An open-label, non-controlled study to immunize healthy volunteers actively working with or in the vicinity of replicating Vaccinia virus with IMVAMUNE® (MVA-BN®)

• Conditions: Healthy subjects actively working with or in the vicinity of replicating Vaccinia virus will receive immunization IMVAMUNE to offer protection against accidential Vaccinia virus infection.; MedDRA version: 12.1Level: PTClassification code 10041197Term: Smallpox; MedDRA version: 12.1Level: LLTClassification code 10066048Term: Vaccinia

• Registration Number: EUCTR2010-018334-51-DE
• Lead Sponsor: Bavarian Nordic A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Healthy male and female subjects who will work with or in the vicinity of replicating Vaccinia virus and are at-risk for contracting vaccinia infection during work and who volunteer for the program.
2.Health status will be assessed by medical history, physical examination and clinical laboratory tests.
3.Age: 18 to 60 (inclusive) years
4.Women of child-bearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to each vaccination.
5.Women of child-bearing potential must agree to use an acceptable method of contraception during the vaccination period, and must continue to use it for at least 28 days after the last vaccination.
6.Read, signed and dated informed consent form (ICF) after being advised of the risks and benefits of the trial in a language understood by the subject prior to performance of any trial specific procedure.

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

1.Pregnant or breast-feeding women.
2.History of any serious medical condition, which in the opinion of the investigator would compromise the safety of the subject.
3.Present uncontrolled serious infection i.e., not responding to antimicrobial therapy.
4.History of or active autoimmune disease.
5.Known or by the clinical investigator suspected relevant impairment of immunologic function including, but not limited to, clinically significant liver disease; uncontrolled diabetes mellitus; moderate to severe kidney impairment or post organ transplant subjects which might interfere with the safety and/or immunogenicity of IMVAMUNE® vaccination.
6.History of malignancy, other than squamous cell or basal cell skin cancer, unless there has been surgical excision that is considered to have achieved cure.
7.History of coronary heart disease, myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure, or any other clinical relevant heart condition to the discretion of the investigator.
8.History of allergies or reactions to eggs, egg products, or gentamycin.
9.History of any anaphylactic shock or severe allergic reaction requiring immediate treatment.
10.Having received any vaccinations or planned vaccinations with a live vaccine within 28 days or a killed vaccine within 14 days prior to or after IMVAMUNE® vaccination.
11.Chronic administration (defined as more than 6 days) of systemic corticosteroids within 90 days of the first planned vaccination.
12.Use of any investigational or non-registered drug or vaccine within 30 days preceding the first IMVAMUNE® vaccine dose, or planned administration of such a drug during the trial period.

Study & Design

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