#1 Clinical Trials Search in Europe

Haemophilus Influenzae

This article examines several clinical trials investigating the use of Haemophilus influenzae as a component in various vaccines. These studies aim to assess the safety, efficacy, and immune responses of vaccines containing H. influenzae for preventing respiratory infections in different populations, including infants, children, and the elderly. The trials cover a range of vaccine formulations and target conditions, providing valuable insights into the potential of H. influenzae-based immunizations.

Table of Contents

What is Haemophilus influenzae?

Haemophilus influenzae (H. influenzae) is a type of bacteria that can cause serious infections, especially in young children[1]. Despite its name, it does not cause influenza (the flu). H. influenzae can lead to severe illnesses like meningitis (infection of the lining of the brain and spinal cord), pneumonia (lung infection), and epiglottitis (swelling in the throat that can block breathing)[1].

There are different strains of H. influenzae, with type b (Hib) historically being the most concerning for children. However, widespread vaccination has greatly reduced Hib infections in many countries[1].

Vaccines Containing Haemophilus influenzae

Several vaccines include protection against H. influenzae, often as part of combination vaccines that guard against multiple diseases. Some examples include:

  • Synflorix: This vaccine primarily targets pneumococcal infections but also includes a protein D derived from non-typeable H. influenzae as a carrier protein[1]. This may provide some additional protection against non-typeable H. influenzae strains.
  • Infanrix hexa: A combination vaccine that protects against six diseases, including Haemophilus influenzae type b (Hib)[2]. It contains Hib polysaccharide conjugated to tetanus toxoid.
  • Vaxelis: Another combination vaccine that includes protection against Hib, along with diphtheria, tetanus, pertussis, hepatitis B, and polio[3]. In this vaccine, the Hib component is conjugated to meningococcal protein.

Benefits of Vaccination

Vaccination against H. influenzae, particularly Hib, has been tremendously successful in reducing the incidence of severe infections in children. Some key benefits include:

  • Prevention of invasive Hib disease, including meningitis and pneumonia
  • Reduction in antibiotic use and hospitalizations related to H. influenzae infections
  • Potential cross-protection against other strains of H. influenzae (with some vaccine formulations)
  • Contribution to overall community immunity, protecting even unvaccinated individuals

Safety and Side Effects

Vaccines containing H. influenzae components have been extensively studied and are generally considered very safe. Common side effects are usually mild and may include[1]:

  • Redness, swelling, or pain at the injection site
  • Mild fever
  • Irritability or fussiness in infants
  • Decreased appetite
  • Drowsiness

Serious side effects are rare. As with any medical intervention, parents should discuss any concerns with their healthcare provider.

Ongoing Research

While current vaccines have been highly effective, researchers continue to study H. influenzae and ways to improve protection. Some areas of ongoing research include:

  • Investigating the immune response to H. influenzae vaccines in different populations, including pregnant women and their infants[3]
  • Studying the potential of bacterial lysate vaccines (like OM-85) in preventing respiratory infections, which may include protection against non-typeable H. influenzae strains[2]
  • Evaluating the long-term effectiveness of current vaccine formulations and exploring potential improvements

In conclusion, Haemophilus influenzae remains an important focus in pediatric health. Thanks to effective vaccines, severe Hib infections have become rare in many countries. However, continued vaccination efforts and ongoing research are crucial to maintain and improve protection against this potentially dangerous bacteria.

