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A phase 2 randomized controlled trial of a multicomponent meningococcal serogroup B vaccine (I)

Roman Prymula1, Susanna Esposito, Gian Vincenzo Zuccotti

  • 1a University Hospital Hradec Kralove; Hradec Kralove, Czech Republic.

Human Vaccines & Immunotherapeutics
|November 27, 2014
PubMed

Insights

Prophylactic paracetamol reduced fever and other reactions when infants received the novel meningococcal serogroup B vaccine (4CMenB) with routine immunizations. Immune responses to 4CMenB and other vaccines remained unaffected, ensuring vaccine effectiveness.

Area of Science:

  • * Vaccinology and Immunology
  • * Pediatric Infectious Diseases

Background:

  • * The novel meningococcal serogroup B vaccine (4CMenB, Bexsero®) is being considered for routine infant immunization.
  • * Concomitant administration with routine vaccines can increase post-vaccination reactions like fever, potentially impacting vaccine acceptance.
  • * Understanding the impact of prophylactic interventions on vaccine tolerability and immunogenicity is crucial for successful public health implementation.

Purpose of the Study:

  • * To evaluate the effect of prophylactic paracetamol on fever and solicited reactions following 4CMenB vaccination in infants.
  • * To assess the impact of paracetamol prophylaxis on immune responses to 4CMenB and routine infant vaccines.
  • * To determine the overall tolerability and safety profile of 4CMenB when co-administered with routine vaccines, with or without paracetamol.

Main Methods:

  • * A prospectively designed study involving a 4-dose series of 4CMenB administered at 2, 3, 4, and 12 months of age.
  • * Infants received 4CMenB concomitantly with DTaP-HBV-IPV/Hib and PCV7, with or without prophylactic paracetamol. A control group received MenC vaccine.
  • * Solicited reactions (local and systemic, including fever) and immune responses to all study vaccines were monitored.

Main Results:

  • * Prophylactic paracetamol significantly decreased the occurrence of fever and other solicited reactions (local and systemic) in infants receiving 4CMenB.
  • * Immune responses to 4CMenB were not diminished by paracetamol prophylaxis.
  • * No clinically relevant negative effects on immune responses to routine infant vaccines (DTaP-HBV-IPV/Hib, PCV7) were observed.

Conclusions:

  • * Co-administration of 4CMenB with routine infant vaccines demonstrates an acceptable tolerability profile.
  • * Prophylactic paracetamol effectively reduces post-vaccination reactions without compromising vaccine immunogenicity.
  • * The use of paracetamol prophylaxis can enhance the acceptability of 4CMenB in routine infant immunization schedules, facilitating control of meningococcal disease.

Keywords:
antipyreticsinfantsmeningococcalserogroup Bvaccination

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