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

NCT01158157 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: VA-006
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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).

Conditions

Smallpox Vaccine Adverse Reaction

Outcome Measures

Primary Outcomes (1)

• Percent of Participants With Adverse Events Related to ACAM2000 Vaccine Administration

  Days 0 to 90 post-vaccination

Study Arms (1)

Vaccination

OTHER

This study was a single arm study. All eligible subjects received ACAM2000.

Biological: ACAM2000

Interventions

ACAM2000 BIOLOGICAL

Percutaneous administration of a droplet (2.5µg) of ACAM2000 using a bifurcated needle.

Vaccination

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Emergent BioSolutions: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Cangene Plasma Resources, Mid-Florida

Altamonte Springs, Florida, 32701, United States

Location

Related Publications (1)

• 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.

  PMID: 10458959 BACKGROUND

Related 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.

MeSH Terms

Interventions

ACAM2000

Results Point of Contact

• Title: Christine Hall, Ph.D. Director Clinical
• Organization: Cangene Corporation

chall@ebsi.com

204-275-4248

Study Officials

• Ronald Brown, MD

  Cangene Plasma Resources, Mid-Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2010
• First Posted: July 8, 2010
• Study Start: September 13, 2010
• Primary Completion: February 14, 2012
• Study Completion: February 14, 2012
• Last Updated: March 18, 2024
• Results First Posted: March 26, 2019

Record last verified: 2024-03

Locations

US (1)