COV002 Phase III - AstraZeneca Clinical Trial

Investigating a Vaccine Against COVID-19
The safety and scientific validity of this study is the responsibility of the study
sponsor and investigators. Listing a study does not mean it has been evaluated
by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04400838
Brief Summary:
A phase 2/3 study to determine the efficacy, safety and immunogenicity of the candidate
Coronavirus Disease (COVID-19) vaccine ChAdOx1 nCoV-19 in healthy UK volunteers.
Condition or
Intervention/treatment Phase
disease
Coronavirus Biological: ChAdOx1 nCoV-19 (Abs 260) Phase 2 Phase 3
Biological: MenACWY vaccine Biological:
ChAdOx1 nCoV-19 (Abs 260) + 2.2x10^10vp
(qPCR) boost Biological: Two dose MenACWY
vaccine Biological: ChAdOx1 nCoV-19 (qPCR)
Biological: ChAdOx1 nCoV-19 0.5mL prime plus
boost Biological: Two dose MenACWY vaccine
min. 4 weeks apart Biological: Two dose ChAdOx1
nCoV-19/Covishield 0.5mL Biological: Two dose
ChAdOx1 nCoV-19/Covishield 0.25mL & 0.5mL
Detailed Description:
There will be 12 study groups and it is anticipated that a total of 12,390 volunteers will be
enrolled. Groups 1, 7 & 9 are adults aged 56-69 years; groups 2, 8 & 10 are adults 70 years
and over; groups 4, 5 & 6 are adults aged 18-55 years; group 11 is adults aged 18-55 years
who have previously received a ChAdOx vectored vaccine; group 12 is HIV positive adults
aged 18-55 years.
The vaccine will be administered intramuscularly into the deltoid of the non-dominant arm
(preferably).
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 Design
Study Type : Interventional (Clinical Trial)
Estimated
12390 participants
Enrollment :
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
A Phase 2/3 Study to Determine the Efficacy, Safety and

Official Title: Immunogenicity of the Candidate Coronavirus Disease (COVID-19)
Vaccine ChAdOx1 nCoV-19
Actual Study Start

