Covid-19 Prevention
Conditions
Keywords
COVID-19, Ad26COVS1, Ad26.COV2.S, SARS CoV 2, Vaccine
Brief summary
The purpose of the study is to assess the safety, reactogenicity, and immunogenicity of Ad26.COV2.S at 2 dose levels, administered intramuscularly (IM) as a single-dose or 2-dose schedule, with a single booster vaccination administered in one cohort in healthy adults aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 years and in adults aged \>= 65 years in good health with or without stable underlying conditions. The purpose of the study is also to assess the safety and reactogenicity of Ad26.COV2.S administered as ad hoc booster vaccination in healthy adults aged \>= 18 to \<= 55 years and in adults \>= 65 years in good health with or without stable underlying conditions.
Interventions
BIOLOGICALAd26.COV2.S
Participants will receive intramuscular (IM) injection of Ad26.COV2.S.
BIOLOGICALPlacebo
Participants will receive Placebo.
Sponsors
Janssen Vaccines & Prevention B.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Participant must sign an informed consent form (ICF) indicating that he or she understands the purpose, procedures, and potential risks and benefits of the study, and is willing to participate in the study * All female participants of childbearing potential must have a negative highly sensitive urine pregnancy test at screening; and have a negative highly sensitive urine pregnancy test immediately prior to each study vaccine administration * Participant must have a body mass index (BMI) less than or equal to (\<=) 30.0 kilograms per square meter (kg/m\^2) * Applicable to Cohorts 1 and 2 only: Participant must be healthy, in the investigator's clinical judgment, as confirmed by medical history, physical examination, clinical laboratory assessments, and vital signs performed at screening, and must not have comorbidities related to an increased risk of severe coronavirus disease-2019 (COVID-19). Applicable to Cohort 3 only: In the investigator's clinical judgment, participant must be either in good or stable health Participants may have underlying illnesses such as hyperlipoproteinemia or hypothyroidism, as long as their symptoms and signs are medically controlled and not considered to be comorbidities related to an increased risk of severe COVID-19 (participants may have medical conditions of mild severity (according to the Toxicity Grading Scale), as long as it is stable and medically controlled as defined by no change in medication over the past 6 months (except for issues of tolerability or use of similar drug with same mechanism of action, for example, thiazides, Beta blockers, Alpha blockers at the same effective dose).
Exclusion criteria
* Participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature greater than or equal to (\>=) 38.0 degree Celsius within 24 hours prior to the planned first dose of study vaccine; randomization at a later date is permitted at the discretion of the investigator and after consultation with the sponsor * Participant has a history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence) * Participant has a history of any neurological disorders or seizures including Guillain-Barre syndrome, with the exception of febrile seizures during childhood * Participant has a positive diagnostic test result for SARS-CoV-2 infection confirmed by polymerase chain reaction (PCR) at screening * Participants with comorbidities that are or might be associated with an increased risk of progression to severe COVID-19, that is, participants with moderate-to-severe asthma; chronic lung diseases such as chronic obstructive pulmonary disease (COPD) (including emphysema and chronic bronchitis), idiopathic pulmonary fibrosis and cystic fibrosis; diabetes (including type 1 or type 2); serious heart conditions, including heart failure, coronary artery disease, congenital heart disease, cardiomyopathies, and (pulmonary) hypertension or high blood pressure; obesity (BMI \>= 30 kg/m\^2); chronic liver disease, including cirrhosis; sickle cell disease; thalassemia; cerebrovascular disease; neurologic conditions (dementia); smoking end stage renal disease; organ transplantation; cancer; HIV infection and other immunodeficiencies; hepatitis B infection; and sleep apnea. Applicable to Cohort 3 only: Participants may have hypertension of mild severity (according to the Toxicity Grading Scale), as long as it is stable and medically controlled as defined by no change in medication over the past 6 months (except for issues of tolerability or use of similar drug with same mechanism of action, for example, thiazides, Beta blockers, Alpha blockers at the same effective dose) * Applicable to Cohorts 1 and 3 only: Participant currently working in an occupation with a high risk of exposure to SARS-CoV-2 (for example, health care worker or emergency response personnel) or considered at the investigator's discretion to be at increased risk to acquire COVID-19 for any other reason
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cohorts 2a and 2b: Number of Participants With Adverse Events of Special Interest (AESIs) | Day 1 up to 6 months post primary regimen (up to Day 183 for Cohort 2a; up to Day 239 for Cohort 2b) | Number of participants with AESIs was reported. AESIs were significant AEs that were judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with Thrombocytopenia Syndrome (TTS), a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia, was considered to be an AESI in this study. A suspected TTS case was defined as: Thrombotic events: suspected deep vessel venous or arterial thrombotic events; Thrombocytopenia, defined as platelet count below 150,000/microliter. |
| Cohort 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Booster Vaccination 2 | 7 days after booster vaccination 2 on Day 422 (Day 429) | Number of participants with solicited systemic AEs for 7 days after booster vaccination 2 in Cohort 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days). |
| Cohort 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination | 7 days after ad hoc booster vaccination (Day 369 up to Day 412) | Number of participants with solicited systemic AEs for 7 days after ad hoc booster vaccination in Cohort 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post ad hoc booster vaccination (day of ad hoc booster vaccination and the subsequent 7 days). |
| Cohort 3: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen | 7 days after vaccination 1 on Day 1 (Day 8) | Number of participants with solicited local AEs for 7 days after vaccination 1 in Cohort 3 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site). |
| Cohort 3: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen | 7 days post-vaccination 1 on Day 1 (Day 8) | Number of participants with solicited systemic AEs for 7 days after vaccination 1 in Cohort 3 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days). |
| Cohort 3: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen | 7 days post-vaccination 2 on Day 57 (Day 64) | Number of participants with solicited local AEs for 7 days after vaccination 2 in Cohort 3 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site). |
| Cohort 3: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen | 7 after post-vaccination 2 on Day 57 (Day 64) | Number of participants with solicited systemic AEs for 7 days after vaccination 2 in Cohort 3 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days). |
| Cohort 3: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination | 7 days after ad hoc booster vaccination (Day 456 up to Day 711) | Number of participants with solicited local AEs for 7 days after ad hoc booster vaccination in Cohort 3 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site). |
| Cohort 3: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination | 7 days after ad hoc booster vaccination (Day 456 up to Day 711) | Number of participants with solicited systemic AEs for 7 days after ad hoc booster vaccination in Cohort 3 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post ad hoc booster vaccination (day of ad hoc booster vaccination and the subsequent 7 days). |
| Cohorts 1a and 1b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 1 in the Primary Regimen | 28 days after vaccination 1 on Day 1 (Day 29) | Number of participants with unsolicited AEs after vaccination 1 in Cohorts 1a and 1b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary. |
| Cohorts 1a and 1b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 2 in the Primary Regimen | 28 days after vaccination 2 on Day 57 (Day 85) | Number of participants with unsolicited AEs after vaccination 2 in Cohorts 1a and 1b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary. |
| Cohorts 1a and 1b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Ad Hoc Booster Vaccination | 28 days after ad hoc booster vaccination (Day 488 up to Day 625) | Number of participants with unsolicited AEs after ad hoc booster vaccination in Cohorts 1a and 1b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary. |
| Cohorts 2a and 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 1 in the Primary Regimen | 28 days after Vaccination 1 on Day 1 (Day 29) | Number of participants with unsolicited AEs after vaccination 1 in Cohorts 2a and 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary. |
| Cohort 2a: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Booster Vaccination 1 | 28 days after booster vaccination 1 on Day 183 (Day 211) | Number of participants with unsolicited AEs after booster 1 vaccination in Cohort 2a were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary. |
| Cohort 2a: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Booster Vaccination 2 | 28 days after booster vaccination 2 on Day 366 (Day 394) | Number of participants with unsolicited AEs after booster vaccination 2 in Cohort 2a were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary. |
| Cohort 2a: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Ad Hoc Booster Vaccination | 28 days after ad hoc booster vaccination (Day 384 up to Day 472) | Number of participants with unsolicited AEs after ad hoc booster vaccination in Cohort 2a were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary. |
| Cohort 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 2 in the Primary Regimen | 28 days after Vaccination 2 on Day 57 (Day 85) | Number of participants with unsolicited AEs after vaccination 1 in Cohort 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary. |
| Cohort 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Booster Vaccination 1 | 28 days after booster vaccination 1 on Day 239 (Day 267) | Number of participants with unsolicited AEs 28 days after booster vaccination 1 in Cohort 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary. |
| Cohort 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Booster Vaccination 2 | 28 days after booster vaccination 2 on Day 422 (Day 450) | Number of participants with unsolicited AEs 28 days after booster vaccination 2 in Cohort 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary. |
| Cohort 3: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 1 in the Primary Regimen | 28 days after vaccination 1 on Day 1 (Day 29) | Number of participants with unsolicited AEs 28 days after vaccination 1 in Cohort 3 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary. |
| Cohort 3: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 2 in the Primary Regimen | 28 days after vaccination 2 on Day 57 (Day 85) | Number of participants with unsolicited AEs 28 days after vaccination 2 in Cohort 3 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary. |
| Cohort 3: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Ad Hoc Booster Vaccination | 28 days after ad hoc booster vaccination (Day 456 up to Day 732) | Number of participants with unsolicited AEs 28 days after ad hoc booster vaccination in Cohort 3 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary. |
| Cohorts 1a and 1b and Cohort 3: Number of Participants With Serious Adverse Events (SAEs) | Day 1 up to 2 years after Vaccination 2 on Day 57 (Day 787) | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. |
| Cohorts 2a and 2b: Number of Participants With Serious Adverse Events (SAEs) | Day 1 up to 6 months post primary regimen (up to Day 183 for Cohort 2a; up to Day 239 for Cohort 2b) | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. |
| Cohorts 1a, 1b and 3: Number of Participants With Adverse Events of Special Interest (AESIs) | Day 1 up to 2 years after Vaccination 2 on Day 57 (Day 787) | Number of participants with AESIs was reported. AESIs were significant AEs that were judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with Thrombocytopenia Syndrome (TTS), a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia, was considered to be an AESI in this study. A suspected TTS case was defined as: Thrombotic events: suspected deep vessel venous or arterial thrombotic events; Thrombocytopenia, defined as platelet count below 150,000/microliter. |
| Cohorts 1a and 1b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen | 7 days post-vaccination 1 on Day 1 (Day 8) | Number of participants with solicited local AEs for 7 days after vaccination 1 in Cohorts 1a and 1b were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). |
| Cohorts 1a and 1b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen | 7 days after vaccination 2 on Day 57 (Day 64) | Number of participants with solicited local AEs for 7 days after vaccination 2 in Cohorts 1a and 1b were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). |
| Cohorts 1a and 1b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination | 7 days after ad hoc booster vaccination (Day 488 up to Day 604) | Number of participants with solicited local AEs for 7 days after ad hoc booster vaccination in Cohorts 1a and 1b were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). |
| Cohorts 2a and 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen | 7 days after Vaccination 1 on Day 1 (Day 8) | Number of participants with solicited local AEs for 7 days after vaccination 1 in Cohorts 2a and 2b were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). |
| Cohort 2a: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Booster Vaccination 1 | 7 days after booster vaccination 1 on Day 183 (Day 190) | Number of participants with solicited local AEs for 7 days after booster vaccination 1 in Cohort 2a were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). |
| Cohort 2a: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Booster Vaccination 2 | 7 days after booster vaccination 2 on Day 366 (Day 373) | Number of participants with solicited local AEs for 7 days after booster vaccination 2 in Cohort 2a were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). |
| Cohort 2a: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination | 7 days after ad hoc booster vaccination (Day 384 up to Day 451) | Number of participants with solicited local AEs for 7 days after ad hoc booster vaccination in Cohort 2a were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). |
| Cohort 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen | 7 days after Vaccination 2 on Day 57 (Day 64) | Number of participants with solicited local AEs for 7 days after Vaccination 2 in Cohort 2b were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). |
