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Tetanus Toxoid Adsorbed On Aluminium Hydroxide, Hydrated And Aluminium Phosphate

This article examines clinical trials involving the use of tetanus toxoid adsorbed on aluminum hydroxide, hydrated and aluminum phosphate in combination vaccines. These trials aim to assess the safety, efficacy, and immune response of tetanus toxoid when administered alongside other vaccine components for protection against multiple diseases.

Table of Contents

What is Tetanus Toxoid?

Tetanus toxoid is a key component of several combination vaccines used to prevent tetanus and other diseases. It is specifically referred to as tetanus toxoid adsorbed on aluminium hydroxide, hydrated and aluminium phosphate. This vaccine is typically found in products like Boostrix, which also protects against diphtheria and pertussis (whooping cough)[1].

How it Works

The tetanus toxoid in the vaccine is a modified form of the toxin produced by the tetanus-causing bacteria. When injected, it stimulates your immune system to produce antibodies against tetanus without causing the disease. The aluminium compounds it’s adsorbed on act as adjuvants, which enhance the immune response to the vaccine[1].

Uses

This vaccine is primarily used to prevent tetanus, a serious bacterial infection that affects the nervous system and can be life-threatening. It’s often combined with vaccines for other diseases in products like Boostrix, which provides protection against:

  • Tetanus: A severe infection caused by bacteria found in soil, dust, and manure
  • Diphtheria: A serious bacterial infection of the nose and throat
  • Pertussis (whooping cough): A highly contagious respiratory tract infection

These combination vaccines are used for both primary immunization in children and as booster doses for adolescents and adults[1].

Administration

The tetanus toxoid vaccine is typically administered as an intramuscular injection. For products like Boostrix, the standard dose is 0.5 ml. It’s usually injected into the deltoid muscle (upper arm) in adolescents and adults[1][2].

Safety and Effectiveness

Clinical trials have shown that tetanus toxoid-containing vaccines like Boostrix are both safe and effective. In one study, 28 days after vaccination, the majority of participants had protective levels of anti-tetanus toxoid antibodies (≥0.1 IU/mL)[2].

Possible Side Effects

Like all vaccines, tetanus toxoid-containing vaccines 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 side effects are usually mild and resolve on their own within a few days[2].

Precautions

Before receiving a tetanus toxoid-containing vaccine, inform your healthcare provider if you:

  • Have had an allergic reaction to any vaccine in the past
  • Are pregnant or breastfeeding
  • Have a fever or acute illness
  • Have a bleeding disorder
  • Have a weakened immune system

Your healthcare provider can help determine if the vaccine is appropriate for you based on your individual health status and medical history[2].

Aspect Details
Vaccine Components Tetanus toxoid, diphtheria toxoid, pertussis components (toxoid, filamentous hemagglutinin, pertactin), Group B Streptococcus (GBS) vaccine (in some trials)
Formulation Adsorbed on aluminum hydroxide, hydrated and aluminum phosphate
Study Populations Healthy adult volunteers, including non-pregnant women aged 18-49 years
Primary Objectives Evaluate immune response, assess safety and tolerability, compare co-administration vs. separate administration
Safety Assessments Monitoring of local and systemic adverse events, serious adverse events
Immunogenicity Measurements Antibody concentrations against tetanus, diphtheria, pertussis components, and GBS antigens
Administration Routes Intramuscular injection
Dosing Schedule Varies by trial; some involve multiple doses over several weeks

FAQ

  • What is the purpose of using tetanus toxoid in these clinical trials? Tetanus toxoid is used as a component in combination vaccines to provide protection against tetanus. It is adsorbed on aluminum compounds to enhance the immune response.
  • What other vaccine components are being tested alongside tetanus toxoid? The trials are testing tetanus toxoid in combination with diphtheria toxoid, pertussis components (toxoid, filamentous hemagglutinin, pertactin), and in some cases, a Group B Streptococcus (GBS) vaccine.
  • Who are the participants in these clinical trials? The trials involve healthy adult volunteers, including non-pregnant women aged 18-49 years in one study. Specific eligibility criteria are set for each trial.
  • How is the safety of the vaccines being evaluated? Safety is assessed by monitoring for adverse events, including local reactions at the injection site, systemic reactions, and any serious adverse events throughout the trial period.
  • What are the main objectives of these clinical trials? The main objectives include evaluating the immune response to the vaccine components, assessing the safety and tolerability of the vaccines, and in some cases, comparing the effects of co-administration versus separate administration of different vaccine components.

Ongoing Clinical Trials on Tetanus 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

  • Tetanus Toxoid: A modified form of the tetanus toxin that stimulates the immune system to produce antibodies against tetanus but does not cause the disease.
  • Adsorbed: In vaccine formulations, this refers to the attachment of antigens to substances like aluminum compounds to enhance the immune response.
  • Aluminum Hydroxide and Aluminum Phosphate: Adjuvants used in vaccines to boost the immune response to the antigens.
  • Diphtheria Toxoid: A modified form of the diphtheria toxin used in vaccines to stimulate immunity against diphtheria.
  • Pertussis: Also known as whooping cough, a highly contagious respiratory disease.
  • Acellular Pertussis Vaccine: A vaccine that contains purified components of the pertussis bacterium rather than whole cells.
  • TDaP Vaccine: A combination vaccine that protects against tetanus, diphtheria, and pertussis.
  • Group B Streptococcus (GBS): A type of bacteria that can cause severe infections, particularly in newborns.
  • 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.
  • 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.

References

  1. http://clinicaltrials.eu/trial/2023-507906-15-00
  2. http://clinicaltrials.eu/trial-id/2023-508563-73-00