Immunogenicity After COVID-19 Vaccines in Adapted Schedules
Status:
Completed
Trial end date:
2022-07-08
Target enrollment:
Participant gender:
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 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