A Randomized, Controlled, Phase III Study to Determine the Safety, Efficacy, and Immunogenicity of the Non-Replicating ChAdOx1 nCoV-19 Vaccine.
There will be 2 study groups and an anticipated enrolment of 10,300 health professionals and adults with high potential for exposure to SARS-CoV-2, aged ≥18 years. All subjects will undergo follow-up for a total of 1 year post last vaccination. Additional visits or procedures may be performed at the discretion of the investigators, e.g., further medical history and physical examination, or additional blood tests and other investigations if clinically relevant
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
10,300
Single dose of ChAdOx1nCOV19 vaccine, 5x10\^10 vp + paracetamol
Single dose of MenACWY + paracetamol
Two dose of ChAdOx1 nCoV-19 vaccine, 5x10\^10vp (prime) and 0.5mL boost (3.5 - 6.5 × 10\^10 vp), 4-12 weeks apart + paracetamol
Instituto D'Or de Pesquisa e Ensino - I'Dor
Salvador, Estado de Bahia, Brazil
RECRUITINGCentro de Pesquisas Clinicas de Natal (CPCLIN)
Natal, Rio Grande do Norte, Brazil
RECRUITINGHospital das Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Evaluate the efficacy of ChAdOx1 nCoV-19 vaccine against COVID-19 disease confirmed with PCR
COVID-19 virologically confirmed symptomatic cases (PCR positive).
Time frame: 12 months post final vaccination
Evaluate the safety, tolerability and reactogenicity profile of ChAdOx1 nCoV-19 candidate vaccine: occurrence of signs and symptoms of local and systemic reactogenicity requested during 7 days after vaccination
Occurrence of signs and symptoms of local and systemic reactogenicity requested during 7 days after vaccination (in a subset of 200 participants)
Time frame: 7 days post vaccination
Evaluate the safety, tolerability and reactogenicity profile of ChAdOx1 nCoV-19 candidate vaccine: occurrence of serious adverse events
Occurrence of serious adverse events
Time frame: 12 months post final vaccination
Evaluate the safety, tolerability and reactogenicity profile of ChAdOx1 nCoV-19 candidate vaccine: occurrence of episodes; intensified disease
Occurrence of episodes; intensified disease
Time frame: 12 months post final vaccination
Evaluate the efficacy of ChAdOx1 nCoV-19 candidate vaccine against severe and non-severe COVID-19 disease: hospitalization for COVID-19 disease confirmed by PCR
Hospitalization for COVID-19 disease confirmed by PCR
Time frame: 12 months post final vaccination
Evaluate the efficacy of ChAdOx1 nCoV-19 candidate vaccine against severe and non-severe COVID-19 disease: COVID-19 serious disease confirmed by PCR
COVID-19 serious disease confirmed by PCR
Time frame: 12 months post final vaccination
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MenACWY prime, and Saline Placebo boost (0.5mL) + paracetamol
Universidade Federal de Santa Maria (UFSM)
Santa Maria, Rio Grande do Sul, Brazil
RECRUITINGInstituto D'Or de Pesquisa e Ensino - I'Dor
Rio de Janeiro, Brazil
RECRUITINGCRIE, Universidade Federal de São Paulo
São Paulo, Brazil
RECRUITINGEvaluate the efficacy of ChAdOx1 nCoV-19 candidate vaccine against severe and non-severe COVID-19 disease: death associated with COVID-19 disease
Death associated with COVID-19 disease
Time frame: 6 months
Evaluate the efficacy of ChAdOx1 nCoV-19 candidate vaccine against severe and non-severe COVID-19 disease: antibodies against SARS-CoV-2 non-Spike protein (serum efficacy rates)
Antibodies against SARS-CoV-2 non-Spike protein (serum efficacy rates).
Time frame: 12 months post final vaccination
Evaluate the humoral immunogenicity of ChAdOx1 nCoV-19: antibodies against the SARS-CoV-2 spike protein (serum conversion rates)
Antibodies against the SARS-CoV-2 spike protein (serum conversion rates)
Time frame: 12 months post final vaccination
Evaluate the humoral immunogenicity of ChAdOx1 nCoV-19: virus neutralizing antibodies (NAb) against live and/or pseudotyped SARS-CoV-2 virus
Virus neutralizing antibodies (NAb) against live and/or pseudotyped SARS-CoV-2 virus
Time frame: 12 months post final vaccination
Assess the cellular immunogenicity of ChAdOx1 nCoV-19 candidate vaccine
Interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot) responses to SARS-CoV-2 spike protein
Time frame: 12 months post final vaccination