ClinicalTrials.gg
CompletedNCT00927719Updated Mar 18, 2024

Safety Surveillance Study of ACAM2000® Vaccinia Vaccine

An observational study in Smallpox, sponsored by Emergent BioSolutions. Completed at 4 sites in United States. Open to participants aged 17 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-18.

Sponsored by Emergent BioSolutions · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
897,227
Ages
17 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Smallpox

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Keywords

  • Smallpox
  • Smallpox Vaccine
  • Vaccinia virus
  • Military
03

In context

Smallpox

73 studies on the registry are indexed under Smallpox; 5 are open to participants now.

Browse Smallpox studies →

Lead sponsor

Emergent BioSolutions is the lead sponsor of 47 studies on the registry; 7 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 7 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
17 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Participants that had received ACAM2000®, vaccinia virus Smallpox vaccine.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male and female military personnel >= 17 years of age.
  • Have received the ACAM2000® smallpox vaccine.

Exclusion criteria

Exclusion Criteria :

  • Not applicable.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
897,227 participants (actual)

Groups and cohorts

  • ACAM2000® vaccinia vaccine Cohort

    Participants had received ACAM2000®, vaccinia virus Smallpox vaccine.

    Biological: ACAM2000® smallpox vaccine

Interventions

06

What researchers measure

Primary outcomes

  1. To provide information concerning the safety following vaccination with ACAM2000® vaccinia vaccine

    Time frame: Entire study duration

07

Study locations

4 sites
  • Twentynine Palms, California 92278, United States
  • Fort Campbell North, Kentucky 42223, United States
  • Fort Bliss, Texas 79906, United States
  • Fort Hood, Texas 76544, United States
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00927719
Responsible party
Sponsor
First posted
Jun 25, 2009
Start date
Dec 2008
Primary completion
Dec 31, 2017
Completion
Dec 31, 2017
Last update
Mar 18, 2024

Study contacts

Medical Director
study director · Emergent BioSolutions

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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