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

Primary Purpose

Smallpox

Status
Completed
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
IMVAMUNE (MVA-BN)
Sponsored by
Bavarian Nordic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Smallpox

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Swiss Pharma Contract

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group 1

Group 2

Group 3

Arm Description

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

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

healthy, vaccinia naïve subjects 1 x 10E8 TCID50 IMVAMUNE (MVA-BN), subcutaneous

Outcomes

Primary Outcome Measures

ELISA seroconversion rate
Seroconversion rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.

Secondary Outcome Measures

ELISA seroconversion rate
Seroconversion rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
ELISA GMT
Geometric Mean Titers (GMT) based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Titers below the detection limit are included with a value of '1'.
PRNT seroconversion rate
Seroconversion rate based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Seroconversion is defined as the appearance of antibody titers ≥ detection limit for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
PRNT GMT
Geometric Mean Titers (GMT) based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Titers below the detection limit are included with a value of '1'.
Cytotoxic T-Lymphocyte response
The Cytotoxic T-Lymphocyte (CTL) response was determined by measuring IFNγ producing cells by Intracellular cytokine staining (ICS)
Serious Adverse Events
Incidence, relationship and intensity of any Serious Adverse Event (SAE)
Solicited Local Adverse Events
Incidence and intensity of solicited local AEs. Percentages based on subjects with at least one completed diary card.
Solicited General Adverse Events
Incidence of solicited general AEs: Intensity and relationship to vaccination. Percentages based on subjects with at least one completed diary card.
Unsolicited Non-serious Adverse Events
Occurrence of unsolicited non-serious AEs: Intensity and relationship to vaccination

Full Information

First Posted
September 11, 2005
Last Updated
January 8, 2019
Sponsor
Bavarian Nordic
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00189956
Brief Title
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

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
November 2003 (Actual)
Study Completion Date
December 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bavarian Nordic
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smallpox

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
165 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
healthy, vaccinia naïve subjects 2 x 10E7 TCID50 IMVAMUNE (MVA-BN), subcutaneous
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
healthy, vaccinia naïve subjects 5 x 10E7 TCID50 IMVAMUNE (MVA-BN), subcutaneous
Arm Title
Group 3
Arm Type
Active Comparator
Arm Description
healthy, vaccinia naïve subjects 1 x 10E8 TCID50 IMVAMUNE (MVA-BN), subcutaneous
Intervention Type
Biological
Intervention Name(s)
IMVAMUNE (MVA-BN)
Intervention Description
Two vaccinations of 0.5 ml MVA-BN vaccine, separated by a 4 week interval.
Primary Outcome Measure Information:
Title
ELISA seroconversion rate
Description
Seroconversion rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
Time Frame
Day 42
Secondary Outcome Measure Information:
Title
ELISA seroconversion rate
Description
Seroconversion rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
Time Frame
Days 28, 84
Title
ELISA GMT
Description
Geometric Mean Titers (GMT) based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Titers below the detection limit are included with a value of '1'.
Time Frame
Days 28, 42, 84
Title
PRNT seroconversion rate
Description
Seroconversion rate based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Seroconversion is defined as the appearance of antibody titers ≥ detection limit for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
Time Frame
Days 28, 42, 84
Title
PRNT GMT
Description
Geometric Mean Titers (GMT) based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Titers below the detection limit are included with a value of '1'.
Time Frame
Days 28, 42, 84
Title
Cytotoxic T-Lymphocyte response
Description
The Cytotoxic T-Lymphocyte (CTL) response was determined by measuring IFNγ producing cells by Intracellular cytokine staining (ICS)
Time Frame
Days 28, 42, 84
Title
Serious Adverse Events
Description
Incidence, relationship and intensity of any Serious Adverse Event (SAE)
Time Frame
within 12 weeks
Title
Solicited Local Adverse Events
Description
Incidence and intensity of solicited local AEs. Percentages based on subjects with at least one completed diary card.
Time Frame
within 8 days after any vaccination
Title
Solicited General Adverse Events
Description
Incidence of solicited general AEs: Intensity and relationship to vaccination. Percentages based on subjects with at least one completed diary card.
Time Frame
within 8 days after any vaccination
Title
Unsolicited Non-serious Adverse Events
Description
Occurrence of unsolicited non-serious AEs: Intensity and relationship to vaccination
Time Frame
within 31 days after any vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rolf Pokorny, M.D.
Organizational Affiliation
Swiss Pharma
Official's Role
Principal Investigator
Facility Information:
Facility Name
Swiss Pharma Contract
City
Basel
ZIP/Postal Code
4123
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19944151
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.
Results Reference
result

Learn more about this trial

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

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