Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06189040
Status:
COMPLETED
Last Update Posted:
2024-01-03
First Post:
2023-12-20
Brief Title:
Immunogenicity After COVID-19 Vaccines in Adapted Schedules
Sponsor:
Universiteit Antwerpen
Organization:
Universiteit Antwerpen
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMCOVAS
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 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None