MeaslesPhase 2BoostMeNCT06667206
Earlier Prime-BOOST Schedule to Improve MEasles Protection in High Burden Settings
A Phase 2 study testing Licenced Measles-Rubella vaccine in people with Measles, run by University of Oxford at 1 site in Uganda.
Trial 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… Read more about this study
- Who is it for?
- Ages 23 to 28 weeksHealthy volunteers can take part
- Conditions the study is for
- Measles
- What is being tested?
- Licenced Measles-Rubella vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteUganda
- Study dates
- 15 Nov 2023to 10 May 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 28 weeks
- All sexes
- Healthy volunteers accepted
- Child
- Trial Participants Children aged 6 months (23 - 28 weeks) at time of screening
- 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
- 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
Trial locations and contacts
1 site in 1 country.
Uganda1 site, 1 recruiting
- Recruiting
Makarere University - Johns Hopkins University Collaboration
Kampala
Kirsty Le Doare
About this study
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.
Read the 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)
- Conditions
- Measles
- Being tested
- Licenced Measles-Rubella vaccine
- Keywords
- measles-rubella vaccine
- Medical subject headings
- Measles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Licenced Measles-Rubella vaccineBiological
Licenced Measles-Rubella vaccine provided by the Ugandan EPI programme
| Study group | Role | What they receive |
|---|---|---|
| Group A: 6 and 12 months | Experimental | Early Prime-Boost schedule: Measles vaccines given at 6 and 12 months of age Receives: Biological: Licenced Measles-Rubella vaccine |
| Group B: 9 and 18 months (standard schedule) | Experimental | Standard schedule: Measles vaccines given at 9 and 18 months of age Receives: Biological: Licenced Measles-Rubella vaccine |
| Group C: 6 and 18 months | Experimental | Early Prime schedule: Measles vaccines given at 6 and 18 months of age Receives: Biological: Licenced Measles-Rubella vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protective measles antibody concentrations at 2.5 years of age
Proportion of participants with protective levels of measles neutralising antibodies (PRNT>120mIUL)
Measured: 2.5 years of age
Local and systemic reactions
Reactogenicity profile from diary cards
Measured: 7 days post each vaccination
Serious Adverse Events
Measured: 2 years: (from baseline vaccination until 2 year follow up visit)
Secondary outcomes (4)
Measles plaque reduction neutralisation titre (PRNT) and immunoglobulin G (IgG) concentration
Measles PRNT and IgG concentrations one month after first dose in infants receiving an early (6 months) compared to standard (9 month) dose of MCV
Measured: one month after first dose
The effect of maternal human immunodeficiency virus (HIV) infection
Infant PRNT and IgG responses post MCV1 and MCV2 in children of mothers with and without HIV
Measured: one month after first dose and second dose
The effect of maternal antibodies on infant immune response
Relationship between baseline titres (pre vaccination) and 4 week post-vaccination titres for PRNT, Measles IgG, and measles ELISpot.
Measured: pre-vaccination, 4 weeks after the first dose, 4 weeks after the second dose
Immune response to rubella component of the vaccine
Anti-rubella IgG
Measured: 4 weeks after a first and second dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start15 Nov 2023
- Primary completion10 May 2026 (estimated)
- Study completion10 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MeaslesStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Equal numbers of participants are randomised to 3 arms.
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- St George's, University of London, MU-JHU CARE
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06667206
- Sponsor's protocol ID
- OVG2022/06
- Acronym
- BoostMe
- Status last verified
- Dec 2023
- First submitted
- 19 Dec 2023
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Businge G, Marchevsky NG, Mupere E, Kelly S, Kakai I, Kyohere M, Edielu A, Ambangira F, Kakayi B, Tusubira V, Komugisha C, Musoke P, Mujadidi YF, Bijlsma MW, Le Doare K, Voysey M. Preliminary safety data from a randomised trial of early versus standard timing of administration of measles-rubella vaccine in Ugandan infants. Discov Med (Singap). 2026;3(1):92. doi: 10.1007/s44337-026-00649-x. Epub 2026 Jul 30.
PubMed 42539769