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Safety and immunogenicity of ChAdOx1 MERS vaccine candidate in healthy Middle Eastern adults (MERS002): an open-label, non-randomised, dose-escalation, phase 1b trial.
Bosaeed, Mohammad; Balkhy, Hanan H; Almaziad, Sultan; Aljami, Haya A; Alhatmi, Hind; Alanazi, Hala; Alahmadi, Mashael; Jawhary, Ayah; Alenazi, Mohammed W; Almasoud, Abdulrahman; Alanazi, Rawan; Bittaye, Mustapha; Aboagye, Jeremy; Albaalharith, Nahla; Batawi, Sarah; Folegatti, Pedro; Ramos Lopez, Fernando; Ewer, Katie; Almoaikel, Khalid; Aljeraisy, Majed; Alothman, Adel; Gilbert, Sarah C; Khalaf Alharbi, Naif.
  • Bosaeed M; Clinical Trial Services, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.
  • Balkhy HH; College of Medicine, King Saud bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.
  • Almaziad S; Department of Medicine, King Abdulaziz Medical City in Riyadh, Riyadh, Saudi Arabia.
  • Aljami HA; World Health Organization, Geneva, Switzerland.
  • Alhatmi H; Department of Medicine, King Abdulaziz Medical City in Riyadh, Riyadh, Saudi Arabia.
  • Alanazi H; Vaccine Development Unit, Infectious Disease Research Department, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.
  • Alahmadi M; Department of Medicine, King Abdulaziz Medical City in Riyadh, Riyadh, Saudi Arabia.
  • Jawhary A; Clinical Trial Services, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.
  • Alenazi MW; Vaccine Development Unit, Infectious Disease Research Department, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.
  • Almasoud A; Clinical Trial Services, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.
  • Alanazi R; Vaccine Development Unit, Infectious Disease Research Department, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.
  • Bittaye M; Vaccine Development Unit, Infectious Disease Research Department, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.
  • Aboagye J; Clinical Trial Services, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.
  • Albaalharith N; The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
  • Batawi S; The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
  • Folegatti P; Department of Nursing, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia.
  • Ramos Lopez F; The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
  • Ewer K; The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
  • Almoaikel K; The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
  • Aljeraisy M; The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
  • Alothman A; Clinical Trial Services, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.
  • Gilbert SC; Clinical Trial Services, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.
  • Khalaf Alharbi N; Clinical Trial Services, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.
Lancet Microbe ; 3(1): e11-e20, 2022 Jan.
Article in English | MEDLINE | ID: covidwho-1915215
ABSTRACT

BACKGROUND:

ChAdOx1-vectored vaccine candidates against several pathogens have been developed and tested in clinical trials and ChAdOx1 nCoV-19 has now been licensed for emergency use for COVID-19. We assessed the safety and immunogenicity of the ChAdOx1 MERS vaccine in a phase 1b trial in healthy Middle Eastern adults.

METHOD:

MERS002 is an open-label, non-randomised, dose-escalation, phase 1b trial. Healthy Middle Eastern adults aged 18-50 years were included in the study. ChAdOx1 MERS was administered as a single intramuscular injection into the deltoid muscle of the non-dominant arm at three different dose groups 5·0 × 109 viral particles in a low-dose group, 2·5 × 1010 viral particles in an intermediate-dose group, and 5·0 × 1010 viral particles in a high-dose group. The primary objective was to assess the safety and tolerability of ChAdOx1 MERS, measured by the occurrence of solicited and unsolicited adverse events after vaccination for up to 28 days and occurrence of serious adverse events up to 6 months. The study is registered with ClinicalTrials.gov, NCT04170829.

FINDINGS:

Between Dec 17, 2019, and June 1, 2020, 24 participants were enrolled (six to the low-dose, nine to the intermediate-dose, and nine to the high-dose group) and received a dose; 23 were available for follow-up at 6 months. The one dose of ChAdOx1 MERS vaccine was well tolerated with no serious adverse event reported during the 6 months of follow-up. Most adverse events were mild (67, 74%) and moderate (17, 19%). Six (7%) severe adverse events were reported by two participants in the intermediate-dose group (two feverish, two headache, one joint pain, and one muscle pain). Pain at the injection site was the most common local and overall adverse event, reported by 15 (63%) of the 24 participants. The most common systemic adverse event was headache, reported by 14 (58%), followed by muscle pain reported by 13 (54%). The vaccine induced both antibody and T cell immune responses in all volunteers; antibodies peaked at day 28 and T cell responses peaked at day 14; and continued until the end of follow-up at 6 months.

INTERPRETATION:

The acceptable safety and immunogenicity data from this phase 1b trial of ChAdOx1 MERS vaccine candidate in Healthy Middle Eastern adults, combined with previous safety and immunogenicity data from a trial in the UK, support selecting the ChAdOx1 MERS vaccine for advancement into phase 2 clinical evaluation.

FUNDING:

UK Department of Health and Social Care, using UK Aid funding, managed by the UK National Institute for Health Research; and King Abdullah International Medical Research Center.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Type of study: Cohort study / Experimental Studies / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Adult / Humans Language: English Journal: Lancet Microbe Year: 2022 Document Type: Article Affiliation country: S2666-5247(21)00193-2

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Type of study: Cohort study / Experimental Studies / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Adult / Humans Language: English Journal: Lancet Microbe Year: 2022 Document Type: Article Affiliation country: S2666-5247(21)00193-2