Clinical trial NCT00189956: Dose-finding Study to Evaluate Immunogenicity of Three Different Dose Levels of the IMVAMUNE (MVA-BN) Smallpox Vaccine.
Official title: Phase II, Double-blind, Randomised, Dose-finding Study to Evaluate the Immunogenicity of Three Different Doses of MVA-BN Smallpox Vaccine in 18-30 Year Old Smallpox naïve Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Smallpox
Lead sponsor: Bavarian Nordic
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2005-09-19
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of the study is to find the optimal dose for the smallpox candidate vaccine IMVAMUNE (MVA-BN). For this purpose the study compares IMVAMUNE (MVA-BN) administered at three different dose levels.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female subjects, aged 18 - 30 years
* Signed informed consent after being advised of the risks and benefits of the study in a language able to understand, and prior to performance of any study specific procedure.
* Free of obvious health problems with acceptable medical history by screening evaluation and physical examination.
* Subject of not of child-bearing potential or all of the following: A urine/serum ß-HCG pregnancy test gives a negative result, use of adequate contraceptive precautions for 30 days before first vaccination.

Exclusion Criteria:

* Known or suspected history of smallpox vaccination or typical vaccinia scar.
* Positive test result in MVA specific ELISA or PRNT at screening.
* Positive result in HIV or HCV antibody test at screening.
* HbsAG positive at screening.
* Pregnancy or breast-feeding.
* Uncontrolled serious infection i.e. not responding to antimicrobial therapy
* History of any serious medical condition, which in the opinion of the investigator, would compromise the safety of the subject.
* History of autoimmune disease
* History of malignancy.
* History of chronic alcohol abuse and/or intravenous drug abuse.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* History of anaphylaxis or severe allergic reaction.
* Acute disease (a moderate or severe illness with or without a fever) at the time of enrolment.
* Any vaccinations within a period starting 30 days prior to administration of the vaccine and ending at study conclusion.
* Chronic administration of immuno-suppressants or other immune-modifying drugs.
* Administration or planned administration of immunoglobulins and/or any blood products during the study period.
* Use of any investigational or non-registered drug or vaccine.

Primary outcomes:
measure: ELISA seroconversion rate
timeFrame: Day 42
Secondary outcomes:
measure: ELISA seroconversion rate
timeFrame: Days 28, 84
measure: ELISA GMT
timeFrame: Days 28, 42, 84
measure: PRNT seroconversion rate
timeFrame: Days 28, 42, 84
measure: PRNT GMT
timeFrame: Days 28, 42, 84
measure: Cytotoxic T-Lymphocyte response
timeFrame: Days 28, 42, 84
measure: Serious Adverse Events
timeFrame: within 12 weeks
measure: Solicited Local Adverse Events
timeFrame: within 8 days after any vaccination
measure: Solicited General Adverse Events
timeFrame: within 8 days after any vaccination
measure: Unsolicited Non-serious Adverse Events
timeFrame: within 31 days after any vaccination
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Swiss Pharma Contract
Study officials:
affiliation: Swiss Pharma
name: Rolf Pokorny, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: von Krempelhuber A, Vollmar J, Pokorny R, Rapp P, Wulff N, Petzold B, Handley A, Mateo L, Siersbol H, Kollaritsch H, Chaplin P. A randomized, double-blind, dose-finding Phase II study to evaluate immunogenicity and safety of the third generation smallpox vaccine candidate IMVAMUNE. Vaccine. 2010 Feb 3;28(5):1209-16. doi: 10.1016/j.vaccine.2009.11.030. Epub 2009 Nov 25.