| Cohort 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Booster Vaccination 1 | 7 days after booster vaccination 1 on Day 239 (Day 246) | Number of participants with solicited local AEs for 7 days after booster vaccination 1 in Cohort 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). |
| Cohort 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Ad Hoc Booster Vaccination | 28 days after ad hoc booster vaccination (Day 369 up to Day 433) | Number of participants with unsolicited AEs 28 days after ad hoc booster vaccination in Cohort 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary. |
| Cohort 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Booster Vaccination 2 | 7 days after booster vaccination 2 on Day 422 (Day 429) | Number of participants with solicited local AEs for 7 days after booster Vaccination 2 in Cohort 2b were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). |
| Cohort 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination | 7 days after ad hoc booster vaccination (Day 369 up to Day 412) | Number of participants with solicited local AEs for 7 days after ad hoc booster vaccination in Cohort 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). |
| Cohorts 1a and 1b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen | 7 days after vaccination 1 on Day 1 (Day 8) | Number of participants with solicited systemic AEs for 7 days after vaccination 1 in Cohorts 1a and 1b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days). |
| Cohorts 1a and 1b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen | 7 days after Vaccination 2 on Day 57 (Day 64) | Number of participants with solicited systemic AEs for 7 days after vaccination 2 in Cohorts 1a and 1b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days). |
| Cohorts 1a and 1b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination | 7 days after ad hoc booster vaccination (Day 488 up to Day 604) | Number of participants with solicited systemic AEs for 7 days after ad hoc booster vaccination in Cohorts 1a and 1b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post Ad Hoc Booster Vaccination (day of Ad hoc booster vaccination and the subsequent 7 days). |
| Cohorts 2a and 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen | 7 days after Vaccination 1 on Day 1 (Day 8) | Number of participants with solicited systemic AEs for 7 days after vaccination 1 in Cohorts 2a and 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days). |
| Cohort 2a: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Booster Vaccination 1 | 7 days after booster vaccination 1 on Day 183 (Day 190) | Number of participants with solicited systemic AEs for 7 days post booster vaccination 1 in Cohort 2a were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days). |
| Cohort 2a: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Booster Vaccination 2 | 7 days after booster vaccination 2 on Day 366 (Day 373) | Number of participants with solicited systemic AEs for 7 days after booster vaccination 2 in Cohort 2a were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days). |
| Cohort 2a: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination | 7 days after ad hoc booster vaccination (Day 384 up to Day 451) | Number of participants with solicited systemic AEs for 7 days after ad hoc booster vaccination in Cohort 2a were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post adhoc booster vaccination (day of ad hoc booster vaccination and the subsequent 7 days). |
| Cohort 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen | 7 days after Vaccination 2 on Day 57 (Day 64) | Number of participants with solicited systemic AEs for 7 days after vaccination 2 in Cohort 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days). |
| Cohort 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Booster Vaccination 1 | 7 days after booster vaccination 1 on Day 239 (Day 246) | Number of participants with solicited systemic AEs for 7 days after booster vaccination 1 in Cohort 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cohort 1b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Days 29 and 71 | Percentage of participants with antibodies binding to SARS-CoV-2 S protein as measured by ELISA was reported. |
| Cohorts 2a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Days 8, 29, 183, 190, 211, 366, 373, and 394, | Percentage of participants with antibodies binding to SARS-CoV-2 S protein as measured by ELISA was reported. |
| Cohort 2b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Days 8, 29, 57, 64, 85, 239, 246, 267 and 422 | Percentage of participants with antibodies binding to SARS-CoV-2 S protein as measured by ELISA was reported. |
| Cohort 3: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Days 15, 29, 87, 100, 114 and 268 | Percentage of participants with antibodies binding to SARS-CoV-2 S protein as measured by ELISA was reported. |
| Cohort 1a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Days 29, 57, 71, 85, 239 and 422 | GMTs of SARS-CoV-2 neutralizing antibodies to the Wild-type VNA were reported. |
| Cohorts 2a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Days 29, 183, 190, 211, 366, 373 and 394 | GMTs of SARS-CoV-2 neutralizing antibodies to the Wild-type VNA were reported. |
| Cohort 3: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Days 15, 29, 87, 100, 114 and 268 | GMTs of SARS-CoV-2 neutralizing antibodies to the Wild-type VNA were reported. |
| Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Baseline, Days 15, 29, 57, 71, 85, 239 and 422 | Percentage of participants with SARS-Cov2 S Specific CD4+ T-cell Responses for IFNg+ or IL2+ not Helper cell type 2 (TH2) was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. |
| Cohorts 2a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Baseline, Days 29 and 366 | Percentage of participants with SARS-Cov2 S Specific CD4+ T-cell Responses for IFNg+ or IL2+ not Helper cell type 2 (TH2) was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. |
| Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Baseline, Days 29, 57, 85 and 422 | Percentage of participants with SARS-Cov2 S Specific CD4+ T-cell Responses for IFNg+ or IL2+ not Helper cell type 2 (TH2) was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. |
| Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IFNg+ or IL2+ Not Helper Cell Type 2 (TH2) | Baseline, Days 15, 29, 87, 100, 114 and 268 | Percentage of participants with SARS-Cov2 S Specific CD4+ T-cell Responses for IFNg+ or IL2+ not Helper cell type 2 (TH2) was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. |
| Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Baseline, Day 15, 29, 57, 71, 85, 239 and 422 | Percentage of participants with SARS-Cov2 S Specific CD4+ T-cell responses for IL4+ and/or (IL5+/IL13+) and CD40L+ was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. |
| Cohort 2a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Baseline, Days 29 and 366 | Percentage of participants with SARS-Cov2 S Specific CD4+ T-cell responses for IL4+ and/or (IL5+/IL13+) and CD40L+ was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. |
| Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Baseline, Days 29, 57, 85 and 422 | Percentage of participants with SARS-Cov2 S Specific CD4+ T-cell responses for IL4+ and/or (IL5+/IL13+) and CD40L+ was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. |
| Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Baseline, Days 15, 29, 87, 100, 114 and 268 | Percentage of participants with SARS-Cov2 S Specific CD4+ T-cell responses for IL4+ and/or (IL5+/IL13+) and CD40L+ was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. |
| Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Baseline, Days 15, 29, 57, 71, 85, 239 and 422 | Percentage of participants with SARS-Cov2 S Specific CD8+ T-cell Responses for IFNg+ or IL2+ was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. |
| Cohort 2a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Baseline, Days 29 and 366 | Percentage of participants with SARS-Cov2 S Specific CD8+ T-cell Responses for IFNg+ or IL2+ was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. |
| Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Baseline, Days 29, 57, 85 and 422 | Percentage of participants with SARS-Cov2 S Specific CD8+ T-cell Responses for IFNg+ or IL2+ was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. |
| Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Baseline, Days 15, 29, 87, 100, 114 and 268 | Percentage of participants with SARS-Cov2 S Specific CD8+ T-cell Responses for IFNg+ or IL2+ was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. |
| Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Days 15, 29, 57, 71, 85, 239 and 422 | Percentage of participants with Th1 (IFN-g OR IL2 NOT TH2) /Th2 (IL4 OR IL5 OR IL13 AND CD40L) ratio \>=1 and \<1 was reported. |
| Cohort 2a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Days 29 and 366 | Percentage of participants with Th1 (IFN-g OR IL2 NOT TH2) /Th2 (IL4 OR IL5 OR IL13 AND CD40L) ratio \>=1 and \<1 was reported. |
| Cohort 2b: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Days 29, 57, 85 and 422 | Percentage of participants with Th1 (IFN-g OR IL2 NOT TH2) /Th2 (IL4 OR IL5 OR IL13 AND CD40L) ratio \>=1 and \<1 was reported. |
| Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Days 15, 29, 87, 100, 114 and 268 | Percentage of participant with Th1 (IFN-g OR IL2 NOT TH2) /Th2 (IL4 OR IL5 OR IL13 AND CD40L) ratio \>=1 and \<1 was reported. |
| Cohort 1a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Days 29, 57, 71, 85, 239, and 422 | Percentage of participants with antibodies binding to SARS-CoV-2 S protein as measured by ELISA was reported. |
Countries
Belgium, United States
Participant flow
Pre-assignment details
A total of 1085 participants were enrolled in the study, out of which 1076 participants received treatment. Remaining 9 participants did not receive any treatment and are excluded from the analyses.
Participants by arm
| Arm | Count |
|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\*10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\*10\^10 \>=6 months after Vaccination 2. | 77 |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\*10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\*10\^10 vp \>=6 months after Vaccination 2. | 75 |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\*10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\*10\^10 vp \>=6 months after Vaccination 2. | 75 |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\*10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\*10\^10 vp \>=6 months after Vaccination 2. | 73 |
| COHORT 1A: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S. | 77 |
| COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\*10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\*10\^10 vp \>=6 months after Vaccination 2. | 5 |
| COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\*10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\*10\^10 vp \>=6 months after Vaccination 2. | 5 |
| COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\*10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\*10\^10 vp \>=6 months after Vaccination 2. | 5 |
| COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\*10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\*10\^10 vp \>=6 months after Vaccination 2. | 5 |
| COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S. | 5 |
| COHORT 2A: Ad26 5e10, B: PL(PL/AHBV: Ad26 5e10) Group 1 and Group 4 healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\*10\^10 vp on Day 1 (Vaccination 1) followed by matching placebo at 6 and 12 months as matching Booster (B) 1 and Booster 2 vaccination. As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S. 5\*10\^10 vp \>=6 months after Vaccination 2. | 58 |
| COHORT 2A: Ad26 5e10, B: Ad26 5e10, PL Group 2 healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\*10\^10 vp on Day 1 (Vaccination 1) followed by first booster vaccination with single IM injection of Ad26.COV2.S 5\*10\^10 vp booster 1 at 6 months and a matching placebo at 12 months to match second Booster vaccination. | 29 |
| COHORT 2A: Ad26 5e10, B: PL, Ad26 5e10 Group 3 healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\*10\^10 vp on Day 1 (Vaccination 1) followed by a matching placebo booster 1 injection after 6 months and Ad26.COV2.S 5\*10\^10 vp after 12 months as Booster 2. | 32 |
| COHORT 2A: Placebo, B: PL Group 5 healthy adult participants received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (Vaccination 1), 6 months (Booster 1) and 12 months (Booster 2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S. | 17 |
| COHORT 2B: Ad26 5e10, Ad26 5e10, B: PL(PL/AHBV: Ad26 5e10) Group 1 and 4 healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\*10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2) and matching placebo at 6 and 12 months after vaccination 2 as Booster 1 and Booster 2 vaccines. As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\*10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2. | 62 |
| COHORT 2B: Ad26 5e10, Ad26 5e10, B: Ad26 5e10, PL Group 2 healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\*10\^10 vp on Day 1 (Vaccination 1), Day 57 (Vaccination 2) and 6 months after Vaccination 2(Booster 1). At 12 months after vaccination 2, participants received placebo matching to Ad26.COV2.S vaccine (Booster 2). | 30 |
| COHORT 2B: Ad26 5e10, Ad26 5e10, B: PL, Ad26 5e10 Group 3 healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\*10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2) and matching placebo at 6 months after vaccination 2 as Booster 1 vaccination and Ad26.COV2.S 5\*10\^10 vp at 12 months after vaccination 2 as Booster 2 vaccination. | 28 |
| COHORT 2B: Placebo, B: PL Group 5 healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (Vaccination 1), Day 57 (Vaccination 2), 8 Month (Booster 1) and 14 months (Booster 2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S. | 15 |
| COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\*10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\*10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2. | 81 |
| COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\*10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\*10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2. | 80 |
| COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\*10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\*10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2. | 82 |
| COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\*10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\*10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2. | 79 |
| COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S. | 81 |
| Total | 1,076 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 | FG016 | FG017 | FG018 | FG019 | FG020 | FG021 | FG022 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 2 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 2 | 2 | 1 | 4 | 1 | 0 | 0 | 1 | 0 | 5 | 5 | 4 | 1 | 7 | 7 | 1 | 0 | 1 | 1 | 2 | 1 | 1 |
| Overall Study | Other | 3 | 2 | 5 | 9 | 23 | 1 | 0 | 0 | 0 | 0 | 3 | 1 | 1 | 2 | 3 | 0 | 0 | 6 | 1 | 0 | 2 | 2 | 60 |
| Overall Study | Physician Decision | 1 | 0 | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 25 | 22 | 24 | 23 | 14 | 0 | 0 | 1 | 0 | 1 | 17 | 7 | 10 | 6 | 20 | 6 | 11 | 4 | 14 | 24 | 24 | 16 | 14 |
Baseline characteristics
