VA-008 ACAM2000® Vaccination of Plasma Donors for the Production of VIGIV

NCT02443623 | Completed Phase 4 Results DMC

• 1 other identifier: VA-008
• Study Type: interventional
• Target: 3,032
• Locations: 1 country
• Sites: 1

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.

Conditions

Smallpox Vaccine Adverse Reaction

Outcome Measures

Primary Outcomes (3)

• Number of Vaccinated Participants With Adverse Events (AEs) Including Serious Adverse Events (SAEs)

  Number of subjects with AEs including SAEs up to 90 days after vaccination.

  Adverse event data was collected from vaccinated participants through Day 90.

• Number of Vaccinated Participants With Related Adverse Events

  Number of subjects with related AEs up to 90 days after vaccination.

  Adverse event data was collected from vaccinated participants through Day 90.

• Number of Vaccinated Participants With Serious Adverse Events (SAEs)

  Number of subjects with SAEs up to 90 days after vaccination.

  Adverse event data was collected from vaccinated participants through Day 90.

Study Arms (1)

Single Arm Vaccinated with ACAM2000

EXPERIMENTAL

* 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

Interventions

Vaccination with ACAM2000 BIOLOGICAL

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.

Single Arm Vaccinated with ACAM2000

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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emergent BioSolutions: lead

Study Sites (1)

Bio Products Laboratory Ltd (plasma vendor of Emergent BioSolutions)

Winnipeg, Manitoba, R3T 5Y3, Canada

Location

MeSH Terms

Interventions

Vaccination; ACAM2000

Intervention Hierarchy (Ancestors)

Immunotherapy, Active; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques; Primary Prevention; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Communicable Disease Control; Public Health Practice; Public Health; Environment and Public Health

Results Point of Contact

• Title: Clinical Development Representative
• Organization: Emergent Biosolutions Inc.

ctgov@ebsi.com

(204) 275-4196

Study Officials

• Christine Hall, PhD

  Emergent BioSolutions

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2015
• First Posted: May 14, 2015
• Study Start: September 1, 2015
• Primary Completion: July 1, 2021
• Study Completion: August 1, 2021
• Last Updated: March 18, 2024
• Results First Posted: October 26, 2022

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)