COVID-19Phase 1/2NCT04568031

Study of AZD1222 for the Prevention of COVID-19 in Japan

A Phase 1/2 study testing AZD1222 and 0.9% (w/v) saline in people with COVID-19, run by AstraZeneca at 5 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The COVID-19 pandemic has caused major disruption to healthcare systems with significant socioeconomic impacts. Currently, there are no licensed preventions available against COVID-19 and accelerated vaccine development is urgently needed. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: COVID-19
What is being tested?: AZD1222 and 0.9% (w/v) saline
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 256 participants
Where: 5 sitesJapan
Study dates: 23 Aug 2020to 22 Nov 2021
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Participants aged 18 to 55 years (Cohort A and C), aged 56 to 69 years (Subcohorts B1 and D1), or aged ≥ 70 years (Subcohorts B2 and D2)

Who cannot join

Known past laboratory-confirmed SARS-CoV-2 infection
Positive SARS-CoV-2 RT PCR test at screening
Seropositivity to SARS-CoV-2 at screening.
Significant infection or other illness, including fever > 37.8°C on the day prior to or day randomization
History of Guillain-Barré syndrome
Any confirmed or suspected immunosuppressive or immunodeficient state; 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)

Show all 15Show fewer

History of allergy to any component of the vaccine
Any history of angioedema
Any history of anaphylaxis
Current diagnosis of or treatment for cancer (except basal cell carcinoma of the skin and uterine cervical carcinoma in situ)
History of serious psychiatric condition likely to affect participation in the study
Bleeding disorder (eg, factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture
Suspected or known current alcohol or drug dependency
Any other significant disease, disorder or finding which may significantly increase the risk to the participant because of participation in the study, affect the ability of the participant 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)

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Japan5 sites

Research Site
Fukuoka, 810-0021
Research Site
Hachioji-shi, 192-0046
Research Site
Minatoku, 108-0075
Research Site
Sumida-ku, 130-0004
Research Site
Toshima-ku, 171-0021

Other trials in Japan

About this study

Official title: A Phase I/II Randomized, Double-blind, Placebo-controlled Multicentre Study in Participants Aged 18 Years or Older to Determine the Safety and Immunogenicity of AZD1222, a Non-replicating ChAdOx1 Vector Vaccine, for the Prevention of COVID-19

Conditions: COVID-19
Being tested: AZD1222, 0.9% (w/v) saline
Keywords: COVID-19 Vaccine
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AZD1222Drug
For subjects in part 1 will have that route of Administration as Intramuscular, 5 × 1010 vp (nominal, ± 1.5 × 1010 vp) on V2
0.9% (w/v) salineDrug
For subjects in placebo will have that route of Administration as Intramuscular 0.9% (w/v) saline on V2 and V6.

Study groups in NCT04568031
Study group	Role	What they receive
Part I	Active comparator	Cohort C will include healthy participants aged 18 to 55 years. Cohort D will include healthy elderly participants aged ≥ 56 years. In Cohort D, the elderly population is further divided into 2 different age subgroups; aged 56 to 69 years (Subcohort D1) and aged ≥ 70 years (Subcohort D2). At least 30% of participants in Cohort D will be secured for participants with age ≥ 70 years. Receives: Drug: AZD1222
Part II	Placebo comparator	Cohort C will include healthy participants aged 18 to 55 years. Cohort D will include healthy elderly participants aged ≥ 56 years. In Cohort D, the elderly population is further divided into 2 different age subgroups; aged 56 to 69 years (Subcohort D1) and aged ≥ 70 years (Subcohort D2). At least 30% of participants in Cohort D will be secured for participants with age ≥ 70 years. Receives: Drug: 0.9% (w/v) saline

