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Safety Surveillance Cohort Study of Vaccinia Vaccine (ACAM2000®) | Clinical Trials | Clareo Health

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Safety Surveillance Cohort Study of Vaccinia Vaccine (ACAM2000®)

A Phase IV Prospective Safety Surveillance Cohort Study Of ACAM2000® In Deploying Military Personnel

NCT00928577•Emergent BioSolutions

Summary

Primary Objectives: * To compare the rates of myopericarditis (subclinical, suspected, probable, or confirmed) in deploying military subjects who received ACAM2000® vaccine to rates among subjects positioned to deploy who would be personally eligible to receive ACAM2000 vaccine but do not receive ACAM2000 vaccine due to recency of prior vaccination (as determined by DoD healthcare providers) or due to conditions or characteristics of their contacts. * To identify cases of subclinical myopericarditis in deploying military subjects who received ACAM2000 vaccine. Secondary Objectives: * To compare the rates of severe and serious dermatologic adverse events observed in deploying military subjects who received ACAM2000® vaccine to rates among subjects positioned to deploy who would be personally eligible to receive ACAM2000 vaccine but do not receive ACAM2000 vaccine due to recency of prior vaccination (as determined by DoD healthcare providers) or due to conditions or characteristics of their contacts. * To compare the rates of severe and serious neurological adverse events observed in deploying military subjects who received ACAM2000® vaccine to rates among subjects positioned to deploy who would be personally eligible to receive ACAM2000 vaccine but do not receive ACAM2000 vaccine due to recency of prior vaccination (as determined by DoD healthcare providers) or due to conditions or characteristics of their contacts. * To compare the rates of adverse events observed in subjects approximately 10 days following their ACAM2000® vaccination to rates among subjects positioned to deploy who would be personally eligible to receive ACAM2000 vaccine but do not receive ACAM2000 vaccine due to recency of prior vaccination (as determined by DoD healthcare providers) or due to conditions or characteristics of their contacts. * To evaluate potential risk factors associated with the development of confirmed, probable, and/or suspected ACAM2000-associated myopericarditis.

Detailed Description

This is a prospective safety surveillance study in a US military Department of Defense (DoD) population. Military subjects either naive to smallpox immunization and have received ACAM2000® vaccine or who have previously been immunized with a vaccinia vaccine, usually Dryvax®, will be enrolled into the study. No vaccine will be administered as part of this study.

Eligibility

Age

17 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Written informed consent obtained prior to the conduct of any study-related procedures.
•Male and Female military personnel positioned for active deployment.
•Participant naïve to previous smallpox vaccination and received the ACAM2000 vaccine (Cohort 1), OR, Participant has not received ACAM2000 vaccine within the prior 3 years, AND is ineligible for current ACAM2000 vaccination either because of recency of prior vaccinia vaccination or for reasons solely attributable to conditions or characteristics of their contacts (such as a healthy soldier who is married to someone with a contraindicated condition) (Cohort 2).

Exclusion Criteria

•Subjects judged by the investigator as unlikely to understand the scope of the study and/or unlikely to be able to be compliant with the study procedures and visits.
•Participation in any other studies involving investigational or marketed products within 30 days prior to Visit 1.

Locations (4)

Twentynine Palms, California, United States

Fort Campbell North, Kentucky, United States

Fort Bliss, Texas, United States

Fort Hood, Texas, United States

Key Dates

Start Date

December 1, 2008

Primary Completion Date

December 1, 2014

Completion Date

December 1, 2015

Last Updated

April 4, 2024

Enrollment

14,108

ACTUAL participants

Conditions

Smallpox

A Randomized Clinical Trial Investigating the Safety, Reactogenicity, and Immunogenicity After Immunization With an mRNA-based Mpox Vaccine Candidate in Africa

NCT07379580

Mpox (Monkeypox)Smallpox+1 more

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ACTIVE_NOT_RECRUITINGPHASE2

Study to Assess the Safety and Immunogenicity of TPOXX® When Administered Orally for 28 Days With JYNNEOS

NCT04957485

Smallpox

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 4, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety Surveillance Cohort Study of Vaccinia Vaccine (ACAM2000®)

Inclusion Criteria

Exclusion Criteria

A Randomized Clinical Trial Investigating the Safety, Reactogenicity, and Immunogenicity After Immunization With an mRNA-based Mpox Vaccine Candidate in Africa

Study to Assess the Safety and Immunogenicity of TPOXX® When Administered Orally for 28 Days With JYNNEOS

A Study to Investigate The Safety, Tolerability, And Immune Response of a Range of Doses of mRNA-1769 Compared With Placebo in Healthy Participants From ≥18 Years of Age to <50 Years of Age

VA-006 Vaccinia Vaccine (ACAM2000) for the Production of VIGIV

A Phase 4, Observational Field Study to Evaluate TPOXX in Patients With Smallpox

A Randomized, Double-blind, Placebo-controlled Study on Immunogenicity and Safety of MVA-BN (IMVAMUNE™) Smallpox Vaccine in Healthy Subjects