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Removal of the commitment for Immune compromised study (D81111C00010) due to recruitment challenges.
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The aim of this study is to assess the immunogenicity and safety of AZD1222 for prevention of COVID-19 in immunocompromised adults.
The purpose of this study is to demonstrate the immunogenicity and safety of AZD1222, AstraZeneca's approved ChAdOx1 vector vaccine against SARS-CoV-2, in SARS-CoV-2 seronegative immunocompromised individuals who are unvaccinated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 - immunocompromised participants with solid organ transplant | Other | Previously unvaccinated immunocompromised participants with solid organ transplant will receive a primary vaccination series with 3 IM doses of AZD1222 separated by 4 weeks and will be followed to the end of the study. The first dose will be administered on Day 1, the second dose will be administered 28 days after dose 1, and the third dose will be administered 28 days after dose 2. |
|
| Cohort 2 - immunocompromised participants with hematopoietic stem cell transplant | Other | Previously unvaccinated immunocompromised participants with hematopoietic stem cell transplant will receive a primary vaccination series with 3 IM doses of AZD1222 separated by 4 weeks and will be followed to the end of the study. The first dose will be administered on Day 1, the second dose will be administered 28 days after dose 1, and the third dose will be administered 28 days after dose 2. |
|
| Cohort 3 - immunocompromised participants with solid organ cancer receiving cytotoxic chemotherapy | Other | Previously unvaccinated immunocompromised participants with solid organ cancer receiving cytotoxic chemotherapy will receive a primary vaccination series with 3 IM doses of AZD1222 separated by 4 weeks and will be followed to the end of the study. The first dose will be administered on Day 1, the second dose will be administered 28 days after dose 1, and the third dose will be administered 28 days after dose 2. |
|
| Cohort 4 - immunocompromised participants with chronic inflammatory disorders |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD1222 | Biological | 10 mM histidine, 7.5% (w/v) sucrose, 35 mM sodium chloride, 1 mM magnesium chloride, 0.1% (w/v) polysorbate 80, 0.1 mM edetate disodium, 0.5% (w/v) ethanol, at pH 6.6 |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMT) for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibodies (nAb) Post 2-Dose Primary Vaccination of AZD1222 as Measured by Pseudo-neutralization Assay | The GMT was calculated as the antilogarithm of Σ (base 2 log transformed titer/n), that is (i.e.), as the antilogarithm transformation of the mean of the log-transformed titer, where n is the number of participants with titer information. | Days 29 and 57 |
| Percentage of Participants With Seroresponse to SARS-CoV-2 nAb Post 2-Dose Primary Vaccination of AZD1222 as Measured by Pseudo-neutralization Assay | The fold rise was calculated as the ratio of the post-vaccination titer level to the pre-vaccination titer level. The percentage of participants with a post-intervention seroresponse (>=4-fold rise in titers from baseline value to 28 days post doses 1 and 2) to SARS-CoV-2 nAb of AZD1222 as measured by pseudo-neutralization assay is reported. The 2-sided 95% CI was calculated using Clopper-Pearson methodology. | Days 29 and 57 |
| GMT for SARS-CoV-2 Anti-Spike Binding Antibodies Post 2-Dose Primary Vaccination of AZD1222 as Measured by Meso Scale Discovery (MSD) Serology Assay | The GMT was calculated as the antilogarithm of Σ (base 2 log transformed titer/n), i.e, as the antilogarithm transformation of the mean of the log-transformed titer, where n is the number of participants with titer information. | Days 29 and 57 |
| Percentage of Participants With Seroresponse to Anti-Spike Binding Antibodies of a 2-Dose Primary Vaccination of AZD1222 as Measured by MSD Serology Assay | The fold rise was calculated as the ratio of the post-vaccination titer level to the pre-vaccination titer level. The percentage of participants with a post-intervention seroresponse (>=4-fold rise in titers from baseline value to 28 days post doses 1 and 2) to anti-spike binding antibodies of AZD1222 as measured by MSD serology assay is reported. The 2-sided 95% CI was calculated using Clopper-Pearson methodology. |
| Measure | Description | Time Frame |
|---|---|---|
| GMT for SARS-CoV-2 nAb Post Second Dose of AZD1222 as Measured by Pseudo-neutralization Assay | The GMT was calculated as the antilogarithm of Σ (base 2 log transformed titer/n), i.e., as the antilogarithm transformation of the mean of the log-transformed titer, where n is the number of participants with titer information. The ratio of SARS-CoV-2 specific GMT titers 28 days post Dose 2 of AZD1222 was calculated as the ratio of the titer levels in the immunocompromised cohort to the immunocompetent cohort. |
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Inclusion Criteria:
Solid organ transplant
Hematopoietic stem cell transplant
Cancer patients on chemotherapy
Chronic inflammatory conditions
Primary immune deficiency
Immunocompetent:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Bangkok | 10700 | Thailand | |||
| Research Site |
Not provided
| Label | URL |
|---|---|
| Redacted CSR Synopsis | View source |
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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.