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Seroresponse to the Spike (S) Antigen of AZD1222 as Measured by Meso Scale Discovery (MSD) Serology Assay
Seroresponse is a binary outcome where a success is when the fold rise in titers compared with baseline is >= 4. The fold rise in titers was calculated as the ratio of the post-vaccination titer level to the baseline titer level. The percentage of participants with a post-vaccination seroresponse (>= 4-fold rise in titers from Day 1 baseline value to Day 57) to the S antigen of AZD1222 as measured by MSD serology assay is reported.
Measured: Baseline (Day 1) and Day 57
Number of Participants With Local Solicited Adverse Events (AE)
Solicited AEs are local or systemic predefined AEs for reactogenicity assessment. Participants were given an axillary thermometer, tape measure, and access to app for the solicited AE eDiary, with instructions on use, along with the emergency 24-hour telephone number to contact the on-call study physician if needed. Participants were instructed to record for 7 days following administration of each dose of AZD1222, the timing and severity of local and systemic solicited AEs, if applicable, and whether medication was taken to relieve the symptoms.
Measured: From Day 1 up to 7 days post each dose of study vaccination, approximately 14 days
Number of Participants With Systemic Solicited AEs
Solicited AEs are local or systemic predefined AEs for reactogenicity assessment. Participants were given an axillary thermometer, tape measure, and access to app for the solicited AE eDiary, with instructions on use, along with the emergency 24-hour telephone number to contact the on-call study physician if needed. Participants were instructed to record for 7 days following administration of each dose of AZD1222, the timing and severity of local and systemic solicited AEs, if applicable, and whether medication was taken to relieve the symptoms.
Measured: From Day 1 up to 7 days post each dose of study vaccination, approximately 14 days
Number of Participants With AEs, Serious AEs (SAE) and Adverse Event of Special Interest (AESI) Occurring Post Each Dose of Study Vaccination
An AE is the development of any untoward medical occurrence in a clinical study participant administered medicinal product and which does not necessarily have a causal relationship with this medicinal product. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is an AE occurring during any study phase that fulfils one or more of the following criteria: death; immediately life-threatening; in-participant hospitalization or prolongation of existing hospitalization; persistent or significant disability or incapacity; congenital abnormality or birth defect; an important medical event. The AESIs were events of scientific and medical interest specific to the further understanding of the study vaccination safety profile and required close monitoring and rapid communication by the investigators to the sponsor.
Measured: From Day 1 up to 28 days post each dose of study vaccination, approximately 57 days
Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters
Clinical laboratory values were evaluated for each laboratory parameter as applicable including hematology and clinical chemistry. The baseline was defined as the last non-missing measurement taken prior to the first dose of study vaccination (including unscheduled measurements, if any).
Measured: From Day 1 up to 28 days post each dose of study vaccination, approximately 57 days

Secondary outcomes (7)

Percentage of Participants With Seroresponse to the Receptor-Binding Domain (RBD) Antigen of AZD1222 as Measured by MSD Serology Assay
Seroresponse is a binary outcome where a success is when the fold rise in titers compared with baseline is >= 4. The fold rise in titers was calculated as the ratio of the post-vaccination titer level to the baseline titer level. The percentage of participants with a post-vaccination seroresponse (>= 4-fold rise in titers from Day 1 baseline value to Day 57) to the RBD antigen of AZD1222 as measured by MSD serology assay is reported.
Measured: Baseline (Day 1) and Day 57
Geometric Mean Titers (GMTs) for SARS-CoV-2 S and RBD Antibodies as Measured by MSD Serology Assay
The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titer/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titer, where 'n' is the number of participants with titer information.
Measured: Baseline (Day 1) and Days 15, 29, 43, 57, 183, and 365
Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 S and RBD Antibodies as Measured by MSD Serology Assay
The fold rise was calculated as the ratio of the post-vaccination titer level to the baseline titer level, where baseline was defined as the last measurement taken before the first dose of study vaccination. The GMFR was calculated as anti-logarithm of Σ (log base 2 transformed (post-vaccination titer/ pre-vaccination titer)/n). Where 'n' is the number of participants with titer information.
Measured: Baseline (Day 1) and Days 15, 29, 43, 57, 183, and 365
Percentage of Participants With Seroresponse to SARS-CoV-2 Neutralizing Antibodies (nAb) of AZD1222 as Measured by Pseudo-Neutralization Assay
Seroresponse is a binary outcome where a success is when the fold rise in titers compared with baseline is >= 4. The fold rise in titers was calculated as the ratio of the post-vaccination titer level to the baseline titer level. The percentage of participants with a post-vaccination seroresponse (>= 4-fold rise in titers from Day 1 baseline value to Day 57) to SARS-CoV-2 nAb of AZD1222 as measured by pseudo-neutralization assay is reported.
Measured: Baseline (Day 1) and Day 57
GMTs for SARS-CoV-2 nAb as Measured by Pseudo-Neutralization Assay
The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titer/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titer, where 'n' is the number of participants with titer information.
Measured: Baseline (Day 1) and Days 29, 57, 183, and 365
GMFR for SARS-CoV-2 nAb as Measured by Pseudo-Neutralization Assay
The fold rise was calculated as the ratio of the post-vaccination titer level to the baseline titer level, where baseline was defined as the last measurement taken before the first dose of study vaccination. The GMFR was calculated as anti-logarithm of Σ (log base 2 transformed (post-vaccination titer/ pre-vaccination titer)/n). Where 'n' is the number of participants with titer information.
Measured: Baseline (Day 1) and Days 29, 57, 183, and 365
Number of Participants With SAEs and AESIs Occurring Throughout the Study
An SAE is an AE occurring during any study phase that fulfils one or more of the following criteria: death; immediately life-threatening; in-participant hospitalization or prolongation of existing hospitalization; persistent or significant disability or incapacity; congenital abnormality or birth defect; an important medical event. The AESIs were events of scientific and medical interest specific to the further understanding of the study vaccination safety profile and required close monitoring and rapid communication by the investigators to the sponsor.
Measured: From Day 1 up to final DCO of 17 January 2022, up to a maximum of 365 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Aug 202022 Nov 2021

