Safety and Immunogenicity of 7-Valent Pneumococcal Conjugate Vaccine in Children Receiving Solid Organ Transplants
Condition: Organ Transplant; Immunosuppression
Study type: Interventional
Phase: Phase 3

Summary: 
      We plan to study whether the 7-valent pneumococcal conjugate vaccine (Prevnar™) is safe and
      effective in protecting children who have had a solid organ transplantation and healthy
      children from pneumococcal infections.

      We expect that two or more doses of Prevnar™ will result in similar antibody responses among
      transplant recipients compared with healthy control subjects, and that children who have
      undergone solid organ transplant will have a similar number of serious vaccine-related
      adverse events within 7 days after Prevnar™ as the healthy patients.
    

Detailed description: 
      Solid organ transplantation (SOT) has emerged as a lifesaving therapy for many patients with
      end organ failure. SOT recipients have a lifelong increased risk for infections as a result
      of immunosuppression, including those caused by pneumococci. The increased susceptibility to
      pneumococcal infections is multi-factorial and is related to underlying immunosuppression as
      well as varying degrees of splenic dysfunction as a result of underlying pretransplantation
      diseases, among other factors.

      The types and severity of invasive pneumococcal disease vary among each transplant
      population. However, comparative data are lacking. Lung transplant recipients have the
      highest incidence of bacterial pneumonia among solid organ transplant recipients. Pneumonia
      secondary to Streptococcus pneumoniae occurs in heart transplant patients at a rate 10 times
      that found in the general population. It is suggested that besides the intensity of
      immunosuppression, ongoing immunosuppression is important as a risk factor for invasive
      pneumococcal disease in transplant recipients.

      Despite the fact that 23-valent polysaccharide pneumococcal vaccine is one of the vaccines
      that receives priority among organ transplant recipients, at the Hospital for Sick Children,
      several cases of pneumococcal disease have been seen. The advent of the 7-valent conjugate
      vaccine affords the opportunity to possibly reduce the burden of pneumococcal disease in the
      patient population by virtue that it may be more immunogenic in transplant patients

      This study will examine the antibody titres achieved among transplant recipients who are
      immunized with Prevnar™, as well as evaluate the safety and tolerability or Prevnar™
      administered as a three-dose regimen to children and adolescents following organ
      transplantation.
    

Intervention name(s): 7-valent pneumococcal conjugate vaccine; Pneumococcal 7-valent Conjugate Vaccine
Intervention type(s): Biological; Biological
Intervention description(s): For transplant patients, vaccination will be started at 4 months or greater after transplantation. The second dose will be given 8 weks following the frist, the third dose 8 weeks after the second, and the fourth will be given 8 weeks after the third.; Healthy infants: The Prevnar schedule for healthy infants consists of 3 doses of 0.5 ml each, at approximately 2 month intervals, followed by a fourth dose of 0.5 ml at 12-15 months of age (i.e., 2, 4, 6, and 12-15 months)
Previously unvaccinated older infants and children, who are beyond the age of the routine infant schedule, should receive the follwong schedule:
7-11 months of age: 3 doses (2 doses at least 4 weeks apart with the third dose after the first birthday and separated from the second dose by at least two months)
12-23 months of age: 2 doses (at least 2 months apart)
≥24 months through 9 years of age: 1 dose
Other intervention name(s): Prevnar; Prevnar
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: organ transplantation; immunosuppression; vaccine; pneumococcal conjugate vaccine; pediatrics