A Phase II Trial to Compare a Liquid-frozen and a Freeze-dried Formulation of IMVAMUNE (MVA-BN®) Smallpox Vaccine in Vaccinia-naïve Healthy Subjects

NCT01668537 | Completed Phase 2 Results DMC

• 1 other identifier: POX-MVA-027
• Study Type: interventional
• Target: 651
• Locations: 1 country
• Sites: 3

Brief Summary

A randomized, double-blind, multicenter Phase II trial to compare the immunogenicity and safety of a liquid-frozen and a freeze-dried formulation of IMVAMUNE (MVA-BN®) smallpox vaccine in vaccinia-naïve healthy subjects

Conditions

Smallpox

Outcome Measures

Primary Outcomes (1)

• 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'

  Week 6

Secondary Outcomes (17)

• Number of Participants With Serious Adverse Events

  up to 32 weeks

• Number of Participants With Adverse Events of Special Interest (AESI)

  up to 32 weeks

• Number of Participants With Related Grade >=3 Adverse Events

  within 29 days after vaccination

• Number of Participants With Unsolicited Adverse Events

  within 29 days after vaccination

• Number of Participants With Solicited Local Averse Events

  8 days after any vaccination

Study Arms (2)

Group 1

EXPERIMENTAL

LF formulation of IMVAMUNE® 2 doses of 1 x 10E8 TCID50, s.c., 4 weeks apart

Biological: LF formulation of IMVAMUNE®

Group 2

EXPERIMENTAL

FD formulation of IMVAMUNE® 2 doses of 1 x 10E8 TCID50, s.c., 4 weeks apart

Biological: FD formulation of IMVAMUNE®

Interventions

LF formulation of IMVAMUNE® BIOLOGICAL

Group 1

FD formulation of IMVAMUNE® BIOLOGICAL

Group 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female subjects, 18-55 years of age
• The subject has read, signed and dated 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 and has signed the Health Insurance Portability and Accountability Act (HIPAA) authorization form
• Body Mass Index (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 (SCR) and a negative urine pregnancy test within 24 hours prior to each vaccination
• White blood cells ≥ 2500/mm3 and \< 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:
• For men: (140 - age in years) x (body weight in kg) ÷ (serum creatinine in mg/dl x 72) = CrCl (ml/min)
• For women: multiply the result by 0.85 = CrCl (ml/min)
• 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
• Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase \< 1.5 x ULN

You may not qualify if:

• Typical vaccinia scar
• Known or suspected history of smallpox vaccination
• History of vaccination with any poxvirus-based vaccine
• US Military service before 1991 or after January 2003
• Pregnant or breast-feeding women
• 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 would limit the subject's ability to complete the trial in the opinion of the investigator
• History of or active autoimmune disease, persons with vitiligo or thyroid disease taking thyroid hormone replacement are not excluded
• Known or suspected impairment of immunologic function including, but not limited to, clinically significant liver disease, diabetes mellitus, moderate to severe kidney impairment
• History of malignancy, other than squamous cell or basal cell skin cancer, unless there has been surgical excision that is considered to have achieved cure. Subjects with history of skin cancer must not be vaccinated at the previous tumor site
• History or clinical manifestation of clinically significant and severe hematological, pulmonary, central nervous, cardiovascular or gastrointestinal disorders
• Clinically significant mental disorder not adequately controlled by medical treatment
• History of coronary heart disease, myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure, or any other heart condition under the care of a doctor
• History of an immediate family member (father, mother, brother, or sister) who has had onset of ischemic heart disease before the age of 50 years
• Twenty percent 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 NOTE: This criterion applies only to subjects 20 years of age and older

Sponsors & Collaborators

• Bavarian Nordic: lead

Study Sites (3)

Miami Research Associates

South Miami, Florida, 33143, United States

Location

PRA

Lenexa, Kansas, 66219, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Smallpox

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: 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: August 14, 2012
• First Posted: August 20, 2012
• Study Start: March 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: June 1, 2014
• Last Updated: October 12, 2020
• Results First Posted: October 12, 2020

Record last verified: 2020-10

Locations

US (3)