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
This study consisted of a screening period (up to 7 days) and a vaccination/follow-up period (up to 365 days). The study was planned to involve a total of 6 cohorts: 5 immunocompromised cohorts (including participants with solid organ transplant, hematopoietic stem cell transplant, solid organ cancer participants receiving cytotoxic chemotherapy, chronic inflammatory disorders and primary immunodeficiency) and 1 immunocompetent cohort.
This Phase IV open-label study was conducted in previously unvaccinated immunocompromised adult participants at 4 sites in Ukraine and Thailand between 31 Jan 2022 and 19 Apr 2023. The study was terminated prematurely due to recruitment challenges, resulting in low sample sizes, especially in the immunocompromised cohorts. Hence, analyses were streamlined.
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| ID | Title | Description |
|---|---|---|
| FG000 | Immunocompromised Cohort | Participants received 3 IM doses of AZD1222 5 × 10^10 vp on Days 1, 29 and 57. |
| FG001 | Immunocompetent Cohort | Participants received 3 IM doses of AZD1222 5 × 10^10 vp on Days 1, 29 and 183. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Safety Analysis set consisted of all participants who received at least 1 dose of study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Immunocompromised Cohort | Participants received 3 IM doses of AZD1222 5 × 10^10 vp on Days 1, 29 and 57. |
| BG001 | Immunocompetent Cohort | Participants received 3 IM doses of AZD1222 5 × 10^10 vp on Days 1, 29 and 183. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Geometric Mean Titers (GMT) for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibodies (nAb) Post 2-Dose Primary Vaccination of AZD1222 as Measured by Pseudo-neutralization Assay | The GMT was calculated as the antilogarithm of Σ (base 2 log transformed titer/n), that is (i.e.), as the antilogarithm transformation of the mean of the log-transformed titer, where n is the number of participants with titer information. | The Immunogenicity Analysis set (IAS) consisted of all participants in the Safety Analysis set who had at least 1 baseline and post-baseline record in immunogenicity data and no protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response. Only those participants with data available were included in the analysis. | Posted | Geometric Mean | 95% Confidence Interval | 1/dilution | Days 29 and 57 |
|
Adverse events are reported from start of treatment administration (Day 1) up to end of study (approximately 15 months)
The Safety Analysis set consisted of all participants who received at least 1 dose of study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Immunocompromised Cohort | Participants received 3 IM doses of AZD1222 5 × 10^10 vp on Days 1, 29 and 57. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Head injury | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
The study was terminated prematurely due to recruitment challenges, resulting in low sample sizes, especially in the immunocompromised cohorts. Hence, all outcome measures, including comparisons between cohorts, should be interpreted with caution.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Lead | AstraZeneca | 1-877-240-9479 | information.center@astrazeneca.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 31, 2022 | Oct 12, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 26, 2023 | Oct 12, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
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| ID | Term |
|---|---|
| D000090985 | ChAdOx1 nCoV-19 |
| ID | Term |
|---|---|
| D019444 | Vaccines, DNA |
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D014612 | Vaccines |
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Previously unvaccinated immunocompromised adults will be enrolled in 5 disease cohorts of approximately 60 participants each:
Immunocompromised participants will receive a third dose (primary vaccination series) 4 weeks or more after dose 2 with AZD1222 and will continue to be followed to the end of the study. Immunocompetent participants will be eligible to receive a third dose booster 6 months after dose 1 and will continue to be followed to the end of the study.
