Official Title
Assessment of the Immunogenicity and Safety of Marketed Vaccines for COVID-19 After Regular Schedule and Adapted Vaccine Schedules and Routes: BNT162b2, mRNA-1273 Vaccine and ChAdOx1-S [Recombinant]
Brief Summary

The goal of this clinical trial is to compare different Coronavirus Disease 2019(COVID-19) vaccination schedules in healthy adults that have not yet been exposed toSARS-CoV-2, the virus causing COVID-19. The main questions it aims to answer are: 1. Is it possible to adapt COVID-19 vaccination schedules while maintaining an adequate humoral immune response? 2. Is it possible to adapt COVID-19 vaccination schedules while maintaining an acceptable safety profile?Participants will be vaccinated twice with a COVID-19 vaccine (on day 0, and on day 28 or84). After each vaccination, they will collect information about adverse events in adiary for 14 days. Information about the occurrence of events such as hospitalizationsand infections with SARS-CoV-2 will be collected by the investigator for up to 364 daysafter the first vaccination. Blood samples will be taken on different timepoints and usedto assess immunity against SARS-CoV-2.Researchers will compare 8 vaccination schedules to see if the immune response and safetyprofile is similar. Each participant will receive 1 of the following 8 vaccine schedules: - BNT162b2 (30µg) on day 0, followed by BNT162b2 (30µg) on day 28 - BNT162b2 (20µg) on day 0, followed by BNT162b2 (20µg) on day 28 - BNT162b2 (30µg) on day 0, followed by BNT162b2 (30µg) on day 84 - BNT162b2 (30µg) on day 0, followed by mRNA-1273 (100µg) on day 28 - BNT162b2 (30µg) on day 0, followed by ChAdOx1-S [recombinant] on day 28 - BNT162b2 (6µg, intradermal administration) on day 0, followed by BNT162b2 (6µg, intradermal administration) on day 28 - mRNA-1273 (100µg) on day 0, followed by mRNA-1273 (100µg) on day 28 - mRNA-1273 (50µg) on day 0, followed by mRNA-1273 (50µg) on day 28

Detailed Description

Not Provided

Completed
Coronavirus Disease 2019
COVID-19

Drug: BNT162b2 30µg

intramuscular administration of 30µg

Drug: BNT162b2 20µg

intramuscular administration of 20µg

Drug: BNT162b2 6µg

intradermal administration of 6µg

Drug: mRNA-1273 100µg

intramuscular administration of 100µg

Drug: mRNA-1273 50µg

intramuscular administration of 50µg

Drug: ChAdOx1-S [Recombinant]

intramuscular administration of not less than 2.5 x 10^8 infectious units

Eligibility Criteria

Inclusion Criteria:

1. Male, female, or X (non-binary gender) subjects, 18-55y inclusive on the day of
signing of the ICF

2. Provision of signed and dated informed consent form

3. Available at all provided timepoints of the study and is not planning to move abroad
for the whole duration of the study

4. In good general health as evidenced by medical history and/or physical examination
or adults with pre-existing medical conditions who are in stable condition. A stable
medical condition is defined as disease not requiring significant change in therapy
or hospitalization for worsening disease during the 3 months before enrollment.

5. Willing and able to comply with all study procedures

6. Participants born female must be either:

- of childbearing potential and using effective contraception for at least 1
month prior to screening and agree to use such a method during study
participation until 1 months following the last study dose administration.

- of non-childbearing potential.

Exclusion Criteria:

1. Previous clinical or microbiological confirmed diagnosis of COVID-19.

2. Febrile illness within 72hours before first vaccination (this is a temporary
exclusion criterion).

3. Unstable, severe, progressive disease in the past 3 months.

4. History of malignancy during the past 5 years.

5. History of severe adverse reaction associated and/or anaphylaxis with a vaccine.

6. Known allergic reactions of any severity to polyethylene glycol [PEG] or to
polysorbate (due to potential cross-reactive hypersensitivity with the vaccine
ingredient PEG).

7. Primary or secondary immunodeficiency disorders (e.g. immunosuppressive disease or
therapy, human immunodeficiency virus (HIV) infection…).

8. Chronic administration (defined as more than 14 days in total) of immunosuppressant
or other immune-modifying drugs during the period starting 6 months prior to the
first vaccine dose. For corticosteroids, this will mean prednisone 20 mg/day, or
equivalent. Inhaled, nasal, opthalmic and topical steroids are allowed.

9. Pregnancy or lactation.

10. History of drug or alcohol abuse.

11. Anything in the opinion of the investigator that would prevent volunteers from
completing the study or put the volunteer at risk, including relevant psychiatric
diagnosis.

12. Previous vaccination or planned to accept other vaccination during this study with
any coronavirus vaccine outside this study.

13. Previous vaccination or planned to accept other vaccination during this study with
any coronavirus vaccine outside this study, with the exception of a third COVID-19
vaccine during fall/winter '21-'22.

14. Receipt of blood/plasma products or immunoglobulin, from 60 days before study
intervention administration or planned receipt throughout the study.

15. Participation in another clinical trial with an IMP or a new medical device within
28 days prior to study entry and/or during study participation.

16. Participant is an employee of the investigator or study site, with direct
involvement in the proposed study or other studies under the direction of that
investigator or study site, as well as first degree family members and household
members of the employees or the investigator, or an employee of the sponsor.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 55 Years
Countries
Belgium
Locations

Centre for the Evaluation of Vaccination (CEV)
Edegem 2799007, Antwerp, Belgium

Centre for Vaccinology (CEVAC)
Ghent 2797656, East Flanders, Belgium

Institute of Tropical Medicine (ITM)
Antwerp 2803138, Belgium

Hôpital Erasme
Brussels 2800866, Belgium

Universiteit Antwerpen
NCT Number
MeSH Terms
COVID-19
BNT162 Vaccine
2019-nCoV Vaccine mRNA-1273
ChAdOx1 nCoV-19