| Characteristic | Total | COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) | COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | COHORT 1A: Placebo, Placebo | COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) | COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) | COHORT 1B: Placebo, Placebo | COHORT 2A: Ad26 5e10, B: PL(PL/AHBV: Ad26 5e10) | COHORT 2A: Ad26 5e10, B: Ad26 5e10, PL | COHORT 2A: Ad26 5e10, B: PL, Ad26 5e10 | COHORT 2A: Placebo, B: PL | COHORT 2B: Ad26 5e10, Ad26 5e10, B: PL(PL/AHBV: Ad26 5e10) | COHORT 2B: Ad26 5e10, Ad26 5e10, B: Ad26 5e10, PL | COHORT 2B: Ad26 5e10, Ad26 5e10, B: PL, Ad26 5e10 | COHORT 2B: Placebo, B: PL | COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) | COHORT 3: Placebo, Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 48.9 years STANDARD_DEVIATION 18.27 | 69.8 years STANDARD_DEVIATION 3.74 | 69.7 years STANDARD_DEVIATION 4.33 | 35.4 years STANDARD_DEVIATION 10.11 | 69.5 years STANDARD_DEVIATION 4.24 | 35.7 years STANDARD_DEVIATION 9.99 | 34.5 years STANDARD_DEVIATION 10.59 | 35.1 years STANDARD_DEVIATION 10.48 | 35 years STANDARD_DEVIATION 9.88 | 43 years STANDARD_DEVIATION 11.45 | 44.4 years STANDARD_DEVIATION 4.39 | 29.6 years STANDARD_DEVIATION 4.34 | 41.2 years STANDARD_DEVIATION 5.54 | 40.8 years STANDARD_DEVIATION 11.97 | 36.8 years STANDARD_DEVIATION 9.27 | 38.1 years STANDARD_DEVIATION 9.98 | 39.2 years STANDARD_DEVIATION 10.53 | 37.5 years STANDARD_DEVIATION 10.41 | 37.6 years STANDARD_DEVIATION 9.93 | 38.3 years STANDARD_DEVIATION 9.81 | 36.1 years STANDARD_DEVIATION 11.48 | 37 years STANDARD_DEVIATION 9.99 | 70.3 years STANDARD_DEVIATION 4.18 | 69.9 years STANDARD_DEVIATION 3.73 |
| Age, Customized 85 years and over | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Age, Customized Adolescents (12-17 years) | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Adults (18-64 years) | 673 Participants | 0 Participants | 0 Participants | 77 Participants | 0 Participants | 75 Participants | 75 Participants | 73 Participants | 77 Participants | 5 Participants | 5 Participants | 5 Participants | 5 Participants | 5 Participants | 58 Participants | 29 Participants | 32 Participants | 17 Participants | 62 Participants | 30 Participants | 28 Participants | 15 Participants | 0 Participants | 0 Participants |
| Age, Customized Children (2-11 years) | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized From 65 to 84 years | 401 Participants | 80 Participants | 81 Participants | 0 Participants | 81 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 78 Participants | 81 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 46 Participants | 1 Participants | 2 Participants | 2 Participants | 0 Participants | 6 Participants | 2 Participants | 2 Participants | 3 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 3 Participants | 2 Participants | 4 Participants | 2 Participants | 5 Participants | 2 Participants | 2 Participants | 3 Participants | 0 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1021 Participants | 78 Participants | 80 Participants | 73 Participants | 81 Participants | 69 Participants | 73 Participants | 71 Participants | 72 Participants | 5 Participants | 5 Participants | 4 Participants | 5 Participants | 4 Participants | 55 Participants | 26 Participants | 28 Participants | 14 Participants | 56 Participants | 28 Participants | 25 Participants | 12 Participants | 79 Participants | 78 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 9 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 28 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 1 Participants | 4 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 4 Participants | 2 Participants | 1 Participants | 2 Participants | 4 Participants | 5 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 38 Participants | 0 Participants | 1 Participants | 4 Participants | 1 Participants | 0 Participants | 4 Participants | 3 Participants | 9 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 4 Participants | 4 Participants | 2 Participants | 0 Participants | 2 Participants | 2 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 992 Participants | 77 Participants | 80 Participants | 71 Participants | 80 Participants | 71 Participants | 70 Participants | 66 Participants | 65 Participants | 4 Participants | 4 Participants | 4 Participants | 5 Participants | 5 Participants | 49 Participants | 22 Participants | 28 Participants | 15 Participants | 55 Participants | 22 Participants | 26 Participants | 14 Participants | 78 Participants | 81 Participants |
| Sex: Female, Male Female | 541 Participants | 36 Participants | 42 Participants | 41 Participants | 40 Participants | 38 Participants | 38 Participants | 42 Participants | 39 Participants | 1 Participants | 4 Participants | 2 Participants | 4 Participants | 3 Participants | 33 Participants | 15 Participants | 12 Participants | 10 Participants | 23 Participants | 10 Participants | 15 Participants | 10 Participants | 40 Participants | 43 Participants |
| Sex: Female, Male Male | 535 Participants | 44 Participants | 40 Participants | 36 Participants | 41 Participants | 37 Participants | 37 Participants | 31 Participants | 38 Participants | 4 Participants | 1 Participants | 3 Participants | 1 Participants | 2 Participants | 25 Participants | 14 Participants | 20 Participants | 7 Participants | 39 Participants | 20 Participants | 13 Participants | 5 Participants | 39 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk | EG018 affected / at risk | EG019 affected / at risk | EG020 affected / at risk | EG021 affected / at risk | EG022 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 77 | 0 / 75 | 0 / 75 | 0 / 73 | 0 / 77 | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 58 | 0 / 29 | 1 / 32 | 0 / 17 | 1 / 62 | 0 / 30 | 0 / 28 | 0 / 15 | 0 / 81 | 2 / 80 | 0 / 82 | 1 / 79 | 0 / 81 |
| other Total, other adverse events | 68 / 77 | 64 / 75 | 69 / 75 | 66 / 73 | 29 / 77 | 5 / 5 | 5 / 5 | 5 / 5 | 5 / 5 | 5 / 5 | 53 / 58 | 27 / 29 | 27 / 32 | 10 / 17 | 59 / 62 | 28 / 30 | 23 / 28 | 9 / 15 | 63 / 81 | 55 / 80 | 69 / 82 | 61 / 79 | 42 / 81 |
| serious Total, serious adverse events | 0 / 77 | 1 / 75 | 1 / 75 | 1 / 73 | 2 / 77 | 1 / 5 | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 5 | 1 / 58 | 0 / 29 | 1 / 32 | 0 / 17 | 1 / 62 | 1 / 30 | 0 / 28 | 0 / 15 | 3 / 81 | 2 / 80 | 2 / 82 | 1 / 79 | 2 / 81 |
Outcome results
Primary
Cohort 2a: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination
Number of participants with solicited local AEs for 7 days after ad hoc booster vaccination in Cohort 2a were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).
Time frame: 7 days after ad hoc booster vaccination (Day 384 up to Day 451)
Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who received Ad Hoc booster vaccination and were evaluable for this outcome measure. Here, 0 in the Overall Number of Participants Analyzed field signifies that no participants were available for the analysis because none of the participants received ad hoc booster vaccination in the respective arms.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2a: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination | 1 Participants |
Primary
Cohort 2a: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Booster Vaccination 1
Number of participants with solicited local AEs for 7 days after booster vaccination 1 in Cohort 2a were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).
Time frame: 7 days after booster vaccination 1 on Day 183 (Day 190)
Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2a: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Booster Vaccination 1 | 6 Participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 2a: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Booster Vaccination 1 | 15 Participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 2a: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Booster Vaccination 1 | 3 Participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 2a: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Booster Vaccination 1 | 0 Participants |
Primary
Cohort 2a: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Booster Vaccination 2
Number of participants with solicited local AEs for 7 days after booster vaccination 2 in Cohort 2a were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).
Time frame: 7 days after booster vaccination 2 on Day 366 (Day 373)
Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure. Here, 0 in the Overall Number of Participants Analyzed field signifies that no participants were available for the analysis because none of the participants received booster vaccination 2 in the respective arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2a: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Booster Vaccination 2 | 3 Participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 2a: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Booster Vaccination 2 | 3 Participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 2a: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Booster Vaccination 2 | 5 Participants |
Primary
Cohort 2a: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination
Number of participants with solicited systemic AEs for 7 days after ad hoc booster vaccination in Cohort 2a were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post adhoc booster vaccination (day of ad hoc booster vaccination and the subsequent 7 days).
Time frame: 7 days after ad hoc booster vaccination (Day 384 up to Day 451)
Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who received Ad Hoc booster vaccination and were evaluable for this outcome measure. Here, 0 in the Overall Number of Participants Analyzed field signifies that no participants were available for the analysis because none of the participants received ad hoc booster vaccination in the respective arms.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2a: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination | 1 Participants |
Primary
Cohort 2a: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Booster Vaccination 1
Number of participants with solicited systemic AEs for 7 days post booster vaccination 1 in Cohort 2a were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).
Time frame: 7 days after booster vaccination 1 on Day 183 (Day 190)
Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2a: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Booster Vaccination 1 | 14 Participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 2a: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Booster Vaccination 1 | 11 Participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 2a: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Booster Vaccination 1 | 5 Participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 2a: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Booster Vaccination 1 | 0 Participants |
Primary
Cohort 2a: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Booster Vaccination 2
Number of participants with solicited systemic AEs for 7 days after booster vaccination 2 in Cohort 2a were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).
Time frame: 7 days after booster vaccination 2 on Day 366 (Day 373)
Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure. Here, 0 in the Overall Number of Participants Analyzed field signifies that no participants were available for the analysis because none of the participants received booster Vaccination 2 in the respective arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2a: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Booster Vaccination 2 | 6 Participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 2a: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Booster Vaccination 2 | 2 Participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 2a: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Booster Vaccination 2 | 2 Participants |
Primary
Cohort 2a: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Ad Hoc Booster Vaccination
Number of participants with unsolicited AEs after ad hoc booster vaccination in Cohort 2a were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.
Time frame: 28 days after ad hoc booster vaccination (Day 384 up to Day 472)
Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who received Ad Hoc booster vaccination and were evaluable for this outcome measure. Here, 0 in the Overall Number of Participants Analyzed field signifies that no participants were available for the analysis because none of the participants received ad hoc booster vaccination in the respective arms.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2a: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Ad Hoc Booster Vaccination | 0 Participants |
Primary
Cohort 2a: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Booster Vaccination 1
Number of participants with unsolicited AEs after booster 1 vaccination in Cohort 2a were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.
Time frame: 28 days after booster vaccination 1 on Day 183 (Day 211)
Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2a: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Booster Vaccination 1 | 2 Participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 2a: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Booster Vaccination 1 | 2 Participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 2a: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Booster Vaccination 1 | 0 Participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 2a: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Booster Vaccination 1 | 0 Participants |
Primary
Cohort 2a: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Booster Vaccination 2
Number of participants with unsolicited AEs after booster vaccination 2 in Cohort 2a were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.
Time frame: 28 days after booster vaccination 2 on Day 366 (Day 394)
Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure. Here, 0 in the Overall Number of Participants Analyzed field signifies that no participants were available for the analysis because none of the participants received booster Vaccination 2 in the respective arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2a: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Booster Vaccination 2 | 2 Participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 2a: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Booster Vaccination 2 | 1 Participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 2a: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Booster Vaccination 2 | 1 Participants |
Primary
Cohort 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination
Number of participants with solicited local AEs for 7 days after ad hoc booster vaccination in Cohort 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).
Time frame: 7 days after ad hoc booster vaccination (Day 369 up to Day 412)
Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who received Ad Hoc booster vaccination and were evaluable for this outcome measure. Here, 0 in the Overall Number of Participants Analyzed field signifies that no participants were available for the analysis because none of the participants received ad hoc booster vaccination in the respective arms.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination | 4 Participants |
Primary
Cohort 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Booster Vaccination 1
Number of participants with solicited local AEs for 7 days after booster vaccination 1 in Cohort 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).
