MedTrace Logo

Immunosuppression and COVID-19 Boosters

NCT05415267 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2026-02-24

No results posted yet for this study

Summary

It is important people receiving immunosuppressive therapy are provided with the best protection against COVID-19 because they are at greater risk of severe illness should they become infected. As severe immunosuppression can reduce the efficacy of COVID-19 vaccination, doctors agree that COVID-19 boosters is are important to maximise the vaccine response in these people. However, we don't currently know the best time to give booster vaccines to people about to start immunosuppressive therapy. This research aims to address this knowledge gap by examining whether the greatest protection is provided by giving the COVID-19 booster just before the immunosuppressive therapy starts or by waiting and giving the booster 6 months after treatment start. At the 6-month timepoint, in many cases the more intensive immunosuppression is often weaning and the immune system is starting to rebuild.

Conditions

Interventions

BIOLOGICAL

diphtheria and tetanus toxoids (adsorbed) vaccine

The diphtheria/tetanus toxoids vaccine will be given to participants enrolled into Group 1 as a comparator vaccine to the mRNA COVID-19 booster vaccine with the aim of determining whether the results related to COVID-19 vaccine timing also apply to more traditional protein-based vaccines.

BIOLOGICAL

COVID-19 vaccine

All participants will receive a COVID-19 booster vaccination at either week 0 or week 24 depending on their randomised study arm

Sponsors & Collaborators

  • Seqirus Pty Ltd, Australia

    collaborator UNKNOWN

  • Medical Research Future Fund

    collaborator OTHER

  • Kirby Institute

    lead OTHER_GOV

Principal Investigators

  • Sarah C Sasson, PhD · The Kirby Institute UNSW Sydney

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-21
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05415267 on ClinicalTrials.gov