Protection Against Pneumococcal Infection in Children With T1DM

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by University of Oxford
Sponsor:
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT01939522
First received: June 4, 2013
Last updated: September 6, 2013
Last verified: September 2013
  Purpose

Children/ young people with diabetes may be at a higher risk of acquiring certain infections. These infections include those caused by a bacterium called the pneumococcus which can cause pneumonia, meningitis and ear infections. In the UK older children with diabetes are given a vaccine against the pneumococcus bug called Pneumovax (or PPS23 for short). Although PPS23 causes a good immune response in children over 2 years of age it is not actually known how well PPS23 protects against infection in children of any age. In addition there is some data in adults and children that PPS23 may result in a reduced response to future doses of pneumococcal vaccines (hyporesponsiveness). Because of the lack of information on how well PPS23 protects and potential hyporesponsiveness the investigators would like to study the use of an alternative vaccine against pneumococcus called Prevenar13 (or pCV13). This vaccine is known to be safe and to work well in babies and young children and there have been no concerns about hyporesponsiveness. It has been approved for use in children up to 17 years of age but there is little information on the size and duration of immune response to PCV13 in children aged 6 years and older.


Condition Intervention Phase
Type 1 Diabetes Mellitus
Biological: 13-valent pneumococcal conjugate vaccine (PCV13)
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: An Open Label Single-arm Trial of the Immunogenicity and Reactogenicity of a 13-valent Pneumococcal Conjugate Vaccine (Prevenar13®) Given to Children With Type 1 Diabetes Mellitus Who Have Not Previously Received a Primary Schedule of Immunisation With Pneumococcal Conjugate Vaccines in Infancy.

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Pneumococcal serotype-specific (SpVS) antibody concentrations at 3 months following a single dose of 13-valent pneumococcal conjugate vaccine (PCV13) [ Time Frame: 3 months after vaccination ] [ Designated as safety issue: No ]
    The geometric mean concentration (GMC), together with 95% confidence intervals, of SpVS antibody at baseline, 3 months and 12 months following a single dose of PCV13.


Secondary Outcome Measures:
  • Pneumococcal serotype-specific GMC for serotypes 4, 7F & 19A at 3 months after immunisation with a single dose of PCV13 in the children who have had a prior dose of PPS23 vs those who have not. [ Time Frame: 3 months after vaccination ] [ Designated as safety issue: No ]
    The difference between the pneumococcal serotype-specific geometric mean antibody concentrations (GMC) for serotypes 4, 7F and 19A at three months after immunisation with a single dose of 13-valent pneumococcal conjugate vaccine (PCV13) in the children who have had a prior dose of 23-valent pneumococcal polysaccharide vaccine (PPS23) versus those who have not.

  • Pneumococcal serotype-specific (SpVS) antibody concentrations at baseline and 12 months following a single dose of 13-valent pneumococcal conjugate vaccine (PCV13). [ Time Frame: 12 months after vaccination ] [ Designated as safety issue: No ]
    The proportion of children with vaccine pneumococcal serotype-specific (SpVS) antibody concentrations >0.35mcg/ml at baseline and 12 months following a single dose of 13-valent pneumococcal conjugate vaccine (PCV13).

  • GMC of SpVS antibody at baseline, 3mnth and 12mnth following 1 dose of PCV13 [ Time Frame: 12 months after vaccination ] [ Designated as safety issue: No ]
    To determine the GMC, together with 95% confidence intervals, of SpVS antibody at baseline, 3mnth and 12mnth following 1 dose of PCV13

  • Pneumococcal serotype-specific GMC for all vaccine-specific serotypes (VS) at baseline, 3 months and 12 months following immunisation with a single dose of PCV13 in children who have had a prior dose of PPS23 and those who have not. [ Time Frame: 12 months after vaccination ] [ Designated as safety issue: No ]
    The difference between the pneumococcal serotype-specific GMC for all vaccine-specific serotypes (VS) at baseline, 3 months and 12 months following immunisation with a single dose of PCV13 in children who have had a prior dose of 23-valent pneumococcal polysaccharide vaccine (PPS23) versus those who have not.

  • Pneumococcal serotype-specific antibody concentrations for all VS in children who have had a prior dose of 23-valent pneumococcal polysaccharide vaccine (PPS23) and those who have not. [ Time Frame: 12 months after vaccination ] [ Designated as safety issue: No ]
    The difference between the proportion of children with pneumococcal serotype-specific antibody concentrations >0.35mcg/ml for all VS in children who have had a prior dose of 23-valent pneumococcal polysaccharide vaccine (PPS23) versus those who have not.

  • Vaccine-specific serotype antibody concentration between baseline and 3 months with HbA1C. [ Time Frame: 3 months after vaccination ] [ Designated as safety issue: No ]
    The correlation coefficient for the increase in VS antibody concentration between baseline and 3 months and HbA1C at baseline.

  • Blood glucose control in the week preceding and the week following immunisation with PCV13 [ Time Frame: One week after vaccination ] [ Designated as safety issue: No ]
    A descriptive analysis of blood glucose control in the week preceding and the week following immunisation with PCV13


Estimated Enrollment: 50
Study Start Date: August 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prevenar13® (13-valent pneumococcal conjugate vaccine)
Prevenar13 administered as a single dose, 0.5ml Intramuscular liquid form intervention at baseline.
Biological: 13-valent pneumococcal conjugate vaccine (PCV13)
Other Name: Prevenar13®

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of T1DM and being followed in the Oxfordshire Children's Diabetes Service.
  • Aged between 6 years and 17 years.
  • Parent/legal guardian willing and able to give informed consent.
  • No previous immunisation with a pneumococcal conjugate vaccine (PCV).
  • Willing to allow the General Practitioner to be notified of participation in the study.

Exclusion Criteria:

  • Known allergic reaction to the vaccine antigen or any of the excipients.
  • Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
  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: NCT01939522

Contacts
Contact: Dominic F Kelly, MB BChir, MRCPCH, PhD 01865231693 dominic.kelly@ouh.nhs.uk
Contact: Julie Edge 01865231673 julie.edge@ouh.nhs.uk

Locations
United Kingdom
Oxford University Hospitals NHS Trust Recruiting
Oxford, Oxfordshire, United Kingdom, OX3 9DU
Contact: Dominic F Kelly         
Sponsors and Collaborators
University of Oxford
  More Information

No publications provided

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01939522     History of Changes
Other Study ID Numbers: OVG 2013/03, 2013-001024-19
Study First Received: June 4, 2013
Last Updated: September 6, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

Keywords provided by University of Oxford:
diabetes
pneumococcal

Additional relevant MeSH terms:
Streptococcal Infections
Diabetes Mellitus
Diabetes Mellitus, Type 1
Pneumococcal Infections
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on July 29, 2014