A Randomized, Double-Blind, Placebo-Controlled Phase III Trial to Evaluate Immunogenicity and Safety of Three Consecutive Production Lots of IMVAMUNE® (MVA-BN®) Smallpox Vaccine in Healthy, Vaccinia-Naïve Subjects

Bavarian Nordic33 sites in 1 country4,005 target enrollmentFebruary 2013

ConditionsSmallpox

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Smallpox
Sponsor: Bavarian Nordic
Enrollment: 4005
Locations: 33
Primary Endpoint: PRNT GMT
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A randomized, double-blind, placebo-controlled Phase III trial to evaluate immunogenicity and safety of three consecutive production lots of IMVAMUNE® (MVA-BN®) smallpox vaccine in healthy, vaccinia-naïve subjects.

Registry

clinicaltrials.gov

Start Date

February 2013

End Date

June 2014

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bavarian Nordic

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male and female subjects, 18 to 40 years of age
•The subject has read, signed and dated the informed consent form, having been advised of the risks and benefits of the trial in a language understood by the subject and prior to performance of any trial specific procedures
•BMI ≥ 18.5 and \< 35
•Women of childbearing potential (WOCBP) must have used an acceptable method of contraception for 30 days prior to the first vaccination, must agree to use an acceptable method of contraception during the trial, and must avoid becoming pregnant for at least 28 days after the last vaccination. A woman is considered of childbearing potential unless post-menopausal or with a history of hysterectomy (Acceptable contraception methods are restricted to abstinence, barrier contraceptives, intrauterine contraceptive devices or licensed hormonal products)
•WOCBP must have a negative serum pregnancy test at screening and a negative urine pregnancy test within 24 hours prior to each vaccination
•White blood cells ≥ 2,500/mm3 \< ULN
•Absolute neutrophil count (ANC) within normal limits
•Hemoglobin within normal limits
•Platelets within normal limits
•Adequate renal function defined as a calculated Creatinine Clearance (CrCl) \> 60 ml/min as estimated by the Cockcroft-Gault equation:

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

PRNT GMT

Time Frame: 2 weeks following the second vaccination

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'.

Secondary Outcomes

ELISA GMT(2 weeks following the second vaccination)
Serious Adverse Events(within 30 weeks)
Unsolicited Non-serious AEs: Intensity(within 29 days after any vaccination)
ELISA Seroconversion Rate(2 weeks following the second vaccination)
Solicited Local AEs(within 8 days after any vaccination)
PRNT Seroconversion Rate(2 weeks following the second vaccination)
Correlation PRNT vs ELISA Titers(2 weeks following the second vaccination)
Cardiac Signs or Symptoms(within 30 weeks)
Related Grade >=3 Adverse Events(within 29 days after any vaccination)
Unsolicited Non-serious AEs: Relationship to Vaccination(within 29 days after any vaccination)
Solicited General AEs(within 8 days after any vaccination)