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Previously unvaccinated immunocompromised participants with chronic inflammatory disorders will receive a primary vaccination series with 3 IM doses of AZD1222 separated by 4 weeks and will be followed to the end of the study. The first dose will be administered on Day 1, the second dose will be administered 28 days after dose 1, and the third dose will be administered 28 days after dose 2. |
|
| Cohort 5 - immunocompromised participants with primary immunodeficiency | Other | Previously unvaccinated immunocompromised participants with primary immunodeficiency will receive a primary vaccination series with 3 IM doses of AZD1222 separated by 4 weeks and will be followed to the end of the study. The first dose will be administered on Day 1, the second dose will be administered 28 days after dose 1, and the third dose will be administered 28 days after dose 2. |
|
| Cohort 6 - immunocompetent participants | Other | Previously unvaccinated immunocompetent participants will receive a primary vaccination series with 2 IM doses of AZD1222 separated by 4 weeks, followed by a booster dose of AZD1222 administered 6 months after the first dose. The first dose will be administered on Day 1, the second dose will be administered 28 days after dose 1. Participants will receive a third dose booster 6 months after dose 1 and will continue to be followed to the end of the study. |
|
| Days 29 and 57 |
| Day 57 |
| Percentage of Participants With Seroresponse to SARS-CoV-2 nAb Post Second Dose of AZD1222 as Measured by Pseudo-neutralization Assay | The fold rise was calculated as the ratio of the post-vaccination titer level to the pre-vaccination titer level. The percentage of participants with a post-intervention seroresponse (>=4-fold rise in titers from baseline value to 28 days post Dose 2) to SARS-CoV-2 nAb of AZD1222 as measured by pseudo-neutralization assay is reported, and the 2-sided 95% CI was calculated using Clopper-Pearson methodology. The difference in seroresponse 28 days post Dose 2 of AZD1222 was calculated as (seroresponse rate of immunocompromised cohort) - (seroresponse rate of immunocompetent cohort), and the 2-sided 95% CI was calculated using the Newcombe score without continuity correction. | Day 57 |
| GMT for SARS-CoV-2 Anti-Spike Binding Antibodies Post Second Dose of AZD1222 as Measured by MSD Serology Assay | The GMT was calculated as the antilogarithm of Σ (base 2 log transformed titer/n), i.e., as the antilogarithm transformation of the mean of the log-transformed titer, where n is the number of participants with titer information. The ratio of SARS-CoV-2 specific GMT titers 28 days post Dose 2 of AZD1222 was calculated as the ratio of the titer levels in the immunocompromised cohort to the immunocompetent cohort. | Day 57 |
| Percentage of Participants With Seroresponse to SARS-CoV-2 Anti-Spike Binding Antibodies Post Second Dose of AZD1222 as Measured by MSD Serology Assay | The fold rise was calculated as the ratio of the post-vaccination titer level to the pre-vaccination titer level. The percentage of participants with a post-intervention seroresponse (>=4-fold rise in titers from baseline value to 28 days post Dose 2) to SARS-CoV-2 nAb of AZD1222 as measured by MSD Serology assay is reported, and the 2-sided 95% CI was calculated using Clopper-Pearson methodology. The difference in seroresponse 28 days post Dose 2 of AZD1222 was calculated as (seroresponse rate of immunocompromised cohort) - (seroresponse rate of immunocompetent cohort), and the 2-sided 95% CI was calculated using the Newcombe score without continuity correction. | Day 57 |
| GMT for SARS-CoV-2 nAb Post Third Dose of AZD1222 as Measured by Pseudo-neutralization Assay | The GMT was calculated as the antilogarithm of Σ (base 2 log transformed titer/n), i.e., as the antilogarithm transformation of the mean of the log-transformed titer, where n is the number of participants with titer information. The ratio of SARS-CoV-2 specific GMT titers 28 days post Dose 3 of AZD1222 was calculated as the ratio of the titer levels in the immunocompromised cohort to the immunocompetent cohort. | Day 85 for immunocompromised cohort and Day 211 for immunocompetent cohort |
| Percentage of Participants With Seroresponse to SARS-CoV-2 nAb Post Third Dose of AZD1222 as Measured by Pseudo-neutralization Assay | The fold rise was calculated as the ratio of the post-vaccination titer level to the pre-vaccination titer level. The percentage of participants with a post-intervention seroresponse (>=4-fold rise in titers from baseline value to 28 days post dose 3) to SARS-CoV-2 nAb of AZD1222 as measured by pseudo-neutralization assay is reported, and the 2-sided 95% CI was calculated using Clopper-Pearson methodology. The difference in seroresponse 28 days post Dose 3 of AZD1222 was calculated as (seroresponse rate of immunocompromised cohort) - (seroresponse rate of immunocompetent cohort). | Day 85 for immunocompromised cohort and Day 211 for immunocompetent cohort |
