Trial Outcomes & Findings for A Study of AZD1222, a Vaccine for the Prevention of COVID-19 in Immunocompromised Adults (NCT NCT05057897)

Last Updated: 2025-01-27

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

34 participants

Primary outcome timeframe

Days 29 and 57

Results posted on

2025-01-27

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Immunocompromised Cohort Participants received 3 IM doses of AZD1222 5 × 10\^10 vp on Days 1, 29 and 57.	Immunocompetent Cohort Participants received 3 IM doses of AZD1222 5 × 10\^10 vp on Days 1, 29 and 183.
Overall Study STARTED	11	23
Overall Study Received 1 Dose	11	23
Overall Study Received 2 Doses	9	20
Overall Study Received 3 Doses	6	13
Overall Study COMPLETED	8	21
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Immunocompromised Cohort Participants received 3 IM doses of AZD1222 5 × 10\^10 vp on Days 1, 29 and 57.	Immunocompetent Cohort Participants received 3 IM doses of AZD1222 5 × 10\^10 vp on Days 1, 29 and 183.
Overall Study Site closure	2	2
Overall Study Death	1	0

Baseline Characteristics

A Study of AZD1222, a Vaccine for the Prevention of COVID-19 in Immunocompromised Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Immunocompromised Cohort n=11 Participants Participants received 3 IM doses of AZD1222 5 × 10\^10 vp on Days 1, 29 and 57.	Immunocompetent Cohort n=23 Participants Participants received 3 IM doses of AZD1222 5 × 10\^10 vp on Days 1, 29 and 183.	Total n=34 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	21 Participants n=7 Participants	28 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	11 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	12 Participants n=7 Participants	16 Participants n=5 Participants
Race/Ethnicity, Customized White	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Asian	9 Participants n=5 Participants	21 Participants n=7 Participants	30 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	11 Participants n=5 Participants	23 Participants n=7 Participants	34 Participants n=5 Participants

PRIMARY outcome

Timeframe: Days 29 and 57

Population: 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.

Outcome measures

Outcome measures
Measure	Immunocompromised Cohort n=9 Participants Participants received 3 IM doses of AZD1222 5 × 10\^10 vp on Days 1, 29 and 57.	Immunocompetent Cohort n=18 Participants Participants received 3 IM doses of AZD1222 5 × 10\^10 vp on Days 1, 29 and 183.
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 Day 29	47.7 1/dilution Interval 14.9 to 152.6	67.9 1/dilution Interval 31.5 to 146.3
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 Day 57	122.0 1/dilution Interval 31.0 to 479.7	166.5 1/dilution Interval 96.2 to 288.1

PRIMARY outcome

Timeframe: Days 29 and 57

Population: 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.

Outcome measures

Outcome measures
Measure	Immunocompromised Cohort n=9 Participants Participants received 3 IM doses of AZD1222 5 × 10\^10 vp on Days 1, 29 and 57.	Immunocompetent Cohort n=18 Participants Participants received 3 IM doses of AZD1222 5 × 10\^10 vp on Days 1, 29 and 183.
Percentage of Participants With Seroresponse to SARS-CoV-2 nAb Post 2-Dose Primary Vaccination of AZD1222 as Measured by Pseudo-neutralization Assay Day 29	22.2 percentage of participants Interval 2.8 to 60.0	44.4 percentage of participants Interval 21.5 to 69.2
Percentage of Participants With Seroresponse to SARS-CoV-2 nAb Post 2-Dose Primary Vaccination of AZD1222 as Measured by Pseudo-neutralization Assay Day 57	62.5 percentage of participants Interval 24.5 to 91.5	92.9 percentage of participants Interval 66.1 to 99.8

PRIMARY outcome

Timeframe: Days 29 and 57

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.

