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Study on the Safety of BIMERVAX and Fluad Tetra for COVID-19 and Influenza in Adults Over 65 Who Are Fully Vaccinated Against COVID-19

Verified siteRegistered drug

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of two vaccines: the BIMERVAX COVID-19 vaccine and a seasonal flu vaccine called Fluad Tetra. The trial is designed for adults over the age of 65 who have already been fully vaccinated against COVID-19. The purpose of the study is to evaluate the safety and immune response when these vaccines are given together compared to when they are given separately.

Participants in the study will receive either the BIMERVAX vaccine, the Fluad Tetra vaccine, both vaccines together, or a placebo, which is a substance with no active ingredients. The vaccines are administered through an injection into the muscle. The study will monitor participants for any reactions or side effects for a period of time after the vaccination. This includes checking for any local reactions at the injection site, as well as any general reactions throughout the body.

The trial will also measure the levels of antibodies, which are proteins made by the immune system to fight infections, in the participants' blood. This will help determine how well the vaccines work when given together. The study aims to provide valuable information on the safety and effectiveness of coadministering these vaccines in older adults, which could help guide future vaccination strategies.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit and screening
Upon joining the study, you will attend an initial visit. During this visit, a Rapid Antigen Test (RAT) will be conducted to ensure a negative result for COVID-19.
Your medical history will be reviewed to confirm eligibility, including verification of age (65 or older) and previous COVID-19 vaccination status. You must have received at least two doses of an mRNA vaccine, with the last dose administered at least six months prior to this visit.
Step 2
Vaccination day
On the day of vaccination, you will receive two injections. The first is the BIMERVAX COVID-19 vaccine, and the second is the seasonal influenza vaccine (SIIV). Both vaccines are administered as intramuscular injections.
You will be monitored for any immediate reactions following the vaccinations.
Step 3
Post-vaccination monitoring
For the first seven days after vaccination, you will be asked to report any local or systemic reactions. Local reactions may include pain or swelling at the injection site, while systemic reactions could involve fever or fatigue.
You will continue to report any adverse events or side effects throughout the duration of the study.
Step 4
Follow-up visit
A follow-up visit will occur 28 days after the vaccination. During this visit, blood samples will be taken to measure the levels of antibodies produced in response to the vaccines.
The results will help assess the immune response generated by the coadministration of the vaccines.
Step 5
End of study
The study is expected to conclude by November 30, 2023. You will be informed of any significant findings related to your participation.
Your participation will contribute to understanding the safety and effectiveness of the vaccines when given together.

Who can join the trial?

5 criteria

Adults aged 65 or older at the start of the study.
Willing and able to sign the informed consent form and attend all study visits and procedures.
Must have received at least a primary series of an mRNA vaccine (2 doses). Booster doses or previous COVID-19 infections are allowed. The last vaccine dose must have been given at least 6 months before the start of the study. A history of COVID-19 infection is allowed if it happened more than 30 days before the start of the study.
Must have a negative Rapid Antigen Test (RAT) on the first day of the study before receiving vaccinations. A Rapid Antigen Test is a quick test to check for the presence of the virus.
Adults who, after a clinical assessment including medical history, are determined to be eligible for the study. This includes adults with pre-existing chronic and stable diseases (not affecting the immune system), if these conditions are stable and well-controlled according to the investigator's judgment.

Who cannot join the trial?

8 criteria

Participants cannot have any current or past infection with SARS-CoV-2 or Influenza.
Participants should not have any serious health conditions that could interfere with the study.
Participants must not be pregnant or planning to become pregnant during the study.
Participants should not have any known allergies to the study vaccines or their components.
Participants must not have received any other vaccines within a certain period before the study.
Participants should not be taking medications that could affect the immune system.
Participants must not have participated in another clinical trial recently.
Participants should not have any condition that, in the opinion of the study doctor, makes them unsuitable for the study.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Eap Osona Sud Alt Congost S.L.P.
Verified
Centelles, Spain
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
Responsive
Barcelona, Spain
Hospital Universitari De Girona Doctor Josep Trueta
Verified
Girona, Spain

Trial locations

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Investigated drugs

BIMERVAX®
is a vaccine designed to help protect people against COVID-19. It works by stimulating the body's immune system to recognize and fight the virus that causes COVID-19. In this trial, BIMERVAX® is being tested to see how safe it is and how well it works when given at the same time as a flu vaccine to older adults who have already been fully vaccinated against COVID-19.
Seasonal Surface Antigen, Inactivated, Adjuvanted Influenza Vaccine (SIIV)
is a type of flu vaccine that helps protect against the influenza virus. This vaccine contains parts of the virus that have been inactivated, meaning they cannot cause the flu. It also includes an adjuvant, which is an ingredient that helps boost the body's immune response to the vaccine. In this trial, the flu vaccine is being given alongside the COVID-19 vaccine to see how safe and effective they are when administered together to older adults.

What is already known about the treatment

BIMERVAX® – BIMERVAX® is administered as an injection and is currently being studied in clinical trials to evaluate its safety and immune response when given alongside a seasonal flu vaccine in older adults. It is primarily used to protect against COVID-19, especially in those who have already been vaccinated. The vaccine works by stimulating the body's immune system to recognize and fight the virus if exposed. It falls under the category of vaccines, which are substances designed to prevent infectious diseases by enhancing the body's natural defenses.

Investigated diseases

COVID-19
COVID-19 is an infectious disease caused by the SARS-CoV-2 virus. It primarily affects the respiratory system, leading to symptoms such as fever, cough, and difficulty breathing. The virus spreads through respiratory droplets from coughs, sneezes, or talking. As the disease progresses, it can cause severe respiratory issues, including pneumonia. In some cases, it may affect other organs, leading to complications. The severity of symptoms can vary widely among individuals.
Influenza
Influenza, commonly known as the flu, is a contagious respiratory illness caused by influenza viruses. It affects the nose, throat, and sometimes the lungs, leading to symptoms like fever, chills, muscle aches, and fatigue. The virus spreads through droplets when an infected person coughs, sneezes, or talks. As the illness progresses, it can lead to more severe respiratory problems, such as pneumonia. The flu can also exacerbate existing health conditions. Symptoms typically appear suddenly and can range from mild to severe.