| GMT for SARS-CoV-2 Anti-Spike Binding Antibodies Post Third Dose of AZD1222 as Measured by MSD Serology Assay | The GMT was calculated as the antilogarithm of Σ (base 2 log transformed titer/n), i.e., as the antilogarithm transformation of the mean of the log-transformed titer, where n is the number of participants with titer information. The ratio of SARS-CoV-2 specific GMT titers 28 days post Dose 3 of AZD1222 was calculated as the ratio of the titer levels in the immunocompromised cohort to the immunocompetent cohort. | Day 85 for immunocompromised cohort and Day 211 for immunocompetent cohort |
| Percentage of Participants With Seroresponse to Anti-Spike Binding Antibodies Post Third Dose of AZD1222 as Measured by MSD Serology Assay | The fold rise was calculated as the ratio of the post-vaccination titer level to the pre-vaccination titer level. The percentage of participants with a post-intervention seroresponse (>=4-fold rise in titers from baseline value to 28 days post dose 3) to anti-spike binding antibodies of AZD1222 as measured by MSD serology assay is reported, and the 2-sided 95% CI was calculated using Clopper-Pearson methodology. The difference in seroresponse 28 days post Dose 3 of AZD1222 was calculated as (seroresponse rate of immunocompromised cohort) - (seroresponse rate of immunocompetent cohort). | Day 85 for immunocompromised cohort and Day 211 for immunocompetent cohort |
| Khon Kaen |
| 40002 |
| Thailand |
| Research Site | Muang | 50200 | Thailand |
| Research Site | Kharkiv | 61052 | Ukraine |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
Participants received 3 IM doses of AZD1222 5 × 10^10 vp on Days 1, 29 and 57.
| OG001 | Immunocompetent Cohort | Participants received 3 IM doses of AZD1222 5 × 10^10 vp on Days 1, 29 and 183. |
|
|
| Primary | Percentage of Participants With Seroresponse to SARS-CoV-2 nAb Post 2-Dose Primary Vaccination of AZD1222 as Measured by Pseudo-neutralization Assay | The fold rise was calculated as the ratio of the post-vaccination titer level to the pre-vaccination titer level. The percentage of participants with a post-intervention seroresponse (>=4-fold rise in titers from baseline value to 28 days post doses 1 and 2) to SARS-CoV-2 nAb of AZD1222 as measured by pseudo-neutralization assay is reported. The 2-sided 95% CI was calculated using Clopper-Pearson methodology. | The IAS consisted of all participants in the Safety Analysis set who had at least 1 baseline and post-baseline record in immunogenicity data and no protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response. Only those participants with data available were included in the analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | Days 29 and 57 |
|
|
|
| Primary | GMT for SARS-CoV-2 Anti-Spike Binding Antibodies Post 2-Dose Primary Vaccination of AZD1222 as Measured by Meso Scale Discovery (MSD) Serology Assay | The GMT was calculated as the antilogarithm of Σ (base 2 log transformed titer/n), i.e, as the antilogarithm transformation of the mean of the log-transformed titer, where n is the number of participants with titer information. | The IAS consisted of all participants in the Safety Analysis set who had at least 1 baseline and post-baseline record in immunogenicity data and no protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response. Only those participants with data available were included in the analysis. | Posted | Geometric Mean | 95% Confidence Interval | arbitrary units (AU)/milliliter (mL) | Days 29 and 57 |
|
|
|
| Primary | Percentage of Participants With Seroresponse to Anti-Spike Binding Antibodies of a 2-Dose Primary Vaccination of AZD1222 as Measured by MSD Serology Assay | The fold rise was calculated as the ratio of the post-vaccination titer level to the pre-vaccination titer level. The percentage of participants with a post-intervention seroresponse (>=4-fold rise in titers from baseline value to 28 days post doses 1 and 2) to anti-spike binding antibodies of AZD1222 as measured by MSD serology assay is reported. The 2-sided 95% CI was calculated using Clopper-Pearson methodology. | The IAS consisted of all participants in the Safety Analysis set who had at least 1 baseline and post-baseline record in immunogenicity data and no protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response. Only those participants with data available were included in the analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | Days 29 and 57 |
