A Phase IV, open label, single arm trial to assess the safety and immunogenicity of BIMERVAX® LP.8.1 against SARS-CoV-2 variants.

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]

Trial duration

28 Oct 2025 → 8 Jan 2026

Decision date (initial)

2025-10-27

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, Safety

1. To assess the safety and tolerability of BIMERVAX® LP.8.1.
2. To measure the immunogenicity against Omicron LP.8.1 and other epidemiologically relevant SARS-CoV-2 variants at Baseline and Day 14.

Secondary objectives 1

1. To evaluate the immunogenicity measured by means of total antibodies against Receptor Binding Domain (RBD) of the Spike protein of SARS-CoV-2 at Baseline and at Day 14.

Conditions and MedDRA coding

COVID-19

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 voluntarily give written consent and can comply with all study visits and procedures.
3. Having a negative Rapid Antigen Test for COVID-19 at Day 0 prior to vaccination.
4. 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, if these are stable and well controlled according to the Investigator’s judgement.
5. Adults with any primary COVID-19 vaccination scheme AND, at least, one booster dose with a vaccine targeting any SARS-CoV-2 Omicron JN.1 or KP.2 variant. Last dose being at least 6 months before Baseline.

Exclusion criteria 10

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. 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 judgement, make the participant inappropriate for the study. - Note: This includes both conditions that may increase the risk associated with study intervention administration or a condition that may interfere with the interpretation of study results.
3. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g. anaphylaxis) to any component of the study intervention.
4. 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.
5. Clinical conditions representing, in the opinion of the Investigator, a contraindication to intramuscular administration of vaccines, or blood draw.
6. Receipt of blood-derived immune globulins, blood, or blood derived products in the 3 months prior to vaccination and throughout the study duration.
7. Participation in other studies involving study intervention if last dose is within 28 days prior to vaccination and/or it is planned to receive during study participation.
8. Received any non-study vaccine within 14 days before or after Baseline. For live or attenuated vaccines, 4 weeks before or after Baseline.
9. SARS-CoV-2 infection reported must have occurred at least 30 days before Day 0. History of SARS-CoV-2 infection/s is allowed.
10. Participants with hepatic or renal impairment as well as history of a diagnosis or other conditions that, in the judgement of the Investigator, may affect study endpoint assessment or compromise participant safety.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 7

1. Number, percentage, and characteristics of solicited local reactions and systemic events through Day 7 after vaccination.
2. Number, percentage, and characteristics of unsolicited 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 (AESIs) through the end of the study.
5. Number and percentage of related medical attended adverse events (MAAEs) through the end of the study.
6. Neutralisation titres against Omicron LP.8.1 and other SARS-CoV-2 variants, measured as inhibitory concentration 50 (IC50) by pseudovirion-based neutralisation assay (PBNA) and reported as reciprocal concentration for each individual sample and geometric mean titre (GMT), at Baseline and at Day 14.
7. Geometric mean fold rise (GMFR) in neutralising antibody titres against Omicron LP.8.1 and other SARS-CoV-2 variants for descriptive analysis from Baseline to Day 14.

Secondary endpoints 2

1. Binding antibody titres measured by an electrochemiluminescence immunoassay (ECLIA) for each individual sample and GMT at Baseline and at Day 14.
2. Percentage of participants experiencing an increase of ≥ 2-fold in total binding antibody titres against SARS-CoV-2 measured by ECLIA from Baseline to Day 14.

Investigational products

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

Test 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 · 3 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

Documents 15 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