VA-008 ACAM2000® Vaccination of Plasma Donors for the Production of VIGIV
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ClinicalTrials.gov Identifier: NCT02443623 |
Recruitment Status :
Completed
First Posted : May 14, 2015
Results First Posted : October 26, 2022
Last Update Posted : October 26, 2022
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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.
Condition or disease | Intervention/treatment | Phase |
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Smallpox Vaccine Adverse Reaction | Biological: Vaccination with ACAM2000 | Phase 4 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 3032 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | Vaccinia Vaccination (ACAM2000®) of Plasma Donors for the Production of Vaccinia Immune Globulin Intravenous (VIGIV) |
Study Start Date : | September 2015 |
Actual Primary Completion Date : | July 2021 |
Actual Study Completion Date : | August 2021 |

Arm | Intervention/treatment |
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Experimental: Single Arm Vaccinated with ACAM2000
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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. |
- Number of Vaccinated Participants With Adverse Events (AEs) Including Serious Adverse Events (SAEs) [ Time Frame: Adverse event data was collected from vaccinated participants through Day 90. ]Number of subjects with AEs including SAEs up to 90 days after vaccination.
- Number of Vaccinated Participants With Related Adverse Events [ Time Frame: Adverse event data was collected from vaccinated participants through Day 90. ]Number of subjects with related AEs up to 90 days after vaccination.
- Number of Vaccinated Participants With Serious Adverse Events (SAEs) [ Time Frame: Adverse event data was collected from vaccinated participants through Day 90. ]Number of subjects with SAEs up to 90 days after vaccination.

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.
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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.
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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)
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02443623
Canada, Manitoba | |
Bio Products Laboratory Ltd (plasma vendor of Emergent BioSolutions) | |
Winnipeg, Manitoba, Canada, R3T 5Y3 |
Study Director: | Christine Hall, PhD | Emergent BioSolutions |
Documents provided by Emergent BioSolutions:
Responsible Party: | Emergent BioSolutions |
ClinicalTrials.gov Identifier: | NCT02443623 |
Other Study ID Numbers: |
VA-008 |
First Posted: | May 14, 2015 Key Record Dates |
Results First Posted: | October 26, 2022 |
Last Update Posted: | October 26, 2022 |
Last Verified: | October 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Smallpox Poxviridae Infections DNA Virus Infections Virus Diseases Infections |