NCT00189956

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

January 10, 2019

Status Verified

December 1, 2018

Enrollment Period

7 months

First QC Date

September 11, 2005

Last Update Submit

January 8, 2019

Conditions

Smallpox

Outcome Measures

Primary Outcomes (1)

  • 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.

    Day 42

Secondary Outcomes (9)

  • ELISA seroconversion rate

    Days 28, 84

  • ELISA GMT

    Days 28, 42, 84

  • PRNT seroconversion rate

    Days 28, 42, 84

  • PRNT GMT

    Days 28, 42, 84

  • Cytotoxic T-Lymphocyte response

    Days 28, 42, 84

  • +4 more secondary outcomes

Study Arms (3)

Group 1

ACTIVE COMPARATOR

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

Biological: IMVAMUNE (MVA-BN)

Group 2

ACTIVE COMPARATOR

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

Biological: IMVAMUNE (MVA-BN)

Group 3

ACTIVE COMPARATOR

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

Biological: IMVAMUNE (MVA-BN)

Interventions

IMVAMUNE (MVA-BN)BIOLOGICAL

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

Group 1Group 2Group 3

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swiss Pharma Contract

Basel, 4123, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 19944151RESULT

MeSH Terms

Conditions

Smallpox

Interventions

smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic

Condition Hierarchy (Ancestors)

Poxviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Rolf Pokorny, M.D.

    Swiss Pharma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2005

First Posted

September 19, 2005

Study Start

April 1, 2003

Primary Completion

November 1, 2003

Study Completion

December 1, 2005

Last Updated

January 10, 2019

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)