Not recruiting

A study to test the safety and immune response of PHH-1V111 vaccine against COVID-19 variants in adults

Verified siteRegistered drugNo placebo

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What is this trial about?

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

This study is looking at a vaccine called BIMERVAX that is designed to protect against COVID-19, which is an infectious disease caused by the SARS-CoV-2 virus. The vaccine being tested contains a substance called PHH-1V111 and is given as an injection into the muscle. The study focuses on how well this vaccine works against different variants of the virus, which are versions of the virus that have changed over time, particularly the Omicron variants that have been spreading recently.

The purpose of this study is to look at how safe the vaccine is and to measure how well it helps the body's defense system respond to different versions of the virus. People taking part in this study will be adults aged 65 or older who have already received their initial COVID-19 vaccination series and at least one additional booster dose, with their last dose given at least six months before joining the study. During the study, participants will receive one dose of the vaccine and will be checked for any side effects that might occur within the first week after vaccination, as well as any other health issues that might happen throughout the entire study period.

The study will also measure the level of antibodies in the blood, which are proteins that help fight off infections. These measurements will be taken before receiving the vaccine and again 14 days after vaccination to see how much the body's immune response has increased. The antibodies will be tested specifically against the Omicron variant and other versions of the virus that are currently important in terms of public health. This information will help researchers understand how well the vaccine prepares the body to fight off these different virus variants.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial vaccination visit
On the first day of the study, referred to as Day 0, you will undergo a rapid antigen test for COVID-19. This is a quick test to check if you currently have a COVID-19 infection.
If the test result is negative, you will receive one dose of BIMERVAX LP.8.1 vaccine. This vaccine is given as an injection into the muscle, typically in the upper arm.
The vaccine is designed to protect against SARS-CoV-2 variants, which are different forms of the virus that causes COVID-19.
Step 2
Monitoring for immediate reactions
After receiving the vaccine, you will be monitored for any immediate reactions at the study site.
Your medical history and current health status will be reviewed to ensure the vaccine is appropriate for you.
Step 3
Recording reactions during the first week
From Day 0 through Day 7 after vaccination, you will need to record any local reactions at the injection site. These may include pain, redness, or swelling where the injection was given.
You will also record any systemic events, which are reactions affecting your whole body, such as fever, headache, fatigue, or muscle aches.
This information will be collected to assess the safety of the vaccine.
Step 4
Follow-up visit and blood sample collection
On Day 14 after vaccination, you will return for a follow-up visit.
A blood sample will be collected to measure your immune response to the vaccine. This involves checking the levels of antibodies, which are proteins your body produces to fight the virus.
The blood test will measure neutralising antibodies, which can prevent the virus from infecting cells, and binding antibodies, which attach to the virus.
These measurements will show how well your immune system has responded to the vaccine against different variants of the virus.
Step 5
Ongoing safety monitoring
Throughout the entire study period, you will be asked to report any adverse events. These are any unwanted or unexpected medical occurrences, whether or not they seem related to the vaccine.
Special attention will be given to serious adverse events, which are medical problems that require hospitalization or are life-threatening.
Adverse events of special interest are specific types of reactions that are particularly important to monitor in vaccine studies.
You will also report any medical attended adverse events, which are health problems for which you sought medical care.
This monitoring will continue until the end of the study to ensure comprehensive safety assessment.
Step 6
Study completion
The study will continue until all safety and immune response data have been collected.
Your participation will be considered complete once all required visits have been attended and all necessary information has been provided.

Who can join the trial?

6 criteria

You must be 65 years of age or older on the day you start the study
You must be willing and able to give your written consent, which means you agree in writing to join the study, and you must be able to attend all required study visits and follow the study procedures
You must have a negative rapid antigen test for COVID-19 on the first day of the study before receiving the vaccine. A rapid antigen test is a quick test that checks if you currently have COVID-19 infection
You must be determined healthy enough to participate based on your medical history, which is a review of your past and current health conditions, and the doctor's assessment. You may have long-term health conditions as long as they are stable and well controlled, meaning your conditions are not getting worse and are being managed properly
You must have completed an initial COVID-19 vaccination series, which means you received the first set of COVID-19 vaccine doses, and you must have received at least one booster dose, which is an additional vaccine dose given after the initial series. This booster dose must have been a vaccine targeting a specific COVID-19 variant called Omicron JN.1
Your last COVID-19 vaccine dose must have been given at least 6 months before you join this study

Who cannot join the trial?

1 criterion

No exclusion criteria have been specified in the available study information.

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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
Hospital Universitari De Girona Doctor Josep Trueta
Verified
Girona, Spain

Trial locations

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Investigated drugs

BIMERVAX LP.8.1 is a vaccine designed to protect against SARS-CoV-2, the virus that causes COVID-19. This vaccine specifically targets the Omicron LP.8.1 variant and other relevant variants of the virus. In this trial, researchers will study how safe the vaccine is and how well it helps the body's immune system create protection against these virus variants.

What is already known about the treatment

BIMERVAX LP.8.1 – This is a vaccine administered as an injection to help protect against COVID-19, specifically targeting the Omicron LP.8.1 variant and other important strains of the SARS-CoV-2 virus. The medication works by training the immune system to recognize and fight the virus by exposing the body to specific viral components, which triggers the production of protective antibodies and immune cells. Currently, this vaccine is being studied in a Phase IV clinical trial to evaluate how safe it is and how well it stimulates the immune response in people who receive it. It belongs to the class of preventive vaccines designed to reduce the risk of infection and severe illness from COVID-19.

Investigated diseases

COVID-19 – COVID-19 is an infectious disease caused by the SARS-CoV-2 virus that primarily affects the respiratory system. The disease spreads from person to person through respiratory droplets when an infected individual coughs, sneezes, or talks. After exposure to the virus, symptoms typically appear within 2 to 14 days and can range from mild to severe. Common symptoms include fever, cough, tiredness, and loss of taste or smell. The disease progresses differently in each person, with some experiencing only mild cold-like symptoms while others develop more serious breathing difficulties. The virus has evolved into various variants, including the Omicron variant, which have different characteristics in terms of how easily they spread.