First posted29 Sep 2020
Study start23 Aug 2020
Primary completion22 Nov 2021
Study completion22 Nov 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for COVID-19Studies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 256 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04568031
Sponsor's protocol ID: D8111C00002
Status last verified: Jul 2023
First submitted: 21 Aug 2020
Last updated: 1 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Publications

Ishikawa K, Nascimento MC, Asano M, Hirata H, Itoh Y, Kelly EJ, Matsui A, Olsson U, Shoemaker K, Green J. One year safety and immunogenicity of AZD1222 (ChAdOx1 nCoV-19): Final analysis of a randomized, placebo-controlled phase 1/2 trial in Japan. Vaccine. 2023 Jun 29;41(29):4199-4205. doi: 10.1016/j.vaccine.2023.05.015. Epub 2023 Jun 2.
PubMed 37271703
Asano M, Okada H, Itoh Y, Hirata H, Ishikawa K, Yoshida E, Matsui A, Kelly EJ, Shoemaker K, Olsson U, Vekemans J. Immunogenicity and safety of AZD1222 (ChAdOx1 nCoV-19) against SARS-CoV-2 in Japan: a double-blind, randomized controlled phase 1/2 trial. Int J Infect Dis. 2022 Jan;114:165-174. doi: 10.1016/j.ijid.2021.10.030. Epub 2021 Oct 22.
PubMed 34688944

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I/II Randomized, Double-blind, Placebo-controlled Multicentre Study in Participants Aged 18 Years or Older to Determine the Safety and Immunogenicity of AZD1222, a Non-replicating ChAdOx1 Vector Vaccine, for the Prevention of COVID-19
ClinicalTrials.gov ID: NCT04568031
Acronym / sponsor ID: D8111C00002
Conditions: COVID-19
Keywords: COVID-19 Vaccine
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 256 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: IQVIA Pty Ltd
Study start: 23 Aug 2020 (actual)
Primary completion: 22 Nov 2021 (actual)
Study completion: 22 Nov 2021 (actual)
First posted: 29 Sep 2020 (actual)
Results: Posted 1 Mar 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Part I	Active comparator	Drug: AZD1222Cohort C will include healthy participants aged 18 to 55 years. Cohort D will include healthy elderly participants aged ≥ 56 years. In Cohort D, the elderly population is further divided into 2 different age subgroups; aged 56 to 69 years (Subcohort D1) and aged ≥ 70 years (Subcohort D2). At least 30% of participants in Cohort D will be secured for participants with age ≥ 70 years.
Part II	Placebo comparator	Drug: 0.9% (w/v) salineCohort C will include healthy participants aged 18 to 55 years. Cohort D will include healthy elderly participants aged ≥ 56 years. In Cohort D, the elderly population is further divided into 2 different age subgroups; aged 56 to 69 years (Subcohort D1) and aged ≥ 70 years (Subcohort D2). At least 30% of participants in Cohort D will be secured for participants with age ≥ 70 years.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Participants aged 18 to 55 years (Cohort A and C), aged 56 to 69 years (Subcohorts B1 and D1), or aged ≥ 70 years (Subcohorts B2 and D2)

Key exclusion criteria (15 listed)

Known past laboratory-confirmed SARS-CoV-2 infection
Positive SARS-CoV-2 RT PCR test at screening
Seropositivity to SARS-CoV-2 at screening.
Significant infection or other illness, including fever > 37.8°C on the day prior to or day randomization
History of Guillain-Barré syndrome

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AZD1222For subjects in part 1 will have that route of Administration as Intramuscular, 5 × 1010 vp (nominal, ± 1.5 × 1010 vp) on V2	Drug	Part I
0.9% (w/v) salineFor subjects in placebo will have that route of Administration as Intramuscular 0.9% (w/v) saline on V2 and V6.	Drug	Part II

