Earlier Prime-BOOST Schedule to Improve MEasles Protection in High Burden Settings

Launched by UNIVERSITY OF OXFORD · Oct 29, 2024

Keywords

ClinConnect Summary

This clinical trial, titled "Earlier Prime-BOOST Schedule to Improve MEasles Protection in High Burden Settings," is studying how the timing of measles vaccinations can affect how well children develop immunity against the virus. The researchers want to find out if giving two doses of the measles vaccine at different ages can produce similar immune responses in children. To do this, they will enroll 450 children and divide them into three groups, each receiving their vaccinations at different times: one group at 6 and 12 months, another at 9 and 18 months, and the last group at 6 and 18 months.

To participate in this trial, children must be between 6 months and 28 weeks old and have received all their previous vaccinations as recommended by their country's immunization schedule. Parents or guardians must also be willing to give their consent for their child's participation. However, children with certain health issues, previous measles vaccinations, or specific family medical histories may not be eligible. Participants can expect to receive the measles vaccine and be monitored over time to assess their immune responses. This study aims to improve measles protection in areas where the disease is more common, which is important for keeping children healthy.

Gender

ALL

Eligibility criteria

• • 1. Trial Participants Children aged 6 months (23 - 28 weeks) at time of screening
• • 2. Inclusion Criteria
• • Aged 6 months (23 - 28 weeks) at time of screening
• • Received all previous vaccines as per country Expanded Programme of Immunization (EPI) schedule, verified by child health card
• • Parents/caretakers willing to give informed consent for their and their children's participation and stay in the geographical area where the study would be conducted
• • 3. Exclusion Criteria
• The participant may not enter the trial if any of the following apply:
• • Child not healthy enough to be vaccinated in the opinion of the investigator
• • Recent family history of measles infection (since birth)
• • Previous receipt of any measles vaccination
• • A family history of congenital or hereditary immunodeficiency other than HIV
• • Receipt of more than 1 week of immunosuppressant or immune modifying drugs e.g. high dose steroids.
• • Major congenital defects or serious chronic illness that in the opinion of the investigator are likely to modify immune responses or the ability to comply with the requirements of the study.
• • History of any neurological disorders or seizures
• • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period
• • Other abnormalities or medical history that contraindicated measles vaccination