NCT06189040

Immunogenicity After COVID-19 Vaccines in Adapted Schedules

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]

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 580 (actual)
• Sponsor: Universiteit Antwerpen · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Conditions

• Coronavirus Disease 2019
• COVID-19

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-05-26
• Primary completion: 2021-11-03
• Completion: 2022-07-08
• First posted: 2024-01-03
• Last updated: 2024-01-03

Locations

4 sites across 1 country: Belgium