Outcome measures

Outcome measures
Measure	Immunocompromised Cohort n=9 Participants Participants received 3 IM doses of AZD1222 5 × 10\^10 vp on Days 1, 29 and 57.	Immunocompetent Cohort n=18 Participants Participants received 3 IM doses of AZD1222 5 × 10\^10 vp on Days 1, 29 and 183.
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 Day 29	3997.2 arbitrary units (AU)/milliliter (mL) Interval 1285.9 to 12425.7	19134.7 arbitrary units (AU)/milliliter (mL) Interval 10824.2 to 33825.8
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 Day 57	13262.8 arbitrary units (AU)/milliliter (mL) Interval 1617.8 to 108732.5	28320.9 arbitrary units (AU)/milliliter (mL) Interval 20744.6 to 38664.1

PRIMARY outcome

Timeframe: Days 29 and 57

Outcome measures

Outcome measures
Measure	Immunocompromised Cohort n=9 Participants Participants received 3 IM doses of AZD1222 5 × 10\^10 vp on Days 1, 29 and 57.	Immunocompetent Cohort n=18 Participants Participants received 3 IM doses of AZD1222 5 × 10\^10 vp on Days 1, 29 and 183.
Percentage of Participants With Seroresponse to Anti-Spike Binding Antibodies of a 2-Dose Primary Vaccination of AZD1222 as Measured by MSD Serology Assay Day 29	88.9 percentage of participants Interval 51.8 to 99.7	100 percentage of participants Interval 81.5 to Due to the point estimate of 100% being on the boundary (0% or 100%), only the lower bound of the confidence interval (CI) is meaningful. To reflect this, the upper bound is reported as NA instead of 100.
Percentage of Participants With Seroresponse to Anti-Spike Binding Antibodies of a 2-Dose Primary Vaccination of AZD1222 as Measured by MSD Serology Assay Day 57	75.0 percentage of participants Interval 34.9 to 96.8	100 percentage of participants Interval 76.8 to Due to the point estimate of 100% being on the boundary (0% or 100%), only the lower bound of the confidence interval (CI) is meaningful. To reflect this, the upper bound is reported as NA instead of 100.

SECONDARY outcome

Timeframe: Day 57

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.

Outcome measures

Outcome measures
Measure	Immunocompromised Cohort n=8 Participants Participants received 3 IM doses of AZD1222 5 × 10\^10 vp on Days 1, 29 and 57.	Immunocompetent Cohort n=14 Participants Participants received 3 IM doses of AZD1222 5 × 10\^10 vp on Days 1, 29 and 183.
GMT for SARS-CoV-2 nAb Post Second Dose of AZD1222 as Measured by Pseudo-neutralization Assay	122.0 1/dilution Interval 31.0 to 479.7	166.5 1/dilution Interval 96.2 to 288.1

SECONDARY outcome

Timeframe: Day 57

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.

Outcome measures

Outcome measures
Measure	Immunocompromised Cohort n=8 Participants Participants received 3 IM doses of AZD1222 5 × 10\^10 vp on Days 1, 29 and 57.	Immunocompetent Cohort n=14 Participants Participants received 3 IM doses of AZD1222 5 × 10\^10 vp on Days 1, 29 and 183.
Percentage of Participants With Seroresponse to SARS-CoV-2 nAb Post Second Dose of AZD1222 as Measured by Pseudo-neutralization Assay	62.5 percentage of participants Interval 24.5 to 91.5	92.9 percentage of participants Interval 66.1 to 99.8

SECONDARY outcome

Timeframe: Day 57

Outcome measures

Outcome measures
Measure	Immunocompromised Cohort n=8 Participants Participants received 3 IM doses of AZD1222 5 × 10\^10 vp on Days 1, 29 and 57.	Immunocompetent Cohort n=14 Participants Participants received 3 IM doses of AZD1222 5 × 10\^10 vp on Days 1, 29 and 183.
GMT for SARS-CoV-2 Anti-Spike Binding Antibodies Post Second Dose of AZD1222 as Measured by MSD Serology Assay	13262.8 arbitrary units (AU)/milliliters (mL) Interval 1617.8 to 108732.5	28320.9 arbitrary units (AU)/milliliters (mL) Interval 20744.6 to 38664.1

SECONDARY outcome

Timeframe: Day 57

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.