|
|
|
| Secondary | GMT for SARS-CoV-2 nAb Post Second Dose of AZD1222 as Measured by Pseudo-neutralization Assay | The GMT was calculated as the antilogarithm of Σ (base 2 log transformed titer/n), i.e., as the antilogarithm transformation of the mean of the log-transformed titer, where n is the number of participants with titer information. The ratio of SARS-CoV-2 specific GMT titers 28 days post Dose 2 of AZD1222 was calculated as the ratio of the titer levels in the immunocompromised cohort to the immunocompetent cohort. | The IAS consisted of all participants in the Safety Analysis set who had at least 1 baseline and post-baseline record in immunogenicity data and no protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response. Only those participants with data available were included in the analysis. | Posted | Geometric Mean | 95% Confidence Interval | 1/dilution | Day 57 |
|
|
|
|
| Secondary | Percentage of Participants With Seroresponse to SARS-CoV-2 nAb Post Second Dose of AZD1222 as Measured by Pseudo-neutralization Assay | The fold rise was calculated as the ratio of the post-vaccination titer level to the pre-vaccination titer level. The percentage of participants with a post-intervention seroresponse (>=4-fold rise in titers from baseline value to 28 days post Dose 2) to SARS-CoV-2 nAb of AZD1222 as measured by pseudo-neutralization assay is reported, and the 2-sided 95% CI was calculated using Clopper-Pearson methodology. The difference in seroresponse 28 days post Dose 2 of AZD1222 was calculated as (seroresponse rate of immunocompromised cohort) - (seroresponse rate of immunocompetent cohort), and the 2-sided 95% CI was calculated using the Newcombe score without continuity correction. | The IAS consisted of all participants in the Safety Analysis set who had at least 1 baseline and post-baseline record in immunogenicity data and no protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response. Only those participants with data available were included in the analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 57 |
|
|
|
|
| Secondary | GMT for SARS-CoV-2 Anti-Spike Binding Antibodies Post Second Dose of AZD1222 as Measured by MSD Serology Assay | The GMT was calculated as the antilogarithm of Σ (base 2 log transformed titer/n), i.e., as the antilogarithm transformation of the mean of the log-transformed titer, where n is the number of participants with titer information. The ratio of SARS-CoV-2 specific GMT titers 28 days post Dose 2 of AZD1222 was calculated as the ratio of the titer levels in the immunocompromised cohort to the immunocompetent cohort. | The IAS consisted of all participants in the Safety Analysis set who had at least 1 baseline and post-baseline record in immunogenicity data and no protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response. Only those participants with data available were included in the analysis. | Posted | Geometric Mean | 95% Confidence Interval | arbitrary units (AU)/milliliters (mL) | Day 57 |
|
|
|
|
| Secondary | Percentage of Participants With Seroresponse to SARS-CoV-2 Anti-Spike Binding Antibodies Post Second Dose of AZD1222 as Measured by MSD Serology Assay | The fold rise was calculated as the ratio of the post-vaccination titer level to the pre-vaccination titer level. The percentage of participants with a post-intervention seroresponse (>=4-fold rise in titers from baseline value to 28 days post Dose 2) to SARS-CoV-2 nAb of AZD1222 as measured by MSD Serology assay is reported, and the 2-sided 95% CI was calculated using Clopper-Pearson methodology. The difference in seroresponse 28 days post Dose 2 of AZD1222 was calculated as (seroresponse rate of immunocompromised cohort) - (seroresponse rate of immunocompetent cohort), and the 2-sided 95% CI was calculated using the Newcombe score without continuity correction. | The IAS consisted of all participants in the Safety Analysis set who had at least 1 baseline and post-baseline record in immunogenicity data and no protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response. Only those participants with data available were included in the analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 57 |
|
|
|
|
