Dose-finding Study to Evaluate Immunogenicity of Three Different Dose Levels of the IMVAMUNE (MVA-BN) Smallpox Vaccine.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2005-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Smallpox

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group 1

healthy, vaccinia naïve subjects 2 x 10E7 TCID50 IMVAMUNE (MVA-BN), subcutaneous

Group Type ACTIVE_COMPARATOR

IMVAMUNE (MVA-BN)

Intervention Type BIOLOGICAL

Two vaccinations of 0.5 ml MVA-BN vaccine, separated by a 4 week interval.

Group 2

healthy, vaccinia naïve subjects 5 x 10E7 TCID50 IMVAMUNE (MVA-BN), subcutaneous

Group Type ACTIVE_COMPARATOR

IMVAMUNE (MVA-BN)

Intervention Type BIOLOGICAL

Two vaccinations of 0.5 ml MVA-BN vaccine, separated by a 4 week interval.

Group 3

healthy, vaccinia naïve subjects

1 x 10E8 TCID50 IMVAMUNE (MVA-BN), subcutaneous

Group Type ACTIVE_COMPARATOR

IMVAMUNE (MVA-BN)

Intervention Type BIOLOGICAL

Two vaccinations of 0.5 ml MVA-BN vaccine, separated by a 4 week interval.

Interventions

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IMVAMUNE (MVA-BN)

Two vaccinations of 0.5 ml MVA-BN vaccine, separated by a 4 week interval.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes