Evaluation of Take and Safety of a Smallpox Vaccine in Healthy Young Adults

Sponsor

Sanofi (Industry)

Overall Status

Completed

CT.gov ID

NCT00258947

Collaborator

(none)

230

Enrollment

Locations

Duration (Months)

38.3

Patients Per Site

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Primary Objective:

To estimate the smallpox vaccination take rate in healthy young adults not previously vaccinated with a smallpox vaccine.

Secondary Objectives:

To describe antibody response to vaccination and evaluate the take for each subject at various timepoints for each batch and pooled batches and to evaluate local signs, symptoms, and overall safety in healthy young adults not previously vaccinated with a smallpox vaccine.

Condition or Disease	Intervention/Treatment	Phase
Smallpox Poxvirus Infection	Biological: Smallpox vaccine, LISTER strain, from chick embryo cells	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

230 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Take Evaluation and Safety of Smallpox Vaccine (LISTER Strain) in Naïve Healthy Adults.

Study Start Date :

Sep 1, 2005

Actual Primary Completion Date :

Dec 1, 2006

Actual Study Completion Date :

Jan 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 25 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Aged 18 to 25 years on the day of screening
Informed consent form signed
Able to attend all scheduled visits and to comply with all trial procedures
For a woman, inability to bear a child or negative serum pregnancy test performed at screening (Visit 01)
Subject entitled to national social security
Subject registered in the French file of healthy volunteers in clinical trials
For a woman of child-bearing potential: use of an effective method of contraception (hormonal or barrier method) from at least 3 months prior to screening to 3 months following trial vaccination
For a woman, inability to bear a child or negative urine pregnancy test.

Exclusion Criteria:

Previous smallpox vaccination confirmed by vaccination record or typical scar
Participation in another trial in the 3 months before or during the trial period
Acute intercurrent or chronic illness during the trial
Breast-feeding
Allergy or sensitivity to any known components of vaccinia immune globulin or previous reaction to immunoglobulins or trial vaccine
Congenital or acquired immunodeficiency or immunosuppressive therapy or any treatment including corticosteroids
Treatment with antiviral drugs within 1 month before vaccination
History of organ or bone marrow transplant or skin disorders
Personal or family history of autoimmune disease or cardiac disease, including cardiac risk factors
History or current central nervous system disease
Ongoing acute infectious disease
Blood or blood-derived products received in the past 6 months
Any vaccination with a live-attenuated vaccine within the 60 days or other vaccines within 40 days preceding the trial vaccination
Vaccination planned in the 8 weeks following the trial vaccination
Planned or foreseeable close contact after vaccination with infants less than 12 months, or with immuno-suppressed persons, pregnant and/or lactating woman, or practice of contact or water sports after vaccination before the crust separates
Skin wound near the vaccination site
Apparent lack of personal hygiene
Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
HIV, hepatitis B or hepatitis C seropositivity (screening tests)
Abnormal lab values for hematological parameters or cardiac enzyme (screening tests)
Feverish illness (oral temperature >=37.5°C, rectal equivalent temperature >=38.0°C) on the day of vaccination.