Immunogenicity After COVID-19 Vaccines in Adapted Schedules

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

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

Sponsors & Collaborators

• Universiteit Antwerpen

  lead OTHER

Principal Investigators

• Katie Steenackers, MD · Centre for the Evaluation of Vaccination

• Nikita Hanning, MD · Centre for the Evaluation of Vaccination

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-05-26

Primary Completion

2021-11-03

Completion

2022-07-08

Countries

• Belgium

Study Locations