Time frame: 7 days after booster vaccination 1 on Day 239 (Day 246)
Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure. Here, 0 in the Overall Number of Participants Analyzed field signifies that no participants were available for the analysis because none of the participants received booster vaccination 1 in the respective arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Booster Vaccination 1 | 4 Participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Booster Vaccination 1 | 15 Participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Booster Vaccination 1 | 4 Participants |
Primary
Cohort 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Booster Vaccination 2
Number of participants with solicited local AEs for 7 days after booster Vaccination 2 in Cohort 2b were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).
Time frame: 7 days after booster vaccination 2 on Day 422 (Day 429)
Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure. Here, 0 in the Overall Number of Participants Analyzed field signifies that no participants were available for the analysis because none of the participants received booster vaccination 2 in the respective arms.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Booster Vaccination 2 | 0 Participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Booster Vaccination 2 | 1 Participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Booster Vaccination 2 | 4 Participants |
Primary
Cohort 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen
Number of participants with solicited local AEs for 7 days after Vaccination 2 in Cohort 2b were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).
Time frame: 7 days after Vaccination 2 on Day 57 (Day 64)
Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen | 42 Participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen | 21 Participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen | 18 Participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen | 3 Participants |
Primary
Cohort 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination
Number of participants with solicited systemic AEs for 7 days after ad hoc booster vaccination in Cohort 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post ad hoc booster vaccination (day of ad hoc booster vaccination and the subsequent 7 days).
Time frame: 7 days after ad hoc booster vaccination (Day 369 up to Day 412)
Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who received Ad Hoc booster vaccination and were evaluable for this outcome measure. Here, 0 in the Overall Number of Participants Analyzed field signifies that no participants were available for the analysis because none of the participants received ad hoc booster vaccination in the respective arms.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination | 2 Participants |
Primary
Cohort 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Booster Vaccination 1
Number of participants with solicited systemic AEs for 7 days after booster vaccination 1 in Cohort 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).
Time frame: 7 days after booster vaccination 1 on Day 239 (Day 246)
Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure. Here, 0 in the Overall Number of Participants Analyzed field signifies that no participants were available for the analysis because none of the participants received booster vaccination 1 in the respective arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Booster Vaccination 1 | 14 Participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Booster Vaccination 1 | 13 Participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Booster Vaccination 1 | 4 Participants |
Primary
Cohort 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Booster Vaccination 2
Number of participants with solicited systemic AEs for 7 days after booster vaccination 2 in Cohort 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).
Time frame: 7 days after booster vaccination 2 on Day 422 (Day 429)
Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure. Here, 0 in the Overall Number of Participants Analyzed field signifies that no participants were available for the analysis because none of the participants received booster vaccination 2 in the respective arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Booster Vaccination 2 | 2 Participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Booster Vaccination 2 | 2 Participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Booster Vaccination 2 | 4 Participants |
Primary
Cohort 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen
Number of participants with solicited systemic AEs for 7 days after vaccination 2 in Cohort 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).
Time frame: 7 days after Vaccination 2 on Day 57 (Day 64)
Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen | 40 Participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen | 17 Participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen | 15 Participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen | 6 Participants |
Primary
Cohort 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Ad Hoc Booster Vaccination
Number of participants with unsolicited AEs 28 days after ad hoc booster vaccination in Cohort 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.
Time frame: 28 days after ad hoc booster vaccination (Day 369 up to Day 433)
Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who received Ad Hoc booster vaccination and were evaluable for this outcome measure. Here, 0 in the Overall Number of Participants Analyzed field signifies that no participants were available for the analysis because none of the participants received ad hoc booster vaccination in the respective arms.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Ad Hoc Booster Vaccination | 0 Participants |
Primary
Cohort 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Booster Vaccination 1
Number of participants with unsolicited AEs 28 days after booster vaccination 1 in Cohort 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.
Time frame: 28 days after booster vaccination 1 on Day 239 (Day 267)
Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure. Here, 0 in the Overall Number of Participants Analyzed field signifies that no participants were available for the analysis because none of the participants received booster Vaccination 1 in the respective arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Booster Vaccination 1 | 1 Participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Booster Vaccination 1 | 4 Participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Booster Vaccination 1 | 2 Participants |
Primary
Cohort 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Booster Vaccination 2
Number of participants with unsolicited AEs 28 days after booster vaccination 2 in Cohort 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.
Time frame: 28 days after booster vaccination 2 on Day 422 (Day 450)
Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure. Here, 0 in the Overall Number of Participants Analyzed field signifies that no participants were available for the analysis because none of the participants received booster vaccination 2 in the respective arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Booster Vaccination 2 | 0 Participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Booster Vaccination 2 | 0 Participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Booster Vaccination 2 | 0 Participants |
Primary
Cohort 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 2 in the Primary Regimen
Number of participants with unsolicited AEs after vaccination 1 in Cohort 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.
Time frame: 28 days after Vaccination 2 on Day 57 (Day 85)
Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 2 in the Primary Regimen | 7 Participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 2 in the Primary Regimen | 4 Participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 2 in the Primary Regimen | 3 Participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 2 in the Primary Regimen | 2 Participants |
Primary
Cohort 3: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination
Number of participants with solicited local AEs for 7 days after ad hoc booster vaccination in Cohort 3 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site).
Time frame: 7 days after ad hoc booster vaccination (Day 456 up to Day 711)
Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who received Ad Hoc booster vaccination and were evaluable for this outcome measure. Here, 0 in the Overall Number of Participants Analyzed field signifies that no participants were available for the analysis because none of the participants received ad hoc booster vaccination in the respective arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 3: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination | 5 Participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 3: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination | 6 Participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 3: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination | 4 Participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 3: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination | 5 Participants |
Primary
Cohort 3: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen
Number of participants with solicited local AEs for 7 days after vaccination 1 in Cohort 3 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site).
Time frame: 7 days after vaccination 1 on Day 1 (Day 8)
Population: FAS included all participants with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 3: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen | 38 Participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 3: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen | 30 Participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 3: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen | 33 Participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 3: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen | 34 Participants |
| COHORT 1A: Placebo, Placebo | Cohort 3: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen | 7 Participants |
Primary
Cohort 3: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen
Number of participants with solicited local AEs for 7 days after vaccination 2 in Cohort 3 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site).
Time frame: 7 days post-vaccination 2 on Day 57 (Day 64)
Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 3: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen | 41 Participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 3: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen | 5 Participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 3: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen | 51 Participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 3: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen | 13 Participants |
| COHORT 1A: Placebo, Placebo | Cohort 3: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen | 11 Participants |
Primary
Cohort 3: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination
Number of participants with solicited systemic AEs for 7 days after ad hoc booster vaccination in Cohort 3 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post ad hoc booster vaccination (day of ad hoc booster vaccination and the subsequent 7 days).
Time frame: 7 days after ad hoc booster vaccination (Day 456 up to Day 711)
Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who received Ad Hoc booster vaccination and were evaluable for this outcome measure. Here, 0 in the Overall Number of Participants Analyzed field signifies that no participants were available for the analysis because none of the participants received ad hoc booster vaccination in the respective arms.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 3: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination | 3 Participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 3: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination | 7 Participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 3: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination | 4 Participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 3: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination | 6 Participants |
Primary
Cohort 3: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen
Number of participants with solicited systemic AEs for 7 days after vaccination 1 in Cohort 3 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).
Time frame: 7 days post-vaccination 1 on Day 1 (Day 8)
Population: FAS included all participants with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 3: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen | 39 Participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 3: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen | 35 Participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 3: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen | 47 Participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 3: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen | 42 Participants |
| COHORT 1A: Placebo, Placebo | Cohort 3: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen | 20 Participants |
Primary
Cohort 3: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen
Number of participants with solicited systemic AEs for 7 days after vaccination 2 in Cohort 3 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).
Time frame: 7 after post-vaccination 2 on Day 57 (Day 64)
Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 3: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen | 33 Participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 3: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen | 24 Participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 3: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen | 40 Participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 3: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen | 24 Participants |
| COHORT 1A: Placebo, Placebo | Cohort 3: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen | 24 Participants |
Primary
Cohort 3: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Ad Hoc Booster Vaccination
Number of participants with unsolicited AEs 28 days after ad hoc booster vaccination in Cohort 3 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.
Time frame: 28 days after ad hoc booster vaccination (Day 456 up to Day 732)
Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who received Ad Hoc booster vaccination and were evaluable for this outcome measure. Here, 0 in the Overall Number of Participants Analyzed field signifies that no participants were available for the analysis because none of the participants received ad hoc booster vaccination in the respective arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 3: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Ad Hoc Booster Vaccination | 1 Participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 3: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Ad Hoc Booster Vaccination | 0 Participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 3: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Ad Hoc Booster Vaccination | 3 Participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 3: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Ad Hoc Booster Vaccination | 1 Participants |
Primary
Cohort 3: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 1 in the Primary Regimen
Number of participants with unsolicited AEs 28 days after vaccination 1 in Cohort 3 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.
Time frame: 28 days after vaccination 1 on Day 1 (Day 29)
Population: FAS included all participants with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 3: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 1 in the Primary Regimen | 16 Participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 3: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 1 in the Primary Regimen | 13 Participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 3: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 1 in the Primary Regimen | 19 Participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 3: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 1 in the Primary Regimen | 26 Participants |
| COHORT 1A: Placebo, Placebo | Cohort 3: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 1 in the Primary Regimen | 16 Participants |
Primary
Cohort 3: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 2 in the Primary Regimen
Number of participants with unsolicited AEs 28 days after vaccination 2 in Cohort 3 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.
Time frame: 28 days after vaccination 2 on Day 57 (Day 85)
Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 3: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 2 in the Primary Regimen | 11 Participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 3: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 2 in the Primary Regimen | 9 Participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 3: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 2 in the Primary Regimen | 12 Participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 3: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 2 in the Primary Regimen | 12 Participants |
| COHORT 1A: Placebo, Placebo | Cohort 3: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 2 in the Primary Regimen | 9 Participants |
Primary
Cohorts 1a, 1b and 3: Number of Participants With Adverse Events of Special Interest (AESIs)
Number of participants with AESIs was reported. AESIs were significant AEs that were judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with Thrombocytopenia Syndrome (TTS), a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia, was considered to be an AESI in this study. A suspected TTS case was defined as: Thrombotic events: suspected deep vessel venous or arterial thrombotic events; Thrombocytopenia, defined as platelet count below 150,000/microliter.
Time frame: Day 1 up to 2 years after Vaccination 2 on Day 57 (Day 787)
Population: FAS included all participants with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohorts 1a, 1b and 3: Number of Participants With Adverse Events of Special Interest (AESIs) | 0 Participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohorts 1a, 1b and 3: Number of Participants With Adverse Events of Special Interest (AESIs) | 0 Participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohorts 1a, 1b and 3: Number of Participants With Adverse Events of Special Interest (AESIs) | 0 Participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohorts 1a, 1b and 3: Number of Participants With Adverse Events of Special Interest (AESIs) | 0 Participants |
| COHORT 1A: Placebo, Placebo | Cohorts 1a, 1b and 3: Number of Participants With Adverse Events of Special Interest (AESIs) | 0 Participants |
| COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohorts 1a, 1b and 3: Number of Participants With Adverse Events of Special Interest (AESIs) | 0 Participants |
| COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohorts 1a, 1b and 3: Number of Participants With Adverse Events of Special Interest (AESIs) | 0 Participants |
| COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohorts 1a, 1b and 3: Number of Participants With Adverse Events of Special Interest (AESIs) | 0 Participants |
| COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohorts 1a, 1b and 3: Number of Participants With Adverse Events of Special Interest (AESIs) | 0 Participants |
| COHORT 1B: Placebo, Placebo | Cohorts 1a, 1b and 3: Number of Participants With Adverse Events of Special Interest (AESIs) | 0 Participants |
| COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohorts 1a, 1b and 3: Number of Participants With Adverse Events of Special Interest (AESIs) | 0 Participants |
| COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohorts 1a, 1b and 3: Number of Participants With Adverse Events of Special Interest (AESIs) | 0 Participants |
| COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohorts 1a, 1b and 3: Number of Participants With Adverse Events of Special Interest (AESIs) | 0 Participants |
| COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohorts 1a, 1b and 3: Number of Participants With Adverse Events of Special Interest (AESIs) | 0 Participants |
| COHORT 3: Placebo, Placebo | Cohorts 1a, 1b and 3: Number of Participants With Adverse Events of Special Interest (AESIs) | 0 Participants |
Primary
Cohorts 1a and 1b and Cohort 3: Number of Participants With Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.
