Intradermal administration of a COVID-19 mRNA vaccine in elderly

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Stichting Radboud University Medical Center

Participant type

Healthy volunteers

Age range

65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Virus Diseases [C02], Phenomena and Processes [G] - Immune system processes [G12]

Trial duration

4 Sep 2023 → 21 Mar 2024

Decision date (initial)

2023-07-26

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2023-503800-99-00

ClinicalTrials.gov

NCT05977127

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

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 objectives 2

1. To assess the neutralising antibody responses of the different intervention groups
2. To assess the reactogenicity of the different intervention groups

Conditions and MedDRA coding

Adult volunteers (M/F) aged ≥75 years who are healthy or have stable disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 11

1. Male or female aged ≥75 years at the moment of immunization.
2. 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.
3. Willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, and other study procedures.
4. 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.
5. Completed a primary series of COVID-19 vaccination.
6. Capable and willing to give personal signed informed consent.
7. Adequate understanding of the procedures of the study and agrees to abide strictly thereby.
8. Fully conversant in the Dutch language.
9. Agrees that their general practitioner is informed about participation in the study.
10. Agrees to provide access to information regarding their vaccination background.
11. Agrees that the study physician and his/her delegates have access to their medical file at Radboudumc.

Exclusion criteria 11

1. 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.
2. Receipt of any other non-study vaccine within 7 days prior and after receiving the study intervention.
3. No decision-making capacity.
4. History of severe adverse reaction to a vaccine or to any component of the study intervention.
5. Dermatological conditions that might interfere with the intradermal vaccination.
6. Receipt of COVID-19 vaccination within 3 months before receiving the study intervention.
7. Known or suspected immunodeficiency, as determined by medical history or medication use (inhalation corticosteroids are allowed).
8. History of autoimmune disease or an active autoimmune disease requiring therapeutic intervention.
9. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
10. Participation in other studies involving other study interventions within 28 days prior and during 28 days after receiving the study intervention.
11. Thrombose with thrombocytopenia syndrome after vaccination with a COVID-19 vaccine

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Anti-S IgG levels in serum 28 days after vaccination, expressed in geometric mean concentrations (GMC)

Secondary endpoints 2

1. SARS-CoV-2 neutralising antibody titres in serum 28 days after vaccination, expressed in geometric mean titres (GMT)
2. 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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Stichting Radboud University Medical Center

Sponsor organisation

Stichting Radboud University Medical Center

Address

Geert Grooteplein Zuid 10

City

Nijmegen

Postcode

6525 GA

Country

Netherlands

Scientific contact point

Organisation

Stichting Radboud University Medical Center

Contact name

Lucille van Beek

Public contact point

Organisation

Stichting Radboud University Medical Center

Contact name

Lucille van Beek

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 2 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications