NCT05736913

Intradermal COVID-19 Vaccination in the Immunocompromised

Status unknown Phase 2 Last updated 8 March 2023

What this trial tests

Phase 2 trial testing ID BNT162b2 vaccine in COVID-19 in 130 participants. Status unknown.

Timeline

1 April 2021

Primary endpoint
31 March 2023

30 June 2023

Quick facts

Lead sponsor	The University of Hong Kong
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	130
Start date	1 April 2021
Primary completion	31 March 2023
Estimated completion	30 June 2023
Sites	1 location across Hong Kong

Drugs / interventions tested

• ID BNT162b2 vaccine — full drug profile →
• IM BNT162b2 vaccine — full drug profile →

Conditions studied

• COVID-19 — all drugs for COVID-19 →

Sponsor

The University of Hong Kong

Who can join

18 and older, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

COVID-19 is an infectious disease caused by SARS-CoV-2 virus, causing millions of deaths around the globe since the beginning of the pandemic. COVID-19 vaccination was proven to be effective at reducing both mortality and development of severe COVID-19 after infection. Vaccine-elicited protection is particularly important for immunocompromised patients, as they are more susceptible to infections with their defective immune response, for instance, previous review had suggested that patients with malignancies and recipients of solid organ transplants may be at increased risk of developing severe COVID-19 disease and even death.

To further complicate the scenario, there are two obstacles: firstly, immunocompromised individuals may have suboptimal response from vaccinations, as studies have shown that recipients of solid organ transplant have suboptimal or even are seronegative after the fourth dose booster vaccination . Secondly, with constant mutation of the SARS-CoV-2 viruses, new variants evolve over time, leading to reduction in vaccine efficacy and breakthrough infection in healthy individuals. Therefore, novel vaccine strategy should be considered to enhance the vaccine response in these immunocompromised individuals.

In this study, intradermal injection instead of intramuscular injection for vaccine delivery is proposed, as the investigators have observed improved immunogenicity and few adverse events from previous experience of influenza vaccination. The study aims to evaluate the immunogenicity, safety and tolerability of intradermal COVID-19 vaccination in immunocompromised patients.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.