Safety and Immunogenicity of SARS-COV-2 VIRUS, VARIANT LP.8.1, SPIKE PROTEIN, RECEPTOR BINDING DOMAIN FUSION HOMODIMER Vaccine in Adults with COVID-19

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What is this study about?

The study focuses on COVID-19, an infection caused by the SARS‑CoV‑2 virus that can lead to fever, cough, and difficulty breathing. The investigational product is a vaccine called BIMERVAX® XFG.1.1, which is given as a single intramuscular injection. The vaccine contains a piece of the virus’s spike protein from the Omicron XFG.1.1 variant, which is designed to help the body recognize and fight that specific strain.

The purpose of the trial is to evaluate how safe the vaccine is and how well it triggers an immune response. Participants receive the injection at the start of the study and then return for brief check‑ins over the next two weeks to report any reactions such as soreness at the injection site, fever, or other symptoms. Blood samples are taken before the shot and again about two weeks later to measure antibodies, which are proteins the immune system makes to block the virus.

1 baseline assessment

on the day you join the study, a study staff member will check your health status, ask about your medical history, and take a small blood sample. this sample is used as a reference point before you receive the vaccine.

the staff will explain what will happen during the trial and answer any questions you may have.

2 vaccination

on day 0 you will receive a single dose of bimervax lp.8.1.

the vaccine contains 40 µg (micrograms) of the virus spike protein and is given as an intramuscular injection, which means the needle is placed into a muscle.

no additional doses are planned after this injection.

3 daily symptom monitoring (days 1‑7)

for the first seven days after the injection you will record any local reactions such as pain, redness, or swelling at the injection site, and any systemic events such as fever, headache, or tiredness.

you can use a diary or an electronic form provided by the study to note the severity and duration of each symptom.

if you notice any unusual or severe symptoms, you should follow the instructions given by the study staff for reporting them.

4 day 7 follow‑up

on day 7 you will have a brief follow‑up contact (by phone or in person) where the study team will review the symptoms you recorded and ask about any adverse events.

5 day 14 blood draw and assessment

on day 14 you will return to the study site for another blood sample.

the sample is tested to measure how well your immune system responded to the vaccine. the tests look at both neutralising antibodies (which can block the virus) and binding antibodies (which attach to the virus).

the study staff will also ask about any side effects that may have occurred since the vaccination.

6 ongoing safety monitoring (until study end)

throughout the remainder of the trial you may be asked to report any new health problems, serious adverse events, or medical visits related to the vaccine.

these reports can be made during scheduled visits, by phone, or through an electronic system, according to the instructions you received.

Who Can Join the Study?

You must be 18 years old or older on the first day of the study.
You must be willing and able to sign a written consent form and attend all study visits and follow the study procedures.
You must have a negative Rapid Antigen Test for COVID‑19 on the first day before receiving the vaccine. Rapid Antigen Test is a quick test that checks for proteins from the virus.
You must be judged by the doctor to be generally healthy enough for the study, even if you have long‑term (chronic) diseases that are stable and well‑controlled.
You must have completed the initial COVID‑19 vaccination series and have received at least one booster dose of a variant‑adapted vaccine during the 2025‑2026 vaccination campaign, with the last dose given at least six months before the study starts. A booster dose is an extra shot that helps keep your protection strong, and a variant‑adapted vaccine is made to target newer versions of the virus.
If you are able to become pregnant, you must have a negative urine pregnancy test on the first day before vaccination. A urine pregnancy test checks for pregnancy hormones in a small urine sample.

Who Cannot Join the Study?

Having a fever of 38 °C (100.4 °F) or higher on the day of vaccination or within the previous 24 hours. A small illness without fever may be allowed, but the doctor decides.
Having any medical condition or past diagnosis that the doctor thinks could affect the study results or make the vaccine unsafe for you.
Having a medical or mental‑health condition, including thoughts of suicide or self‑harm in the past year, that could increase risk from the study or make results hard to understand.
Having previously had a serious reaction to any vaccine, or a severe allergy such as anaphylaxis (a rapid, life‑threatening allergic reaction) to any part of the study vaccine.
Being immunocompromised — meaning your immune system is weak — because of inherited immune problems, chemotherapy, or drugs that suppress immunity (except low‑dose steroids up to 30 mg of prednisone per day for no more than 30 days).
Having a health problem that, in the doctor’s opinion, makes it unsafe to give a vaccine into the muscle (intramuscular) or to have blood drawn.
Having received blood products, immune‑globulin (a medicine made from donated blood), or any blood‑derived treatment in the past 3 months, or during the study.
Taking part in another clinical trial where you received a study drug within 28 days before vaccination, or planning to receive another study drug while in this trial.
Having had COVID‑19 (infection with the SARS‑CoV‑2 virus) less than 30 days before the first vaccination day. Infections that happened at least 30 days ago are allowed.
Having liver (hepatic) or kidney (renal) problems that the doctor believes could affect the study results or your safety.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country
Hospital Universitari De Girona Doctor Josep Trueta	Girona	Spain
Hospital Universitario Hm Puerta Del Sur	Mostoles	Spain
Ccm Ctotxpzyq	Centelles	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not yet recruiting	21.09.2026

Trial locations

Investigated Drugs:

SARS-COV-2 VIRUS, VARIANT LP.8.1, SPIKE PROTEIN, RECEPTOR BINDING DOMAIN FUSION HOMODIMER

BIMERVAX LP.8.1 emulsion for injection COVID-19 Vaccine is a recombinant COVID‑19 vaccine that contains a piece of the virus’s spike protein from the Omicron XFG.1.1 variant. The spike protein piece is designed to teach the immune system to recognize and fight the virus. The vaccine is mixed with an adjuvant, which helps the body’s immune response become stronger. It is given as an injection into the muscle. In this trial, the vaccine is being studied to see how safe it is and how well it triggers an immune response against the Omicron XFG.1.1 variant.

Investigated Diseases:

COVID-19

COVID-19 – COVID-19 is an infectious illness caused by the SARS‑CoV‑2 virus. It usually begins with fever, cough, and tiredness, and may include loss of taste or smell. In many people the symptoms stay mild and improve within a week. Some individuals develop increased breathing difficulty as the infection spreads to the lungs. The disease can progress from upper airway involvement to lower respiratory inflammation, leading to cough and shortness of breath.

Trial ID:

2026-527363-16-00

Protocol code:

HIPRA-HH-18

Trial Phase:

Therapeutic confirmatory (Phase III)

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Safety and Immunogenicity of SARS-COV-2 VIRUS, VARIANT LP.8.1, SPIKE PROTEIN, RECEPTOR BINDING DOMAIN FUSION HOMODIMER Vaccine in Adults with COVID-19

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?