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

Sanofi

Status: Completed

Conditions: Smallpox

Study type: Observational

Funder types: Industry

Identifiers

NCT00998543

VVL05

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 147 patients

Sex: All

Ages: 18 to 25 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

147 participants in 1 patient group

Smallpox Vaccine (LISTER Strain) Group

Description:

Participants were vaccinated with the second-generation smallpox vaccine in Study VVL04 (NCT 00258947).