VA-006 Vaccinia Vaccine (ACAM2000) for the Production of VIGIV

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

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).

Study Overview

• Status: Completed
• Conditions: Smallpox Vaccine Adverse Reaction
• Intervention / Treatment: Biological: ACAM2000

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Florida
    • Altamonte Springs, Florida, United States, 32701
      • Cangene Plasma Resources, Mid-Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent of Participants With Adverse Events Related to ACAM2000 Vaccine Administration	Days 0 to 90 post-vaccination

Collaborators and Investigators

• Sponsor: Emergent BioSolutions
• Collaborators: Centers for Disease Control and Prevention
• Investigators: Principal Investigator: Ronald Brown, MD, Cangene Plasma Resources, Mid-Florida

Publications and helpful links

General Publications

• Russell PK. Vaccines in civilian defense against bioterrorism. Emerg Infect Dis. 1999 Jul-Aug;5(4):531-3. doi: 10.3201/eid0504.990413. No abstract available.

Helpful Links

• World Health Organization. Declaration of global eradication of smallpox. Wkly. Epidemiol. Rec., 55:145-152, 1980.
• Centers for Disease Control and Prevention (CDC). Public Health Service recommendations on smallpox vaccination. MMWR, 20:339, 1971.
• CDC. Recommendation of the Immunization Practices Advisory Committee (ACIP). Smallpox vaccination of hospital and health personnel. MMWR, 25:9, 1976.
• CDC. Smallpox vaccine no longer available for civilians-United States. MMWR, 32:387, 1983.
• CDC. Vaccinia (smallpox) vaccine recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR, 40:1-10, 1991.

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2010
• Primary Completion (Actual): February 14, 2012
• Study Completion (Actual): February 14, 2012

Study Registration Dates

• First Submitted: July 5, 2010
• First Submitted That Met QC Criteria: July 6, 2010
• First Posted (Estimated): July 8, 2010

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Virus Diseases; Infections; DNA Virus Infections; Poxviridae Infections; Smallpox; Vaccinia
• Other Study ID Numbers: VA-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No