A Study to Evaluate Safety and Immunogenicity of One and Two Doses of IMVAMUNE® Smallpox Vaccine in 56-80 Year Old Vaccinia-experienced Subjects

NCT00857493 | Completed Phase 2 Results DMC

• 1 other identifier: POX-MVA-024
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 4

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

Conditions

Smallpox

Outcome Measures

Primary Outcomes (1)

• Related Serious Adverse Events

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

  within 8 weeks

Secondary Outcomes (13)

• Unsolicited Non-serious AEs: Intensity

  within 29 days after any vaccination

• Unsolicited Non-serious AEs: Relationship to Vaccination

  within 29 days after any vaccination

• 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

Study Arms (2)

Group 1

EXPERIMENTAL

Biological: IMVAMUNE

Group 2

EXPERIMENTAL

Biological: IMVAMUNE

Interventions

IMVAMUNE BIOLOGICAL

Two s.c. vaccinations with 0.5 ml IMVAMUNE® vaccine containing 1 x 10E8 TCID50 / dose

Group 1

Eligibility Criteria

• Age: 56 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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/mm3.
• Absolute neutrophil count within normal limits.
• Hemoglobin within normal limits.
• Platelets within normal limits.
• Adequate renal function defined as:
• Urine protein ≤ +1 (by dip stick)
• Serum creatinine within normal limits
• Adequate hepatic function defined as:
• Total bilirubin ≤ 1.5 x upper limit of normal (ULN) in the absence of other evidence of significant liver disease.

You may not qualify if:

• 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.
• Uncontrolled high blood pressure defined as systolic blood pressure ≥ 150 mm Hg and/or ≥ diastolic blood pressure ≥ 100 mm Hg within the last six months.
• Subjects with active coronary heart disease manifested by angina, even if on medication.
• % or greater risk of developing a myocardial infarction or coronary death within the next 10 years using the National Cholesterol Education Program's Risk Assessment Tool: http://hin.nhlbi.nih.gov/atpiii/calculator.asp
• Clinically significant mental disorder not adequately controlled by medical treatment.
• History of chronic alcohol abuse (40 g/day, e.g. 3 glasses of beer or 2 glasses of wine for at least six months) and/or intravenous drug abuse (within the last six months). Subjects with a history of other substance and/or alcohol abuse are also excluded if - in the opinion of the investigator - the abuse could prevent the subject from complying with study requirements.

Sponsors & Collaborators

• Bavarian Nordic: lead

Study Sites (4)

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

University of Kentucky, School of Medicine, Department of Medicine

Lexington, Kentucky, 40536-0084, United States

Location

University of Rochester, Medical Center

Rochester, New York, 16462, United States

Location

Related Publications (1)

• Greenberg RN, Hay CM, Stapleton JT, Marbury TC, Wagner E, Kreitmeir E, Roesch S, von Krempelhuber A, Young P, Nichols R, Meyer TP, Schmidt D, Weigl J, Virgin G, Arndtz-Wiedemann N, Chaplin P. A Randomized, Double-Blind, Placebo-Controlled Phase II Trial Investigating the Safety and Immunogenicity of Modified Vaccinia Ankara Smallpox Vaccine (MVA-BN(R)) in 56-80-Year-Old Subjects. PLoS One. 2016 Jun 21;11(6):e0157335. doi: 10.1371/journal.pone.0157335. eCollection 2016.

  PMID: 27327616 DERIVED

MeSH Terms

Conditions

Smallpox

Interventions

smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic

Condition Hierarchy (Ancestors)

Poxviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Results Point of Contact

• Title: Program Lead, Clinical Operations
• Organization: Bavarian Nordic A/S

info@bavarian-nordic.com

+45 3326

Study Officials

• Richard N Greenberg, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2009
• First Posted: March 6, 2009
• Study Start: June 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: January 10, 2019
• Results First Posted: January 10, 2019

Record last verified: 2019-01

Locations

US (4)