Measels Aerosols Project

 

Title: Pivotal study to evaluate the immunogenicity and safety of a measles vaccine given  by aerosolized inhalation randomized controlled trial.

Duration: August 2009 to November 2011

Collaborators: 

  • King Edward Memorial Hospital Research Centre, Pune, India; 
  • National Institute of Virology, Pune, India; 
  • Christian Medical College, Vellore, India; 
  • Health Protection Agency, London, UK
  •  University of Bern, Bern, Swithzerland

Sponsors:                  

  • World Health Organization (WHO)
  • Serum Institute of India Ltd, Pune (SIIL)

Investigator:              

  • Dr Siddhi Hirve (Aug 2009 till June 2010) 
  • Dr AshishBavdekar (Jul 2010 till Nov 2011)

Protocol number:  WHO/MAP/IN/002

KEMHRC study number: 0824               

CTRI number: CTRI/2009/091/000673

 Rationale:                  

Measles is one of the most common causes of death in children under five-years old globally.  The global goal of WHO is to reduce measles mortality for which activities need to be fully implemented in large number of countries with a very high measles burden such as India, Pakistan, and Indonesia.  To achieve this goal, continued progress needs to be made in delivering measles vaccines to the world’s children.

Aims:  The Measles Aerosol Project aims to develop and license at least one method for respiratory delivery of currently licensed measles vaccines which would be used for measles mass campaigns. The overall aim of the study is to demonstrate that measles vaccine delivered as an aerosol to the respiratory tract is sufficiently safe and immunogenic to obtain licensure for the nebulizer/vaccine combination device.

Objective:  To compare immunogenicity of measles vaccine delivered via a nebulizer/vaccine combination product with a licensed subcutaneous vaccine in infants who are eligible to receive a first dose of measles vaccination but no older than 12 months.  To describe the frequency of adverse events following measles aerosol and subcutaneous vaccination.

Study design:  A phase II/III pivotal trial with Randomized, open level, active-controlled, parallel group, and non-inferiority study design.

Study population:  2000 infants of 9-12 months of age.  This study was conducted in three administrative blocks of Shirur, Haveli, and Khed with the support of primary health care centres.  It included around 110 villages with a total population of 500,000.

Status of the study:  Enrollment of 2000 infants of 9-12 months of age was achieved in four and half months. Main cohort was followed for 91 days post vaccination and subset of 372 subjects from Vadu region was followed for 364 days.  Follow-up compliance was more than 96%.  Re-vaccination program was undertaken for participants with inadequate immunogenicity.  The study closeout was officially accomplished on 16 November 2011.

Outcome:  Analysis, results, dissemination, and publication are awaited.

 

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