May 28, 2020
Date :
Estimated Primary
December 31, 2021
Completion Date :
Estimated Study
December 31, 2021
Completion Date :
Arms and Interventions
Arm Intervention/treatment
Experimental: Group 1 a1 Biological: ChAdOx1 nCoV-19 (Abs 260)
Volunteers will receive a single dose A single dose of 5x10^10vp of ChAdOx1
ChAdOx1 nCOV19 vaccine, 5x10^10vp nCoV-19 measured by spectrophotometry at
(Abs 260) Abs260
Experimental: Group 1 a3 Biological: ChAdOx1 nCoV-19 0.5mL
Volunteers will receive two doses of prime plus boost
ChAdOx1 nCoV19 vaccine: 5x10^10vp Two dose ChAdOx1 nCoV-19 0.5mL (3.5 -
(Abs 260) prime and 0.5mL (3.5 - 6.5 × 6.5 × 10^10 vp Abs 260)
10^10 vp, Abs 260) boost, minimum 4
weeks from prime
Experimental: Group 1 b1 Biological: ChAdOx1 nCoV-19 (Abs 260) +
Volunteers will receive two dose ChAdOx1 2.2x10^10vp (qPCR) boost
nCOV19 vaccine, 5x10^10vp (Abs 260) A single dose of 5x10^10vp of ChAdOx1
prime and 2.2x10^10vp (qPCR) boost (4-6 nCoV-19 measured by spectrophotometry at
weeks apart) Abs260 and 2.2x10^10vp ChAdOx1 nCoV-
19 boost measured by qPCR 4-6 weeks later
ChAdOx1 nCOV19 vaccine, 5x10^10vp nCoV-19 measured by spectrophotometry at
(Abs 260) Abs260
weeks apart
.Volunteers will receive two dose ChAdOx1 2.2x10^10vp (qPCR) boost
prime and 2.2x10^10vp (qPCR) boost 4-6 nCoV-19 measured by spectrophotometry at
weeks apart Abs260 and 2.2x10^10vp ChAdOx1 nCoV-
ChAdOx1 nCoV19 vaccine, 5x10^10vp nCoV-19 measured by spectrophotometry at
(Abs 260) Abs260
Volunteers will receive two dose ChAdOx1 2.2x10^10vp (qPCR) boost
prime and 2.2x10^10vp (qPCR) boost 4-6 nCoV-19 measured by spectrophotometry at
weeks apart Abs260 and 2.2x10^10vp ChAdOx1 nCoV-
Experimental: Group 4 c1 Biological: ChAdOx1 nCoV-19 0.5mL
ChAdOx1 nCOV19 vaccine, 5x10^10vp Two dose ChAdOx1 nCoV-19 0.5mL (3.5 -
(Abs260) prime and 2.2x10^10vp (qPCR) 6.5 × 10^10 vp Abs 260)
boost*, at least 4 weeks apart
ChAdOx1 nCoV19 vaccine, 5x10^10vp, nCoV-19 measured by spectrophotometry at
(Abs 260) Abs260
weeks from prime
Experimental: Group 5 b1 Biological: ChAdOx1 nCoV-19 (qPCR)
A single dose of 5x10^10vp of ChAdOx1
nCoV-19 measured by qPCR
Volunteers will receive a single dose
ChAdOx1 nCoV19 vaccine, 5x1010vp,
(qPCR)
Experimental: Group 5 c1 Biological: ChAdOx1 nCoV-19 (Abs 260)
ChAdOx1 nCoV19 vaccine, 5x10^10vp, nCoV-19 measured by spectrophotometry at
(qPCR) Abs260
Experimental: Group 5 d1 Biological: ChAdOx1 nCoV-19 0.5mL
ChAdOx1 nCoV19 vaccine, 0.5mL (3.5 - Two dose ChAdOx1 nCoV-19 0.5mL (3.5 -
6.5 × 10^10 vp, Abs 260)* 4-6 weeks apart 6.5 × 10^10 vp Abs 260)
Experimental: Group 5 e1 Biological: Two dose ChAdOx1 nCoV-
Two dose ChAdOx1 nCoV-19 0.5mL 19/Covishield 0.5mL
(Covishield 0.9 x 10^11 vp/mL), 4-6 weeks Two dose ChAdOx1 nCoV-19 0.5mL
apart (Covishield 0.9 x 10^11 vp/mL), 4-6 weeks
apart
Experimental: Group 5 f1 Biological: Two dose ChAdOx1 nCoV-
Two dose ChAdOx1 nCoV-19 (Covishield 19/Covishield 0.25mL & 0.5mL
0.9 x 10^11 vp/mL), 0.25mL prime and Two dose ChAdOx1 nCoV-19 (Covishield
0.5mL boost 4-6 weeks apart 0.9 x 10^11 vp/mL), 0.25mL prime and
0.5mL boost 4-6 weeks apart
Experimental: Group 6 a1 Biological: ChAdOx1 nCoV-19 (qPCR)
ofChAdOx1 nCoV19 vaccine, 5x1010vp nCoV-19 measured by qPCR
(qPCR)
Experimental: Group 6 b1 Biological: ChAdOx1 nCoV-19 0.5mL
ChAdOx1 nCoV19 vaccine, 5x1010vp Two dose ChAdOx1 nCoV-19 0.5mL (3.5 -
(Abs260) prime and 0.5mL (3.5 - 6.5 × 1010 6.5 × 10^10 vp Abs 260)
vp, Abs 260)* boost* at least 4 weeks apart
ChAdOx1nCOV19 vaccine, 5x10^10vp nCoV-19 measured by qPCR
(qPCR)
ChAdOx1nCOV19 vaccine, 5x10^10vp Two dose ChAdOx1 nCoV-19 0.5mL (3.5 -
(qPCR)* 4-6 weeks apart 6.5 × 10^10 vp Abs 260)
ChAdOx1nCOV19 vaccine, 5x10^10vp nCoV-19 measured by qPCR
(qPCR)
Experimental: Group 11 Biological: ChAdOx1 nCoV-19 0.5mL
Experimental: Group 12 Biological: ChAdOx1 nCoV-19 0.5mL
Active Comparator: Single dose Biological: MenACWY vaccine
MenACWY Standard single dose of MenACWY vaccine
Groups 1 a2, 2 a2, 4 a2, 5 a2, 5 b2, 5 c2, 6 Other Names:
a2, 7 a2 & 8 a2 will receive a standard
single dose of MenACWY vaccine • Menveo
• Nimenrix
Active Comparator: Two dose MenACWY Biological: Two dose MenACWY vaccine
4 - 6 weeks Two standard doses of MenACWY vaccine
Groups 1 b2, 2 b2, 4 b2, 5 d2, 7 b2, 8 b2, 9 4-6 weeks apart
a2 & 10 a2 will receive two doses of Other Names:
MenACWY 4-6 weeks apart
• Menveo
• Nimenrix
Active Comparator: Two dose MenACWY Biological: Two dose MenACWY vaccine
minimum 4 weeks min. 4 weeks apart
Groups 1 a4, 2 a4, 4 c2, 5 a4, 6b2 will Two standard doses of MenACWY vaccine
receive two doses of MenACWY at least 4 minimum 4 weeks apart
weeks apart Other Names:
• Menveo
• Nimenrix
Outcome Measures
Primary Outcome Measures :

