A Long-Term Study of Healthy Adults Vaccinated With One Dose of Smallpox Vaccine (LISTER Strain)

The purpose of this study is to provide long-term follow-up immunogenicity and safety data on participants who were vaccinated with the second-generation smallpox vaccine in Study VVL04 (NCT 00258947).

Primary Objectives:

Immunogenicity: To yearly describe the vaccinia antibody persistence up to 5 years post-vaccination.

Safety: To follow-up the long-term safety up to 5 years post-vaccination.

Completed

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Key information

Conditions

Smallpox DNA Virus Infections Infections Poxviridae Infections Virus Diseases

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gières, France

About this study

None of the participants in this study will receive any vaccination as part of the study. All participants will provide blood samples for immunogenicity testing at the 1, 2, 3, 4, and 5 year anniversaries of vaccination. Safety will be assessed for up to 5 years after vaccination, including follow-up of reactions that occurred during Study VVL04 (NCT 00258947).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subject vaccinated and who completed the Phase II VVL04 trial.
Informed consent form signed.
Subject able to comply with all trial procedures.
Subject entitled to national social security.

Exclusion criteria

Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.

Treatment and study plan

Primary outcomes

To provide information concerning the immune response of live vaccinia virus (LISTER strain) after primary vaccination.

Time frame: 1 to 5 years post-vaccination
To provide information concerning the safety after primary administration of live vaccinia virus (LISTER strain).

Time frame: 1 to 5 years post-vaccination

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

A Long-Term Safety and Immunogenicity Follow-up of Healthy Adults Vaccinated With One Dose of Smallpox Vaccine (LISTER Strain)

Important dates

Study start: 2006
Primary completion: 2011
Study completion: 2012
First posted: Oct 20, 2009
Registry last updated: Aug 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed