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BoostME

Earlier prime-BOOST schedule to improve MEasles protection in high burden settings

Funder

Bill and Melinda Gates Foundation

Type of Study

Phase IIb, Randomised controlled trial, open label

Sponsor

University of Oxford

Country

Uganda

Chief Investigator

Prof Merryn Voysey (Co-chief Investigator: Prof Kirsty Le Doare)

Participants

Infants aged 6 months (23-28 weeks) at screening visit who have not received prior vaccination against measles

Summary

Primary Objectives:

  • To compare protective measles antibody concentrations at 2.5 years of age in infants receiving an early (6 months) compared to standard (9 month) dose of MCV, and a booster dose at 18 months of age (Primary comparison 1)
  • To compare protective measles antibody concentrations one month after a second dose of MCV given at 12 months (early) compared to standard (18 months), in those who received an early (6 months) first dose (Primary comparison 2)
 
Secondary Objectives:
  • To describe the measles antibody concentrations one month after first dose in infants receiving an early (6 months) compared to standard (9 month) dose of MCV
  • To describe the effect of maternal antibodies on infant humoral and cellular immune response to first and second doses in children vaccinated under different schedules
  • To describe the effect of maternal HIV infection on infant antibody responses post MCV1 and MCV2 given at different schedules
  • To describe the impact of different vaccination schedules on responses to the rubella component of the vaccine

Duration

October 2022 – October 2025

Collaborators