Study to Evaluate Safety, Dose Response and Immunogenicity of the Measles Vaccine MVA mBN85B in Healthy Children Aged 6 Months to 6 Years

This study has been completed.
Sponsor:
Information provided by:
Bavarian Nordic
ClinicalTrials.gov Identifier:
NCT00891007
First received: April 29, 2009
Last updated: July 26, 2012
Last verified: July 2012
  Purpose

Partially randomized, controlled Phase II study to evaluate safety, immunogenicity and dose response of the measles vaccine MVA mBN85B in healthy children aged 6 months to 6 years.


Condition Intervention Phase
Measles
Biological: MVA-mBN85B
Biological: Rouvax
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Partially Randomized, Controlled Phase II Study to Evaluate Safety, Dose Response and Immunogenicity of the Measles Vaccine MVA mBN85B in Healthy Children Aged 6 Months to 6 Years

Resource links provided by NLM:


Further study details as provided by Bavarian Nordic:

Enrollment: 90
Study Start Date: June 2009
Study Completion Date: August 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1 Biological: MVA-mBN85B
Low Dose arm, 1x 10E7 TCID50
Experimental: Group 2 Biological: MVA-mBN85B
Normal Dose arm, 1x 10E8 TCID50
Active Comparator: Group 3 Biological: Rouvax
Standard measles vaccine, approved in South Africa

Detailed Description:

Open label study to assess the safety and immunogenicity of MVA-mBN85B in healthy vaccine-naive, measles-naive and measles-experienced children. The study is comprised of three groups with 30 children each. Two groups will receive two subcutaneous (s.c.) immunizations 4 weeks (28±3 days) apart of either either 1 x 10E7 TCID50 (Group A) or 1 x 10E8 TCID50 (Group B) MVA mBN85B. The control group (Group C) will receive two s.c. doses (0.5 ml, 1000 TCID50) of Rouvax® (Sanofi-Pasteur) 24 weeks apart.

  Eligibility

Ages Eligible for Study:   6 Months to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Read, signed and dated informed consent document from one parent/guardian of the child after being advised of the risks and benefits of the study in a language understood by the parent/guardian. This document must be signed prior to performance of any study specific procedure.
  2. Male or female child between the age of 6 months to 6 years (Group C: 9 months to 6 years).
  3. Prior or no prior measles vaccination indicated on the RTHC.
  4. No known exposure to measles within 30 days prior to study entry.
  5. No history of measles disease.
  6. Negative human immunodeficiency virus antibody test (anti-HIV) and hepatitis B surface antigen (HBsAG).
  7. Child is in good health as determined by medical history, physical examination and clinical judgment.
  8. Children for whom the investigator reasonably believes its parents/guardian can and will comply with the requirements of the protocol

Exclusion Criteria:

  1. Any clinically significant condition that may influence participation in this study, including febrile convulsions.
  2. Severe malnutrition as assessed by the investigator by weight for age and clinical criteria.
  3. History of splenectomy.
  4. Clinically significant anaemia (laboratory and clinical criteria).
  5. Having received any vaccinations or planned vaccinations with a live vaccine within 30 days prior to or after study vaccination.
  6. Having received any vaccinations or planned vaccinations with a killed vaccine within 14 days prior to or after study vaccination.
  7. Administration or planned administration of immunoglobulins and/or any blood products during a period starting from 3 months prior to administration of the vaccine and ending at study conclusion.
  8. Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the first dose of the study vaccine, or planned administration of such a drug during the study period.
  9. History of any serious medical condition, which in the opinion of the investigator, would compromise the safety of the child.
  10. History of or currently active autoimmune disease. Children with vitiligo or thyroid disease on thyroid replacement therapy are not excluded.
  11. History of malignancy, especially leukaemia or lymphoma.
  12. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  13. History of anaphylaxis or severe allergic reaction.
  14. Known allergy to egg proteins, gelatine, neomycin or gentamycin.
  15. Chronic administration (defined as more than 14 days) of systemic high dose immuno-suppressant drugs during a period starting from six months prior to administration of the vaccine and ending at study conclusion. High dose is defined as 2 mg/kg/day or more of prednisolone or its equivalent, or 20 mg/day or more for children who weigh more than 10 kg.
  16. Previous participation in an MVA-based vaccination study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00891007

Locations
South Africa
Chris Hani Baragwanath Hospital, Respiratory and Meningeal Pathogens Research Unit
Bertsham, South Africa, 2013
Sponsors and Collaborators
Bavarian Nordic
  More Information

No publications provided

Responsible Party: Monika Fluer, Bavarian Nordic
ClinicalTrials.gov Identifier: NCT00891007     History of Changes
Other Study ID Numbers: MEA-HFN-002
Study First Received: April 29, 2009
Last Updated: July 26, 2012
Health Authority: South Africa: Medicines Control Council

Keywords provided by Bavarian Nordic:
Measles
Virus Disease
Paediatric Diseases
Paramyoxyviridae

Additional relevant MeSH terms:
Measles
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 16, 2014