Primary outcome

Percentage of Participants With Seroresponse to the Spike (S) Antigen of AZD1222 as Measured by Meso Scale Discovery (MSD) Serology Assay
Time frame: Baseline (Day 1) and Day 57
Seroresponse is a binary outcome where a success is when the fold rise in titers compared with baseline is >= 4. The fold rise in titers was calculated as the ratio of the post-vaccination titer level to the baseline titer level. The percentage of participants with a post-vaccination seroresponse (>= 4-fold rise in titers from Day 1 baseline value to Day 57) to the S antigen of AZD1222 as measured by MSD serology assay is reported.
Number of Participants With Local Solicited Adverse Events (AE)
Time frame: From Day 1 up to 7 days post each dose of study vaccination, approximately 14 days
Solicited AEs are local or systemic predefined AEs for reactogenicity assessment. Participants were given an axillary thermometer, tape measure, and access to app for the solicited AE eDiary, with instructions on use, along with the emergency 24-hour telephone number to contact the on-call study physician if needed. Participants were instructed to record for 7 days following administration of each dose of AZD1222, the timing and severity of local and systemic solicited AEs, if applicable, and whether medication was taken to relieve the symptoms.
Number of Participants With Systemic Solicited AEs
Time frame: From Day 1 up to 7 days post each dose of study vaccination, approximately 14 days
Solicited AEs are local or systemic predefined AEs for reactogenicity assessment. Participants were given an axillary thermometer, tape measure, and access to app for the solicited AE eDiary, with instructions on use, along with the emergency 24-hour telephone number to contact the on-call study physician if needed. Participants were instructed to record for 7 days following administration of each dose of AZD1222, the timing and severity of local and systemic solicited AEs, if applicable, and whether medication was taken to relieve the symptoms.
Number of Participants With AEs, Serious AEs (SAE) and Adverse Event of Special Interest (AESI) Occurring Post Each Dose of Study Vaccination
Time frame: From Day 1 up to 28 days post each dose of study vaccination, approximately 57 days
An AE is the development of any untoward medical occurrence in a clinical study participant administered medicinal product and which does not necessarily have a causal relationship with this medicinal product. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is an AE occurring during any study phase that fulfils one or more of the following criteria: death; immediately life-threatening; in-participant hospitalization or prolongation of existing hospitalization; persistent or significant disability or incapacity; congenital abnormality or birth defect; an important medical event. The AESIs were events of scientific and medical interest specific to the further understanding of the study vaccination safety profile and required close monitoring and rapid communication by the investigators to the sponsor.
Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters
Time frame: From Day 1 up to 28 days post each dose of study vaccination, approximately 57 days
Clinical laboratory values were evaluated for each laboratory parameter as applicable including hematology and clinical chemistry. The baseline was defined as the last non-missing measurement taken prior to the first dose of study vaccination (including unscheduled measurements, if any).

7 secondary outcomes

Percentage of Participants With Seroresponse to the Receptor-Binding Domain (RBD) Antigen of AZD1222 as Measured by MSD Serology Assay
Time frame: Baseline (Day 1) and Day 57
Geometric Mean Titers (GMTs) for SARS-CoV-2 S and RBD Antibodies as Measured by MSD Serology Assay
Time frame: Baseline (Day 1) and Days 15, 29, 43, 57, 183, and 365
Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 S and RBD Antibodies as Measured by MSD Serology Assay
Time frame: Baseline (Day 1) and Days 15, 29, 43, 57, 183, and 365
Percentage of Participants With Seroresponse to SARS-CoV-2 Neutralizing Antibodies (nAb) of AZD1222 as Measured by Pseudo-Neutralization Assay
Time frame: Baseline (Day 1) and Day 57
GMTs for SARS-CoV-2 nAb as Measured by Pseudo-Neutralization Assay
Time frame: Baseline (Day 1) and Days 29, 57, 183, and 365
GMFR for SARS-CoV-2 nAb as Measured by Pseudo-Neutralization Assay
Time frame: Baseline (Day 1) and Days 29, 57, 183, and 365
Number of Participants With SAEs and AESIs Occurring Throughout the Study
Time frame: From Day 1 up to final DCO of 17 January 2022, up to a maximum of 365 days

Results and safety

Results posted to the registry on 1 Mar 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort C: AZD1222	96	93
Cohort C: Placebo	32	32
Cohort D: AZD1222	96	91
Cohort D: Placebo	32	31

Primary outcome: Percentage of Participants With Seroresponse to the Spike (S) Antigen of AZD1222 as Measured by Meso Scale Discovery (MSD) Serology Assay