Time frame: Day 1 up to 2 years after Vaccination 2 on Day 57 (Day 787)
Population: FAS included all participants with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohorts 1a and 1b and Cohort 3: Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohorts 1a and 1b and Cohort 3: Number of Participants With Serious Adverse Events (SAEs) | 1 Participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohorts 1a and 1b and Cohort 3: Number of Participants With Serious Adverse Events (SAEs) | 1 Participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohorts 1a and 1b and Cohort 3: Number of Participants With Serious Adverse Events (SAEs) | 1 Participants |
| COHORT 1A: Placebo, Placebo | Cohorts 1a and 1b and Cohort 3: Number of Participants With Serious Adverse Events (SAEs) | 2 Participants |
| COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohorts 1a and 1b and Cohort 3: Number of Participants With Serious Adverse Events (SAEs) | 1 Participants |
| COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohorts 1a and 1b and Cohort 3: Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
| COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohorts 1a and 1b and Cohort 3: Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
| COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohorts 1a and 1b and Cohort 3: Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
| COHORT 1B: Placebo, Placebo | Cohorts 1a and 1b and Cohort 3: Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
| COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohorts 1a and 1b and Cohort 3: Number of Participants With Serious Adverse Events (SAEs) | 3 Participants |
| COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohorts 1a and 1b and Cohort 3: Number of Participants With Serious Adverse Events (SAEs) | 2 Participants |
| COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohorts 1a and 1b and Cohort 3: Number of Participants With Serious Adverse Events (SAEs) | 2 Participants |
| COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohorts 1a and 1b and Cohort 3: Number of Participants With Serious Adverse Events (SAEs) | 1 Participants |
| COHORT 3: Placebo, Placebo | Cohorts 1a and 1b and Cohort 3: Number of Participants With Serious Adverse Events (SAEs) | 2 Participants |
Primary
Cohorts 1a and 1b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination
Number of participants with solicited local AEs for 7 days after ad hoc booster vaccination in Cohorts 1a and 1b were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).
Time frame: 7 days after ad hoc booster vaccination (Day 488 up to Day 604)
Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure. Here, 0 in the Overall Number of Participants Analyzed field signifies that no participants were available for the analysis because none of the participants received ad hoc booster vaccination in the respective arms.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination | 5 Participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination | 5 Participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination | 6 Participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination | 5 Participants |
| COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination | 0 Participants |
| COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination | 1 Participants |
| COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination | 2 Participants |
Primary
Cohorts 1a and 1b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen
Number of participants with solicited local AEs for 7 days after vaccination 1 in Cohorts 1a and 1b were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).
Time frame: 7 days post-vaccination 1 on Day 1 (Day 8)
Population: Full analysis set (FAS) included all participants with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen | 50 Participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen | 50 Participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen | 57 Participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen | 59 Participants |
| COHORT 1A: Placebo, Placebo | Cohorts 1a and 1b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen | 8 Participants |
| COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen | 4 Participants |
| COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen | 3 Participants |
| COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen | 5 Participants |
| COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen | 4 Participants |
| COHORT 1B: Placebo, Placebo | Cohorts 1a and 1b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen | 0 Participants |
Primary
Cohorts 1a and 1b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen
Number of participants with solicited local AEs for 7 days after vaccination 2 in Cohorts 1a and 1b were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).
Time frame: 7 days after vaccination 2 on Day 57 (Day 64)
Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen | 49 Participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen | 5 Participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen | 55 Participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen | 7 Participants |
| COHORT 1A: Placebo, Placebo | Cohorts 1a and 1b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen | 2 Participants |
| COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen | 4 Participants |
| COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen | 0 Participants |
| COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen | 5 Participants |
| COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen | 1 Participants |
| COHORT 1B: Placebo, Placebo | Cohorts 1a and 1b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen | 0 Participants |
Primary
Cohorts 1a and 1b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination
Number of participants with solicited systemic AEs for 7 days after ad hoc booster vaccination in Cohorts 1a and 1b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post Ad Hoc Booster Vaccination (day of Ad hoc booster vaccination and the subsequent 7 days).
Time frame: 7 days after ad hoc booster vaccination (Day 488 up to Day 604)
Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who received Ad Hoc booster vaccination and were evaluable for this outcome measure. Here, 0 in the Overall Number of Participants Analyzed field signifies that no participants were available for the analysis because none of the participants received ad hoc booster vaccination in the respective arms.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination | 5 Participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination | 6 Participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination | 3 Participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination | 4 Participants |
| COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination | 0 Participants |
| COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination | 2 Participants |
| COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination | 2 Participants |
Primary
Cohorts 1a and 1b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen
Number of participants with solicited systemic AEs for 7 days after vaccination 1 in Cohorts 1a and 1b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).
Time frame: 7 days after vaccination 1 on Day 1 (Day 8)
Population: FAS included all participants with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen | 48 Participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen | 52 Participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen | 63 Participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen | 62 Participants |
| COHORT 1A: Placebo, Placebo | Cohorts 1a and 1b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen | 17 Participants |
| COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen | 4 Participants |
| COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen | 3 Participants |
| COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen | 5 Participants |
| COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen | 5 Participants |
| COHORT 1B: Placebo, Placebo | Cohorts 1a and 1b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen | 4 Participants |
Primary
Cohorts 1a and 1b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen
Number of participants with solicited systemic AEs for 7 days after vaccination 2 in Cohorts 1a and 1b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).
Time frame: 7 days after Vaccination 2 on Day 57 (Day 64)
Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen | 43 Participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen | 23 Participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen | 51 Participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen | 19 Participants |
| COHORT 1A: Placebo, Placebo | Cohorts 1a and 1b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen | 15 Participants |
| COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen | 3 Participants |
| COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen | 2 Participants |
| COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen | 4 Participants |
| COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen | 1 Participants |
| COHORT 1B: Placebo, Placebo | Cohorts 1a and 1b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen | 3 Participants |
Primary
Cohorts 1a and 1b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Ad Hoc Booster Vaccination
Number of participants with unsolicited AEs after ad hoc booster vaccination in Cohorts 1a and 1b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.
Time frame: 28 days after ad hoc booster vaccination (Day 488 up to Day 625)
Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who received Ad Hoc booster vaccination and were evaluable for this outcome measure. Here, 0 in the Overall Number of Participants Analyzed field signifies that no participants were available for the analysis because none of the participants received ad hoc booster vaccination in the respective arms.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Ad Hoc Booster Vaccination | 0 Participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Ad Hoc Booster Vaccination | 1 Participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Ad Hoc Booster Vaccination | 1 Participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Ad Hoc Booster Vaccination | 0 Participants |
| COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Ad Hoc Booster Vaccination | 0 Participants |
| COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Ad Hoc Booster Vaccination | 0 Participants |
| COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Ad Hoc Booster Vaccination | 0 Participants |
Primary
Cohorts 1a and 1b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 1 in the Primary Regimen
Number of participants with unsolicited AEs after vaccination 1 in Cohorts 1a and 1b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.
Time frame: 28 days after vaccination 1 on Day 1 (Day 29)
Population: FAS included all participants with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 1 in the Primary Regimen | 11 Participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 1 in the Primary Regimen | 20 Participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 1 in the Primary Regimen | 26 Participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 1 in the Primary Regimen | 24 Participants |
| COHORT 1A: Placebo, Placebo | Cohorts 1a and 1b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 1 in the Primary Regimen | 14 Participants |
| COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 1 in the Primary Regimen | 2 Participants |
| COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 1 in the Primary Regimen | 3 Participants |
| COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 1 in the Primary Regimen | 4 Participants |
| COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 1 in the Primary Regimen | 4 Participants |
| COHORT 1B: Placebo, Placebo | Cohorts 1a and 1b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 1 in the Primary Regimen | 2 Participants |
Primary
Cohorts 1a and 1b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 2 in the Primary Regimen
Number of participants with unsolicited AEs after vaccination 2 in Cohorts 1a and 1b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.
Time frame: 28 days after vaccination 2 on Day 57 (Day 85)
Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 2 in the Primary Regimen | 10 Participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 2 in the Primary Regimen | 4 Participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 2 in the Primary Regimen | 7 Participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 2 in the Primary Regimen | 12 Participants |
| COHORT 1A: Placebo, Placebo | Cohorts 1a and 1b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 2 in the Primary Regimen | 6 Participants |
| COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 2 in the Primary Regimen | 2 Participants |
| COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 2 in the Primary Regimen | 0 Participants |
| COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 2 in the Primary Regimen | 1 Participants |
| COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohorts 1a and 1b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 2 in the Primary Regimen | 0 Participants |
| COHORT 1B: Placebo, Placebo | Cohorts 1a and 1b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 2 in the Primary Regimen | 1 Participants |
Primary
Cohorts 2a and 2b: Number of Participants With Adverse Events of Special Interest (AESIs)
Number of participants with AESIs was reported. AESIs were significant AEs that were judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with Thrombocytopenia Syndrome (TTS), a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia, was considered to be an AESI in this study. A suspected TTS case was defined as: Thrombotic events: suspected deep vessel venous or arterial thrombotic events; Thrombocytopenia, defined as platelet count below 150,000/microliter.
Time frame: Day 1 up to 6 months post primary regimen (up to Day 183 for Cohort 2a; up to Day 239 for Cohort 2b)
Population: FAS included all participants with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohorts 2a and 2b: Number of Participants With Adverse Events of Special Interest (AESIs) | 0 Participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohorts 2a and 2b: Number of Participants With Adverse Events of Special Interest (AESIs) | 0 Participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohorts 2a and 2b: Number of Participants With Adverse Events of Special Interest (AESIs) | 0 Participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohorts 2a and 2b: Number of Participants With Adverse Events of Special Interest (AESIs) | 0 Participants |
| COHORT 1A: Placebo, Placebo | Cohorts 2a and 2b: Number of Participants With Adverse Events of Special Interest (AESIs) | 0 Participants |
| COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohorts 2a and 2b: Number of Participants With Adverse Events of Special Interest (AESIs) | 0 Participants |
| COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohorts 2a and 2b: Number of Participants With Adverse Events of Special Interest (AESIs) | 0 Participants |
| COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohorts 2a and 2b: Number of Participants With Adverse Events of Special Interest (AESIs) | 0 Participants |
Primary
Cohorts 2a and 2b: Number of Participants With Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.
Time frame: Day 1 up to 6 months post primary regimen (up to Day 183 for Cohort 2a; up to Day 239 for Cohort 2b)
Population: FAS included all participants with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohorts 2a and 2b: Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohorts 2a and 2b: Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohorts 2a and 2b: Number of Participants With Serious Adverse Events (SAEs) | 1 Participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohorts 2a and 2b: Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
| COHORT 1A: Placebo, Placebo | Cohorts 2a and 2b: Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
| COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohorts 2a and 2b: Number of Participants With Serious Adverse Events (SAEs) | 1 Participants |
| COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohorts 2a and 2b: Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
| COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohorts 2a and 2b: Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
Primary
Cohorts 2a and 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen
Number of participants with solicited local AEs for 7 days after vaccination 1 in Cohorts 2a and 2b were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).
Time frame: 7 days after Vaccination 1 on Day 1 (Day 8)
Population: FAS included all participants with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohorts 2a and 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen | 48 Participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohorts 2a and 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen | 24 Participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohorts 2a and 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen | 19 Participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohorts 2a and 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen | 4 Participants |
| COHORT 1A: Placebo, Placebo | Cohorts 2a and 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen | 52 Participants |
| COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohorts 2a and 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen | 23 Participants |
| COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohorts 2a and 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen | 18 Participants |
| COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohorts 2a and 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen | 0 Participants |
Primary
Cohorts 2a and 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen
Number of participants with solicited systemic AEs for 7 days after vaccination 1 in Cohorts 2a and 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).
