Saul N. Faust (United Kingdom)

University of Southampton NIHR Southampton Clinical Research Facility
Saul Faust FRCPCH PhD, is Professor of Paediatric Immunology & Infectious Diseases at the University of Southampton, Director of the National Institute for Health Research (NIHR) Southampton Clinical Research Facility, Clinical Director of the Wessex Local Clinical Research Network and a NIHR Senior Investigator. Saul is a clinical researcher with projects bridging the clinical-laboratory interface, developing local and national collaborative clinical trials for paediatric and adult vaccines and antimicrobials. For COVID vaccine clinical trials, Saul is UK chief investigator for the Janssen 2-dose COVID-19 vaccine trial and both teenage and paediatric Janssen trials in the UK. Saul is a member of the National Immunisation Schedule Evaluation Consortium (NISEC) and is UK Chief Investigator for the UK national COV-BOOST trial. Saul Chairs the RECOVERY trial paediatric working group, the UK Clinical Research Facilities Directors Committee, the University Hospital Association R&D Directors Group, and is a member of the National Institute for Health Research Health Technology Programme Commissioning Board. Outside of research, Saul chaired the UK NICE Guideline Committees for sepsis in children and adults (2016) and for Lyme Disease (2018) and is a member of the NHS England Paediatric Medicine Clinical Reference Group for national specialist commissioning.

Author Of 1 Presentation

SAFETY AND IMMUNOGENICTY OF CHADOX1 NCOV-19 (AZD1222) VACCINE IN CHILDREN AGED 6-17 YEARS: A PRELIMINARY REPORT OF A RANDOMISED CONTROLLED TRIAL

Date
Fri, 13.05.2022
Session Time
10:00 - 11:30
Session Type
Oral Presentations Session
Room
BANQUETING HALL
Lecture Time
11:02 - 11:12

Abstract

Backgrounds:

Few data are published on immune responses against SARS-CoV-2 induced by COVID-19 vaccines in people under the age of 18 years compared with adults.

Methods:

COV006 is a phase 1/2, single-blind, randomised controlled trial of ChAdOx1 nCoV-19 (ChAd) in children and adolescents aged 6-17 years in the UK. Participants were randomised 4:1:4:1 to receive two doses of ChAd or control (capsular group B meningococcal) vaccine (4:1), 28 days (short-interval) or 84 days (long-interval) apart. The primary outcome was safety and tolerability, with immunogenicity in the baseline-seronegative participants as the secondary outcome. Due to the restrictions in the use of ChAd introduced during the study, only participants aged 12-17 years randomised to the short-interval were vaccinated as planned (D28). The remaining participants received their second dose at D112.

Results:

Of 262 participants, 211 and 51 were randomised to the ChAd and control arms, respectively. No serious adverse events related to ChAd administration were recorded. Solicited adverse reactions were reported more frequently after the first dose compared with the second dose, across all age and interval groups.

In participants aged 12-17 years, anti-SARS-CoV-2 IgG and pseudoneutralising antibody titres at D28 post-second dose were higher in the long-interval arm (geometric mean ratios (GMR): 1.70, 95%CI: 1.27-2.26 and 1.99, 95%CI: 1.39-2.86, respectively) than after a short-interval.

Humoral responses were higher in participants aged 6-11 years than those aged 12-17 years (GMR: 1.48, 95%CI: 1.07-2.07 and 2.96, 95%CI: 1.89-4.62 for anti-SARS-CoV-2 IgG and pseudoneutralising antibody titres, respectively). Cellular responses peaked after a first dose of ChAd across all age and interval groups.

Conclusions/Learning Points:

ChAdOx1 nCoV-19 is well-tolerated and immunogenic in children aged 6-17 years. No safety concerns were raised in this trial.

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