SARS-CoV-2 MedDRA version: 23.0 Level: PT Classification code 10051905 Term: Coronavirus infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: ChAdOx1 nCoV-19
Pharmaceutical Form: Solution for injection
Trade Name: Nimenrix
Product Name: Nimenrix
Pharmaceutical Form: Powder and solvent for solution for injection
Trade Name: M
Sponsors
CTRG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adults aged 18 years or older (groups 4 and 6); aged 18-55 years (group 5 and 11) Adults aged 56-69 years (groups 1,7 and 9) Adults aged 70 years and older (groups 2,8 and 10) Able and willing (in the Investigator’s opinion) to comply with all study requirements. 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 of childbearing potential 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. Parent/Guardian provides informed consent Additional Inclusion criteria to Group 12 (HIV sub-study): HIV positive Receiving antiretroviral therapy Undetectable HIV viral load CD4>350 cells/mL 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 11090 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1240
Exclusion criteria
Exclusion criteria: • Participation in COVID-19 prophylactic drug trials for the duration of the study. Note: Participation in COVID-19 treatment trials is allowed in the event of hospitalisation due to COVID-19. The COV002 study team should be informed as soon as possible. • Participation in SARS-CoV-2 serological surveys where participants are informed of their serostatus for the duration of the study. Note: Disclosure of serostatus post enrolment may accidently unblind participants to group allocation. Participation in COV002 can only be allowed if volunteers are kept blinded to their serology results from local/national serological surveys • Receipt of any vaccine (licensed or investigational) other than the study intervention within 30 days before and after each study vaccination, with the .exception of the licensed seasonal influenza vaccination and the licenced pneumococcal vaccination. Participants will be encouraged to receive these vaccination at least 7 days before or after their study vaccine. • Prior or planned receipt of an investigational or licensed vaccine or product likely to impact on interpretation of the trial data (e.g. Adenovirus vectored vaccines, any coronavirus vaccines). ). This exclusion criteria will not apply to group 11, as recruitment will be targeted at those volunteers who previously received a ChAdOx1 vectored vaccine. • Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate. • Any confirmed or suspected immunosuppressive or immunodeficient state (except group 12, where HIV infected participants are allowed); asplenia; recurrent severe infections and use of immunosuppressant medication within the past 6 months, except topical steroids or short-term oral steroids (course lasting =14 days) • History of allergic disease or reactions likely to be exacerbated by any component of ChAdOx1 nCoV-19 or MenACWY • Any history of angioedema. • Any history of anaphylaxis. • Pregnancy, lactation or willingness/intention to become pregnant during the study. • Current diagnosis of or treatment for cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ). • History of serious psychiatric condition likely to affect participation in the study. • Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture. • Continuous use of anticoagulants, such as coumarins and related anticoagulants (i.e. warfarin) or novel oral anticoagulants (i.e. apixaban, rivaroxaban, dabigatran and edoxaban) • Suspected or known current alcohol or drug dependency. • Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data. • Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness (mild/moderate well controlled comorbidities are allowed) • History of laboratory confirmed COVID-19 (except groups 5d, 5e, 9, 10 and 11). - Seropositivity to SARS-CoV-2 before enrolment (except groups 5d, 5e, 9, 10 and 11) - NB: volunteers with previous PCR or other NAAT positive result are also allowed in groups 9, 10 and 11 Additional Exclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess efficacy of the candidate ChAdOx1 nCoV-19 against COVID-19 in adults aged 18 years and older. To assess the safety of the candidate vaccine ChAdOx1 nCoV-19 in adults. ;Secondary Objective: To assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV-19 To assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 To assess humoral immunogenicity of ChAdOx1 nCoV-19 To assess cellular immunity of ChAdOx1 nCoV-19 in older adults (groups 1, 2, 7 and 8 only) To assess the safety and immunogenicity of a booster dose of ChAdOx1 nCoV-19 in older adults aged 56 years or older (two-dose schedules for groups 1, 2, 7 and 8 only) Exploratory Immunology Measure exposure to COVID-19 To assess efficacy of the candidate ChAdOx1 nCoV-19 against SARS-CoV-2 infection Compare safety, reactogenicity and immunogenicity between different manufacturing batches of ChAdOx1 nCoV-19 used in COV001 and COV002 Compare safety, reactogenicity and immunogenicity between different dosing methods (Abs260, Abs260 corrected for PS80 and qPCR) of ChAdOx1 nCoV-19 To assess vaccine induced mucosal immunity To compare viral shedding on sto;Primary end point(s): Virologically confirmed (PCR or other NAAT positive result) symptomatic COVID-19 infection;Timepoint(s) of evaluation of this end point: As required | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV-19 To assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 To assess humoral immunogenicity of ChAdOx1 nCoV-19 To assess cellular immunity of ChAdOx1 nCoV-19 in older adults and in children (groups 1, 2, 7 and 8 only) To assess the safety and immunogenicity of a booster dose of ChAdOx1 nCOV-19 in older adults aged 56 years or older (two-dose schedules for groups 1, 2, 7 and 8 only) To assess efficacy of the candidate ChAdOx1 nCoV-19 against SARS-CoV-2 infection Compare safety, reactogenicity and immunogenicity between different manufacturing batches of ChAdOx1 nCoV-19 used in COV001 and COV002 Compare safety, reactogenicity and immunogenicity between different dosing methods (Abs260, Abs260 corrected for PS80 and qPCR) of ChAdOx1 nCoV-19 To assess vaccine induced mucosal immunity To compare viral shedding on stool samples and/or rectal swabs of SARS-CoV-2 PCR or other NAAT positive individuals To compare immunogenicity of ChAdOx1 nCoV-19 in participants receiving 1 or 2 doses (groups 1, 2, 7 and 8) To describe the impact of previous vaccination with other ChAdOx1 vectored vaccines in immune responses to ChAdOx1 nCoV-19 To assess the cell-mediated and humoral immunogenicity profile of ChAdOx1 nCoV-19 vaccine in HIV infected adults To assess whether increasing age and or CD4 nadir are associated with a lack of immune response in HIV infected adults To assess the safety of the candidate vaccine ChAdOx1 nCoV-19 in HIV infected adults To assess Impact of vaccination on HIV reservoirs ;Timepoint(s) of evaluation of this end point: Safety, tolerability and reactogenicity - for 7 days after the vaccination and occurence of unsolicited adverse events for 28 days To assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 - throughout study To assess humoral and cellular immunogeni | — |
Countries
United Kingdom
Contacts
Public ContactAndrew Pollard
University of Oxford
Outcome results
None listed