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Raxtozinameran

This article provides an overview of clinical trials investigating the use of Raxtozinameran, also known as Comirnaty or the Pfizer-BioNTech COVID-19 vaccine, in various populations. These trials aim to assess the safety, efficacy, and immune response of Raxtozinameran, particularly when used as a booster dose or in combination with other vaccines.

Table of Contents

What is RAXTOZINAMERAN?

RAXTOZINAMERAN is the active substance in several COVID-19 mRNA vaccines developed to protect against SARS-CoV-2, the virus that causes COVID-19[1]. It is also known by its brand name Comirnaty, which is produced by BioNTech Manufacturing GmbH[1]. This vaccine is part of a new generation of vaccines that use messenger RNA (mRNA) technology to stimulate the body’s immune response against the virus.

How Does RAXTOZINAMERAN Work?

RAXTOZINAMERAN works by delivering genetic instructions (mRNA) to our cells, prompting them to produce a harmless piece of the SARS-CoV-2 virus called the spike protein[1]. This spike protein is found on the surface of the virus and is crucial for its entry into human cells. Once our cells produce this protein, our immune system recognizes it as foreign and creates antibodies and T-cells to fight it. This process prepares our body to recognize and fight the actual virus if we are exposed to it in the future.

Vaccine Formulations

There are several formulations of the RAXTOZINAMERAN vaccine, each targeting specific variants of the SARS-CoV-2 virus:

  • Comirnaty Omicron XBB.1.5 30 micrograms/dose dispersion for injection[1]
  • Comirnaty JN.1 30 micrograms/dose dispersion for injection[2]

These formulations are designed to provide protection against the most prevalent variants of the virus at the time of their development.

Clinical Trials and Research

Several clinical trials have been conducted to evaluate the safety, efficacy, and immune response of RAXTOZINAMERAN vaccines. These studies have included various populations and have examined different aspects of the vaccine’s performance:

  • A Phase IIb/III trial assessed the safety and immunogenicity of a booster vaccination with an adapted recombinant protein RBD fusion homodimer candidate (PHH-1V81) against SARS-CoV-2, compared to Comirnaty in adults previously vaccinated against COVID-19[1].
  • Another study evaluated the co-administration of RAXTOZINAMERAN with an RSV (Respiratory Syncytial Virus) vaccine in adults aged 50 years and above[3].
  • A longitudinal follow-up study (COVICO) is examining SARS-CoV-2 immunity in immunocompromised populations in Belgium, including the use of RAXTOZINAMERAN vaccines[2].

Effectiveness and Immune Response

Clinical trials have shown that RAXTOZINAMERAN vaccines elicit a strong immune response against SARS-CoV-2. The effectiveness is typically measured by:

  • Neutralizing antibody titers against various SARS-CoV-2 variants[1]
  • Binding antibody levels[1]
  • T-cell mediated responses[1]

These measures help researchers understand how well the vaccine stimulates both the humoral (antibody-mediated) and cellular (T-cell-mediated) arms of the immune system.

Safety and Side Effects

The safety profile of RAXTOZINAMERAN vaccines has been extensively studied. Common side effects may include:

  • Pain and swelling at the injection site
  • Fatigue
  • Headache
  • Muscle pain
  • Chills
  • Fever

These side effects are generally mild to moderate and resolve within a few days[1]. Serious adverse events are rare but are closely monitored in ongoing studies and post-marketing surveillance.

Administration and Dosage

RAXTOZINAMERAN vaccines are typically administered as an intramuscular injection. The dosage may vary depending on the specific formulation and the vaccination schedule:

  • For adults, the standard dose is usually 30 micrograms per 0.3 mL injection[1].
  • Booster doses may be recommended at specific intervals after the primary vaccination series.

Always follow the guidance of healthcare professionals and local health authorities regarding vaccination schedules and dosing.

Special Populations

Research has been conducted on the use of RAXTOZINAMERAN vaccines in various populations, including:

  • Immunocompromised individuals (e.g., organ transplant recipients, dialysis patients)[2]
  • Older adults (aged 50 years and above)[3]
  • Individuals with chronic medical conditions

These studies aim to understand how different groups respond to the vaccine and whether specific recommendations are needed for certain populations.

Future Research and Development

Ongoing research on RAXTOZINAMERAN vaccines focuses on:

  • Long-term effectiveness and durability of immune response
  • Efficacy against emerging SARS-CoV-2 variants
  • Optimal booster strategies
  • Combination with other vaccines (e.g., RSV vaccines)

These efforts aim to ensure that the vaccines remain effective against the evolving SARS-CoV-2 virus and to optimize vaccination strategies for different populations.

