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Pertussis Pertactin Adsorbed On Aluminium Hydroxide, Hydrated And Aluminium Phosphate

This article discusses clinical trials involving the use of pertussis pertactin adsorbed on aluminium hydroxide, hydrated and aluminium phosphate as a component in combination vaccines. These trials aim to evaluate the safety, effectiveness, and immune response of vaccines containing this pertussis antigen along with other components like diphtheria and tetanus toxoids. The studies focus on assessing the vaccines’ ability to protect against whooping cough (pertussis) as well as diphtheria and tetanus when administered to various age groups.

Table of Contents

What is Pertussis Pertactin?

Pertussis pertactin is a component of vaccines used to prevent whooping cough (pertussis). It is a protein found on the surface of the bacteria that causes pertussis, Bordetella pertussis. When included in vaccines, pertussis pertactin helps stimulate the immune system to produce antibodies against the bacteria, providing protection against the disease[1].

Vaccine Composition

The vaccine containing pertussis pertactin is typically part of a combination vaccine that protects against multiple diseases. The full composition includes:

  • Diphtheria toxoid: Provides protection against diphtheria
  • Tetanus toxoid: Offers immunity against tetanus
  • Pertussis components:
    • Pertussis toxoid
    • Pertussis filamentous hemagglutinin
    • Pertussis pertactin

All these components are adsorbed on aluminum hydroxide (hydrated) and aluminum phosphate, which act as adjuvants to enhance the immune response[1].

Medical Conditions Treated

This vaccine is primarily used for the prevention of three infectious diseases:

  • Pertussis (whooping cough): A highly contagious respiratory disease characterized by severe coughing fits
  • Diphtheria: A serious bacterial infection affecting the mucous membranes of the nose and throat
  • Tetanus: A severe disease caused by a toxin-producing bacteria that affects the nervous system

The vaccine containing pertussis pertactin is used for both primary immunization in children and booster doses in adolescents and adults[1].

Administration

The vaccine is administered as an intramuscular injection, typically in the deltoid muscle (upper arm) for adolescents and adults. The standard dose is 0.5 ml. For primary immunization, multiple doses are given according to the recommended vaccination schedule. Booster doses may be recommended at specific intervals or in certain situations, such as pregnancy or potential exposure to pertussis[1].

Effectiveness and Safety

Clinical trials have shown that vaccines containing pertussis pertactin are effective in preventing pertussis, diphtheria, and tetanus. The immune response is measured by the concentration of antibodies produced against each component of the vaccine. For example, after vaccination, individuals typically show anti-tetanus toxoid and anti-diphtheria toxoid antibody concentrations ≥0.1 IU/mL, which is considered protective[1].

Potential Side Effects

Like all vaccines, those containing pertussis pertactin can cause side effects, although not everyone experiences them. Common side effects may include:

  • Pain, redness, or swelling at the injection site
  • Fatigue
  • Headache
  • Fever
  • Nausea

These reactions are usually mild and resolve within a few days. Serious allergic reactions are rare but can occur[1].

Precautions and Contraindications

The vaccine should not be given to individuals with:

  • A history of severe allergic reaction to any component of the vaccine
  • A history of severe adverse reaction associated with a previous dose of the vaccine
  • Acute febrile illness (the vaccination should be postponed)

Pregnant women should consult their healthcare provider before receiving the vaccine. While it is generally considered safe during pregnancy, the potential risks and benefits should be evaluated on an individual basis[1].

Aspect Details
Vaccine Components Pertussis pertactin, diphtheria toxoid, tetanus toxoid, pertussis toxoid, filamentous hemagglutinin
Adjuvant Aluminium hydroxide, hydrated and aluminium phosphate
Administration Intramuscular injection, typically 0.5 ml dose
Target Population Adolescents and adults for booster vaccination
Clinical Trial Objectives Evaluate safety, effectiveness, immunogenicity, and reactogenicity
Primary Endpoints Antibody concentrations, adverse events (local and systemic)
Secondary Endpoints Medically attended adverse events (MAAEs)
Study Design Randomized, observer-blind trials with various administration groups
Follow-up Period Typically up to 28 days after each dose, with longer monitoring for safety

FAQ

  • What is pertussis pertactin? Pertussis pertactin is one of the components of acellular pertussis vaccines. It is a protein found on the surface of Bordetella pertussis bacteria, which causes whooping cough. When included in vaccines, it helps stimulate an immune response against pertussis.
  • Why is the pertussis pertactin adsorbed on aluminium compounds? The pertussis pertactin is adsorbed on aluminium hydroxide and aluminium phosphate to enhance the immune response. These aluminium compounds act as adjuvants, which help boost the effectiveness of the vaccine by stimulating a stronger immune reaction.
  • What other components are typically included with pertussis pertactin in these combination vaccines? The combination vaccines typically include diphtheria toxoid, tetanus toxoid, and other pertussis antigens like pertussis toxoid and filamentous hemagglutinin. This allows for protection against multiple diseases with a single vaccine.
  • Who are these combination vaccines typically given to? These combination vaccines are often given as booster doses to adolescents and adults. They are designed to provide continued protection against pertussis, diphtheria, and tetanus in individuals who have previously received childhood vaccinations for these diseases.
  • What are the main goals of the clinical trials involving these vaccines? The main goals of the clinical trials are to evaluate the safety, effectiveness, and immune response generated by the vaccines. This includes assessing any side effects, measuring antibody levels produced against the vaccine components, and comparing the performance of different vaccine formulations or administration methods.

Ongoing Clinical Trials on Pertussis Pertactin 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: Also known as whooping cough, pertussis is a highly contagious respiratory disease caused by the bacterium Bordetella pertussis. It can cause severe coughing fits, especially in young children.
  • Acellular pertussis vaccine: A type of pertussis vaccine that uses only specific parts of the pertussis bacterium, such as pertussis toxoid, filamentous hemagglutinin, and pertactin, rather than the whole killed bacteria.
  • Adjuvant: A substance added to vaccines to enhance the body's immune response, helping to produce more antibodies and longer-lasting immunity.
  • Diphtheria: A serious bacterial infection caused by Corynebacterium diphtheriae that affects the mucous membranes of the nose and throat.
  • Tetanus: A serious bacterial infection caused by Clostridium tetani that affects the nervous system, leading to painful muscle contractions.
  • Toxoid: A modified bacterial toxin that has been made harmless but still can stimulate the production of antibodies when used in a vaccine.
  • Antibody: A protein produced by the immune system to identify and neutralize foreign substances like bacteria and viruses.
  • Booster dose: An additional dose of a vaccine given after the initial series to 'boost' the immune system and ensure continued protection against a disease.
  • 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, usually mild and self-limited, such as pain at injection site or fever.

References

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