Time frame: 7 days after Vaccination 1 on Day 1 (Day 8)
Population: FAS included all participants with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohorts 2a and 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen | 47 Participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohorts 2a and 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen | 23 Participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohorts 2a and 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen | 21 Participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohorts 2a and 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen | 8 Participants |
| COHORT 1A: Placebo, Placebo | Cohorts 2a and 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen | 50 Participants |
| COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohorts 2a and 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen | 23 Participants |
| COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohorts 2a and 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen | 21 Participants |
| COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohorts 2a and 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen | 5 Participants |
Primary
Cohorts 2a and 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 1 in the Primary Regimen
Number of participants with unsolicited AEs after vaccination 1 in Cohorts 2a and 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.
Time frame: 28 days after Vaccination 1 on Day 1 (Day 29)
Population: FAS included all participants with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohorts 2a and 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 1 in the Primary Regimen | 15 Participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohorts 2a and 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 1 in the Primary Regimen | 5 Participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohorts 2a and 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 1 in the Primary Regimen | 7 Participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohorts 2a and 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 1 in the Primary Regimen | 5 Participants |
| COHORT 1A: Placebo, Placebo | Cohorts 2a and 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 1 in the Primary Regimen | 11 Participants |
| COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohorts 2a and 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 1 in the Primary Regimen | 6 Participants |
| COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohorts 2a and 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 1 in the Primary Regimen | 5 Participants |
| COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohorts 2a and 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 1 in the Primary Regimen | 2 Participants |
Secondary
Cohort 1a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA)
GMTs of SARS-CoV-2 neutralizing antibodies to the Wild-type VNA were reported.
Time frame: Days 29, 57, 71, 85, 239 and 422
Population: PPI population was analyzed. 'N' (Overall number of participants analyzed) =participants who were evaluable for this outcome measure and n (number analyzed) =participants who were evaluable for specified time points. Due to the change in planned analysis, data was not collected and analyzed for Cohort 1b and thus no data was reported for this outcome measure. 0 in the number analyzed field signifies that no participant was available for the analysis at the specified timepoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 1a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 85 | 919 Titers |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 1a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 239 | 465 Titers |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 1a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 29 | 233 Titers |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 1a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 422 | 328 Titers |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 1a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 71 | 862 Titers |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 1a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 57 | 310 Titers |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 1a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 71 | 294 Titers |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 1a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 29 | 224 Titers |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 1a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 422 | 235 Titers |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 1a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 85 | 317 Titers |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 1a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 57 | 284 Titers |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 1a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 239 | 215 Titers |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 1a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 85 | 1127 Titers |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 1a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 239 | 771 Titers |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 1a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 57 | 458 Titers |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 1a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 29 | 333 Titers |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 1a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 422 | 425 Titers |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 1a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 71 | 1189 Titers |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 1a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 422 | 307 Titers |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 1a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 29 | 219 Titers |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 1a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 57 | 392 Titers |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 1a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 71 | 414 Titers |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 1a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 85 | 422 Titers |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 1a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 239 | 408 Titers |
| COHORT 1A: Placebo, Placebo | Cohort 1a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 239 | NA Titers |
| COHORT 1A: Placebo, Placebo | Cohort 1a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 85 | NA Titers |
| COHORT 1A: Placebo, Placebo | Cohort 1a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 71 | NA Titers |
| COHORT 1A: Placebo, Placebo | Cohort 1a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 57 | NA Titers |
| COHORT 1A: Placebo, Placebo | Cohort 1a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 29 | NA Titers |
Secondary
Cohort 1a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Percentage of participants with antibodies binding to SARS-CoV-2 S protein as measured by ELISA was reported.
Time frame: Days 29, 57, 71, 85, 239, and 422
Population: Per protocol immunogenicity (PPI) population included all randomized and vaccinated participants for whom immunogenicity data were available excluding participants with major protocol deviations expecting to impact the immunogenicity outcomes. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure and n (number analyzed) signifies those participants who were evaluable for specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 29 | 98.4 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 57 | 100.0 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 71 | 100.0 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 85 | 100.0 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 239 | 100.0 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 422 | 100.0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 239 | 98.3 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 422 | 92.0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 29 | 98.4 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 71 | 100.0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 85 | 98.4 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 57 | 98.4 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 85 | 100.0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 239 | 100.0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 29 | 100.0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 71 | 100.0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 57 | 100.0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 422 | 100.0 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 85 | 96.6 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 57 | 96.7 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 71 | 96.4 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 422 | 100.0 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 239 | 94.2 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 29 | 98.4 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 1a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 239 | 2.0 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 1a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 71 | 1.6 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 1a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 57 | 1.5 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 1a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 422 | 66.7 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 1a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 85 | 4.7 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 1a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 29 | 1.4 Percentage of participants |
Secondary
Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+
Percentage of participants with SARS-Cov2 S Specific CD4+ T-cell responses for IL4+ and/or (IL5+/IL13+) and CD40L+ was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination.
Time frame: Baseline, Day 15, 29, 57, 71, 85, 239 and 422
Population: PPI population was analyzed. Here, 'N' (Overall number of participants analyzed) =participants who were evaluable for this outcome measure and n (number analyzed) =participants who were evaluable for specified time points. Due to the change in planned analysis, data was not collected and analyzed for Cohort 1b and thus no data was reported for this outcome measure. 0 in the number analyzed field signifies that no participant was available for the analysis at the specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Baseline | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 85 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 239 | 3 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 15 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 422 | 5 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 29 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 57 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 71 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 71 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 29 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 85 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 239 | 6 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Baseline | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 57 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 422 | 4 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 15 | 3 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 57 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 15 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 422 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 29 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 239 | 17 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 71 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 85 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Baseline | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 422 | 9 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 15 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 29 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 57 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 71 | 4 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 85 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 239 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Baseline | 0 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 29 | 0 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Baseline | 0 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 15 | 0 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 57 | 6 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 85 | 0 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 71 | 0 Percentage of participants |
Secondary
Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2)
Percentage of participants with SARS-Cov2 S Specific CD4+ T-cell Responses for IFNg+ or IL2+ not Helper cell type 2 (TH2) was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination.
Time frame: Baseline, Days 15, 29, 57, 71, 85, 239 and 422
Population: PPI population was analyzed. Here, 'N' (Overall number of participants analyzed) =participants who were evaluable for this outcome measure and n (number analyzed) =participants who were evaluable for specified time points. Due to the change in planned analysis, data was not collected and analyzed for Cohort 1b and thus no data was reported for this outcome measure. 0 in the number analyzed field signifies that no participant was available for the analysis at the specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Day 57 | 75 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Day 239 | 47 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Baseline | 8 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Day 422 | 27 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Day 71 | 63 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Day 15 | 76 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Day 85 | 68 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Day 29 | 73 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Day 422 | 43 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Day 15 | 76 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Day 57 | 53 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Day 29 | 70 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Day 239 | 47 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Day 71 | 47 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Day 85 | 46 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Baseline | 8 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Day 29 | 78 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Day 85 | 85 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Day 15 | 83 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Baseline | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Day 422 | 54 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Day 239 | 75 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Day 57 | 77 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Day 71 | 91 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Day 422 | 36 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Baseline | 3 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Day 15 | 82 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Day 29 | 72 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Day 57 | 63 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Day 71 | 61 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Day 85 | 59 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Day 239 | 38 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Day 71 | 16 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Baseline | 0 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Day 57 | 12 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Day 29 | 19 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Day 15 | 8 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Day 85 | 12 Percentage of participants |
Secondary
Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+
Percentage of participants with SARS-Cov2 S Specific CD8+ T-cell Responses for IFNg+ or IL2+ was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination.
Time frame: Baseline, Days 15, 29, 57, 71, 85, 239 and 422
Population: PPI population was analyzed. Here, 'N' (Overall number of participants analyzed) =participants who were evaluable for this outcome measure and n (number analyzed) =participants who were evaluable for specified time points. Due to the change in planned analysis, data was not collected and analyzed for Cohort 1b and thus no data was reported for this outcome measure. 0 in the number analyzed field signifies that no participant was available for the analysis at the specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 71 | 68 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 29 | 68 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Baseline | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 422 | 52 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 57 | 72 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 239 | 62 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 85 | 73 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 15 | 54 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 239 | 62 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 85 | 69 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 422 | 57 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 15 | 45 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 29 | 59 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Baseline | 3 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 57 | 81 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 71 | 72 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 239 | 92 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 422 | 77 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 71 | 86 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 57 | 89 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 15 | 56 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 85 | 88 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 29 | 81 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Baseline | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 422 | 82 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Baseline | 3 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 15 | 71 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 29 | 75 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 71 | 79 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 85 | 83 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 239 | 85 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 57 | 83 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 29 | 3 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 57 | 6 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 15 | 8 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Baseline | 5 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 85 | 9 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 71 | 9 Percentage of participants |
Secondary
Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1
Percentage of participants with Th1 (IFN-g OR IL2 NOT TH2) /Th2 (IL4 OR IL5 OR IL13 AND CD40L) ratio \>=1 and \<1 was reported.
Time frame: Days 15, 29, 57, 71, 85, 239 and 422
Population: PPI population was analyzed. Here, 'N' (Overall number of participants analyzed) =participants who were evaluable for this outcome measure and n (number analyzed) =participants who were evaluable for specified time points. Due to the change in planned analysis, data was not collected and analyzed for Cohort 1b and thus no data was reported for this outcome measure. 0 in the number analyzed field signifies that no participant was available for the analysis at the specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 57: Th1/Th2 <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 29: Th1/Th2 <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 15: Th1/Th2 >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 57: Th1/Th2 >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 239: Th1/Th2 <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 15: Th1/Th2 <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 422: Th1/Th2 <1 | 14 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 239: Th1/Th2 >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 85: Th1/Th2 <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 85: Th1/Th2 >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 29: Th1/Th2 >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 422: Th1/Th2 >=1 | 86 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 71: Th1/Th2 <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 71: Th1/Th2 >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 29: Th1/Th2 <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 15: Th1/Th2 >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 15: Th1/Th2 <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 29: Th1/Th2 >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 57: Th1/Th2 >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 57: Th1/Th2 <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 71: Th1/Th2 >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 71: Th1/Th2 <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 85: Th1/Th2 >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 85: Th1/Th2 <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 239: Th1/Th2 >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 239: Th1/Th2 <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 422: Th1/Th2 >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 422: Th1/Th2 <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 57: Th1/Th2 <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 71: Th1/Th2 >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 29: Th1/Th2 >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 422: Th1/Th2 <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 71: Th1/Th2 <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 422: Th1/Th2 >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 85: Th1/Th2 >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 85: Th1/Th2 <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 15: Th1/Th2 <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 15: Th1/Th2 >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 239: Th1/Th2 >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 29: Th1/Th2 <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 239: Th1/Th2 <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 57: Th1/Th2 >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 239: Th1/Th2 >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 71: Th1/Th2 >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 239: Th1/Th2 <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 85: Th1/Th2 <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 422: Th1/Th2 <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 29: Th1/Th2 <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 71: Th1/Th2 <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 85: Th1/Th2 >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 57: Th1/Th2 <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 57: Th1/Th2 >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 15: Th1/Th2 <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 422: Th1/Th2 >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 29: Th1/Th2 >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 15: Th1/Th2 >=1 | 100 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 29: Th1/Th2 <1 | 0 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 85: Th1/Th2 >=1 | 100 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 85: Th1/Th2 <1 | 0 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 57: Th1/Th2 >=1 | 100 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 57: Th1/Th2 <1 | 0 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 71: Th1/Th2 >=1 | 100 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 15: Th1/Th2 >=1 | 100 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 71: Th1/Th2 <1 | 0 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 15: Th1/Th2 <1 | 0 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 29: Th1/Th2 >=1 | 100 Percentage of participants |
Secondary
Cohort 1b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Percentage of participants with antibodies binding to SARS-CoV-2 S protein as measured by ELISA was reported.