Trial Aspect Details
Populations Studied Adults 18+, 50+, immunocompromised individuals, kidney transplant recipients, those at risk for Type 1 diabetes
Main Objectives Assess safety and efficacy of Raxtozinameran as booster, evaluate immune response, study effects in specific populations
Immune Response Measurements Neutralizing antibody titers, T-cell responses, binding antibody levels
Safety Monitoring Local and systemic reactions, serious adverse events, adverse events of special interest
Co-administration Studies With RSV vaccine, other COVID-19 vaccines
Variants Studied Omicron subvariants (e.g., XBB.1.5, XBB.1.16)
Duration of Follow-up Varies by study, ranging from 28 days to 6 months post-vaccination

FAQ

  • What is Raxtozinameran? Raxtozinameran is the active ingredient in Comirnaty, also known as the Pfizer-BioNTech COVID-19 mRNA vaccine. It is designed to protect against SARS-CoV-2, the virus that causes COVID-19.
  • What populations are being studied in these clinical trials? The trials are studying various populations, including healthy adults, immunocompromised individuals, kidney transplant recipients, and people at risk for Type 1 diabetes. Some trials focus on adults aged 50 and older or specific age groups like 18 to 105 years old.
  • What are the main objectives of these clinical trials? The main objectives include assessing the safety and efficacy of Raxtozinameran as a booster dose, evaluating its immune response when co-administered with other vaccines, and studying its effects in specific populations such as immunocompromised individuals.
  • How is the immune response being measured in these trials? The immune response is primarily measured through neutralizing antibody titers against various SARS-CoV-2 variants, including Omicron subvariants. Some trials also assess T-cell responses and binding antibody levels.
  • Are there any safety concerns being monitored in these trials? Yes, the trials are monitoring for various safety aspects, including local and systemic reactions, serious adverse events, and adverse events of special interest. Some trials specifically exclude individuals with a history of severe allergic reactions to vaccine components or previous COVID-19 vaccinations.

Ongoing Clinical Trials on Raxtozinameran

  • Study on the Effect of Raxtozinameran Vaccine in Reducing Type 1 Diabetes Risk in Children with High Genetic Susceptibility

    Recruiting

    3 1 1
    Investigated drugs:
    Austria Belgium Germany Italy Poland Sweden

  • Study on COVID-19 Immunity in Immunocompromised Adults Using Raxtozinameran and Bretovameran in Belgium

    Not yet recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium

  • Study on Immune Responses to COVID-19 Vaccines: Raxtozinameran, Bretovameran, and Drug Combination for COVID-19 Patients

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Finland

  • Study on the Safety and Immune Response of PHH-1V81 Booster for Adults Vaccinated Against COVID-19

    Not recruiting

    4 1 1 1
    Investigated drugs:
    Spain

  • Study on the Immune Response and Safety of RSVPreF3 OA Vaccine Alone and with COVID-19 mRNA Vaccine in Adults Aged 50 and Above

    Not recruiting

    3 1 1 1
    Investigated drugs:
    Belgium The Netherlands Spain

  • Study on Everolimus and Mycophenolate Mofetil for Improving COVID-19 Vaccine Response in Kidney Transplant Patients

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

Glossary

  • Raxtozinameran: The active ingredient in the Pfizer-BioNTech COVID-19 mRNA vaccine (Comirnaty), designed to protect against SARS-CoV-2.
  • mRNA vaccine: A type of vaccine that uses messenger RNA to instruct cells to produce a specific protein, in this case, the SARS-CoV-2 spike protein, to trigger an immune response.
  • Neutralizing antibodies: Antibodies that can bind to a virus and prevent it from infecting cells, effectively 'neutralizing' the virus.
  • Immunogenicity: The ability of a substance, such as a vaccine, to provoke an immune response in the body.
  • Booster dose: An additional dose of a vaccine given after the initial vaccination series to enhance or prolong the immune response.
  • Variant of concern (VOC): A version of the SARS-CoV-2 virus that has genetic changes affecting virus characteristics and may pose increased risks.
  • Pseudovirus neutralization assay: A laboratory test used to measure the ability of antibodies to neutralize a virus, using a modified virus that mimics SARS-CoV-2.
  • T-cell response: Part of the immune response involving T lymphocytes, which can directly attack infected cells or help other immune cells fight infection.
  • Geometric mean titer (GMT): A type of average used to represent antibody levels in a group, calculated by multiplying all values and taking the nth root.
  • Adverse event (AE): Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.

References

  1. http://clinicaltrials.eu/trial-id/2023-508458-25-00
  2. http://clinicaltrials.eu/trial-id/2024-518098-33-01
  3. http://clinicaltrials.eu/trial-id/2023-510196-59-00