#1 Clinical Trials Search in Europe

Cx-037231

A new clinical trial is underway to evaluate the potential of mRNA-1010, a candidate seasonal influenza vaccine. This study aims to compare the safety, effectiveness, and immune response of mRNA-1010 to a licensed inactivated seasonal influenza vaccine in adults aged 50 and older. The trial will assess various aspects of the vaccine’s performance, including its ability to prevent influenza-like illness and generate protective antibodies.

Table of Contents

What is CX-037231?

CX-037231 is an active substance that is part of a new influenza vaccine called mRNA-1010[1]. This vaccine is currently being studied to see how well it works and how safe it is for adults who are 50 years old or older. The vaccine is given as an injection into the muscle (intramuscular injection)[1].

How does CX-037231 work?

CX-037231 is part of an mRNA vaccine. mRNA stands for messenger ribonucleic acid, which is a type of genetic material. This vaccine uses mRNA technology to teach your body how to fight against the flu virus[1]. It’s different from traditional flu vaccines because it doesn’t contain the actual virus. Instead, it gives your cells instructions to make a harmless piece of the virus. This helps your immune system recognize and fight the real virus if you’re exposed to it later.

What conditions does CX-037231 treat?

CX-037231, as part of the mRNA-1010 vaccine, is designed to prevent influenza (commonly known as the flu) in adults aged 50 and older[1]. Influenza is a viral infection that can cause symptoms like fever, cough, body aches, and fatigue. It can be especially serious for older adults, which is why this vaccine is being studied in this age group.

Ongoing Clinical Trial

A large clinical trial (known as a Phase 3 trial) is currently underway to study mRNA-1010, which contains CX-037231[1]. This trial aims to:

  • Compare the safety and effectiveness of mRNA-1010 to an already approved flu vaccine
  • See how well mRNA-1010 protects against flu-like illness caused by any type of influenza A or B virus
  • Measure the immune response produced by mRNA-1010

Eligibility Criteria

To participate in this study, individuals must meet certain criteria. Some key points include[1]:

  • Be 50 years of age or older
  • Be capable of giving informed consent
  • Not have received a flu vaccine in the past 180 days
  • Not have had a flu infection in the past 180 days
  • Not have certain medical conditions that might affect the study results

There are also specific requirements for women who can become pregnant, including using acceptable contraception methods.

Safety and Effectiveness Measures

The study will closely monitor participants for any side effects and measure how well the vaccine works. Some key things they’ll be looking at include[1]:

  1. Local reactions at the injection site (like pain or swelling) and systemic reactions (like fever or fatigue) in the week after vaccination
  2. Any unexpected side effects in the month after vaccination
  3. Serious side effects or medically important events for about 6 months after vaccination
  4. How well the vaccine prevents flu-like illness
  5. The body’s immune response to the vaccine, measured by blood tests

This thorough evaluation will help determine if mRNA-1010, containing CX-037231, is safe and effective for preventing flu in older adults.

Aspect Details
Study Type Phase 3, Randomized, Observer-blind, Active-controlled
Participant Age 50 years and older
Main Objective Evaluate safety, efficacy, and immunogenicity of mRNA-1010
Comparison mRNA-1010 vs. licensed inactivated seasonal influenza vaccine
Primary Endpoints Adverse reactions, influenza-like illness occurrence
Secondary Endpoints Antibody levels, seroconversion rates
Study Duration Approximately 181 days
Key Exclusions Recent illness, certain vaccinations, severe allergies to vaccines

FAQ

  • What is the main goal of this clinical trial? The main goal is to evaluate the safety and effectiveness of mRNA-1010 compared to a licensed influenza vaccine in adults 50 years and older. The study will look at how well the vaccine prevents influenza-like illness and its ability to produce protective antibodies.
  • Who can participate in this study? Adults aged 50 and older who meet specific health criteria can participate. Participants must be capable of giving informed consent and follow the study requirements. Women who can become pregnant must use acceptable contraception methods during the study.
  • What are some reasons why someone might not be able to participate? People who have recently been ill, received certain vaccines, participated in other clinical studies, or have a history of severe allergic reactions to vaccines may not be eligible. Additionally, those with certain medical conditions or who have recently had influenza may be excluded.
  • How long does the study last? The study lasts approximately 181 days (about 6 months). Participants will be monitored for safety and effectiveness throughout this period.
  • What kind of results will the study measure? The study will measure the number of participants experiencing side effects, the time it takes for participants to develop influenza-like illness, and the levels of protective antibodies produced by the vaccine. It will also compare these results to those of a licensed influenza vaccine.

Ongoing Clinical Trials on Cx-037231

  • Study of mRNA-1010 Influenza Vaccine Compared to Standard Flu Vaccine in Adults 50 Years and Older

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Bulgaria Estonia Finland Germany

Glossary

  • mRNA vaccine: A type of vaccine that uses a copy of a molecule called messenger RNA (mRNA) to produce an immune response. It teaches our cells how to make a protein that triggers an immune response inside our bodies.
  • Influenza-like illness (ILI): A set of symptoms similar to those caused by influenza, which may include fever, cough, and body aches. In this study, specific definitions are used to identify cases of ILI.
  • Hemagglutination Inhibition (HAI): A laboratory test used to measure the level of antibodies in the blood that can prevent influenza viruses from attaching to red blood cells. It helps determine how well a vaccine is working.
  • Seroconversion: The development of detectable antibodies in the blood directed against an infectious agent. In vaccine studies, it indicates that the vaccine has triggered an immune response.
  • Adverse Event (AE): Any unfavorable and unintended sign, symptom, or disease that occurs during the study, whether or not it is related to the study treatment.
  • Serious Adverse Event (SAE): An adverse event that results in death, is life-threatening, requires hospitalization, causes persistent or significant disability, or is a birth defect.
  • Immunogenicity: The ability of a substance, such as a vaccine, to provoke an immune response in the body.

References

  1. http://clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-mrna-1010-influenza-vaccine-compared-to-a-licensed-vaccine-for-adults-aged-50-and-older/