Investigating a Vaccine Against COVID-19

Inclusion Criteria:

- Adults aged 18 - 55 years (groups 4, 5, 6 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.

Additional Inclusion criteria to Group 12 (HIV sub-study):

- HIV positive

- Receiving antiretroviral therapy

- Undetectable HIV viral load

- CD4>350 cells/mL

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 licensed pneumococcal vaccination.
Participants will be encouraged to receive these vaccinations 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, 5f, 9, 10 and 11).

- Seropositivity to SARS-CoV-2 before enrolment (except groups 5d, 5e, 5f, 9, 10 and 11)

- NB: volunteers with previous NAAT positive results are also allowed in groups 9, 10
and 11

Additional Exclusion criteria to Groups 4, 6, 9 and 10

- History of allergic disease or reactions likely to be exacerbated by Paracetamol

- Note: Caution should be taken when recommending paracetamol to adults who already take
paracetamol chronically

Re-vaccination exclusion criteria (two-dose groups only)

- Anaphylactic reaction following administration of vaccine

- Pregnancy. An exception to this will be prior to receipt of a booster dose at extra
visit B. If a pregnant woman has discussed vaccination with their usual clinician
(e.g. GP) and chooses to receive a COVID-19 vaccination, this may be administered by
the trial team as part of extra visit B. (Protocol 19.0) or as part of the provision
of treatment to controls.

- Any AE that in the opinion of the Investigator may affect the safety of the
participant or the interpretation of the study results