Intradermal COVID-19 Vaccination in the Immunocompromised

NCT05736913 | Unknown Phase 2 DMC

• 1 other identifier: UW 21-214
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19

Keywords

immunogenicity; safety; intradermal; COVID-19; vaccine; immunocompromised

Outcome Measures

Primary Outcomes (1)

• vMN geometric mean titre

  microneutralization GMT

  day 28 after vaccination

Secondary Outcomes (2)

• vMN geometric meant titre fold increase

  day 28 after vaccination

• Safety of the intradermal vaccination

  day 28 after vaccination

Study Arms (2)

Intradermal

ACTIVE COMPARATOR

One dose of 30ug (0.3mL) intradermal BNT162b2

Biological: ID BNT162b2 vaccine

Intramuscular

ACTIVE COMPARATOR

One dose of 30ug (0.3mL) intramuscular BNT162b2

Biological: IM BNT162b2 vaccine

Interventions

ID BNT162b2 vaccine BIOLOGICAL

intradermal BNT162b2 vaccine

Intradermal

IM BNT162b2 vaccine BIOLOGICAL

intramuscular BNT162b2 vaccine

Intramuscular

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Recruited subjects include adult subjects ≥18 years
• Immunocompromised subjects as defined by the following.
• Patients who have undergone solid organ or stem cell transplantation and on immunosuppressive medication.
• Patients who are on chemotherapy, biologics or other immunosuppressive therapy.
• Patients who are on high-dose corticosteroid (prednisolone 0.5mg/kg daily or equivalent)
• Negative IgG antibody response against Covid19 14 days after the second dose of Covid19 vaccination.
• All subjects have to give written informed consent.
• Subjects must be available to complete the study and comply with study procedures. Willingness to allow for serum samples to be stored beyond the study period, for potential additional future testing to better characterize immune response

You may not qualify if:

• Inability to comprehend and to follow all required study procedures.
• Have a recent history (documented, confirmed or suspected) of a flu-like disease within a week of vaccination.
• Have a known allergy to polyethylene glycol (PEG) or other components of the study vaccines, or history of any anaphylaxis, serious vaccine reactions, to any excipients.
• Have known active human immunodeficiency virus (HIV) infection.
• Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to vaccination in this study or expect to receive an experimental agent during this study. Unwilling to refuse participation in another clinical study through the end of this study.
• Tympanic temperature ≥ 38°C within 3 days of intended study vaccination
• Have a history of alcohol or drug abuse in the last 5 years.
• Have any condition that the investigator believes may interfere with successful completion of the study

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, 852, Hong Kong

RECRUITING

Related Publications (2)

• Tawinprai K, Siripongboonsitti T, Porntharukchareon T, Wittayasak K, Thonwirak N, Soonklang K, Sornsamdang G, Auewarakul C, Mahanonda N. Immunogenicity and safety of an intradermal fractional third dose of ChAdOx1 nCoV-19/AZD1222 vaccine compared with those of a standard intramuscular third dose in volunteers who previously received two doses of CoronaVac: A randomized controlled trial. Vaccine. 2022 Mar 15;40(12):1761-1767. doi: 10.1016/j.vaccine.2022.02.019. Epub 2022 Feb 21.

  PMID: 35210118 RESULT

• Niyomnaitham S, Atakulreka S, Wongprompitak P, Copeland KK, Toh ZQ, Licciardi PV, Srisutthisamphan K, Jansarikit L, Chokephaibulkit K. Immunogenicity and reactogenicity of accelerated regimens of fractional intradermal COVID-19 vaccinations. Front Immunol. 2023 Jan 17;13:1080791. doi: 10.3389/fimmu.2022.1080791. eCollection 2022.

  PMID: 36733395 RESULT

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ivan FN Hung, MD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ivan FN Hung, MD

CONTACT

22553424; ivanhung@hku.hk

Ricky Zhang, PhD

CONTACT

22554049; zhangrq@hku.hk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective, open-labelled, randomized trial

Study Record Dates

• First Submitted: February 19, 2023
• First Posted: February 21, 2023
• Study Start: April 1, 2021
• Primary Completion: March 31, 2023
• Study Completion: June 30, 2023
• Last Updated: March 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 12 months
• Access Criteria: email to the principal investigator

Locations

HK (1)