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Cx-044933

This article discusses a clinical trial exploring the use of mRNA-1010, a new candidate for seasonal influenza vaccination. The 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. This research is important for developing potentially more effective flu vaccines for older adults, who are often at higher risk of complications from influenza.

Table of Contents

What is CX-044933?

CX-044933 is one of the active substances in a new influenza vaccine called mRNA-1010[1]. This vaccine is currently being studied as a potential new option for preventing seasonal influenza in adults aged 50 and older. It’s important to note that CX-044933 is not used alone, but is part of a combination with two other substances, CX-039776 and CX-037231, to form the complete mRNA-1010 vaccine[1].

Purpose of the Study

The main goal of the ongoing clinical trial is to evaluate how safe and effective mRNA-1010 is compared to an already licensed seasonal influenza vaccine[1]. Researchers are particularly interested in:

  • Assessing the safety and how well people tolerate the new vaccine
  • Measuring how effective it is at preventing influenza-like illness caused by any influenza A or B strains
  • Comparing its effectiveness to existing flu vaccines
  • Studying the immune response it generates

How the Vaccine Works

mRNA-1010, which includes CX-044933, is an mRNA vaccine. This type of vaccine uses a molecule called messenger RNA (mRNA) to teach our cells how to make a protein that triggers an immune response[1]. This immune response helps protect us from getting sick if we encounter the real virus later. It’s a new technology that has been successfully used in some COVID-19 vaccines.

In this case, the mRNA vaccine is designed to protect against influenza, commonly known as the flu. The vaccine is given through an intramuscular injection, which means it’s injected directly into a muscle, typically in the upper arm[1].

Eligibility Criteria

The study is focused on adults who are 50 years of age or older. There are specific criteria for who can and cannot participate in the trial. Some key points include[1]:

  • Participants must be able to give informed consent
  • Women who can become pregnant must use acceptable contraception methods
  • People who have had a flu vaccine in the past 180 days or plan to get one during the study are not eligible
  • Those with certain medical conditions, such as immunodeficiency or recent cancer, are excluded

Safety and Effectiveness Measures

The researchers will be closely monitoring several aspects to determine the vaccine’s safety and effectiveness[1]:

  • Any side effects that occur shortly after vaccination (within 7 days)
  • Any unexpected health issues that arise within 28 days of vaccination
  • Serious health problems or events of special interest for up to 181 days
  • How well the vaccine prevents flu-like illness, confirmed by laboratory tests
  • The immune response generated by the vaccine, measured by blood tests

Potential Benefits

While the study is still ongoing and results are not yet available, the potential benefits of this new mRNA flu vaccine could include[1]:

  • Potentially improved effectiveness against multiple flu strains
  • Possibly faster production times compared to traditional flu vaccines
  • The ability to quickly update the vaccine to match circulating flu strains

It’s important to remember that these potential benefits are still being studied and have not yet been proven. The ongoing clinical trial will help determine if mRNA-1010, including CX-044933, offers advantages over current flu vaccines.

Aspect Details
Study Type Phase 3, Randomized, Observer-blind, Active-controlled, Case-driven
Participants Adults aged 50 and older
Intervention mRNA-1010 candidate seasonal influenza vaccine
Comparison Licensed inactivated seasonal influenza vaccine
Primary Objectives Evaluate safety, reactogenicity, and relative vaccine efficacy
Secondary Objectives Assess efficacy against various influenza strains, humoral immunogenicity, and correlates of protection
Duration Approximately 181 days (one influenza season)
Key Measurements Adverse reactions, influenza-like illness episodes, immune response (HAI titers)

FAQ

  • What is mRNA-1010? mRNA-1010 is a candidate seasonal influenza vaccine being tested in clinical trials. It uses mRNA technology, which is a new approach to creating vaccines.
  • Who can participate in this clinical trial? The trial is open to adults aged 50 and older who meet specific health criteria. Participants must not have recently received other vaccines or had influenza.
  • What is the main goal of this study? The main goal is to evaluate the safety of mRNA-1010 and its effectiveness compared to an existing licensed influenza vaccine in preventing influenza-like illness.
  • How long does the study last? The study lasts approximately 181 days (about 6 months), which covers a typical influenza season.
  • What will researchers measure during the trial? Researchers will track side effects, immune responses, and cases of influenza-like illness among participants to assess the vaccine's safety and effectiveness.

Ongoing Clinical Trials on Cx-044933

  • 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 genetic material called messenger RNA (mRNA) to teach cells how to make a protein that triggers an immune response against a specific virus.
  • Influenza-like illness (ILI): A set of symptoms similar to those caused by influenza, which may include fever, cough, and body aches.
  • Active comparator: An already approved and effective treatment or vaccine used as a comparison in a clinical trial to evaluate a new drug or vaccine.
  • Immunogenicity: The ability of a substance, such as a vaccine, to provoke an immune response in the body.
  • Hemagglutination Inhibition (HAI): A laboratory test used to measure the body's immune response to influenza viruses or vaccines.
  • Seroconversion: The development of detectable antibodies in the blood against a specific infection or after vaccination.
  • Adverse Event (AE): Any unfavorable and unintended sign, symptom, or disease that occurs during a clinical trial, whether or not it is related to the treatment being studied.
  • RT-PCR: Reverse Transcriptase-Polymerase Chain Reaction, a sensitive laboratory technique used to detect specific genetic material from a virus, including influenza.

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/