1. Assess the efficacy of the candidate ChAdOx1 nCoV-19 against COVID-19 in adults
aged 18 years and older. [ Time Frame: Study duration (12 months from last
vaccination) ]
Number of virologically confirmed (PCR or NAAT positive) symptomatic cases of

COVID-19
2. Assess the safety of the candidate vaccine ChAdOx1 nCoV-19 in adults

[ Time Frame: Study duration (12 months from last vaccination) ]
Occurrence of serious adverse events (SAEs) throughout the study duration.

Secondary Outcome Measures :
1. Assess the safety, tolerability and reactogenicity profile of the candidate vaccine
ChAdOx1 nCoV-19: occurrence of solicited local reactogenicity signs and symptoms
for 7 days following [ Time Frame: 7 days post vaccination ]
Occurrence of solicited local reactogenicity signs and symptoms for 7 days following
vaccination
ChAdOx1 nCoV-19: occurrence of solicited systemic reactogenicity signs and
symptoms for 7 days following [ Time Frame: 7 days post vaccination ]
Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days

following vaccination
ChAdOx1 nCoV-19: occurrence of unsolicited adverse events (AEs) for 28 days
following vaccination [ Time Frame: 28 days post vaccination ]
Occurrence of unsolicited adverse events (AEs) for 28 days following vaccination
ChAdOx1 nCoV-19 through standard blood tests (full blood count, liver and kidney
function tests) [ Time Frame: 6 months ]
Frequency of participants with clinically significant changes from baseline for safety
laboratory measures (haematology and biochemistry blood results; except groups 4, 6,
9 & 10)
ChAdOx1 nCoV-19 by measuring the number of disease enhancement episodes
Occurrence of disease enhancement episodes
6. Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe
COVID-19: hospital admissions [ Time Frame: Study duration (12 months from last
vaccination) ]
Number of hospital admissions associated with COVID-19
COVID-19 [ Time Frame: 6 months ]
Number of intensive care unit (ICU) admissions associated with COVID-19
COVID-19: number of deaths [ Time Frame: 6 months ]
Number of deaths associated with COVID-19
COVID-19 by measuring seroconversion rates [ Time Frame: 6 months ]
Proportion of people who become seropositive for non-Spike SARS-CoV-2 antigens

during the study
COVID-19 by measuring incidence of Covid-19 [ Time Frame: Study duration (12
months from last vaccination) ]
Proportion of people diagnosed with severe Covid-19 disease (defined according to

clinical severity scales)
11. Assess humoral immunogenicity of ChAdOx1 nCoV-19: antibody quantification