Outcome measures

Outcome measures
Measure	Immunocompromised Cohort n=8 Participants Participants received 3 IM doses of AZD1222 5 × 10\^10 vp on Days 1, 29 and 57.	Immunocompetent Cohort n=14 Participants Participants received 3 IM doses of AZD1222 5 × 10\^10 vp on Days 1, 29 and 183.
Percentage of Participants With Seroresponse to SARS-CoV-2 Anti-Spike Binding Antibodies Post Second Dose of AZD1222 as Measured by MSD Serology Assay	75.0 percentage of participants Interval 34.9 to 96.8	100 percentage of participants Interval 76.8 to Due to the point estimate of 100% being on the boundary (0% or 100%), only the lower bound of the confidence interval (CI) is meaningful. To reflect this, the upper bound is reported as NA instead of 100.

SECONDARY outcome

Timeframe: Day 85 for immunocompromised cohort and Day 211 for immunocompetent cohort

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.

Outcome measures

Outcome measures
Measure	Immunocompromised Cohort n=2 Participants Participants received 3 IM doses of AZD1222 5 × 10\^10 vp on Days 1, 29 and 57.	Immunocompetent Cohort n=12 Participants Participants received 3 IM doses of AZD1222 5 × 10\^10 vp on Days 1, 29 and 183.
GMT for SARS-CoV-2 nAb Post Third Dose of AZD1222 as Measured by Pseudo-neutralization Assay	224.5 1/dilution Interval 13.6 to 3717.8	710.3 1/dilution Interval 345.3 to 1461.3

SECONDARY outcome

Timeframe: Day 85 for immunocompromised cohort and Day 211 for immunocompetent cohort

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).

Outcome measures

Outcome measures
Measure	Immunocompromised Cohort n=2 Participants Participants received 3 IM doses of AZD1222 5 × 10\^10 vp on Days 1, 29 and 57.	Immunocompetent Cohort n=12 Participants Participants received 3 IM doses of AZD1222 5 × 10\^10 vp on Days 1, 29 and 183.
Percentage of Participants With Seroresponse to SARS-CoV-2 nAb Post Third Dose of AZD1222 as Measured by Pseudo-neutralization Assay	100 percentage of participants Interval 15.8 to Due to the point estimate of 100% being on the boundary (0% or 100%), only the lower bound of the confidence interval (CI) is meaningful. To reflect this, the upper bound is reported as NA instead of 100.	100 percentage of participants Interval 73.5 to Due to the point estimate of 100% being on the boundary (0% or 100%), only the lower bound of the confidence interval (CI) is meaningful. To reflect this, the upper bound is reported as NA instead of 100.

SECONDARY outcome

Timeframe: Day 85 for immunocompromised cohort and Day 211 for immunocompetent cohort

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.

Outcome measures

Outcome measures
Measure	Immunocompromised Cohort n=2 Participants Participants received 3 IM doses of AZD1222 5 × 10\^10 vp on Days 1, 29 and 57.	Immunocompetent Cohort n=12 Participants Participants received 3 IM doses of AZD1222 5 × 10\^10 vp on Days 1, 29 and 183.
GMT for SARS-CoV-2 Anti-Spike Binding Antibodies Post Third Dose of AZD1222 as Measured by MSD Serology Assay	48303.4 arbitrary units (AU)/milliliters (mL) Interval 4118.7 to 566496.7	86462.9 arbitrary units (AU)/milliliters (mL) Interval 47538.3 to 157259.2

SECONDARY outcome

Timeframe: Day 85 for immunocompromised cohort and Day 211 for immunocompetent cohort

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).

