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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-000715-19-FR

Enrollment

230

Registered

2006-03-29

Start date

2006-04-10

Completion date

Unknown

Last updated

2018-07-23

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

Conditions

Five year follow-up of healthy adults already vaccinated in a previous trial

Interventions

Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Subject vaccinated and who completed the Phase II VVL04 trial. 2) Informed consent form signed. 3) Subject able to attend all scheduled visits and to comply with all trial procedures. 4) Subject entitled to national social security. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1) 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
Main Objective: 1) To yearly describe the anti-vaccinia antibody persistence up to five years post VVL04 vaccination. 2) To follow-up the long-term safety up to five years post VVL04 vaccination;Secondary Objective: ;Primary end point(s): Immunogenicity: 1) Neutralizing Ab titers at 12, 24, 36, 48, and 60 months post VVL04 vaccination (i.e. M12, M24; M36, M48, and M60). 2) Titer ratio: M12/Day 28, M24/M12, M36/M24, M48/M36, and M60/M48. 3) Persistence of detectable neutralizing Ab titer, i.e. = 10 (1/dil) on M12, M24; M36, M48, and M60. D28 titers are measured in VVL04 and, after M12, annual titers will be compared to previous year only Safety: 1) Evolution of smallpox vaccine reactions experienced by subjects during or after VVL04. 2) Occurrence of:· - Any SAE related to smallpox vaccination - Other specific events such as: - cardiac events such as myocarditis, myopericarditis, pericarditis, ischemic heart disease (including angina pectoris and myocardial infarction) - neurological events such as encephalitis and seizure - cutaneous events such as degenerescence of the scar at or near the vaccination site 3) Pregnancy (including outcome)	—

Measure

Time frame

Main Objective: 1) To yearly describe the anti-vaccinia antibody persistence up to five years post VVL04 vaccination. 2) To follow-up the long-term safety up to five years post VVL04 vaccination;Secondary Objective: ;Primary end point(s): Immunogenicity: 1) Neutralizing Ab titers at 12, 24, 36, 48, and 60 months post VVL04 vaccination (i.e. M12, M24; M36, M48, and M60). 2) Titer ratio: M12/Day 28*, M24/M12, M36/M24, M48/M36, and M60/M48. 3) Persistence of detectable neutralizing Ab titer, i.e. = 10 (1/dil) on M12, M24; M36, M48, and M60. *D28 titers are measured in VVL04 and, after M12, annual titers will be compared to previous year only Safety: 1) Evolution of smallpox vaccine reactions experienced by subjects during or after VVL04. 2) Occurrence of:· - Any SAE related to smallpox vaccination - Other specific events such as: - cardiac events such as myocarditis, myopericarditis, pericarditis, ischemic heart disease (including angina pectoris and myocardial infarction) - neurological events such as encephalitis and seizure - cutaneous events such as degenerescence of the scar at or near the vaccination site 3) Pregnancy (including outcome)

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Countries

France

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026