[ Time Frame: 28 days post vaccination ]
Quantify antibodies against SARS-CoV-2 spike protein (seroconversion rates)
12. Assess humoral immunogenicity of ChAdOx1 nCoV-19: seroconversion

Proportion of seroconversion to antibodies against SARS-CoV-2 spike protein at Day

28 post-vaccination
13. Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 through ELISpot
assays (groups 1, 2, 7 and 8 only) [ Time Frame: 6 months ]
Interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot) responses to SARS-

CoV-2 spike protein
14. 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):
local reactogenicity [ Time Frame: 7 days post vaccination ]
Occurrence of solicited local reactogenicity signs and symptoms for 7 days following
booster vaccination
older adults aged 56 years or older (two-dose schedules for groups 1 and 2 only):
systemic reactogenicity [ Time Frame: 7 days post vaccination ]
Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days

following booster vaccination
older adults aged 56 years or older (two-dose schedules for groups 1 and 2 only)
Occurrence of unsolicited adverse events (AEs) for 28 days following booster
vaccination
through standard blood tests (full blood count, liver and kidney function tests)
[ Time Frame: 6 months ]
Frequency of participants with clinically significant changes from baseline from pre-
booster for safety laboratory measures (haematology and biochemistry blood results)
older adults aged 56 years or older (two-dose schedules for groups 1 and 2 only) via
seroconversion [ Time Frame: 56 days post vaccination ]
Antibodies against SARS-CoV-2 spike protein at Day 56 post-vaccination

(seroconversion rates)
Proportion of seroconversion to antibodies against SARS-CoV-2 spike protein at Day

56 post-vaccination
Other Outcome Measures:

1. Exploratory Immunology by virus neutralising antibody assays [ Time Frame: 6
months ]
Virus neutralising antibody (NAb) assays against live and/or pseudotype SARS-CoV-
2 virus
2. Exploratory Immunology by flow cytometry [ Time Frame: 6 months ]
Cell analysis by flow cytometry assays
3. Exploratory Immunology by functional antibody assays [ Time Frame: 6 months ]
Functional antibody assays
4. Exploratory Immunology: anti-vector immunity [ Time Frame: 6 months ]
Anti-vector immunity induced by 1 or 2 doses of ChAdOx1 nCoV-19
5. Measure exposure to COVID-19 [ Time Frame: 6 months ]
Reported by weekly survey to collect information about cases amongst household

contacts and friends, contact with the general public, infection control procedures
6. Exploratory efficacy against infection: assess efficacy of the candidate ChAdOx1
nCoV-19 against SARS-CoV-2 infection by PCR or NAAT [ Time Frame: 6 months ]
Number of PCR or NAAT positive cases of COVID-19 infection
7. Exploratory efficacy against infection: assess efficacy of the candidate ChAdOx1

nCoV-19 against SARS-CoV-2 infection [ Time Frame: 6 months ]
Measure of differences in viral loads between those with severe, mild, and
asymptomatic PCR+ SARS-CoV-2 infections
8. Compare safety, reactogenicity and immunogenicity between different manufacturing

batches of ChAdOx1 nCoV-19 used in COV001 and COV002 [ Time Frame: 6
months ]
Differences in safety, reactogenicity and immunogenicity profiles between Group 1 in

COV001 and Group 5 in COV002 (proportion of Grade 3 solicited AEs, occurrence
of fevers, seroconversion rates at D28, neutralising antibody titres and differences in
T-cell responses at D14).
9. Compare safety, reactogenicity and immunogenicity between different methods for

measuring doses [ Time Frame: 6 months ]
Differences in safety, reactogenicity and immunogenicity profiles between Groups 1,

