SmallpoxNCT00927719
Safety Surveillance Study of ACAM2000® Vaccinia Vaccine
An observational study of Smallpox, run by Emergent BioSolutions at 4 sites in United States.
Trial summary
This is an enhanced safety surveillance study that will occur within the military Service Member population. Primary Objective: To evaluate the rates of suspected, probable, and confirmed myocarditis and/or pericarditis in temporal association with ACAM2000® vaccination. Read more about this study
- Who is it for?
- Ages 17 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smallpox
- What is being tested?
- ACAM2000® smallpox vaccine
- Type of treatment
- Vaccines
- How many people
- 897,227 participants
- Where
- 4 sitesUnited States
- Study dates
- Dec 2008to 31 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 17 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants that had received ACAM2000®, vaccinia virus Smallpox vaccine.
Who may be able to join
- Male and female military personnel >= 17 years of age.
- Have received the ACAM2000® smallpox vaccine.
Who cannot join
- Not applicable.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Study site
Fort Bliss, Texas, 79906
Study site
Fort Campbell North, Kentucky, 42223
Study site
Fort Hood, Texas, 76544
Study site
Twentynine Palms, California, 92278
About this study
Official title: A Phase IV Enhanced Safety Surveillance Study of ACAM2000® in Military Personnel
This is an enhanced safety surveillance study that will occur within the military Service Member population.
Primary Objective:
- To evaluate the rates of suspected, probable, and confirmed myocarditis and/or pericarditis in temporal association with ACAM2000® vaccination.
Secondary Objectives:
- To evaluate the rates of cardiovascular adverse events in temporal association with ACAM2000® vaccination.
- To evaluate the rates of neurological adverse events in temporal association with ACAM2000® vaccination.
Read the detailed description
The Armed Forces Health Surveillance Activity (AFHSA) will perform comprehensive health surveillance through the operation of the Defense Medical Surveillance System (DMSS). Demographic and medical information gathered within monthly reports from the DMSS will be collected from approximately 100,000 to 200,000 military Service Members who received the ACAM2000® smallpox vaccine.
- Conditions
- Smallpox
- Being tested
- ACAM2000® smallpox vaccine
- Keywords
- Smallpox, Smallpox Vaccine, Vaccinia virus, Military
- Medical subject headings
- Smallpox, Vaccinia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACAM2000® smallpox vaccineBiological
Also called ACAM2000®
Previous vaccination, no vaccine is administered in this study.
| Study group | Role | What they receive |
|---|---|---|
| ACAM2000® vaccinia vaccine Cohort | Participants had received ACAM2000®, vaccinia virus Smallpox vaccine. Receives: Biological: ACAM2000® smallpox vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To provide information concerning the safety following vaccination with ACAM2000® vaccinia vaccine
Measured: Entire study duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2009 (estimated)
- Study startDec 2008
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SmallpoxStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 897,227 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emergent BioSolutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Emergent BioSolutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00927719
- Sponsor's protocol ID
- H-406-005
- Status last verified
- Mar 2024
- First submitted
- 24 Jun 2009
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Decker MD, Garman PM, Hughes H, Yacovone MA, Collins LC, Fegley CD, Lin G, DiPietro G, Gordon DM. Enhanced safety surveillance study of ACAM2000 smallpox vaccine among US military service members. Vaccine. 2021 Sep 15;39(39):5541-5547. doi: 10.1016/j.vaccine.2021.08.041. Epub 2021 Aug 26.
PubMed 34454787
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
- A Phase IV Enhanced Safety Surveillance Study of ACAM2000® in Military Personnel
- ClinicalTrials.gov ID
- NCT00927719
- Acronym / sponsor ID
- H-406-005
- Conditions
- Smallpox
- Keywords
- Smallpox, Smallpox Vaccine, Vaccinia virus, Military
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 897,227 participants (actual)
- Lead sponsor
- Emergent BioSolutionsIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 25 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an enhanced safety surveillance study that will occur within the military Service Member population.
Primary Objective:
- To evaluate the rates of suspected, probable, and confirmed myocarditis and/or pericarditis in temporal association with ACAM2000® vaccination.
Secondary Objectives:
- To evaluate the rates of cardiovascular adverse events in temporal association with ACAM2000® vaccination.
- To evaluate the rates of neurological adverse events in temporal association with ACAM2000® vaccination.
Detailed description
The Armed Forces Health Surveillance Activity (AFHSA) will perform comprehensive health surveillance through the operation of the Defense Medical Surveillance System (DMSS). Demographic and medical information gathered within monthly reports from the DMSS will be collected from approximately 100,000 to 200,000 military Service Members who received the ACAM2000® smallpox vaccine.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACAM2000® vaccinia vaccine Cohort | – | Biological: ACAM2000® smallpox vaccineParticipants had received ACAM2000®, vaccinia virus Smallpox vaccine. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants that had received ACAM2000®, vaccinia virus Smallpox vaccine.
Key inclusion criteria (2 listed)
- Male and female military personnel >= 17 years of age.
- Have received the ACAM2000® smallpox vaccine.
Key exclusion criteria (1 listed)
- Not applicable.
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 |
|---|---|---|
| ACAM2000® smallpox vaccineAlso: ACAM2000®Previous vaccination, no vaccine is administered in this study. | Biological | ACAM2000® vaccinia vaccine Cohort |
Primary outcome
To provide information concerning the safety following vaccination with ACAM2000® vaccinia vaccine
Time frame: Entire study duration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Derived from this study: PubMed 34454787Decker MD, Garman PM, Hughes H, Yacovone MA, Collins LC, Fegley CD, Lin G, DiPietro G, Gordon DM. Enhanced safety surveillance study of ACAM2000 smallpox vaccine among US military service members. Vaccine. 2021 Sep 15;39(39):5541-5547. doi: 10.1016/j.vaccine.2021.08.041. Epub 2021 Aug 26.
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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.
Medical Director study director
Emergent BioSolutions
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smallpox, run by Emergent BioSolutions at 4 sites 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 2 inclusion and 1 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 4 sites 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To provide information concerning the safety following vaccination with ACAM2000® vaccinia vaccine (time frame: Entire study duration). 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 NCT00927719, 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.