Assessment of the Natural Antibody Response to Pneumococcal Surface Proteins During Acute Otitis Media in Children

This study is currently recruiting participants.
Verified September 2011 by NasVax Ltd
Sponsor:
Information provided by (Responsible Party):
NasVax Ltd
ClinicalTrials.gov Identifier:
NCT01214538
First received: October 3, 2010
Last updated: September 26, 2011
Last verified: September 2011
  Purpose

This clinical study is designed to assess prospectively the sero-responses to various proteins in cases of pneumococcal Acute Otitis Media.


Condition
Acute Otitis Media

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Assessment of the Natural Antibody Response to Pneumococcal Surface Proteins During Acute Otitis Media in Children

Resource links provided by NLM:


Further study details as provided by NasVax Ltd:

Primary Outcome Measures:
  • Serological studies of pneumococcal proteins and their development over time following otitis media infections [ Time Frame: 3 months per individual ] [ Designated as safety issue: No ]
    The serological studies will study the natural immune response to protective pneumococcal vaccine antigens.


Biospecimen Retention:   Samples Without DNA

Plasma


Estimated Enrollment: 100
Study Start Date: October 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Control group - culture negative
50 children with pneumococcal culture-negative Acute Otitis Media
study group- culture positive
50 children with pneumococcal culture-positive Acute Otitis Media

  Eligibility

Ages Eligible for Study:   3 Months to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

100 subjects with acute otitis media infection will be enrolled. The expectation is for ≥50 children with pneumococcal culture-positive MEF (Middle Ear Fluid) and ≥50 children with culture-negative MEF to be enrolled

Criteria

Inclusion Criteria:

  • Male and female Jewish and Bedouin children.
  • Patients can be either ambulatory or hospitalized.
  • Presenting with acute otitis media.
  • Tympanocentesis was performed at least in one ear for a clinical indication.
  • Culture of middle ear fluid was obtained.
  • Parents agreeing to participate in the study and to submit their children for follow-up, blood test and nasopharyngeal/oropharyngeal (NP/OP) cultures.

Exclusion Criteria:

  • Having another infection that is likely to be caused by S. pneumoniae.
  • Known immunodeficiency.
  • Known previous recent pneumococcal infections (<1 month prior to current visit).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01214538

Locations
Israel
Ben-Gurion University of the Negev Recruiting
Beer Sheva, Israel, 84101
Contact: Ron Dagan, Prof MD    +972 + 8-6400547    rdagan@bgu.ac.il   
Sponsors and Collaborators
NasVax Ltd
Investigators
Principal Investigator: Ron Dagan, Prof. MD. Ben-Gurion University of the Negev
  More Information

No publications provided

Responsible Party: NasVax Ltd
ClinicalTrials.gov Identifier: NCT01214538     History of Changes
Other Study ID Numbers: NX10-07
Study First Received: October 3, 2010
Last Updated: September 26, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by NasVax Ltd:
Vaccine pneumococcal natural history Acute otitis media

Additional relevant MeSH terms:
Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on April 17, 2014