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| Name | Class |
|---|---|
| St George's, University of London | OTHER |
| MU-JHU CARE | OTHER |
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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: 6 and 12 months | Experimental | Early Prime-Boost schedule: Measles vaccines given at 6 and 12 months of age |
|
| Group B: 9 and 18 months (standard schedule) | Experimental | Standard schedule: Measles vaccines given at 9 and 18 months of age |
|
| Group C: 6 and 18 months | Experimental | Early Prime schedule: Measles vaccines given at 6 and 18 months of age |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Licenced Measles-Rubella vaccine | Biological | Licenced Measles-Rubella vaccine provided by the Ugandan EPI programme |
|
| Measure | Description | Time Frame |
|---|---|---|
| Protective measles antibody concentrations at 2.5 years of age | Proportion of participants with protective levels of measles neutralising antibodies (PRNT>120mIUL) | 2.5 years of age |
| Local and systemic reactions | Reactogenicity profile from diary cards | 7 days post each vaccination |
| Serious Adverse Events | 2 years: (from baseline vaccination until 2 year follow up visit) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | one month after first dose |
| The effect of maternal human immunodeficiency virus (HIV) infection |
| Measure | Description | Time Frame |
|---|---|---|
| Public perceptions of measles immunisation | Focus group interviews with the public and parents/guardians of enrolled children | Baseline until 2 year follow up visit |
Trial Participants Children aged 6 months (23 - 28 weeks) at time of screening
Inclusion Criteria
Exclusion Criteria
The participant may not enter the trial if any of the following apply:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oxford Vaccine Group | Contact | 01865 611400 | info@ovg.ox.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Makarere University - Johns Hopkins University Collaboration | Recruiting | Kampala | Uganda |
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| ID | Term |
|---|---|
| D008457 | Measles |
| ID | Term |
|---|---|
| D018185 | Morbillivirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
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Equal numbers of participants are randomised to 3 arms.
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All participants receive the same vaccines but are randomised to the timing of administration of the vaccines.
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Infant PRNT and IgG responses post MCV1 and MCV2 in children of mothers with and without HIV |
| 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. | 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 | 4 weeks after a first and second dose |
| D014777 | Virus Diseases |
| D007239 | Infections |