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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00213265
Recruitment Status : Unknown
Verified August 2013 by Upton Allen, The Hospital for Sick Children.
Recruitment status was:  Active, not recruiting
First Posted : September 21, 2005
Last Update Posted : August 16, 2013
Information provided by (Responsible Party):
Upton Allen, The Hospital for Sick Children

Brief 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.

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

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : July 2002

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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. ]
  2. Serious vaccine related adverse events [ Time Frame: 7 days post-vaccination ]

Secondary Outcome Measures :
  1. Nature of immune suppression [ Time Frame: 24-28 weeks ]
  2. Presence of bacterial, viral or other opportunistic infections [ Time Frame: 24-28 weeks ]
  3. Presence of rejection after enrollment [ Time Frame: 24-28 weeks ]
  4. Presence of concurrent diseases or conditions including alterations of renal, hepatic, cardiac and bowel function [ Time Frame: 24-28 weeks ]

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Ages Eligible for Study:   2 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00213265

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

Responsible Party: Upton Allen, Chief, Division of Infectious Diseases, The Hospital for Sick Children Identifier: NCT00213265     History of Changes
Other Study ID Numbers: 0020020011
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: August 16, 2013
Last Verified: August 2013

Keywords provided by Upton Allen, The Hospital for Sick Children:
organ transplantation
pneumococcal conjugate vaccine

Additional relevant MeSH terms:
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs