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Pertussis Toxoid Adsorbed On Aluminium Hydroxide, Hydrated And Aluminium Phosphate

This article examines clinical trials involving the use of pertussis toxoid adsorbed on aluminum hydroxide and aluminum phosphate as a component in combination vaccines. These trials aim to assess the safety, efficacy, and immune response of vaccines containing this pertussis component along with other antigens like diphtheria and tetanus toxoids. The studies focus on evaluating different administration methods and comparing immune responses when given alone or in combination with other vaccines.

Table of Contents

What is PERTUSSIS TOXOID ADSORBED ON ALUMINIUM HYDROXIDE, HYDRATED AND ALUMINIUM PHOSPHATE?

PERTUSSIS TOXOID ADSORBED ON ALUMINIUM HYDROXIDE, HYDRATED AND ALUMINIUM PHOSPHATE is a component of a vaccine known as Boostrix. This vaccine is designed to protect against three bacterial diseases: diphtheria, tetanus, and pertussis (whooping cough)[1]. The pertussis component, which we’re focusing on, is a crucial part of this combination vaccine.

How does it work?

Pertussis toxoid is a modified form of the toxin produced by the bacteria that cause whooping cough. It has been altered to remove its harmful effects while retaining its ability to stimulate an immune response. When this toxoid is adsorbed (attached) to aluminium compounds like aluminium hydroxide and aluminium phosphate, it creates a more potent and longer-lasting immune response in the body[1].

The aluminium compounds act as adjuvants, which are substances that enhance the body’s immune response to the vaccine. This means that the vaccine can provide better protection with a smaller amount of the active ingredient (the toxoid)[1].

What is it used for?

This vaccine component is primarily used for the prevention of pertussis, also known as whooping cough. It’s part of the Boostrix vaccine, which is used as a booster dose for adolescents and adults to maintain immunity against diphtheria, tetanus, and pertussis[1].

Pertussis is a highly contagious respiratory disease that can be especially severe in infants. By vaccinating adolescents and adults, we can reduce the spread of the disease and protect vulnerable populations, such as newborns who are too young to be fully vaccinated[2].

How is it administered?

The vaccine containing PERTUSSIS TOXOID ADSORBED ON ALUMINIUM HYDROXIDE, HYDRATED AND ALUMINIUM PHOSPHATE is typically administered as an intramuscular injection. This means it’s injected directly into a muscle, usually in the upper arm (deltoid muscle)[1].

The standard dose is 0.5 ml, and it’s usually given as a single dose. However, the exact dosing schedule may vary depending on your age, previous vaccination history, and local health guidelines[1].

Safety and side effects

Like all vaccines, Boostrix can cause side effects, although not everyone experiences them. Common side effects may include:

  • Pain, redness, or swelling at the injection site
  • Fatigue
  • Headache
  • Mild fever

These side effects are usually mild and resolve on their own within a few days[1].

Serious allergic reactions are rare but can occur. If you experience symptoms of a severe allergic reaction (such as difficulty breathing, swelling of the face or throat, or rapid heartbeat) after receiving the vaccine, seek medical attention immediately[1].

Current clinical trials

A current clinical trial is investigating the use of Boostrix (which contains PERTUSSIS TOXOID ADSORBED ON ALUMINIUM HYDROXIDE, HYDRATED AND ALUMINIUM PHOSPHATE) in combination with a new Group B Streptococcus (GBS) vaccine[2].

This trial aims to:

  • Evaluate the safety and effectiveness of administering the GBS vaccine together with Boostrix
  • Assess the immune response to both vaccines when given together compared to when they are given separately
  • Examine the safety profile of the combined vaccination approach

The study involves healthy non-pregnant women aged 18 to 49 years. This research could potentially lead to more efficient vaccination strategies in the future, providing protection against multiple diseases with fewer injections[2].

Aspect Details
Study Type Randomized, observer-blind clinical trials
Vaccine Components Pertussis toxoid, diphtheria toxoid, tetanus toxoid, adsorbed on aluminum hydroxide and aluminum phosphate
Administration Intramuscular injection, single or multiple doses
Primary Objectives Evaluate safety, immunogenicity, and reactogenicity of the vaccines
Key Outcomes Measured Antibody concentrations, adverse events (local and systemic), serious adverse events
Study Duration Varies, up to 240 weeks in one trial
Participant Demographics Healthy adults, including non-pregnant women aged 18-49 years
Comparison Groups Vaccine administered alone vs. co-administered with other vaccines

FAQ

  • What is the main purpose of these clinical trials? The main purpose is to evaluate the safety, efficacy, and immune response of combination vaccines containing pertussis toxoid adsorbed on aluminum compounds, often in combination with diphtheria and tetanus components.
  • Who are the participants in these trials? The trials involve healthy adult volunteers, including non-pregnant women aged 18-49 years in one study.
  • How is the pertussis component administered in these vaccines? The pertussis toxoid is adsorbed on aluminum hydroxide and aluminum phosphate, and is administered as an intramuscular injection, often in combination with other vaccine components.
  • What are some of the key outcomes being measured? Key outcomes include antibody concentrations against various antigens, occurrence of adverse events (both local and systemic), and comparison of immune responses when the vaccine is given alone or co-administered with other vaccines.
  • How long do these trials typically last? The duration varies, but one trial mentioned follows participants for up to 240 weeks (about 4.5 years) to assess long-term safety and efficacy.

Ongoing Clinical Trials on Pertussis 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

  • Pertussis toxoid: A modified form of the toxin produced by Bordetella pertussis (the bacteria causing whooping cough) that has been treated to remove its toxic properties while maintaining its ability to stimulate an immune response.
  • Adsorbed: In vaccine formulations, this refers to the process where antigens (like toxoids) are attached to a carrier substance (like aluminum compounds) to enhance the immune response.
  • Aluminum hydroxide and aluminum phosphate: Compounds used as adjuvants in vaccines to boost the immune response to the antigens.
  • Combination vaccine: A vaccine that provides protection against multiple diseases in a single injection, such as the DTaP (Diphtheria, Tetanus, acellular Pertussis) vaccine.
  • 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.
  • Antibody concentration: A measure of the amount of specific antibodies present in the blood, used to assess immune response to a vaccine.
  • Adverse event (AE): Any unfavorable and unintended sign, symptom, or disease temporarily 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, causes significant disability, or leads to a congenital anomaly/birth defect.
  • Co-administration: The practice of giving two or more vaccines during the same healthcare visit, often to different areas of the body.

References

  1. http://clinicaltrials.eu/trial/study-on-long-term-safety-and-effectiveness-of-ofatumumab-for-patients-with-relapsing-multiple-sclerosis/
  2. http://clinicaltrials.eu/trial-id/2023-508563-73-00