Time frame: Baseline (Day 1) and Day 57. Number. Unit: percentage of participants

Measure	Cohort C: AZD1222 n = 83	Cohort C: Placebo n = 29	Cohort D: AZD1222 n = 91	Cohort D: Placebo n = 31
Value	100.0	0.0	100.0	0.0

Cohort C: AZD1222 vs Cohort C: Placebo: p < 0.001, Fisher Exact
Cohort D: AZD1222 vs Cohort D: Placebo: p < 0.001, Fisher Exact

Population analysed: The Fully vaccinated analysis set (FVS) for immunogenicity included all participants in the TVS who received 2 study vaccinations and had no important protocol deviations judged to have the potential to interfere with the generation or interpretation of immune responses. Only participants evaluated for seroresponse at Day 57 are reported. Participants with seroresponse to nucleocapsid antibodies by MSD serology assay at post-baseline up to Day 57 were excluded from this analysis set.

Primary outcome: Number of Participants With Local Solicited Adverse Events (AE)

Time frame: From Day 1 up to 7 days post each dose of study vaccination, approximately 14 days. Count of participants. Unit: Participants

Measure	Cohort C: AZD1222 n = 96	Cohort C: Placebo n = 32	Cohort D: AZD1222 n = 96	Cohort D: Placebo n = 32
After first vaccination	70	4	46	2
After second vaccination	37	3	36	0
After any vaccination	74	5	53	2

Population analysed: The TVS included all participants who received at least 1 dose of study vaccination.

Primary outcome: Number of Participants With Systemic Solicited AEs

Time frame: From Day 1 up to 7 days post each dose of study vaccination, approximately 14 days. Count of participants. Unit: Participants

Measure	Cohort C: AZD1222 n = 96	Cohort C: Placebo n = 32	Cohort D: AZD1222 n = 96	Cohort D: Placebo n = 32
After first vaccination	65	6	41	3
After second vaccination	30	7	24	3
After any vaccination	68	11	47	5

Population analysed: The TVS included all participants who received at least 1 dose of study vaccination.

Primary outcome: Number of Participants With AEs, Serious AEs (SAE) and Adverse Event of Special Interest (AESI) Occurring Post Each Dose of Study Vaccination

Time frame: From Day 1 up to 28 days post each dose of study vaccination, approximately 57 days. Count of participants. Unit: Participants

Measure	Cohort C: AZD1222 n = 96	Cohort C: Placebo n = 32	Cohort D: AZD1222 n = 96	Cohort D: Placebo n = 32
AEs	28	4	22	9
SAEs	0	1	3	1
AESIs	0	0	0	0

Population analysed: The TVS included all participants who received at least 1 dose of study vaccination. Unsolicited AEs that started after the inoculation of non-study coronavirus disease 2019 vaccine were not included in this analysis.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs are reported from first administration of study vaccination up to final DCO of 17 January 2022, up to a maximum of 365 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohorts C + D: AZD1222	3 of 192 (1.6%)	11 of 192 (5.7%)	0 of 192
Cohorts C + D: Placebo	3 of 64 (4.7%)	0 of 64 (0%)	0 of 64

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37271703Ishikawa K, Nascimento MC, Asano M, Hirata H, Itoh Y, Kelly EJ, Matsui A, Olsson U, Shoemaker K, Green J. One year safety and immunogenicity of AZD1222 (ChAdOx1 nCoV-19): Final analysis of a randomized, placebo-controlled phase 1/2 trial in Japan. Vaccine. 2023 Jun 29;41(29):4199-4205. doi: 10.1016/j.vaccine.2023.05.015. Epub 2023 Jun 2.
Derived from this study: PubMed 34688944Asano M, Okada H, Itoh Y, Hirata H, Ishikawa K, Yoshida E, Matsui A, Kelly EJ, Shoemaker K, Olsson U, Vekemans J. Immunogenicity and safety of AZD1222 (ChAdOx1 nCoV-19) against SARS-CoV-2 in Japan: a double-blind, randomized controlled phase 1/2 trial. Int J Infect Dis. 2022 Jan;114:165-174. doi: 10.1016/j.ijid.2021.10.030. Epub 2021 Oct 22.
Redacted SAPLink provided by the sponsor.
Redacted CSPLink provided by the sponsor.
CSR SynopsisLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AZD1222 and 0.9% (w/v) saline in people with COVID-19, run by AstraZeneca at 5 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Seroresponse to the Spike (S) Antigen of AZD1222 as Measured by Meso Scale Discovery (MSD) Serology Assay (time frame: Baseline (Day 1) and Day 57). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04568031, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2024.