Take evaluation and safety of smallpox vaccine (LISTER strain) in naïve healthy adults

Phase 1

• Conditions: Vaccination of vaccinia-naive healthy adults (18-25 years old)

• Registration Number: EUCTR2005-002175-32-FR
• Lead Sponsor: Sanofi Pasteur SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06-21
• Last Update Posted: 23 July 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

1. Patients aged 18 to 25 years on the day of screening
2. Informed consent form signed
3. Able to attend all scheduled visits and to comply with all trial procedures
4. For a woman, inability to bear a child or negative serum pregnancy test performed at screening (checked at V01)
5. Subject entitled to national social security
6. Subject registered in the French file of healthy volunteers in clinical trials
7. For a woman of child-bearing potential: use of an effective method of contraception (hormonal or barrier method) from at least three months prior to screening to three months following trial vaccination
8. For a woman, inability to bear a child or negative urine pregnancy test

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 to 27 will be checked at screening and on D0:
1. Previous smallpox vaccination confirmed by vaccination record or typical scar
2. Participation in another clinical trial in the three months preceding the trial vaccination
3. Planned participation in another clinical trial during the present trial period
4. Chronic illness at a stage that could interfere with trial conduct or completion
5. Breast-feeding
6. Allergy to any known components of vaccinia immune globulin or previous allergic reaction to immunoglobulins
7. Systemic hypersensitivity to eggs or to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances as the trial vaccine
8. Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding six months, or any treatment including corticosteroids (systemic, topical, ophthalmic)
9. Treatment with antiviral drugs (interferon, vidarabine, acyclovir, etc.) within one month before vaccination
10. History of organ or bone marrow transplant
11. History of skin disorders or atopy (such as progressive eczema, eczema, atopic dermatitis, Darier’s disease, severe acnea, etc.)
12. History of autoimmune disease (multiple sclerosis, lupus, etc.) in the subject’s parents, siblings or children
13. History or current cardiac disease: ECG abnormalities, pericarditis, myopericarditis, myocardial infarction/heart attack, angina pectoris, congestive heart failure, cardiomyopathy, arrhythmia, stroke or transient ischemic attacks, or chest pain or shortness of breath with activity (such as walking up stairs), or other coronary artery disease and heart conditions under the care of a physician and associated with a heart condition, or family history of sudden death before the age of 50 years
14. History or current central nervous system disease: neurodegenerative, infectious, or progressive tumoral disease, or epilepsy
15. Subject having three or more major risk factors, including: current tobacco use, hypertension, hypercholesterolemia, hypertriglyceridemia, diabetes mellitus, or family history of heart disease (a heart condition before age 50 in a parent, brother, or sister)
16. Ongoing acute infectious disease
17. Blood or blood-derived products received in the past six months
18. Any vaccination with a live-attenuated vaccine within the 60 days preceding the trial vaccination
19. Any vaccination (other than a live-attenuated vaccine) in the four weeks preceding the trial vaccination
20. Vaccination planned in the eight weeks following the trial vaccination
21. Current abuse of alcohol or drug addiction that may interfere with the subject’s ability to comply with trial procedures
22. Planned or foreseeable close contact after vaccination with infants of less than 12 months of age, or with immunosuppressed persons, pregnant and/or lactating woman, or with persons known to have chronic eczema, or severe skin disorders until the crust separates, leaving a permanent scar at the vaccination site
23. Planned practice of contact sports or water sports after vaccination until the crust separates, leaving a permanent scar at the vaccination site
24. Cutaneous lesion near the vaccination site
25. Apparent lack of personal hygiene
26. Lack of understanding of the questionnaire
27. Subject deprived of freedom by an administrative or court order, or in an
emergency setting, or hospitalized without his/her con

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To estimate the smallpox vaccination take rate in naïve healthy adults.;Secondary Objective: 1) To describe local signs and symptoms of the take.<br>2) To describe the safety of the vaccine in naïve healthy adults<br>3) To describe the antibody response to vaccination on D0 and D28;Primary end point(s): To evaluate the take for each subject on D9 (Day), D14, D21, and D28. The take is defined as the occurrence of a post-vaccination pock at the vaccination site (a pock is a typical major cutaneous lesion [erythematous papule, vesicle, or pustule]).