2, and 5A compared with Groups, 7, 8, and 5B, C and D respectively (proportion of
Grade 3 solicited AEs, occurrence of fevers, seroconversion rates at D28, neutralising
antibody titres and differences in T-cell responses at D14).
10. Assess vaccine induced mucosal immunity: Nasal mucosa IgA levels at D0 and D28
in a subset of individuals [ Time Frame: 6 months ]
Nasal mucosa IgA levels at D0 and D28 in a subset of individuals
11. Compare viral shedding on stool samples of SARS-CoV-2 PCR or NAAT positive
individuals [ Time Frame: 6 months ]
Differences in viral shedding on stool at 7 days and beyond post SARS-CoV-2 PCR
or NAAT positivity
12. Compare immunogenicity of ChAdOx1 nCoV-19 in participants receiving 1 or 2

doses in groups 1, 2, 7 and 8: differences in antibody titres [ Time Frame: 6 months ]
Differences in antibody titres (ELISA and Neutralising antibodies) in participants who

received 1 or 2 doses of ChAdOx1 nCoV-19 (groups 1, 2, 7 and 8)
13. Compare immunogenicity of ChAdOx1 nCoV-19 in participants receiving 1 or 2

doses in groups 1, 2, 7 and 8: longevity of immune responses [ Time Frame: 6
months ]
Longevity of immune responses in participants who received 1 or 2 doses of
ChAdOx1 nCoV-19
14. Describe the impact of previous vaccination with other ChAdOx1 vectored vaccines
on safety and immune responses to ChAdOx1 nCoV-19 [ Time Frame: 6 months ]
Differences reactogenicity profile, antibody titres and T-cell responses between

groups 5d and 11 and their relationship with anti-vector neutralising antibody titres.
15. Assess the cell-mediated and humoral immunogenicity profile of ChAdOx1 nCoV-19
vaccine in HIV infected adults [ Time Frame: 6 months ]
Cell-mediated and humoral responses against SARS-Cov-2 These will be measured

by the following:
1. Proportion of seroconversion to antibodies (Ab) against SARS-CoV-2 spike
protein measured by ELISA.
2. Interferon-gamma enzyme linked immunospot (ELISpot) responses to SARS-
CoV-2 spike protein
3. Intracellular Cytokine analyses of CD4 and CD8-specific SARS-CoV-2 spike
protein responses
4. Further exploratory immunology including immune responses to a further
dose administered via the NHS national roll out
16. Assess whether increasing age and or CD4 nadir are associated with a lack of immune
response in HIV infected adults: CD4 count-vaccine immune responses
[ Time Frame: 6 months ]
Relationship between nadir CD4 count vs vaccine immune responses
response in HIV infected adults: age vs vaccine immune responses [ Time Frame: 6
months ]
Relationship between age at enrolment and vaccine immune response
response in HIV infected adults [ Time Frame: 6 months ]
Immune responses to ChAdOx1 nCoV-19 (assessed as described above)
19. Assess the safety of the candidate vaccine ChAdOx1 nCoV-19 in HIV infected adults
Measured by the following:

1. Occurrence of serious adverse events (SAEs) throughout the study duration
2. Occurrence of solicited local reactogenicity signs and symptoms for 7 days
following vaccination
3. Occurrence of solicited systemic signs and symptoms for 7 days following
each vaccination
4. Occurrence of unsolicited AEs for 28 days following each vaccination
20. To assess Impact of vaccination on HIV reservoirs [ Time Frame: Study duration (12
months from last vaccination) ]
Change in Total HIV DNA copies per million CD4 T cells
21. To assess immunological correlates of protection in relation to occurrence of COVID-

