A phase II, randomized, double-blind, multi-centre trial to evaluate the safety and immunogenicity of BIMERVAX® when coadministered with seasonal surface antigen, inactivated, adjuvanted influenza vaccine (SIIV) in adults older than 65 years of age fully vaccinated against COVID-19.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Hipra Scientific S.L.

Participant type

Healthy volunteers

Age range

65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Virus Diseases [C02], Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

4 Sep 2023 → 3 Nov 2023

Decision date (initial)

2023-07-14

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: Safety

To assess and compare the safety and tolerability of BIMERVAX® coadministered with SIIV in adults with respect to each vaccine when administered alone.

Secondary objectives 2

1. To determine and compare the immunogenicity measured by means of total antibody against RBD of the Spike protein of SARS-CoV-2 quantification, measured by electrochemiluminescence immunoassay (ECLIA) at Baseline, and at Day 28 in cohorts 2 and 3 vaccinated with BIMERVAX®.
2. To determine and compare the immunogenicity measured by Influenza strain specific titres, measured by haemagglutination inhibition (HAI) at Baseline and at Day 28 in cohorts 1 and 3, vaccinated with SIIV.

Conditions and MedDRA coding

SARS-CoV-2 and Influenza

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Adults aged 65 or older at Day 0.
2. Are willing and able to sign the informed consent and can comply with all study visits and procedures.
3. Participant must have received at least a primary scheme of an mRNA vaccine (2 doses). Booster doses or previous COVID-19 infections are allowed. Last dose must have been administered at least 6 months before Day 0. History of COVID-19 infection is allowed if occurred at least >30 days before Day 0.
4. Have a negative Rapid Antigen Test (RAT) at Day 0 before vaccinations.
5. Adults determined by clinical assessment, including medical history and clinical judgement, to be eligible for the study, including adults with pre-existing chronic and stable diseases (non-immunocompromised), if these are stable and well-controlled according to the investigator’s judgment.

Exclusion criteria 12

1. Acute illness with fever ≥ 38.0°C at Day 0 or within 24 hours prior to vaccination. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator.
2. Allergy to egg proteins (egg or egg products) or chicken proteins.
3. History of Guillain-Barré syndrome (GBS)
4. History of COVID-19 infection (described as a positive RAT or PCR), in the previous 30 days before Day 0.
5. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behaviour that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
6. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g. anaphylaxis) to any component of the study intervention(s).
7. Immunocompromised individuals defined as those with primary and secondary immune deficiencies and those receiving chemotherapy or immunosuppressant drugs other than steroids and glucocorticoids (maximum 30 mg/day of prednisone, or equivalent, by any administration route for a maximum of 30 consecutive days), within 90 days prior to vaccination or during the study.
8. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
9. Receipt of blood-derived immune globulins, blood, or blood-derived products in the past 3 months.
10. Participation in other studies involving study intervention within 28 days prior to screening and/or during study participation.
11. Received any non-study vaccine within 14 days before or after screening. For live or attenuated vaccines, 4 weeks before or after screening.
12. History of a diagnosis or other conditions that, in the judgment of the investigator, may affect study endpoint assessment or compromise participant safety.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 4

1. Number, percentage, and characteristics of solicited local and systemic reactions through Day 7 after vaccination.
2. Number, percentage, and characteristics of unsolicited local and systemic adverse events (AEs) through the end of the study.
3. Number and percentage of serious adverse events (SAEs) through the end of the study.
4. Number and percentage of adverse events of special interest (AESI) through the end of the study.

Secondary endpoints 4

1. Binding antibodies titre measured for each individual sample and GMT for treatment group comparison at Baseline and at Day 28 elicited by BIMERVAX® when coadministered with SIIV or administered alone.
2. Geometric mean fold rise (GMFR) in binding antibodies titre from Baseline and Day 28 elicited by BIMERVAX® when coadministered with SIIV or administered alone.
3. Strain specific HAI antibody titers (expressed as GMT) at Baseline and at Day 28, elicited by SIIV when coadministered with BIMERVAX®, or administered alone.
4. Geometric mean fold rise (GMFR) in strain specific HAI titers elicited at Day 28 by SIIV when coadministered with BIMERVAX® or administered alone.

Investigational products

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

Test 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Hipra Scientific S.L.

Sponsor organisation

Hipra Scientific S.L.

Address

Avinguda Selva 135

City

Amer

Postcode

17170

Country

Spain

Scientific contact point

Organisation

Hipra Scientific S.L.

Contact name

Teresa Prat

Public contact point

Organisation

Hipra Scientific S.L.

Contact name

Teresa Prat

Locations

1 EU/EEA country · 8 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

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