Earlier Prime-BOOST Schedule to Improve MEasles Protection in High Burden Settings
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- University of Oxford
- Enrollment
- 450
- Locations
- 1
- Primary Endpoint
- Protective measles antibody concentrations at 2.5 years of age
Study Overview
Brief Summary
This is a phase IIb clinical trial investigating the non-inferiority of immune responses in children given two doses of measles vaccine at different timepoints. The study will randomise 450 children to 3 groups: group A will receive measles containing vaccine (MCV) at 6 and 12 months ; group B at 9 and 18 months; Group C at 6 and 18 months.
Detailed Description
Two doses of measles containing vaccine (MCV) are recommended in young children with the first dose given at different times depending on the setting. In low-incidence settings the MCV1 is given at 12 months of age or later as more infants over 12 months of age respond to MCV1 due to the absence of maternal antibody interference and an overall better immune response due to the maturation of the infant immune system. In high measles incidence settings MCV1 is given earlier at 9 months of age as there is no remaining protection from maternal antibody at this age and risk of infection if unvaccinated can be high. However, in children born with low levels or rapid decay of maternal antibody, the 9-month timing for MCV1 means the infant may be susceptible to infection for some months prior to vaccination. Therefore, in settings of high infant measles incidence, an early first dose at 6 months of age may bridge this susceptibility gap.
Our study will assess differences in protective levels of measles antibody in children randomised to receive early (6 months) or standard (9 months) MCV1 in a high incidence measles setting, and early (12 months) or standard (18 months) booster vaccines, in those who are given early MCV1. There will be 5 blood draws over 2 years. The study will compare children who received a) two doses of measles vaccine at 6 and 18 months with 9 and 18 months, and b) two doses of measles vaccine at 6 and 12 months compared with 6 and 18 months.
The study is funded by the Bill & Melinda Gates Foundation (INV-048650)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Masking Description
All participants receive the same vaccines but are randomised to the timing of administration of the vaccines.
Eligibility Criteria
- Ages
- 23 Weeks to 28 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Group A: 6 and 12 months
Early Prime-Boost schedule: Measles vaccines given at 6 and 12 months of age
Intervention: Licenced Measles-Rubella vaccine (Biological)
Group B: 9 and 18 months (standard schedule)
Standard schedule: Measles vaccines given at 9 and 18 months of age
Intervention: Licenced Measles-Rubella vaccine (Biological)
Group C: 6 and 18 months
Early Prime schedule: Measles vaccines given at 6 and 18 months of age
Intervention: Licenced Measles-Rubella vaccine (Biological)
Outcomes
Primary Outcomes
Protective measles antibody concentrations at 2.5 years of age
Time Frame: 2.5 years of age
Proportion of participants with protective levels of measles neutralising antibodies (PRNT\>120mIUL)
Local and systemic reactions
Time Frame: 7 days post each vaccination
Reactogenicity profile from diary cards
Serious Adverse Events
Time Frame: 2 years: (from baseline vaccination until 2 year follow up visit)
Secondary Outcomes
- Measles plaque reduction neutralisation titre (PRNT) and immunoglobulin G (IgG) concentration(one month after first dose)
- The effect of maternal human immunodeficiency virus (HIV) infection(one month after first dose and second dose)
- The effect of maternal antibodies on infant immune response(pre-vaccination, 4 weeks after the first dose, 4 weeks after the second dose)
- Immune response to rubella component of the vaccine(4 weeks after a first and second dose)