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Safety and Immunogenicity of 7-Valent Pneumococcal Conjugate Vaccine in Children Receiving Solid Organ Transplants

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Upton Allen, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00213265
First received: September 13, 2005
Last updated: August 15, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Organ Transplant
Immunosuppression
Biological: 7-valent pneumococcal conjugate vaccine
Biological: Pneumococcal 7-valent Conjugate Vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Immunogenicity of 7-Valent Pneumococcal Conjugate Vaccine Among Solid Organ Transplant Recipients: Protocol 1A and 1B

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Geometric Mean Concentration of pneumococcal antibodies [ Time Frame: Transplant patients: at baseline, just before dose 3, and 6-8 weeks after dose 3; Controls: at baseline, just before dose 3, and 6-8 weeks after dose 3. For those whose series consisted of 1 or 2 doses, at baseline, and 6-8 weeks after doses 1 and 2. ] [ Designated as safety issue: No ]
  • Serious vaccine related adverse events [ Time Frame: 7 days post-vaccination ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Nature of immune suppression [ Time Frame: 24-28 weeks ] [ Designated as safety issue: No ]
  • Presence of bacterial, viral or other opportunistic infections [ Time Frame: 24-28 weeks ] [ Designated as safety issue: No ]
  • Presence of rejection after enrollment [ Time Frame: 24-28 weeks ] [ Designated as safety issue: No ]
  • Presence of concurrent diseases or conditions including alterations of renal, hepatic, cardiac and bowel function [ Time Frame: 24-28 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: July 2002
Arms Assigned Interventions
Active Comparator: 1 Biological: Pneumococcal 7-valent Conjugate Vaccine

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 Name: Prevnar
Experimental: 2 Biological: 7-valent pneumococcal conjugate vaccine
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.
Other Name: Prevnar

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.

  Eligibility

Ages Eligible for Study:   2 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Transplant recipients:

  • Children 4 months of age up to 18 years of age
  • received a kidney, liver, heart, lung or other solid organ transplantation in a Canadian transplant centre
  • Informed consent obtained

Healthy Infants and Children:

  • Children 2 months to 9 years of age
  • no underlying chronic medical conditions
  • Informed consent obtained

Exclusion Criteria:

  • Previous immunization with pneumococcal vaccine.
  • Known hypersensitivity to any of the components of the vaccine, including diphtheria toxoid. Besides the saccharides and CRM197 carrier protein, the vaccine contains aluminum phosphate adjuvant.
  • Any significant infection and/or fever at the time of vaccination
  • Major acute illness such as clinical instability and acute graft rejection
  • Latex allergy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00213265

Locations
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Upton Allen, MD The Hospital for Sick Children, Toronto Canada
Study Chair: Upton Allen The Hospital for Sick Children
  More Information

No publications provided

Responsible Party: Upton Allen, Chief, Division of Infectious Diseases, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00213265     History of Changes
Other Study ID Numbers: 0020020011
Study First Received: September 13, 2005
Last Updated: August 15, 2013
Health Authority: Canada: Health Canada

Keywords provided by The Hospital for Sick Children:
organ transplantation
immunosuppression
vaccine
pneumococcal conjugate vaccine
pediatrics

ClinicalTrials.gov processed this record on November 25, 2014