A Phase 2 interventional study of Licenced Measles-Rubella vaccine in Measles, sponsored by University of Oxford. Recruiting at 1 site in Uganda. Open to participants aged 23 Weeks to 28 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-31.
Sponsored by University of Oxford · Phase 2, Interventional, and Prevention
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)
134 studies on the registry are indexed under Measles; 17 are open to participants now.
This study's planned enrollment of 450 is below the median of 852 across 105 interventional studies indexed under Measles.
Browse Measles studies →University of Oxford is the lead sponsor of 812 studies on the registry; 119 are open to participants now.
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Aged 6 months (23 - 28 weeks) at time of screening
The participant may not enter the trial if any of the following apply:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Early Prime-Boost schedule: Measles vaccines given at 6 and 12 months of age
Biological: Licenced Measles-Rubella vaccine
Standard schedule: Measles vaccines given at 9 and 18 months of age
Biological: Licenced Measles-Rubella vaccine
Early Prime schedule: Measles vaccines given at 6 and 18 months of age
Biological: Licenced Measles-Rubella vaccine
Licenced Measles-Rubella vaccine provided by the Ugandan EPI programme
Protective measles antibody concentrations at 2.5 years of age
Proportion of participants with protective levels of measles neutralising antibodies (PRNT\>120mIUL)
Time frame: 2.5 years of age
Local and systemic reactions
Reactogenicity profile from diary cards
Time frame: 7 days post each vaccination
Serious Adverse Events
Time frame: 2 years: (from baseline vaccination until 2 year follow up visit)
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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 4 weeks after a first and second dose
Public perceptions of measles immunisation
Focus group interviews with the public and parents/guardians of enrolled children
Time frame: Baseline until 2 year follow up visit
Plan to share: Yes
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