Smallpox Vaccine Adverse ReactionPhase 4NCT02443623
VA-008 ACAM2000® Vaccination of Plasma Donors for the Production of VIGIV
A Phase 4 study testing Vaccination with ACAM2000 in people with Smallpox Vaccine Adverse Reaction, run by Emergent BioSolutions at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Smallpox Vaccine Adverse Reaction
- What is being tested?
- Vaccination with ACAM2000
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,032 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2015to Aug 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Bio Products Laboratory Ltd (plasma vendor of Emergent BioSolutions)
Winnipeg, Manitoba, R3T 5Y3
About this study
Official title: Vaccinia Vaccination (ACAM2000®) of Plasma Donors for the Production of Vaccinia Immune Globulin Intravenous (VIGIV)
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.
Read the 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).
- Conditions
- Smallpox Vaccine Adverse Reaction
- Being tested
- Vaccination with ACAM2000
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccination with ACAM2000Biological
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Vaccination with ACAM2000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Adverse event data was collected from vaccinated participants through Day 90.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2015 (estimated)
- Study startSep 2015
- Primary completionJul 2021
- Study completionAug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Smallpox Vaccine Adverse ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,032 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emergent BioSolutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christine Hall, PhD, Study director, Emergent BioSolutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02443623
- Sponsor's protocol ID
- VA-008
- Status last verified
- Mar 2024
- First submitted
- 6 May 2015
- Last updated
- 18 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaccinia Vaccination (ACAM2000®) of Plasma Donors for the Production of Vaccinia Immune Globulin Intravenous (VIGIV)
- ClinicalTrials.gov ID
- NCT02443623
- Acronym / sponsor ID
- VA-008
- Conditions
- Smallpox Vaccine Adverse Reaction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,032 participants (actual)
- Lead sponsor
- Emergent BioSolutionsIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Jul 2021 (actual)
- Study completion
- Aug 2021 (actual)
- First posted
- 14 May 2015 (estimated)
- Results
- Posted 26 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm Vaccinated with ACAM2000 | Experimental | Biological: Vaccination 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (35 listed)
- 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:
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaccination with ACAM2000In 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. | Biological | Single Arm Vaccinated with ACAM2000 |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Hall, PhD study director
Emergent BioSolutions
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vaccination with ACAM2000 in people with Smallpox Vaccine Adverse Reaction, run by Emergent BioSolutions at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.