A phase I/II study to determine efficacy, safety and immunogenicity of the candidate Coronavirus Disease (COVID-19) vaccine ChAdOx1 nCoV-19 in UK healthy adult volunteers

INTERVENTION: Product Name: ChAdOx1 nCoV‐19 Pharmaceutical Form: Solution for injection Pharmaceutical form of the placebo: Powder and solvent for solution for injection Route of administration of the placebo: Intramuscular use Trade Name: Nimenrix Product Name: Nimenrix Pharmaceutical Form: Powder and solvent for solution for injection Trade Name: Menveo Product Name: Menveo Pharmaceutical Form: Powder and solvent for solution for injection CONDITION: COVID‐19 ; MedDRA version: 23.0 Level: PT Classification code 10051905 Term: Coronavirus infection System Organ Class: 10021881 ‐ Infections and infestations Therapeutic area: Diseases [C] ‐ Virus Diseases [C02] PRIMARY OUTCOME: Main Objective: To assess efficacy of ChAdOx1 nCoV‐19 against COVID‐19; ; To assess the safety of the candidate vaccine ChAdOx1 nCoV Primary end point(s): To assess efficacy of the candidate ChAdOx1 nCoV‐19 against COVID‐19:; a)Virologically confirmed (PCR positive) symptomatic cases of COVID‐19; ; To assess the safety of the candidate vaccine ChAdOx1 nCoV:; a)Occurrence of serious adverse events (SAEs) throughout the study duration Secondary Objective: To assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV; To assess efficacy of the candidate ChAdOx1 nCoV‐19 against severe and non‐severe COVID‐19; To assess cellular and humoral immunogenicity of ChAdOx1 nCoV‐19; Exploratory Immunology; To assess immunogenicity of ChAdOx1 nCoV‐19 given as homologous prime‐boost Timepoint(s) of evaluation of this end point: Throughout the study duration SECONDARY OUTCOME: Secondary end point(s): 1)To assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV; a) occurrence of solicited local reactogenicity signs and symptoms for 7 days following vaccination; ; b) occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following vaccination;; c) occurrence of unsolicited adverse events (AEs) for 28 days following vaccination; ; d) change from baseline for safety laboratory measures and; ; e) Occurrence of disease enhancement episodes; ; 2)To assess efficacy of the candidate ChAdOx1 nCoV‐19 against severe and non‐severe COVID‐19; a) Hospital admissions associated with COVID‐19; b) Intensive care unit (ICU) admissions associated with COVID‐19; c) Deaths associated with COVID‐19; d) Seroconversion against non‐Spike SARS‐CoV‐2 antigens ; ; 3)To assess cellular and humoral immunogenicity of ChAdOx1 nCoV‐19; a) Interferon‐gamma (IFN‐?) enzyme‐linked immunospot (ELISpot) responses to SARS‐CoV‐2 spike protein;; b) Enzyme‐linked immunosorbent assay (ELISA) to quantify antibodies against SARS‐CoV‐2 spike protein (seroconversion rates);; c) virus neutralising antibody (NAb) assays against live and/or pseudotype SARS‐CoV‐2 virus ; ; 4) To assess immunogenicity of ChAdOx1 nCoV‐19 given as homologous prime‐boost Timepoint(s) of evaluation of this end point: 1) Safety Secondary endpoints: a) 7 days; b) 7 days; c) 28 days; d) At D0 (baseline), D2, D7 and D28 (Groups 1 and 3) / At D0 (baseline) and D28 (Group 2); ; 2) Efficacy Secondary endpoints: throughout the study; ; 3) Immunology secondary endpoints: immunology assays will be conducted at multiple timepoints throughout the study. In summary at D0, D7, D14, D28, D56m D182 and D364 (Group 1); at D0, D28, D182 and D364 (Group 2); and D0, D7, D14, D28, D35, D42, D56, D182, D364 (Group 3); ; 4) D0, D14 and D28 post each vaccination (prime and boost); ; ; INCLUSION CRITERIA: • Healthy adults aged 18‐55 years. • Able and willing (in the Investigator’s opinion) to comply with all study requirements (participants must not rely on public transport or taxis). • Willing to allow the investigators to discuss the volunteer’s medical history with their General Practitioner and access all medical records when relevant to study procedures. • For females only, willingness to practice continuous effective contraception (see below) during the study and a negative pregnancy test on the day(s) of screening and vaccination. • Agreement to refrain from blood donation during the course of the study. • Provide written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 1112 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0