Clinical Trial: Early Two-dose Measles Vaccination Trial

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Measles Vaccination in Guinea-Bissau. Strategies to Reduce Disease Burden and Improve Child Survival

Brief Summary:

The specific aims are to examine in Guinea-Bissau:

  • whether the standard titre Schwarz (SW) or standard-titre Edmonston-Zagreb (EZ) measles vaccine will be the best vaccine strain for use in a routine one-dose measles vaccination schedule and a two-dose measles vaccination schedule in terms of antibody response, protection against measles and child survival, and
  • whether the standard-titre Edmonston-Zagreb (EZ) vaccine will be suitable for use in a very early two-dose schedule vaccinating at 4½ and 9 months of age

Detailed Summary:

BACKGROUND:

Two dose schedules:

After the failure of the high-titre measles vaccine, which was to be administered at 6 months of age it was suggested to perform trials of early two-dose measles vaccination schedules to lower the age of vaccination. The standard titre SW measles vaccine has been shown to be associated with a non-specific beneficial effect on child mortality that cannot be ascribed to the protection against measles. The two measles vaccines most commonly used in the Expanded Programme on Immunization (EPI) are the standard titre SW and the standard titre EZ vaccine. Surprisingly, these two vaccines have never been compared in a randomised trial with child mortality as end-point, and it is not clear which would be most suitable for use in a two-dose vaccination schedule.

From 1995 to 2002, all children in the BHP study area were included in an early two-dose measles vaccination trial from 6 months of age. The children were randomised to either a one-dose group receiving an inactivated polio vaccine (IPV) at 6 months of age and a measles vaccine at 9 months of age, or a two-dose group receiving two doses of measles vaccine at 6 and 9 months of age. For the first 6 months of the trial, the standard-titre EZ measles vaccine was used, for the rest of the trial the standard-titre SW vaccine was used. Results from the trial showed that an early two-dose schedule increased coverage considerably and provided better protection against measles among infants than the recommended one-dose at 9 months of age schedule. The EZ and the SW vaccine were used in two different cohorts - so a direct comparison was not possible, but the EZ vaccine seemed to boost a secondary immune response better than the SW vaccine. Further, the SW vaccine was less able to induce a protective lev
Sponsor: Bandim Health Project

Current Primary Outcome:

  • Vaccine efficacy [ Time Frame: Assessed by study completion ]
  • Measles specific mortality [ Time Frame: Assessed by study completion ]
  • All cause sex-specific mortality until 3 years of age [ Time Frame: Assessed by study completion ]


Original Primary Outcome:

  • Vaccination coverage
  • Vaccine efficacy
  • Measles specific mortality
  • All cause mortality untill 3 years of age


Current Secondary Outcome:

  • Measles antibody level at 4½, 9, 18 and 24 months of age [ Time Frame: Assessed by study completion ]
  • Morbidity from 4½ to 12 months of age [ Time Frame: Assessed by study completion ]
  • Anthropometric measures at 4½, 9, 18 and 24 months of age [ Time Frame: Assessed by study completion ]


Original Secondary Outcome:

  • Measles antibody level at 4½, 9, 18 and 24 months of age
  • Morbidity from 4½ to 12 months of age
  • Anthropometric measures at 4½, 9, 18 and 24 months of age


Information By: Bandim Health Project

Dates:
Date Received: September 9, 2005
Date Started: July 2003
Date Completion:
Last Updated: March 4, 2012
Last Verified: March 2012