Trial Number Vaccine/Drug Target Population Primary Objective Key Endpoints
2023-505154-18-00 Pneumococcal Conjugate Candidate Healthy toddlers 12-15 months Assess safety profile Local reactions, systemic events, adverse events
2023-506449-40-00 Meningococcal Combined ABCWY Vaccine Healthy infants 55-89 days old Evaluate safety, tolerability, and immunogenicity Adverse events, immune responses to vaccine strains
2024-511083-90-00 OM-85 Children 6 months to 5 years with recurrent wheezing Assess efficacy in reducing wheezing episodes Rate of wheezing episodes, use of oral corticosteroids
2024-511581-37-00 OM-85 Children 6 months to 5 years with recurrent RTIs Evaluate efficacy in reducing RTIs Number of RTIs, wLRIs during 12-month treatment
2024-512937-34-00 Buccalin Adults 18-99 years with recurrent LRTIs Confirm efficacy in prophylaxis of RLRTIs Reduction in infection episodes, antibiotic use
2024-513592-41-00 OM-85 Elderly patients ≥75 years with history of RTIs Evaluate reduction in RTIs over 12 months Number of RTIs, hospital admissions, antibiotic use
2024-517893-73-00 Vaxelis (DTaP-IPV-HB-Hib vaccine) Pregnant women and their infants Identify determinants of infant immunity to pertussis Antibody responses, transfer of maternal antibodies

FAQ

  • What is Haemophilus influenzae and why is it used in vaccines? Haemophilus influenzae is a type of bacteria that can cause serious infections, especially in young children. It is used in vaccines because it helps stimulate the immune system to produce antibodies against the bacteria, providing protection against potential infections.
  • What age groups are being studied in these clinical trials? The clinical trials are studying various age groups, including infants as young as 6 months, children up to 5 years old, and elderly patients. Some studies also involve pregnant women to assess maternal vaccination and its effects on infant immunity.
  • What types of conditions are these vaccines targeting? The vaccines in these trials are primarily targeting respiratory tract infections, including recurrent lower respiratory tract infections, pneumococcal infections, and pertussis (whooping cough). Some studies also focus on preventing meningococcal infections.
  • How is the effectiveness of these vaccines being measured? The effectiveness is being measured through various methods, including tracking the number and severity of respiratory infections, assessing immune responses through blood tests, monitoring hospitalization rates, and evaluating the need for antibiotic treatments.
  • Are there any safety concerns associated with these vaccines? While safety is a primary concern in all clinical trials, the studies are designed to carefully monitor for any adverse events. Common side effects being tracked include local reactions at the injection site, fever, and other systemic events. Serious adverse events are also closely monitored and reported.

Ongoing Clinical Trials on Haemophilus Influenzae

  • Study on Buccalin for Preventing Recurrent Lower Respiratory Infections in Adults

    Recruiting

    1 1 1
    Investigated drugs:
    Italy

  • A study to evaluate the effectiveness of a drug combination in reducing respiratory tract infections in children aged 3 to 12 years.

    Not yet recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Poland

Glossary

  • Haemophilus influenzae: A type of bacteria that can cause serious infections, particularly in young children. It is often used in vaccines to stimulate immunity against potential infections.
  • Pneumococcal infections: Infections caused by Streptococcus pneumoniae bacteria, which can lead to pneumonia, meningitis, and other serious conditions.
  • Pertussis: Also known as whooping cough, it is a highly contagious respiratory disease caused by the bacterium Bordetella pertussis.
  • Recurrent Lower Respiratory Tract Infections (RLRTIs): Repeated infections affecting the airways and lungs, often causing symptoms like coughing, wheezing, and difficulty breathing.
  • Immunogenicity: The ability of a substance, such as a vaccine, to provoke an immune response in the body.
  • Adverse event: Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • Placebo: A substance or treatment with no active therapeutic effect, used as a control in clinical trials to test the effectiveness of new drugs or vaccines.
  • Randomized controlled trial: A type of scientific experiment where participants are randomly allocated to receive either the treatment under investigation or a placebo/standard treatment.
  • Antibody: A protein produced by the immune system to identify and neutralize foreign substances like bacteria and viruses.
  • Conjugate vaccine: A type of vaccine that combines a weak antigen with a strong antigen to enhance the body's immune response, particularly effective in young children.

References

  1. http://clinicaltrials.eu/trial-id/2023-505154-18-00
  2. http://clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-om-85-for-children-aged-6-months-to-5-years-with-recurrent-wheezing/
  3. http://clinicaltrials.eu/trial-id/2024-517893-73-00