A study of a new vaccine against MERS Virus in adults aged 50 to 70

  • Research type

    Research Study

  • Full title

    A phase I study to determine the safety and immunogenicity of a new vaccine against Middle East Respiratory Syndrome Coronavirus in Adults aged 50 to 70

  • IRAS ID

    1006223

  • Contact name

    Maheshi Ramasamy

  • Contact email

    maheshi.ramasamy@paediatrics.ox.ac.uk

  • Sponsor organisation

    University of Oxford, Research Governance, Ethics & Assurance (RGEA) Team

  • Eudract number

    2022-002159-21

  • ISRCTN Number

    ISRCTN17936606

  • Research summary

    This is a trial of a new vaccine against Middle East Respiratory Syndrome (MERS) in volunteers aged 50 to 70 years old.
    MERS has been identified as one of the most worrying outbreak diseases. It is a viral respiratory illness that can cause severe pneumonia and even death. The MERS virus was identified in 2012 in Saudi Arabia. 2,300 cases and over 800 deaths have occurred so far. It continues to cause a small number of cases each year in Saudi Arabia. Currently, there is no treatment for MERS and no approved vaccine.
    This study is of a vaccine against MERS, called ChAdOx1 MERS, which has been developed by The University of Oxford. The vaccine is very similar to the Oxford/AstraZeneca COVID-19 vaccine, and is made using the same technology.
    We have already completed two small clinical trials using ChAdOx1 MERS in healthy adults aged 18 to 50 years.
    The purpose of this new study is to:
    • Assess the safety and the immune response to the MERS vaccine in older adults
    • Investigate whether having previously received doses of the Oxford/AstraZeneca COVID-19 vaccine affects the immune response to the MERS vaccine.
    We plan to recruit up to 84 people aged 50 to 70 years to this study, half of whom will have previously been vaccinated with at least 2 doses of the Oxford/AstraZeneca COVID-19 vaccine. Participants will be screened for eligibility with an initial online questionnaire followed by a phone call and an in-person medical assessment.
    Eligible participants will be invited to attend the first vaccination visit when they will be assigned at random to get two doses (given 12 weeks apart) of either the study vaccine or a ‘placebo’ injection (sterile salt water). For every 6 participants recruited, 5 will receive the trial vaccine and 1 will receive the placebo. Neither the participants nor the study team will know if vaccine or placebo was given until the end of the study.
    Participants will be followed up for 1 year to monitor their safety and immune responses.

  • REC name

    South Central - Oxford A Research Ethics Committee

  • REC reference

    23/SC/0047

  • Date of REC Opinion

    21 Apr 2023

  • REC opinion

    Further Information Favourable Opinion