Smallpox Vaccine Adverse ReactionPhase 3NCT01158157
VA-006 Vaccinia Vaccine (ACAM2000) for the Production of VIGIV
A Phase 3 study testing ACAM2000 in people with Smallpox Vaccine Adverse Reaction, run by Emergent BioSolutions at 1 site in United States.
Trial 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). 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?
- ACAM2000
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2010to 14 Feb 2012
- Phase
- Phase 3
- 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 - 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:
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cangene Plasma Resources, Mid-Florida
Altamonte Springs, Florida, 32701
About this study
Official title: 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).
- Conditions
- Smallpox Vaccine Adverse Reaction
- Being tested
- ACAM2000
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACAM2000Biological
Percutaneous administration of a droplet (2.5µg) of ACAM2000 using a bifurcated needle.
| Study group | Role | What they receive |
|---|---|---|
| Vaccination | Other | This study was a single arm study. All eligible subjects received ACAM2000. Receives: Biological: ACAM2000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Participants With Adverse Events Related to ACAM2000 Vaccine Administration
Measured: Days 0 to 90 post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2010 (estimated)
- Study start13 Sep 2010
- Primary completion14 Feb 2012
- Study completion14 Feb 2012
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emergent BioSolutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Ronald Brown, MD, Principal investigator, Cangene Plasma Resources, Mid-Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01158157
- Sponsor's protocol ID
- VA-006
- Status last verified
- Mar 2024
- First submitted
- 5 Jul 2010
- Last updated
- 18 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 10458959
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 Vaccine (ACAM2000) for the Production of Vaccinia Immune Globulin Intravenous (VIGIV)
- ClinicalTrials.gov ID
- NCT01158157
- Acronym / sponsor ID
- VA-006
- Conditions
- Smallpox Vaccine Adverse Reaction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Emergent BioSolutionsIndustry (pharma, biotech, devices)
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 13 Sep 2010 (actual)
- Primary completion
- 14 Feb 2012 (actual)
- Study completion
- 14 Feb 2012 (actual)
- First posted
- 8 Jul 2010 (estimated)
- Results
- Posted 26 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaccination | Other | Biological: ACAM2000This study was a single arm study. All eligible subjects received ACAM2000. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (34 listed)
- 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:
- 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).
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 |
|---|---|---|
| ACAM2000Percutaneous administration of a droplet (2.5µg) of ACAM2000 using a bifurcated needle. | Biological | Vaccination |
Primary outcome
Percent of Participants With Adverse Events Related to ACAM2000 Vaccine Administration
Time frame: Days 0 to 90 post-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.
- Background: PubMed 10458959Russell 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.
- World Health Organization. Declaration of global eradication of smallpox. Wkly. Epidemiol. Rec., 55:145-152, 1980.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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.
Ronald Brown, MD principal investigator
Cangene Plasma Resources, Mid-Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ACAM2000 in people with Smallpox Vaccine Adverse Reaction, run by Emergent BioSolutions at 1 site in United States.
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 10 inclusion and 34 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 United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Mar 2019). 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?
Percent of Participants With Adverse Events Related to ACAM2000 Vaccine Administration (time frame: Days 0 to 90 post-vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01158157, which also lists 1 linked publication.
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.