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

Smallpox Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00189956
• Other study ID #: POX-MVA-004
• Status: Completed
• Phase: Phase 2
• Start date: April 2003
• Est. completion date: December 2005

Study information

• Verified date: December 2018
• Source: Bavarian Nordic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: December 2005
• Est. primary completion date: November 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Smallpox

Intervention

Biological:
• IMVAMUNE (MVA-BN)
Two vaccinations of 0.5 ml MVA-BN vaccine, separated by a 4 week interval.

Locations

Country	Name	City	State
Switzerland	Swiss Pharma Contract	Basel

Sponsors (2)

Lead Sponsor	Collaborator
Bavarian Nordic	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

Switzerland, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Days 28, 84
Secondary	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'.	Days 28, 42, 84
Secondary	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.	Days 28, 42, 84
Secondary	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'.	Days 28, 42, 84
Secondary	Cytotoxic T-Lymphocyte response	The Cytotoxic T-Lymphocyte (CTL) response was determined by measuring IFN? producing cells by Intracellular cytokine staining (ICS)	Days 28, 42, 84
Secondary	Serious Adverse Events	Incidence, relationship and intensity of any Serious Adverse Event (SAE)	within 12 weeks
Secondary	Solicited Local Adverse Events	Incidence and intensity of solicited local AEs. Percentages based on subjects with at least one completed diary card.	within 8 days after any vaccination
Secondary	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.	within 8 days after any vaccination
Secondary	Unsolicited Non-serious Adverse Events	Occurrence of unsolicited non-serious AEs: Intensity and relationship to vaccination	within 31 days after any vaccination