A Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate Safety and Immunogenicity of One and Two Doses of IMVAMUNE® Smallpox Vaccine in 56-80 Year Old Vaccinia-experienced Subjects

Bavarian Nordic4 sites in 1 country120 target enrollmentJune 2009

ConditionsSmallpox

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Smallpox
Sponsor: Bavarian Nordic
Enrollment: 120
Locations: 4
Primary Endpoint: Related Serious Adverse Events
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 II Study to Evaluate Safety and Immunogenicity of One and Two Doses of IMVAMUNE® Smallpox Vaccine in 56-80 Year Old Vaccinia-Experienced Subjects

Registry

clinicaltrials.gov

Start Date

June 2009

End Date

August 2010

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 56-70 years of age. If no safety concerns are identified upon review of the safety data from the first 30 subjects enrolled, the age range is extended up to 80 years.
•Time since most current smallpox vaccination \> 10 years.
•The subject has read, signed and dated the Informed Consent Form (ICF), successfully completed (at least 90% correct \[no more than 3 attempts allowed\]) the test of understanding and has signed the Health Insurance Portability and Accountability Act (HIPAA) authorization form.
•Women must have a negative serum pregnancy test at screening and negative urine pregnancy test within 24 hours prior to vaccination.
•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 study and must not plan to become pregnant for at least 28 days after the last vaccination. (Acceptable contraception methods are restricted to abstinence, barrier contraceptives, intrauterine contraceptive devices or licensed hormonal products).
•Weight: ≥ 100 pounds (45.5 kg) and ≤ 330 pounds (150 kg).
•White blood cells ≥ 2500/mm3 and \< 11,000/mm
•Absolute neutrophil count within normal limits.
•Hemoglobin within normal limits.
•Platelets within normal limits.

Exclusion Criteria

•History of or active immunodeficiency or immuno-suppression caused by acquired or congenital diseases or caused by treatments such as chronic administration (\> 14 days) of systemic, i.e. parenteral or oral, corticosteroids (\> 5 mg prednisone \[or equivalent\] per day), radiation or immune-modifying drugs.
•Periodic steroid injections, e.g. intraarticular, are not allowed within 30 days prior to the first vaccination and throughout the study until Visit 5 (V5).
•Post organ transplant subjects whether or not receiving chronic immunosuppressive therapy.
•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 or prevent the subject from complying with study requirements.
•History of or active autoimmune disease, e.g. Type I diabetes. Persons with vitiligo or thyroid disease taking thyroid hormone replacement are not excluded.
•Skin cancer in the past six months. If treatment for skin cancer was successfully completed more than six months ago and the malignancy is considered to be cured, the subject may be enrolled. Subjects with history of skin cancer must not be vaccinated at the previous site of cancer.
•Any other malignancy in the past five years. If treatment for cancer was successfully completed more than 5 years ago and the malignancy is considered to be cured, the subject may be enrolled.
•Clinically significant hematological, renal, hepatic, pulmonary, central nervous, cardiovascular or gastrointestinal disorders which are not adequately controlled by medical treatment within the last 12 weeks before vaccination as judged by the site's Principal Investigator.
•History of myocardial infarction, congestive heart failure with marked limitation of activity due to symptoms, e.g. walking short distances \[20 100 m\] (i.e. \> Grade II according to the New York Heart Association), cardiomyopathy and stroke or transient ischemic attack in the past two years.

Outcomes

Primary Outcomes

Related Serious Adverse Events

Time Frame: within 8 weeks

Incidence of Serious Adverse Events (SAEs) probably, possibly or definitely related to the trial vaccine

Secondary Outcomes

Related Grade >=3 Adverse Events(within 29 days after any vaccination)
Cardiac Signs or Symptoms(within 32 weeks)
Solicited Local Adverse Events(within 8 days after any vaccination)
Unsolicited Non-serious AEs: Intensity(within 29 days after any vaccination)
Unsolicited Non-serious AEs: Relationship to Vaccination(within 29 days after any vaccination)
PRNT Seroconversion Rate(within 32 weeks)
Solicited General Adverse Events(within 8 days after any vaccination)
ELISA Seroconversion Rate(within 32 weeks)
ELISA GMT(within 32 weeks)
PRNT Response Rate(within 32 weeks)
PRNT GMT(within 32 weeks)
Correlation PRNT vs ELISA Titers(within 32 weeks)
ELISA Response Rate(within 32 weeks)