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Study on the Safety and Immune Response of BIMERVAX as a COVID-19 Booster in Adolescents Aged 12 to 17 Years

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 clinical trial is focused on studying the prevention of COVID-19 in adolescents aged 12 to less than 18 years. The study involves a vaccine called BIMERVAX, which is an emulsion for injection designed to boost the immune response against the virus. The vaccine targets specific parts of the virus, including the spike protein, which is crucial for the virus to enter human cells. The trial aims to assess the safety and immune response of this vaccine when used as a booster in adolescents who have already received two doses of the Comirnaty vaccine, which is another COVID-19 vaccine.

The purpose of the study is to compare the immune response generated by the BIMERVAX booster in adolescents with the response seen in young adults aged 18 to 25 years. Participants will receive a single booster dose of BIMERVAX, and their immune response will be measured at the start of the study and again 14 days after receiving the booster. The study will also monitor any side effects or reactions to the vaccine, both immediately after vaccination and over a longer period.

Throughout the study, researchers will keep track of any local or systemic reactions, such as redness or swelling at the injection site, as well as any other adverse events that may occur. The study is designed to ensure the safety and tolerability of the BIMERVAX vaccine in adolescents, providing valuable information on its effectiveness as a booster for preventing COVID-19 in this age group.

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 screening
Upon joining the study, the first step involves an initial screening to ensure eligibility. This includes checking age, health status, and previous vaccination history. A Rapid Antigen Test (RAT) is conducted to confirm a negative result for COVID-19.
For participants who are biologically able to become pregnant, a urine pregnancy test is performed. Adequate contraception or abstinence is required for at least 28 days before the booster dose and must continue for 3 months after the dose.
Step 2
Baseline assessment
A baseline assessment is conducted to measure initial health parameters. This includes collecting blood samples to evaluate the immune response before receiving the booster dose.
Step 3
Administration of BIMERVAX
The BIMERVAX vaccine is administered as an intramuscular injection. This is a single dose given to boost immunity against COVID-19.
Step 4
Monitoring period
After receiving the vaccine, there is a monitoring period to observe any immediate reactions. This includes checking for local and systemic reactions for up to 7 days post-vaccination.
Participants are also monitored for any adverse events for 28 days after vaccination. This includes any unexpected symptoms or health issues.
Step 5
Follow-up assessments
Follow-up assessments are conducted to evaluate the immune response at Day 14 after vaccination. Blood samples are collected to measure changes in immunity.
Participants are also monitored for any serious adverse events or medically attended adverse events throughout the study duration.
Step 6
End of study
The study concludes with a final assessment to ensure participant safety and to gather data on the long-term effects of the booster dose.

Who can join the trial?

10 criteria

Adolescents aged from 12 to less than 18 years at the time of screening.
The participant's parent(s) or legal guardian(s) must be willing and able to sign the informed consent form and comply with all study visits and procedures. A written agreement (assent) will be required from all participants.
The participant must have received two previous doses of the Comirnaty vaccine, with the last dose being at least 6 months before screening.
The participant must have a body mass index (BMI) at or above the third percentile according to local Child Growth Standards at the screening visit. Body mass index (BMI) is a measure that uses height and weight to estimate body fat.
Healthy participants and those with pre-existing, chronic, and stable diseases (non-immunocompromised) are eligible if their conditions are stable and well-controlled according to the investigator's judgment. Non-immunocompromised means the participant's immune system is not weakened.
The participant must have a negative Rapid Antigen Test (RAT) at Day 0 before receiving the BIMERVAX® vaccine. A Rapid Antigen Test (RAT) is a quick test to check for the presence of the virus.
Participants who are biologically able to have children may join the study if they meet all the following criteria:
- Have a negative urine pregnancy test at screening (Day 0), only for those who can become pregnant.
- Have practiced adequate contraception or abstained from activities that could result in pregnancy for at least 28 days before the booster dose, only for those who can become pregnant. Contraception refers to methods used to prevent pregnancy.
- Have agreed to continue adequate contraception or abstinence for 3 months following the booster dose.
- The participant must have a body weight greater than 50 kg at the screening visit to be eligible for the cellular immunology tests. Cellular immunology tests are tests that study the immune system's response at the cellular level.

Who cannot join the trial?

4 criteria

Having an active SARS-CoV-2 infection (the virus that causes COVID-19).
Not having received two doses of the Comirnaty vaccine (a COVID-19 vaccine).
Being outside the age range of adolescents (typically 12-17 years old).
Being part of a vulnerable population (such as those with certain health conditions that make them more at risk).

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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
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Responsive
Madrid, Spain
Hospital Universitari De Girona Doctor Josep Trueta
Verified
Girona, Spain

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Investigated drugs

BIMERVAX is a vaccine being tested as a booster shot to help protect against COVID-19. It is given to adolescents who have already received two doses of another COVID-19 vaccine called Comirnaty. The goal of this booster is to strengthen the immune system's response to the virus, especially against a variant known as Omicron BA.1. The study is looking at how well this booster works and how safe it is for teenagers. By comparing the immune response in adolescents to that in young adults, researchers hope to understand how effective the booster is in different age groups.

SARS-COV-2 VIRUS, VARIANTS B.1.351-B.1.1.7, SPIKE PROTEIN, RECEPTOR BINDING DOMAIN FUSION HETERODIMER

What is already known about the treatment

BIMERVAX – BIMERVAX is administered as an injection, typically given as a booster shot to enhance immunity against COVID-19, specifically targeting the Omicron BA.1 variant. It is currently being studied in clinical trials to assess its safety and effectiveness in adolescents aged 12 to less than 18 years, who have previously received two doses of the Comirnaty vaccine. The main purpose of BIMERVAX is to boost the immune response against the SARS-CoV-2 virus, helping to prevent COVID-19. It works by stimulating the body's immune system to recognize and fight the virus more effectively. BIMERVAX is classified as a vaccine, which is a type of medication designed to prevent infectious diseases by enhancing the body's natural defenses.

Investigated diseases

SARS-CoV-2 infection – This disease is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It primarily affects the respiratory system, leading to symptoms such as fever, cough, and difficulty breathing. The virus spreads through respiratory droplets when an infected person coughs, sneezes, or talks. As the infection progresses, it can lead to more severe respiratory issues, including pneumonia. In some cases, it may affect other organs, leading to a wide range of symptoms. The progression and severity of the disease can vary significantly among individuals.