Time frame: Days 29 and 71
Population: PPI population included all randomized and vaccinated participants for whom immunogenicity data were available excluding participants with major protocol deviations expecting to impact the immunogenicity outcomes. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure and n (number analyzed) signifies those participants who were evaluable for specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 1b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 29 | 80.0 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 1b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 71 | 100.0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 1b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 29 | 100.0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 1b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 71 | 100.0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 1b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 29 | 100.0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 1b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 71 | 100.0 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 1b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 71 | 100.0 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 1b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 29 | 100.0 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 1b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 29 | 0.0 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 1b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 71 | 0.0 Percentage of participants |
Secondary
Cohort 2a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+
Percentage of participants with SARS-Cov2 S Specific CD4+ T-cell responses for IL4+ and/or (IL5+/IL13+) and CD40L+ was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination.
Time frame: Baseline, Days 29 and 366
Population: PPI population was analyzed. Here, 'N' (Overall number of participants analyzed) =participants who were evaluable for this outcome measure and n (number analyzed) =participants who were evaluable for specified time points. 0 in the number analyzed field signifies that no participant was available for the analysis at the specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Baseline | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 29 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 366 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 2a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 29 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 2a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Baseline | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 2a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 366 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 2a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 29 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 2a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Baseline | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 2a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 366 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 2a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 29 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 2a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Baseline | 0 Percentage of participants |
Secondary
Cohort 2a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+
Percentage of participants with SARS-Cov2 S Specific CD8+ T-cell Responses for IFNg+ or IL2+ was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination.
Time frame: Baseline, Days 29 and 366
Population: PPI population was analyzed. Here, 'N' (Overall number of participants analyzed) =participants who were evaluable for this outcome measure and n (number analyzed) =participants who were evaluable for specified time points. 0 in the number analyzed field signifies that no participant was available for the analysis at the specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Baseline | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 29 | 91 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 366 | 78 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 2a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 29 | 100 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 2a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Baseline | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 2a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 366 | 75 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 2a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 29 | 100 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 2a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Baseline | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 2a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 366 | 100 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 2a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 29 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 2a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Baseline | 0 Percentage of participants |
Secondary
Cohort 2a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1
Percentage of participants with Th1 (IFN-g OR IL2 NOT TH2) /Th2 (IL4 OR IL5 OR IL13 AND CD40L) ratio \>=1 and \<1 was reported.
Time frame: Days 29 and 366
Population: PPI population was analyzed. Here, 'N' (Overall number of participants analyzed) =participants who were evaluable for this outcome measure and n (number analyzed) =participants who were evaluable for specified time points. Due to change in planned analysis, data was not collected and analyzed for COHORT 2A: Placebo, B: PL arm in this outcome measure. 0 in the number analyzed field signifies that no participant was available for the analysis at the specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 29: Th1/Th2 >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 366: Th1/Th2 <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 366: Th1/Th2 >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 29: Th1/Th2 <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 2a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 366: Th1/Th2 <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 2a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 29: Th1/Th2 >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 2a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 29: Th1/Th2 <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 2a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 366: Th1/Th2 >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 2a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 29: Th1/Th2 <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 2a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 29: Th1/Th2 >=1 | 100 Percentage of participants |
Secondary
Cohort 2b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Percentage of participants with antibodies binding to SARS-CoV-2 S protein as measured by ELISA was reported.
Time frame: Days 8, 29, 57, 64, 85, 239, 246, 267 and 422
Population: PPI population was analyzed. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure and n (number analyzed) signifies those participants who were evaluable for specified time points. 0 in the number analyzed field signifies that no participant was available for the analysis at the specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 8 | 0.0 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 29 | 95.9 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 57 | 95.8 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 64 | 100.0 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 85 | 97.8 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 239 | 97.4 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 246 | 97.4 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 267 | 97.2 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 422 | 100.0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 422 | 100.0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 246 | 100.0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 64 | 100.0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 239 | 95.5 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 57 | 100.0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 29 | 96.4 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 8 | 3.8 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 267 | 100.0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 85 | 100.0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 246 | 93.8 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 57 | 100.0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 64 | 100.0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 85 | 100.0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 267 | 93.8 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 239 | 94.4 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 422 | 100.0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 8 | 4.5 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 29 | 100.0 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 85 | 0.0 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 64 | 0.0 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 57 | 0.0 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 29 | 0.0 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 8 | 0.0 Percentage of participants |
Secondary
Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+
Percentage of participants with SARS-Cov2 S Specific CD4+ T-cell responses for IL4+ and/or (IL5+/IL13+) and CD40L+ was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination.
Time frame: Baseline, Days 29, 57, 85 and 422
Population: PPI population was analyzed. Here, 'N' (Overall number of participants analyzed) =participants who were evaluable for this outcome measure and n (number analyzed) =participants who were evaluable for specified time points. 0 in the number analyzed field signifies that no participant was available for the analysis at the specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 422 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Baseline | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 57 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 85 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 29 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 57 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Baseline | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 29 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 85 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 422 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 29 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 422 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 85 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Baseline | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 57 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 57 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Baseline | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 85 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 29 | 0 Percentage of participants |
Secondary
Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2)
Percentage of participants with SARS-Cov2 S Specific CD4+ T-cell Responses for IFNg+ or IL2+ not Helper cell type 2 (TH2) was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination.
Time frame: Baseline, Days 29, 57, 85 and 422
Population: PPI population was analyzed. Here, 'N' (Overall number of participants analyzed) =participants who were evaluable for this outcome measure and n (number analyzed) =participants who were evaluable for specified time points. 0 in the number analyzed field signifies that no participant was available for the analysis at the specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Day 422 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Baseline | 25 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Day 57 | 75 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Day 85 | 60 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Day 29 | 82 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Day 57 | 80 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Baseline | 20 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Day 29 | 40 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Day 85 | 80 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Day 422 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Day 29 | 67 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Day 422 | 100 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Day 85 | 50 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Baseline | 17 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Day 57 | 40 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Day 57 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Baseline | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Day 85 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Day 29 | 0 Percentage of participants |
Secondary
Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+
Percentage of participants with SARS-Cov2 S Specific CD8+ T-cell Responses for IFNg+ or IL2+ was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination.
Time frame: Baseline, Days 29, 57, 85 and 422
Population: PPI population was analyzed. Here, 'N' (Overall number of participants analyzed) =participants who were evaluable for this outcome measure and n (number analyzed) =participants who were evaluable for specified time points. 0 in the number analyzed field signifies that no participant was available for the analysis at the specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 422 | 100 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Baseline | 8 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 57 | 92 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 85 | 80 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 29 | 82 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 57 | 100 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Baseline | 20 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 29 | 80 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 85 | 100 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 422 | 100 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 29 | 83 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 422 | 100 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 85 | 83 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Baseline | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 57 | 80 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 57 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Baseline | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 85 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 29 | 0 Percentage of participants |
Secondary
Cohort 2b: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1
Percentage of participants with Th1 (IFN-g OR IL2 NOT TH2) /Th2 (IL4 OR IL5 OR IL13 AND CD40L) ratio \>=1 and \<1 was reported.
Time frame: Days 29, 57, 85 and 422
Population: PPI population was analyzed. Here, 'N' (Overall number of participants analyzed) =participants who were evaluable for this outcome measure and n (number analyzed) =participants who were evaluable for specified time points. Due to change in planned analysis, data was not collected and analyzed for COHORT 2B: Placebo, B: PL arm in this outcome measure. 0 in the number analyzed field signifies that no participant was available for the analysis at the specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 57: Th1/Th2 >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 29: Th1/Th2 <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 29: Th1/Th2 >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 57: Th1/Th2 <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 85: Th1/Th2 <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 85: Th1/Th2 >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 57: Th1/Th2 <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 29: Th1/Th2 >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 29: Th1/Th2 <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 57: Th1/Th2 >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 85: Th1/Th2 >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 85: Th1/Th2 <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 29: Th1/Th2 <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 422: Th1/Th2 >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 85: Th1/Th2 >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 29: Th1/Th2 >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 422: Th1/Th2 <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 85: Th1/Th2 <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 57: Th1/Th2 >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 2b: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 57: Th1/Th2 <1 | 0 Percentage of participants |
Secondary
Cohort 3: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA)
GMTs of SARS-CoV-2 neutralizing antibodies to the Wild-type VNA were reported.
Time frame: Days 15, 29, 87, 100, 114 and 268
Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure and n (number analyzed) signifies those participants who were evaluable for specified time points. 0 in the number analyzed field signifies that no participant was available for the analysis at the specified timepoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 3: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 15 | 190 Titers |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 3: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 114 | 954 Titers |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 3: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 100 | 878 Titers |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 3: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 87 | 224 Titers |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 3: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 29 | 267 Titers |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 3: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 87 | 165 Titers |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 3: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 15 | 153 Titers |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 3: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 29 | 229 Titers |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 3: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 100 | 168 Titers |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 3: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 114 | 164 Titers |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 3: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 268 | 114 Titers |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 3: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 114 | 895 Titers |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 3: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 87 | 245 Titers |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 3: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 29 | 261 Titers |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 3: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 15 | 209 Titers |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 3: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 100 | 574 Titers |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 3: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 114 | 158 Titers |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 3: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 29 | 174 Titers |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 3: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 87 | 198 Titers |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 3: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 100 | 178 Titers |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 3: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 15 | 140 Titers |
| COHORT 1A: Placebo, Placebo | Cohort 3: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 114 | NA Titers |
| COHORT 1A: Placebo, Placebo | Cohort 3: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 15 | NA Titers |
| COHORT 1A: Placebo, Placebo | Cohort 3: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 100 | NA Titers |
| COHORT 1A: Placebo, Placebo | Cohort 3: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 87 | NA Titers |
| COHORT 1A: Placebo, Placebo | Cohort 3: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 29 | NA Titers |
Secondary
Cohort 3: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Percentage of participants with antibodies binding to SARS-CoV-2 S protein as measured by ELISA was reported.
Time frame: Days 15, 29, 87, 100, 114 and 268
Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure and n (number analyzed) signifies those participants who were evaluable for specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 15 | 78.0 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 29 | 95.8 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 87 | 97.0 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 100 | 98.4 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 114 | 98.5 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 268 | 98.3 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 114 | 97.0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 268 | 85.5 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 15 | 72.4 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 87 | 97.0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 100 | 97.1 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 29 | 97.2 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 100 | 98.4 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 114 | 98.4 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 15 | 79.6 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 87 | 96.9 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 29 | 95.8 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 268 | 100.0 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 100 | 98.6 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 29 | 97.3 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 87 | 98.6 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 268 | 87.7 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 114 | 98.6 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 15 | 77.4 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 3: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 114 | 1.5 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 3: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 87 | 1.5 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 3: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 29 | 0.0 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 3: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 268 | 16.7 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 3: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 100 | 0.0 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 3: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 15 | 1.6 Percentage of participants |
Secondary
Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IFNg+ or IL2+ Not Helper Cell Type 2 (TH2)
Percentage of participants with SARS-Cov2 S Specific CD4+ T-cell Responses for IFNg+ or IL2+ not Helper cell type 2 (TH2) was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination.