| Secondary | GMT for SARS-CoV-2 nAb Post Third Dose of AZD1222 as Measured by Pseudo-neutralization Assay | The GMT was calculated as the antilogarithm of Σ (base 2 log transformed titer/n), i.e., as the antilogarithm transformation of the mean of the log-transformed titer, where n is the number of participants with titer information. The ratio of SARS-CoV-2 specific GMT titers 28 days post Dose 3 of AZD1222 was calculated as the ratio of the titer levels in the immunocompromised cohort to the immunocompetent cohort. | The IAS consisted of all participants in the Safety Analysis set who had at least 1 baseline and post-baseline record in immunogenicity data and no protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response. Only those participants with data available were included in the analysis. | Posted | Geometric Mean | 95% Confidence Interval | 1/dilution | Day 85 for immunocompromised cohort and Day 211 for immunocompetent cohort |
|
|
|
|
| Secondary | Percentage of Participants With Seroresponse to SARS-CoV-2 nAb Post Third Dose of AZD1222 as Measured by Pseudo-neutralization Assay | The fold rise was calculated as the ratio of the post-vaccination titer level to the pre-vaccination titer level. The percentage of participants with a post-intervention seroresponse (>=4-fold rise in titers from baseline value to 28 days post dose 3) to SARS-CoV-2 nAb of AZD1222 as measured by pseudo-neutralization assay is reported, and the 2-sided 95% CI was calculated using Clopper-Pearson methodology. The difference in seroresponse 28 days post Dose 3 of AZD1222 was calculated as (seroresponse rate of immunocompromised cohort) - (seroresponse rate of immunocompetent cohort). | The IAS consisted of all participants in the Safety Analysis set who had at least 1 baseline and post-baseline record in immunogenicity data and no protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response. Only those participants with data available were included in the analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 85 for immunocompromised cohort and Day 211 for immunocompetent cohort |
|
|
|
|
| Secondary | GMT for SARS-CoV-2 Anti-Spike Binding Antibodies Post Third Dose of AZD1222 as Measured by MSD Serology Assay | The GMT was calculated as the antilogarithm of Σ (base 2 log transformed titer/n), i.e., as the antilogarithm transformation of the mean of the log-transformed titer, where n is the number of participants with titer information. The ratio of SARS-CoV-2 specific GMT titers 28 days post Dose 3 of AZD1222 was calculated as the ratio of the titer levels in the immunocompromised cohort to the immunocompetent cohort. | The IAS consisted of all participants in the Safety Analysis set who had at least 1 baseline and post-baseline record in immunogenicity data and no protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response. Only those participants with data available were included in the analysis. | Posted | Geometric Mean | 95% Confidence Interval | arbitrary units (AU)/milliliters (mL) | Day 85 for immunocompromised cohort and Day 211 for immunocompetent cohort |
|
|
|
|
| Secondary | Percentage of Participants With Seroresponse to Anti-Spike Binding Antibodies Post Third Dose of AZD1222 as Measured by MSD Serology Assay | The fold rise was calculated as the ratio of the post-vaccination titer level to the pre-vaccination titer level. The percentage of participants with a post-intervention seroresponse (>=4-fold rise in titers from baseline value to 28 days post dose 3) to anti-spike binding antibodies of AZD1222 as measured by MSD serology assay is reported, and the 2-sided 95% CI was calculated using Clopper-Pearson methodology. The difference in seroresponse 28 days post Dose 3 of AZD1222 was calculated as (seroresponse rate of immunocompromised cohort) - (seroresponse rate of immunocompetent cohort). | The IAS consisted of all participants in the Safety Analysis set who had at least 1 baseline and post-baseline record in immunogenicity data and no protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response. Only those participants with data available were included in the analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 85 for immunocompromised cohort and Day 211 for immunocompetent cohort |
|
|
|
|
| 1 |
| 11 |
| 1 |
| 11 |
| 7 |
| 11 |
| EG001 | Immunocompetent Cohort | Participants received 3 IM doses of AZD1222 5 × 10^10 vp on Days 1, 29 and 183. | 0 | 23 | 4 | 23 | 11 | 23 |
| COVID-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Oxygen saturation decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 25.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Allergy to arthropod sting | Immune system disorders | MedDRA 25.1 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
Not provided
Not provided
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001688 |
| Biological Products |
| D045424 | Complex Mixtures |
| D000086663 | COVID-19 Vaccines |
| D014765 | Viral Vaccines |
| Day 57 |
|
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| Day 57 |
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| Day 57 |
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