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Measles-mumps-rubella vaccine at 6 months of age, immunology, and childhood morbidity in a high-income setting: study protocol for a randomized controlled trial

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BACKGROUND: Measles is a highly contagious and serious infection. Before the introduction of vaccination, measles caused yearly epidemics putting vulnerable children at risk of brain damage and death. Despite safe and cost-effective vaccines, measles remains a leading cause of death in children globally. Due to insufficient vaccine coverage and low levels of in utero transferred antibodies from vaccinated mothers, outbreaks of measles in Denmark and other high-income countries are observed at increasing frequency. The current vaccine was introduced in Denmark in 1987 as a one-shot measles-mumps-rubella vaccine at 15 months, a timing chosen to avoid inhibition of the infant's immune response by maternal antibodies. One generation later, the MMR vaccinated mothers have lower antibody levels compared to the naturally infected, and their infants are already susceptible at 6 months of age or earlier, thus increasing the risk of epidemics.

METHODS: The Danish MMR trial is a double-blind randomized clinical trial recruiting between March 2019 and December 2021 with last patient last visit in February 2022. Altogether N = 6500 infants aged 6 months will be randomly assigned to intramuscular vaccination with routine MMR (M-M-R VaxPro) or placebo (solvent only). According to the Danish Childhood vaccination program, all infants will receive a routine MMR vaccination at 15 months of age. At randomization, 1 month later, and 1 month after routine MMR vaccination at 15 months of age, a blood sample is drawn from app. 10% (N = 600) of the population. Additionally, hair, saliva, and urine are sampled at randomization. The co-primary study outcomes are immunogenicity 1 month after MMR vaccination at 6 months of age assessed as plaque-reduction neutralization test, and incidence of infectious disease hospitalizations from randomization to 12 months of age. Six weeks post randomization, all participants are interviewed regarding adverse events.

TRIAL REGISTRATION: The trial is registered in the EU Clinical Trials Registry. EudraCT registration number: 2016-001901-18 . Registered on 14 February 2017.

OriginalsprogEngelsk
TidsskriftTrials
Vol/bind21
Udgave nummer1
Sider (fra-til)1015
ISSN1745-6215
DOI
StatusUdgivet - 10 dec. 2020

Bibliografisk note

Funding Information:
The trial is initiated and planned by the researchers and funded by the two involved hospitals and the Innovation Fund Denmark. Trial participants and The Ethical Committee are informed about the funders and amount. The Patient Insurance Act insures the study participants. There is no remuneration for participation in the MMR trial. The funding body has no influence on the design of the study and analysis, interpretation of data, nor in writing the manuscript. An appointed steering group consisting of one representative from each project partner oversees the data collection continuously to ensure sufficient speed.

Publisher Copyright:
© 2020, The Author(s).

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