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 to SARS-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 or 84). After each vaccination, they will collect information about adverse events in a diary for 14 days. Information about the occurrence of events such as hospitalizations and infections with SARS-CoV-2 will be collected by the investigator for up to 364 days after the first vaccination. Blood samples will be taken on different timepoints and used to assess immunity against SARS-CoV-2. Researchers will compare 8 vaccination schedules to see if the immune response and safety profile 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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
580
intramuscular administration of 30µg
intramuscular administration of 20µg
intradermal administration of 6µg
intramuscular administration of 100µg
intramuscular administration of 50µg
intramuscular administration of not less than 2.5 x 10\^8 infectious units
Centre for the Evaluation of Vaccination (CEV)
Edegem, Antwerp, Belgium
Centre for Vaccinology (CEVAC)
Ghent, East Flanders, Belgium
Institute of Tropical Medicine (ITM)
Antwerp, Belgium
Hôpital Erasme
Brussels, Belgium
Geometric mean titre of antibodies binding to the Receptor Binding Domain of SARS-CoV-2 S protein of the ancestral D614 SARS-CoV-2 virus strain
Time frame: 28 days after the administration of the second study vaccine
Occurrence of solicited adverse events
Time frame: within 5 days after the administration of each study vaccine
Occurrence of unsolicited adverse events
Time frame: within 14 days after the administration of each study vaccine
Occurrence of medically attended adverse events, adverse of special interest and serious adverse events
Time frame: through study completion (up to 1 year after the first study vaccination)
Occurrence of absenteeism
Time frame: within 5 days after the administration of each study vaccine
Geometric mean titre of antibodies binding to the Receptor Binding Domain of SARS-CoV-2 S protein of the ancestral D614 SARS-CoV-2 virus strain
Time frame: 28 days after the administration of the third COVID-19 vaccine
Geometric mean titre of neutralizing antibodies to the ancestral D614 SARS-CoV-2 virus strain and variants of concern
Time frame: 28 days after the administration of the second study vaccin
Geometric mean titre of neutralizing antibodies to the ancestral D614 SARS-CoV-2 virus strain and variants of concern
Time frame: 28 days after the administration of the third COVID-19 vaccine
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