Intradermal administration of a COVID-19 mRNA vaccine in elderly

Phase 1

• Conditions: Adult volunteers (M/F) aged =75 years who are healthy or have stable disease; Therapeutic area: Phenomena and Processes [G] - Immune system processes [G12]; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: CTIS2023-503800-99-00
• Lead Sponsor: Stichting Radboud University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-03
• Study Completion: 2024-03-21
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Male or female aged =75 years at the moment of immunization., Agrees to provide access to information regarding their vaccination background., Agrees that the study physician and his/her delegates have access to their medical file at Radboudumc., Healthy, determined by medical history and clinical judgment of the investigator. Participants with a pre-existing illness that is stable, defined as disease not requiring significant change in therapy or hospitalisation during the 6 weeks before enrolment and not expected to require any intervention during the study, can be included., Willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, and other study procedures., Willing to postpone their regular COVID-19 vaccination upon invitation by the Municipal Health Service or general practitioner until at least four months after receiving the intervention., Completed a primary series of COVID-19 vaccination., Capable and willing to give personal signed informed consent., Adequate understanding of the procedures of the study and agrees to abide strictly thereby., Fully conversant in the Dutch language., Agrees that their general practitioner is informed about participation in the study.

Exclusion Criteria

Medical or psychiatric condition that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study., Participation in other studies involving other study interventions within 28 days prior and during 28 days after receiving the study intervention., Thrombose with thrombocytopenia syndrome after vaccination with a COVID-19 vaccine, Receipt of any other non-study vaccine within 7 days prior and after receiving the study intervention., No decision-making capacity., History of severe adverse reaction to a vaccine or to any component of the study intervention., Dermatological conditions that might interfere with the intradermal vaccination., Receipt of COVID-19 vaccination within 3 months before receiving the study intervention., Known or suspected immunodeficiency, as determined by medical history or medication use (inhalation corticosteroids are allowed)., History of autoimmune disease or an active autoimmune disease requiring therapeutic intervention., Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: In the present study, we will investigate the immunogenicity of a 20 mcg dose of the COVID-19 mRNA Comirnaty vaccine through intradermal administration with silicon microneedles in elderly people (75 years and older), and compare these to the immunogenicity of intramuscular administration of a 20 mcg dose and a 30 mcg dose (30 mcg is the standard intramuscular dose).;Secondary Objective: To assess the neutralising antibody responses of the different intervention groups, To assess the reactogenicity of the different intervention groups;Primary end point(s): Anti-S IgG levels in serum 28 days after vaccination, expressed in geometric mean concentrations (GMC)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):SARS-CoV-2 neutralising antibody titres in serum 28 days after vaccination, expressed in geometric mean titres (GMT);Secondary end point(s):The percentage of participants reporting: -Solicited adverse events (AEs) (local reactions, reaction of regional lymph nodes, and systemic reactions up to 14 days following vaccination), unsolicited AEs up to 28 days following vaccination, serious AEs (SAEs) up to 28 days following vaccination and use of antipyretics and analgesics up to 14 days following vaccination.