Outcome measures

Outcome measures
Measure	Immunocompromised Cohort n=2 Participants Participants received 3 IM doses of AZD1222 5 × 10\^10 vp on Days 1, 29 and 57.	Immunocompetent Cohort n=12 Participants Participants received 3 IM doses of AZD1222 5 × 10\^10 vp on Days 1, 29 and 183.
Percentage of Participants With Seroresponse to Anti-Spike Binding Antibodies Post Third Dose of AZD1222 as Measured by MSD Serology Assay	100 percentage of participants Interval 15.8 to Due to the point estimate of 100% being on the boundary (0% or 100%), only the lower bound of the confidence interval (CI) is meaningful. To reflect this, the upper bound is reported as NA instead of 100.	100 percentage of participants Interval 73.5 to Due to the point estimate of 100% being on the boundary (0% or 100%), only the lower bound of the confidence interval (CI) is meaningful. To reflect this, the upper bound is reported as NA instead of 100.

Adverse Events

Immunocompromised Cohort

Serious events: 1 serious events

Other events: 7 other events

Deaths: 1 deaths

Immunocompetent Cohort

Serious events: 4 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Immunocompromised Cohort n=11 participants at risk Participants received 3 IM doses of AZD1222 5 × 10\^10 vp on Days 1, 29 and 57.	Immunocompetent Cohort n=23 participants at risk Participants received 3 IM doses of AZD1222 5 × 10\^10 vp on Days 1, 29 and 183.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	9.1% 1/11 • Number of events 1 • 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.	0.00% 0/23 • 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.
Infections and infestations COVID-19	0.00% 0/11 • 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.	17.4% 4/23 • Number of events 4 • 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.

Other adverse events

Additional Information

Global Clinical Lead

AstraZeneca

Phone: 1-877-240-9479

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Immunocompromised Cohort n=11 participants at risk Participants received 3 IM doses of AZD1222 5 × 10\^10 vp on Days 1, 29 and 57.	Immunocompetent Cohort n=23 participants at risk Participants received 3 IM doses of AZD1222 5 × 10\^10 vp on Days 1, 29 and 183.
Injury, poisoning and procedural complications Head injury	0.00% 0/11 • 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.	4.3% 1/23 • Number of events 1 • 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.
Injury, poisoning and procedural complications Ligament sprain	9.1% 1/11 • Number of events 1 • 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.	0.00% 0/23 • 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.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/11 • 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.	4.3% 1/23 • Number of events 1 • 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.
Investigations Alanine aminotransferase increased	9.1% 1/11 • Number of events 1 • 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.	0.00% 0/23 • 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.
Investigations Aspartate aminotransferase increased	9.1% 1/11 • Number of events 1 • 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.	0.00% 0/23 • 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.
Investigations Oxygen saturation decreased	0.00% 0/11 • 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.	4.3% 1/23 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/11 • 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.	4.3% 1/23 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/11 • 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.	4.3% 1/23 • Number of events 1 • 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.
Skin and subcutaneous tissue disorders Urticaria	9.1% 1/11 • Number of events 1 • 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.	0.00% 0/23 • 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.
Blood and lymphatic system disorders Eosinophilia	0.00% 0/11 • 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.	4.3% 1/23 • Number of events 1 • 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.
Vascular disorders Hypertension	0.00% 0/11 • 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.	4.3% 1/23 • Number of events 1 • 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.
Ear and labyrinth disorders Vertigo	9.1% 1/11 • Number of events 1 • 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.	0.00% 0/23 • 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.
Gastrointestinal disorders Dyspepsia	0.00% 0/11 • 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.	4.3% 1/23 • Number of events 1 • 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.
Gastrointestinal disorders Toothache	0.00% 0/11 • 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.	4.3% 1/23 • Number of events 1 • 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.
General disorders Injection site pain	0.00% 0/11 • 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.	4.3% 1/23 • Number of events 1 • 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.
Immune system disorders Allergy to arthropod sting	9.1% 1/11 • Number of events 1 • 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.	0.00% 0/23 • 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.
Infections and infestations COVID-19	45.5% 5/11 • Number of events 5 • 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.	21.7% 5/23 • Number of events 6 • 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.
Infections and infestations Upper respiratory tract infection	0.00% 0/11 • 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.	4.3% 1/23 • Number of events 1 • 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.