Phase 1 study of CV0501 mRNA COVID-19 Vaccine in Adults

• Research type

  Research Study

• Full title

  A Phase 1, Open-label, Safety and Immunogenicity Study of a Booster Dose of the Investigational CV0501 mRNA COVID-19 Vaccine in Adults at Least 18 Years Old

• IRAS ID

  1006052

• Contact name

  Roshan Ramanathan

• Sponsor organisation

  GlaxoSmithKline Biologicals SA

• Eudract number

  2022-001293-58

• Research summary

  This trial is recruiting healthy male and female adults, at least 18 years old, who have received at least 2 doses of mRNA COVID-19 vaccine. with the last dose received at least 6months before joining this study. In this study, participants will receive a single dose (a booster) of a new mRNA vaccine and they will be in the study for approximately 6 months and will have 7 scheduled visits.
  Participants will be asked about their health and medications, have a physical examination, vital signs measurement, blood testing, pregnancy testing (if applicable), 12-lead ECG, nasal swab testing and maintain an ediary. About 180 healthy adults will take part in this study. This study will be conducted at approximately 5 sites in the United Kingdom.

  The study is sponsored by GlaxoSmithKline Biologicals SA.
  Following a screening assessment, eligible participants will be assigned to receive the study vaccine according to a specific cohort, dose group, and age group.
  In this trial, the participant, study doctor, site staff and researchers will know which dose level of vaccine which the participant receives (open-label). The trial will start with the lowest dose of the vaccine and the lowest dose group will be
  tested first in younger adults ≥18 years to < 65 Years old) then move on to older adults (> 65 years old) (age-escalation). Once the lowest does is determined to be safe and tolerable, the study may move on to a higher dose (dose-escalation).
  Low Dose in Part B of the study is only for the younger age group.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  22/LO/0561

• Date of REC Opinion

  14 Oct 2022

• REC opinion

  Further Information Unfavourable Opinion