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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00998543

Enrollment

147

Registered

2009-10-20

Start date

2006-10-31

Completion date

2012-03-31

Last updated

2012-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smallpox

Keywords

Smallpox Vaccinia Virus Smallpox Vaccine Variola Virus

Brief summary

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.

Detailed 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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 25 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Countries

France

Outcome results