E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Healthy volunteers (Prevention of COVID-19) |
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E.1.1.1 | Medical condition in easily understood language |
Healthy volunteers (Prevention of COVID-19) |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the safety and reactogenicity of Ad26COVS1 at 2 dose levels, 5×10e10 virus particles (vp) and 1×10e11 vp, administered intramuscularly (IM) as a single-dose or 2-dose schedule in healthy adults aged ≥18 to ≤55 years and in adults aged ≥65 years in good health with or without stable underlying conditions. |
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E.2.2 | Secondary objectives of the trial |
To assess the humoral and cellular immune response to Ad26COVS1 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Applicable to Cohorts 1 and 2 only: Participant is male or female and 18 to 55 years of age, inclusive, on the day of signing the ICF.
Applicable to Cohort 3 only: Participant is male or female and 65 years of age or older on the day of signing the ICF. For study sites in Belgium, participant is 65 to 75 years of age, inclusive, on the day of signing the ICF.
2. Participant must have a body mass index (BMI) <30.0 kg/m2.
3. 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 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. If they are on medication for a condition, the medication dose must have been stable for at least 12 weeks preceding vaccination and expected to remain stable for the duration of the study. Participants will be included on the basis of physicalnexamination, clinical laboratory assessments, medical history, and vital signs.
4. All female participants of childbearing potential must:
a. Have a negative highly sensitive urine pregnancy test at screening
b. Have a negative highly sensitive urine pregnancy test immediately prior to each study vaccine administration.
5. Participant agrees to not donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after receiving the last dose of study vaccine. |
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E.4 | Principal exclusion criteria |
1. Participant has a clinically significant acute illness or temperature ≥38.0ºC (100.4°F) within 24 hours prior to the planned first dose of study vaccine.
2. Participant has a history of malignancy within 5 years before screening.
3. Participant has a history of any neurological disorders or seizures including Guillain-Barré syndrome, with the exception of febrile seizures during childhood.
4. Participant previously received a coronavirus vaccine.
5. Participant has a positive diagnostic test result for SARS-CoV-2 infection, confirmed by PCR, at screening.
6. Seropositive participants are enrolled in specific circumstances.
7. Participants with comorbidities that are or might be associated with an increased risk of progression to severe COVID-19, ie, participants with moderateto-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/m2); 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, 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, eg, thiazides, Beta blockers, Alpha blockers at the same effective dose). |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Solicited local and systemic AEs for 7 days after each vaccination in the primary regimen
2. Unsolicited AEs for 28 days after each vaccination in the primary regimen
3. Serious adverse events (SAEs) and adverse events of special interest (AESIs) from the first vaccination until 2 years after the second vaccination for Cohorts 1 and 3, and until 6 months after the primary regimen for Cohort 2 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. 7 days after each vaccination in the primary regimen
2. 28 days after each vaccination in the primary regimen
3. Cohorts 1 & 3: throughout the study from the first vaccination until 1 year after the second vaccination; Cohort 2: throughout the study until 6 months after the primary regimen |
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E.5.2 | Secondary end point(s) |
1. SARS-CoV-2 neutralization measured by a virus neutralization assay
2. SARS-CoV-2-binding antibodies measured by enzyme-linked immunosorbent assay
3. Th1 and Th2 immune responses measured by flow cytometry or IFNγ and IL-4 enzyme-linked immunospot (ELISpot) assay (for a subset of participants in Cohorts 1, 2, and 3) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Day 1 (pre-vaccination), Day 15±3, Day 29±3, Day 57-3/+7 (pre-vaccination), Day 71±3, Day 85±3, Day 239±21, Day 366±21
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Reactogenicity and Immunogenicity |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | Yes |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 7 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 6 |