Time frame: Baseline, Days 15, 29, 87, 100, 114 and 268
Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure and n (number analyzed) signifies those participants who were evaluable for specified time points. 0 in the number analyzed field signifies that no participant was available for the analysis at the specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IFNg+ or IL2+ Not Helper Cell Type 2 (TH2) | Day 100 | 61 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IFNg+ or IL2+ Not Helper Cell Type 2 (TH2) | Day 29 | 66 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IFNg+ or IL2+ Not Helper Cell Type 2 (TH2) | Day 87 | 42 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IFNg+ or IL2+ Not Helper Cell Type 2 (TH2) | Baseline | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IFNg+ or IL2+ Not Helper Cell Type 2 (TH2) | Day 268 | 59 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IFNg+ or IL2+ Not Helper Cell Type 2 (TH2) | Day 15 | 61 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IFNg+ or IL2+ Not Helper Cell Type 2 (TH2) | Day 114 | 71 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IFNg+ or IL2+ Not Helper Cell Type 2 (TH2) | Day 87 | 48 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IFNg+ or IL2+ Not Helper Cell Type 2 (TH2) | Day 15 | 63 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IFNg+ or IL2+ Not Helper Cell Type 2 (TH2) | Day 29 | 69 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IFNg+ or IL2+ Not Helper Cell Type 2 (TH2) | Day 268 | 73 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IFNg+ or IL2+ Not Helper Cell Type 2 (TH2) | Day 114 | 69 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IFNg+ or IL2+ Not Helper Cell Type 2 (TH2) | Day 100 | 61 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IFNg+ or IL2+ Not Helper Cell Type 2 (TH2) | Baseline | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IFNg+ or IL2+ Not Helper Cell Type 2 (TH2) | Day 268 | 40 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IFNg+ or IL2+ Not Helper Cell Type 2 (TH2) | Day 87 | 39 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IFNg+ or IL2+ Not Helper Cell Type 2 (TH2) | Baseline | 3 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IFNg+ or IL2+ Not Helper Cell Type 2 (TH2) | Day 15 | 67 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IFNg+ or IL2+ Not Helper Cell Type 2 (TH2) | Day 29 | 68 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IFNg+ or IL2+ Not Helper Cell Type 2 (TH2) | Day 100 | 78 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IFNg+ or IL2+ Not Helper Cell Type 2 (TH2) | Day 114 | 69 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IFNg+ or IL2+ Not Helper Cell Type 2 (TH2) | Day 87 | 52 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IFNg+ or IL2+ Not Helper Cell Type 2 (TH2) | Day 268 | 57 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IFNg+ or IL2+ Not Helper Cell Type 2 (TH2) | Day 100 | 58 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IFNg+ or IL2+ Not Helper Cell Type 2 (TH2) | Day 15 | 62 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IFNg+ or IL2+ Not Helper Cell Type 2 (TH2) | Day 114 | 44 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IFNg+ or IL2+ Not Helper Cell Type 2 (TH2) | Baseline | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IFNg+ or IL2+ Not Helper Cell Type 2 (TH2) | Day 29 | 76 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IFNg+ or IL2+ Not Helper Cell Type 2 (TH2) | Day 15 | 6 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IFNg+ or IL2+ Not Helper Cell Type 2 (TH2) | Day 87 | 4 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IFNg+ or IL2+ Not Helper Cell Type 2 (TH2) | Day 29 | 14 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IFNg+ or IL2+ Not Helper Cell Type 2 (TH2) | Day 100 | 3 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IFNg+ or IL2+ Not Helper Cell Type 2 (TH2) | Day 114 | 17 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IFNg+ or IL2+ Not Helper Cell Type 2 (TH2) | Baseline | 6 Percentage of participants |
Secondary
Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+
Percentage of participants with SARS-Cov2 S Specific CD4+ T-cell responses for IL4+ and/or (IL5+/IL13+) and CD40L+ was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination.
Time frame: Baseline, Days 15, 29, 87, 100, 114 and 268
Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure and n (number analyzed) signifies those participants who were evaluable for specified time points. 0 in the number analyzed field signifies that no participant was available for the analysis at the specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Baseline | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 268 | 7 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 114 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 29 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 15 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 87 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 100 | 6 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 100 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 87 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 15 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Baseline | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 114 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 29 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 268 | 8 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 87 | 4 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Baseline | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 15 | 3 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 29 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 100 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 114 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 268 | 20 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 29 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Baseline | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 100 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 15 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 268 | 7 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 114 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 87 | 0 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 87 | 0 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 114 | 0 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 100 | 0 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 15 | 0 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Baseline | 0 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ | Day 29 | 0 Percentage of participants |
Secondary
Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+
Percentage of participants with SARS-Cov2 S Specific CD8+ T-cell Responses for IFNg+ or IL2+ was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination.
Time frame: Baseline, Days 15, 29, 87, 100, 114 and 268
Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure and n (number analyzed) signifies those participants who were evaluable for specified time points. 0 in the number analyzed field signifies that no participant was available for the analysis at the specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Baseline | 3 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 268 | 57 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 114 | 75 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 29 | 58 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 15 | 35 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 87 | 59 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 100 | 65 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 100 | 52 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 87 | 58 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 15 | 23 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Baseline | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 114 | 47 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 29 | 51 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 268 | 50 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 87 | 45 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Baseline | 6 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 15 | 26 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 29 | 52 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 100 | 65 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 114 | 62 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 268 | 78 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 29 | 64 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Baseline | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 100 | 67 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 15 | 26 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 268 | 71 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 114 | 68 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 87 | 71 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 87 | 0 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 114 | 0 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 100 | 0 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 15 | 3 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Baseline | 0 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ | Day 29 | 0 Percentage of participants |
Secondary
Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1
Percentage of participant with Th1 (IFN-g OR IL2 NOT TH2) /Th2 (IL4 OR IL5 OR IL13 AND CD40L) ratio \>=1 and \<1 was reported.
Time frame: Days 15, 29, 87, 100, 114 and 268
Population: FAS included all participant with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure and n (number analyzed) signifies those participants who were evaluable for specified time points. 0 in the number analyzed field signifies that no participant was available for the analysis at the specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 15: Th1/Th2 ratio <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 15: Th1/Th2 ratio >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 114: Th1/Th2 ratio <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 29: Th1/Th2 ratio <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 87: Th1/Th2 ratio <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 268: Th1/Th2 ratio >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 29: Th1/Th2 ratio >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 114: Th1/Th2 ratio >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 87: Th1/Th2 ratio >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 100: Th1/Th2 ratio >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 268: Th1/Th2 ratio <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 100: Th1/Th2 ratio <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 100: Th1/Th2 ratio <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 87: Th1/Th2 ratio <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 100: Th1/Th2 ratio >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 15: Th1/Th2 ratio <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 268: Th1/Th2 ratio >=1 | 94 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 29: Th1/Th2 ratio >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 15: Th1/Th2 ratio >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 114: Th1/Th2 ratio <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 29: Th1/Th2 ratio <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 268: Th1/Th2 ratio <1 | 6 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 114: Th1/Th2 ratio >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 87: Th1/Th2 ratio >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 15: Th1/Th2 ratio <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 15: Th1/Th2 ratio >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 29: Th1/Th2 ratio >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 29: Th1/Th2 ratio <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 87: Th1/Th2 ratio >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 87: Th1/Th2 ratio <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 100: Th1/Th2 ratio >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 100: Th1/Th2 ratio <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 114: Th1/Th2 ratio >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 114: Th1/Th2 ratio <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 268: Th1/Th2 ratio >=1 | 80 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 268: Th1/Th2 ratio <1 | 20 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 87: Th1/Th2 ratio >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 268: Th1/Th2 ratio >=1 | 89 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 100: Th1/Th2 ratio <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 29: Th1/Th2 ratio <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 114: Th1/Th2 ratio >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 29: Th1/Th2 ratio >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 15: Th1/Th2 ratio >=1 | 100 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 114: Th1/Th2 ratio <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 15: Th1/Th2 ratio <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 87: Th1/Th2 ratio <1 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 268: Th1/Th2 ratio <1 | 11 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 100: Th1/Th2 ratio >=1 | 100 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 87: Th1/Th2 ratio >=1 | 100 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 100: Th1/Th2 ratio <1 | 0 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 29: Th1/Th2 ratio <1 | 0 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 114: Th1/Th2 ratio <1 | 0 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 15: Th1/Th2 ratio >=1 | 100 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 15: Th1/Th2 ratio <1 | 0 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 114: Th1/Th2 ratio >=1 | 100 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 29: Th1/Th2 ratio >=1 | 100 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 100: Th1/Th2 ratio >=1 | 100 Percentage of participants |
| COHORT 1A: Placebo, Placebo | Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 | Day 87: Th1/Th2 ratio <1 | 0 Percentage of participants |
Secondary
Cohorts 2a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA)
GMTs of SARS-CoV-2 neutralizing antibodies to the Wild-type VNA were reported.
Time frame: Days 29, 183, 190, 211, 366, 373 and 394
Population: PPI population was analyzed. Here, 'N' (Overall number of participants analyzed) =participants who were evaluable for this outcome measure and n (number analyzed) =participants who were evaluable for specified time points. Due to the change in planned analysis, data was not collected and analyzed for Cohort 2b and thus no data was reported for this outcome measure. 0 in the number analyzed field signifies that no participant was available for the analysis at the specified timepoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohorts 2a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 29 | 311 Titers |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohorts 2a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 183 | 241 Titers |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohorts 2a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 190 | 208 Titers |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohorts 2a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 211 | 216 Titers |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohorts 2a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 366 | 224 Titers |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohorts 2a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 373 | 245 Titers |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohorts 2a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 394 | 297 Titers |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohorts 2a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 373 | 1248 Titers |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohorts 2a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 394 | 1387 Titers |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohorts 2a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 183 | 379 Titers |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohorts 2a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 366 | 1137 Titers |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohorts 2a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 190 | 1576 Titers |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohorts 2a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 29 | 326 Titers |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohorts 2a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 211 | 2035 Titers |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohorts 2a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 183 | 172 Titers |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohorts 2a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 190 | 162 Titers |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohorts 2a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 373 | 973 Titers |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohorts 2a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 211 | 157 Titers |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohorts 2a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 394 | 3061 Titers |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohorts 2a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 366 | 124 Titers |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohorts 2a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 29 | 369 Titers |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohorts 2a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 29 | NA Titers |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohorts 2a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 211 | 486 Titers |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohorts 2a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 190 | 961 Titers |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohorts 2a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) | Day 183 | 833 Titers |
Secondary
Cohorts 2a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA)
Percentage of participants with antibodies binding to SARS-CoV-2 S protein as measured by ELISA was reported.
Time frame: Days 8, 29, 183, 190, 211, 366, 373, and 394,
Population: PPI population was analyzed. Here, 'N' (Overall number of participants analyzed) =participants who were evaluable for this outcome measure and n (number analyzed) =participants who were evaluable for specified time points. 0 in the number analyzed field signifies that no participant was available for the analysis at the specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohorts 2a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 211 | 100.0 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohorts 2a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 373 | 94.1 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohorts 2a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 366 | 95.2 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohorts 2a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 183 | 97.0 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohorts 2a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 8 | 6.0 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohorts 2a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 394 | 92.3 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohorts 2a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 190 | 96.8 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohorts 2a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 29 | 98.0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohorts 2a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 190 | 100.0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohorts 2a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 211 | 100.0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohorts 2a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 29 | 100.0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohorts 2a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 183 | 100.0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohorts 2a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 373 | 100.0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohorts 2a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 366 | 100.0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohorts 2a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 8 | 0.0 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohorts 2a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 394 | 100.0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohorts 2a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 394 | 100.0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohorts 2a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 8 | 0.0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohorts 2a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 29 | 100.0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohorts 2a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 183 | 86.7 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohorts 2a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 190 | 92.3 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohorts 2a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 211 | 85.7 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohorts 2a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 366 | 83.3 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohorts 2a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 373 | 100.0 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohorts 2a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 190 | 100.0 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohorts 2a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 8 | 0.0 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohorts 2a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 183 | 100.0 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohorts 2a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 29 | 6.7 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohorts 2a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) | Day 211 | 100.0 Percentage of participants |
Secondary
Cohorts 2a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2)
Percentage of participants with SARS-Cov2 S Specific CD4+ T-cell Responses for IFNg+ or IL2+ not Helper cell type 2 (TH2) was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination.
Time frame: Baseline, Days 29 and 366
Population: PPI population was analyzed. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure and n (number analyzed) signifies those participants who were evaluable for specified time points. 0 in the number analyzed field signifies that no participant was available for the analysis at the specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohorts 2a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Baseline | 9 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohorts 2a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Day 29 | 82 Percentage of participants |
| COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) | Cohorts 2a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Day 366 | 11 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohorts 2a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Day 29 | 100 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohorts 2a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Baseline | 20 Percentage of participants |
| COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) | Cohorts 2a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Day 366 | 20 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohorts 2a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Day 29 | 80 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohorts 2a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Baseline | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) | Cohorts 2a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Day 366 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohorts 2a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Day 29 | 0 Percentage of participants |
| COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) | Cohorts 2a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) | Baseline | 33 Percentage of participants |