination history, current medications, detailed demographics, BMI, physical exam, vital signs, and assessment for pericarditis/myocarditis symptoms, blood samples will be collected and a baseline EKG (if applicable).

Baseline (Day 0) prior to vaccination:

-Physical exam and vital signs, urine pregnancy test for all female subjects of child-bearing potential, current medications, assessment for pericarditis/myocarditis.

Baseline (Day 0) vaccination and post-vaccination:

-Vaccination with ACAM2000, vaccination site inspection 30 post-vaccination, unanticipated problems, all adverse events including all cardiovascular adverse events (symptoms and signs), concomitant medications.

Post-vaccination Day 3 (±1):

-Assessment for pericarditis/myocarditis, vaccination site inspection, unanticipated problems, unexpected and serious adverse reactions or complications post-vaccination, all adverse events including all cardiovascular adverse events (symptoms and signs).

Post-vaccination Day 7 (±1):

-Assessment of pericarditis/myocarditis symptoms, urine pregnancy test, vaccination site inspection, unanticipated problems, all adverse events including all cardiovascular adverse events (symptoms and signs), concomitant medications.

Post-vaccination Day 12 (±2), 21 (±3), and 28 (±3):

-Assessment of pericarditis/myocarditis symptoms, urine pregnancy test, vaccination site inspection, unanticipated problems, all adverse events including all cardiovascular adverse events (symptoms and signs), concomitant medications.

End of study post-vaccination Day 35 (±3) or Early Withdrawal:

Vital signs, assessment of pericarditis/myocarditis symptoms, urine pregnancy test, vaccination site inspection, unanticipated problems, all adverse events including all cardiovascular adverse events (symptoms and signs), concomitant medications.

Final Safety Assessment Day 90 (±3):

Assessment for pericarditis/myocarditis, unanticipated problems, unexpected and serious adverse reactions or complications post-vaccination, all adverse events including all cardiovascular adverse events (symptoms and signs).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Smallpox Vaccine Adverse Reaction
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Biological: Vaccination with ACAM2000
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 17, 2021)
3032
Original Estimated Enrollment  ICMJE
 (submitted: May 11, 2015)
3000
Actual Study Completion Date  ICMJE August 2021
Actual Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

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). Women of child-bearing potential (WOCBP) are temporarily excluded due to COVID.
  • 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
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 Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02443623
Other Study ID Numbers  ICMJE VA-008
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Emergent BioSolutions
Study Sponsor  ICMJE Emergent BioSolutions
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Christine Hall, PhD Emergent BioSolutions
PRS Account Emergent BioSolutions
Verification Date August 2021

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