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Diphtheria Toxoid Adsorbed On Aluminium Hydroxide, Hydrated And Aluminium Phosphate

This article discusses clinical trials involving the use of Diphtheria Toxoid Adsorbed On Aluminium Hydroxide, Hydrated And Aluminium Phosphate in combination with other vaccine components. These trials aim to evaluate the safety, efficacy, and immune response of this vaccine formulation, particularly when administered alongside other vaccines like tetanus and pertussis. The studies focus on various aspects, including dosage, administration methods, and potential side effects.

Table of Contents

What is Diphtheria Toxoid Adsorbed on Aluminium Hydroxide, Hydrated and Aluminium Phosphate?

Diphtheria Toxoid Adsorbed on Aluminium Hydroxide, Hydrated and Aluminium Phosphate is a key component of several vaccines, including the Boostrix vaccine. It is a form of the diphtheria toxin that has been inactivated and made harmless, but still stimulates the immune system to produce antibodies against diphtheria[1]. The toxoid is adsorbed onto aluminium compounds, which act as adjuvants to enhance the immune response.

What is it used for?

This component is primarily used in vaccines to prevent diphtheria, a serious bacterial infection that affects the nose and throat. It is often combined with other vaccine components to provide protection against multiple diseases in a single shot. For example, in the Boostrix vaccine, it is combined with tetanus toxoid and pertussis antigens to create a Tdap (Tetanus, Diphtheria, and Pertussis) vaccine[1].

Composition and Formulation

The vaccine containing this component is typically formulated as a suspension for injection. It includes:

  • Diphtheria toxoid adsorbed on aluminium hydroxide, hydrated and aluminium phosphate
  • Tetanus toxoid adsorbed on aluminium hydroxide, hydrated and aluminium phosphate
  • Pertussis toxoid adsorbed on aluminium hydroxide, hydrated and aluminium phosphate
  • Pertussis pertactin adsorbed on aluminium hydroxide, hydrated and aluminium phosphate
  • Pertussis filamentous haemagglutinin on aluminium hydroxide, hydrated and aluminium phosphate
These components work together to provide a comprehensive immune response against multiple diseases[1].

How is it administered?

The vaccine is typically administered as an intramuscular injection. For adults and adolescents, it is usually given in the deltoid muscle of the upper arm. The standard dose is 0.5 ml[1].

Effectiveness

The effectiveness of this vaccine component is measured by the immune response it generates. In clinical trials, researchers look at antibody concentrations against various antigens, including:

  • Anti-tetanus toxoid antibodies
  • Anti-diphtheria toxoid antibodies
  • Anti-pertussis toxin antibodies
  • Anti-FHA (Filamentous Hemagglutinin) antibodies
  • Anti-PRN (Pertactin) antibodies
A successful immune response is typically defined as an antibody concentration ≥0.1 IU/mL for both tetanus and diphtheria toxoids[1].

Safety and Side Effects

The safety profile of vaccines containing this component is generally good. However, like all vaccines, it can cause side effects. These are typically monitored in clinical trials and may include:

  • Solicited local reactions (such as pain, redness, or swelling at the injection site)
  • Solicited systemic reactions (such as fatigue, headache, or fever)
  • Unsolicited adverse events
  • Serious adverse events (SAEs)
  • Medically attended adverse events (MAAEs)
Most side effects are mild and resolve within a few days. Serious side effects are rare[1].

Ongoing Research

Research is ongoing to further improve vaccines containing this component. For example, a recent clinical trial (2023-508563-73-00) is investigating the co-administration of a Group B Streptococcus vaccine (GBS-NN/NN-2) with the Tdap vaccine in healthy non-pregnant women. This study aims to evaluate the immunogenicity, safety, and reactogenicity of the combined administration compared to when each vaccine is given alone[1].

These ongoing studies help to ensure the continued safety and effectiveness of vaccines, as well as explore new ways to protect against multiple diseases with fewer injections.

Aspect Details
Vaccine Components Diphtheria Toxoid, Tetanus Toxoid, Pertussis Toxoid, all adsorbed on Aluminium Hydroxide and Aluminium Phosphate
Administration Method Intramuscular injection, single or multiple doses
Study Population Healthy non-pregnant women aged 18-49 years
Primary Objectives Evaluate safety, efficacy, and immune response of the vaccine
Key Measurements Antibody concentrations, adverse events, serious adverse events
Trial Duration Multiple doses over several weeks with follow-up periods
Special Considerations Co-administration with other vaccines, different injection site strategies

FAQ

  • What is the main purpose of these clinical trials? The main purpose is to evaluate the safety, efficacy, and immune response of the Diphtheria Toxoid vaccine when administered alone or in combination with other vaccines like tetanus and pertussis.
  • Who are the participants in these trials? The trials involve healthy non-pregnant women aged 18 to 49 years. Participants must meet specific inclusion criteria and not have any conditions that would exclude them from the study.
  • How is the vaccine administered in these trials? The vaccine is administered as an intramuscular injection, either alone or in combination with other vaccines. Some trials explore different administration methods, such as injecting in one or two deltoid muscles.
  • What are the primary endpoints being measured? Primary endpoints include antibody concentrations for various antigens, occurrence of local and systemic adverse events, and serious adverse events throughout the trial period.
  • How long do these clinical trials last? The duration varies, but typically involves multiple doses over several weeks, with follow-up periods to monitor long-term effects and immune responses.

Ongoing Clinical Trials on Diphtheria Toxoid Adsorbed On Aluminium Hydroxide, Hydrated And Aluminium Phosphate

  • Study on the Safety and Immune Response of GBS-NN/NN2 and Tdap Vaccines in Preventing Group B Strep Infection in Healthy Women Aged 18-49

    Not yet recruiting

    4 1 1
    Investigated drugs:
    Belgium Poland

  • Study on Long-Term Safety and Effectiveness of Ofatumumab for Patients with Relapsing Multiple Sclerosis

    Not recruiting

    3 1 1 1
    Investigated drugs:
    Austria Belgium Bulgaria Croatia Czechia Denmark +15

Glossary

  • Diphtheria Toxoid: A modified form of the diphtheria toxin that has been treated to remove its toxic properties while retaining its ability to stimulate an immune response against diphtheria.
  • Aluminium Hydroxide and Aluminium Phosphate: Adjuvants used in vaccines to enhance the body's immune response to the vaccine components.
  • Tdap Vaccine: A combination vaccine that protects against tetanus, diphtheria, and pertussis (whooping cough).
  • Intramuscular Injection: A technique of administering a substance deep into the muscles, commonly used for vaccine delivery.
  • Antibody Concentration: The amount of specific antibodies present in the blood, used to measure the immune response to a vaccine.
  • Adverse Event (AE): Any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medical treatment or procedure.
  • Serious Adverse Event (SAE): An adverse event that results in death, is life-threatening, requires hospitalization, or causes significant disability.
  • Immunogenicity: The ability of a substance, such as a vaccine, to provoke an immune response in the body.
  • Reactogenicity: The capacity of a vaccine to produce common, expected adverse reactions, particularly excessive immunological responses and associated signs and symptoms.
  • Group B Streptococcus (GBS): A type of bacteria that can cause severe infections in newborns, often targeted by vaccines given to pregnant women or women of childbearing age.

References

  1. http://clinicaltrials.eu/trial/2023-508563-73-00