Immunogenicity of licensed MF59 adjuvanted Influenza and SARS-CoV-2 vaccine combinations for Older Adults (ISOLDA)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Cr2o B.V.

Participant type

Healthy volunteers

Age range

65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Virus Diseases [C02]

Trial duration

2 Oct 2024 → 4 Mar 2025

Decision date (initial)

2024-09-30

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

The primary objective of this trial is to assess the humoral immune response elicited by a licensed COVID-19 vaccine when co-administered with a licensed MF59 adjuvanted seasonal FLU vaccine in adults aged 65 years and over, relative to the licensed COVID-19 vaccine co-administered with an unadjuvanted seasonal FLU vaccine or the COVID-19 vaccine alone.

Secondary objectives 2

1. The secondary objective of this trial is to evaluate the cellular immune response elicited by a licensed COVID-19 vaccine when co-administered with a licensed MF59 adjuvanted seasonal FLU vaccine in adults aged 65 years and over, relative to a licensed COVID-19 vaccine co-administered with an unadjuvanted seasonal FLU vaccine or the COVID-19 vaccine alone
2. The safety objective of this trial is to assess the safety and reactogenicity of a licensed COVID-19 vaccine when co-administered with a licensed MF59 adjuvanted seasonal FLU vaccine in adults aged 65 years and over, compared to a licensed COVID-19 vaccine co-administered with an unadjuvanted seasonal FLU vaccine or the COVID-19 vaccine alone.

Conditions and MedDRA coding

COVID-19 and flu

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Willingness to provide written informed consent.
2. Men or women aged 65 years or older at the time of consent.
3. Ability to comply with the trial protocol requirements

Exclusion criteria 14

1. Presence of any chronic disease, or history of significant disease, that might interfere with the conduct or completion of the trial. Certain conditions may be accepted if they have been stable for at least 3 months preceding the start of the trial (visit 1), such as hypertension, at discretion of the Investigator.
2. Confirmed or suspected (at the discretion of the Investigator) immuno-suppressive or immuno-deficient condition.
3. Receipt of a blood transfusion, blood products, or immunoglobulins within the 3-month period preceding start of the trial (Visit 1), or planned infusion within 90 days after the end of the trial.
4. Presence of acute disease and/or fever (≥38°C measured by the oral route) at the time of vaccine administration.
5. Vaccinated with any SARS-CoV-2 vaccine, or history of documented COVID-19, within four months prior to trial vaccination
6. Vaccination with a FLU vaccine within a 6-month period preceding the start of the trial (Visit 1)
7. Vaccination other than COVID-19 or FLU within 6 months prior to trial or expected during the trial period – with the exception of the routine vaccination campaign against Pneumococcus, or vaccines administered in the context of this trial
8. Presence of any other significant findings that, in the opinion of the Investigator, would increase the risk of experiencing adverse outcomes from participating in the trial.
9. Use of any investigational drug within 90 days prior to trial entry.
10. Being an employee of the Investigator or trial site, with direct involvement in the proposed trial or other studies under the direction of that Investigator or trial site or being a family member of an employee or the Investigator.
11. Use of B-cell depleting therapy (i.e. Rituximab) within 12 months prior to vaccination, or within 90 days following vaccination
12. Reported Human Immunodeficiency Virus (HIV) infection with a CD4 lymphocyte count of < 100 cells per mm3 in the year prior to vaccination
13. Administration of immunosuppressant or immuno-modifying drugs for more than 3 months prior of trial start, or intended future use of any other immunosuppressant medication, judged by the Investigator to result in a severely reduced response to the vaccine. Asthma inhalers are exempt from this requirement.
14. Use of systemic corticosteroids ≥20 mg of prednisone per day, or equivalent within 28 days prior to vaccination, or planned treatment within 90 days following vaccination

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. A. Serum neutralizing antibody response (pseudotype, and whole virus neutralizing antibodies (VNAb)) to SARS-CoV-2 variants of concern (VOCs) at days 0, 10, and 28
2. B. Change in Geometric mean titres (GMT) of serum anti SARS-CoV-2 spike glycoprotein specific binding antibody – kinetics and magnitude at days 10, and 28, relative to those measured on Day 0
3. C. Longevity of humoral responses as measured by serum neutralizing antibody response (pseudotype, and whole VNAb) and binding antibody response to SARS-CoV-2 VOCs at day 90.

Secondary endpoints 5

1. A. Characterization of cellular immunity (antigen specific cytotoxic T cells (CTL), T helper cells (Th) responses and T cell memory): ELISpot and/or intracellular cytokine staining (Flow cytometry) to SARS-CoV-2 at days 0 and 28
2. B. Longevity of cellular immune responses to SARS-CoV-2 as measured by cellular immunity assays (described under a) on day 90
3. Safety and reactogenicity A. The frequency and severity of solicited local (injection site) and systemic adverse events (AEs) reported within 7 days of vaccination
4. Safety and reactogenicity B. All unsolicited AEs reported within 28 days of vaccination;
5. Safety and reactogenicity C. All serious adverse events (SAEs) reported from day 0 until day 90 or end of trial.

Investigational products

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

Test 3

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Cr2o B.V.

Sponsor organisation

Cr2o B.V.

Address

Bisonspoor 3002/c 701

City

Maarssen

Postcode

3605 LT

Country

Netherlands

Scientific contact point

Organisation

Cr2o B.V.

Contact name

Nick van den Bulk

Public contact point

Organisation

Cr2o B.V.

Contact name

Nick van den Bulk

Locations

2 EU/EEA countries · 2 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 31 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