19 disease in ChAdOx1 nCoV-19 recipients [ Time Frame: Throughout the study,
average of 18 months] ]
Immunological endpoints (antibody & cellular responses to SARS-COV2 spike

protein) and COVID-19 disease endpoints (SARS-COV2 PCR positivity plus
symptoms) in ChAdOx1 nCoV-19 recipients
Eligibility Criteria
Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using
the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04400838
Investigators
Principal Investigator: Andrew Pollard, Prof University of Oxford

COV002 Phase III - AstraZeneca Clinical Trial

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COV002 Phase III - AstraZeneca Clinical Trial

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Investigating a Vaccine Against COVID-19

ClinicalTrials.gov Identifier: NCT04400838

Intervention Model: Sequential Assignment

Masking: Single (Participant)

Primary Purpose: Prevention

A Phase 2/3 Study to Determine the Efficacy, Safety and

Actual Study Start

Arms and Interventions

Primary Outcome Measures :

Number of virologically confirmed (PCR or NAAT positive) symptomatic cases of

2. Assess the safety of the candidate vaccine ChAdOx1 nCoV-19 in adults

Occurrence of serious adverse events (SAEs) throughout the study duration.

Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days

Occurrence of unsolicited adverse events (AEs) for 28 days following vaccination

Occurrence of disease enhancement episodes

Number of hospital admissions associated with COVID-19

Number of intensive care unit (ICU) admissions associated with COVID-19

Proportion of people who become seropositive for non-Spike SARS-CoV-2 antigens

Proportion of people diagnosed with severe Covid-19 disease (defined according to

11. Assess humoral immunogenicity of ChAdOx1 nCoV-19: antibody quantification

Quantify antibodies against SARS-CoV-2 spike protein (seroconversion rates)

12. Assess humoral immunogenicity of ChAdOx1 nCoV-19: seroconversion

Proportion of seroconversion to antibodies against SARS-CoV-2 spike protein at Day

Interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot) responses to SARS-

Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days

Antibodies against SARS-CoV-2 spike protein at Day 56 post-vaccination

Proportion of seroconversion to antibodies against SARS-CoV-2 spike protein at Day

Other Outcome Measures:

2. Exploratory Immunology by flow cytometry [ Time Frame: 6 months ]

Cell analysis by flow cytometry assays

3. Exploratory Immunology by functional antibody assays [ Time Frame: 6 months ]

Functional antibody assays

4. Exploratory Immunology: anti-vector immunity [ Time Frame: 6 months ]

Anti-vector immunity induced by 1 or 2 doses of ChAdOx1 nCoV-19

5. Measure exposure to COVID-19 [ Time Frame: 6 months ]

Reported by weekly survey to collect information about cases amongst household

Number of PCR or NAAT positive cases of COVID-19 infection

7. Exploratory efficacy against infection: assess efficacy of the candidate ChAdOx1

8. Compare safety, reactogenicity and immunogenicity between different manufacturing

Differences in safety, reactogenicity and immunogenicity profiles between Group 1 in

9. Compare safety, reactogenicity and immunogenicity between different methods for

Differences in safety, reactogenicity and immunogenicity profiles between Groups 1,

Nasal mucosa IgA levels at D0 and D28 in a subset of individuals

12. Compare immunogenicity of ChAdOx1 nCoV-19 in participants receiving 1 or 2

Differences in antibody titres (ELISA and Neutralising antibodies) in participants who

13. Compare immunogenicity of ChAdOx1 nCoV-19 in participants receiving 1 or 2

Differences reactogenicity profile, antibody titres and T-cell responses between

Cell-mediated and humoral responses against SARS-Cov-2 These will be measured

Relationship between nadir CD4 count vs vaccine immune responses

Relationship between age at enrolment and vaccine immune response

Immune responses to ChAdOx1 nCoV-19 (assessed as described above)

Measured by the following:

Change in Total HIV DNA copies per million CD4 T cells

21. To assess immunological correlates of protection in relation to occurrence of COVID-

Immunological endpoints (antibody & cellular responses to SARS-COV2 spike

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

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

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

Information from the National Library of Medicine

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