Pneumonia Vaccine in Liver Transplant Recipients: a Booster Strategy Using a Conjugate Vaccine

NCT00152802 | Unknown Phase 4

• 1 other identifier: 04-0450-A
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

The trial will compare a group of patients whose immune system is primed with the pneumococcal conjugate vaccine and then given a boost with polysaccharide vaccine (prime-boost strategy) vs. a group vaccinated with the standard 23-valent polysaccharide vaccine alone. It is hypothesized that the conjugate vaccine priming will provide an enhanced response in these immunosuppressed individuals who may respond poorly to standard vaccination.

Conditions

Transplant

Keywords

liver transplant; antibody response; opsonophagocytic assay; pneumococcal conjugate vaccine; pneumococcal polysaccharide vaccine

Outcome Measures

Primary Outcomes (1)

• Antibody titres to the seven serotypes contained in conjugate vaccine (4, 6B, 9V, 14, 19F, 23F) measured at baseline, 8 and 16 weeks. Primary outcome measure will be the anticapsular antibody concentration at 16 weeks.

Secondary Outcomes (3)

• i) Functional Antibody concentration: The titer of functional antibody against the seven pneumococcal serotypes contained in the conjugate vaccine will be determined

• ii) Adverse Reactions: Any adverse effects attributed to conjugate or polysaccharide vaccines will be documented. These will include local reactions such as redness, swelling, tenderness and systemic reactions such as fever.

• iii) Invasive Pneumococcal Disease: The study is not sufficiently powered to look at differences in pneumococcal disease between the two groups. However, any occurrence of documented pneumococcal disease in vaccinated patients will be recorded.

Interventions

The polysaccharide vaccine Pneumovax (Merck-Frosst) BIOLOGICAL

The conjugate vaccine used will be Prevnar (Wyeth vaccines) BIOLOGICAL

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female outpatients who fulfill the following criteria will be eligible for the study:
• Liver transplant recipients greater than 3 months post-transplant
• No prior pneumococcal vaccination within the last 5 years
• Stable allograft function as evidenced by a alanine aminotransferase \<10 times the upper limit of normal (mmol/L) that is not worsening
• Able to provide written informed consent and comply with study protocol
• Age \> 16

You may not qualify if:

• Unable to provide informed consent or comply with protocol
• Prior pneumococcal vaccination within 5 years of enrolment
• Splenectomy
• Admitted to hospital for acute illness
• Febrile illness in the past 2 weeks
• Intravenous Immunoglobulin in the last 6 months
• Current episode of allograft rejection
• Currently on full-dose anticoagulation as a contraindication to intramuscular injection

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, M5G2N2, Canada

Location

Related Publications (1)

• Kumar D, Chen MH, Wong G, Cobos I, Welsh B, Siegal D, Humar A. A randomized, double-blind, placebo-controlled trial to evaluate the prime-boost strategy for pneumococcal vaccination in adult liver transplant recipients. Clin Infect Dis. 2008 Oct 1;47(7):885-92. doi: 10.1086/591537.

  PMID: 18715160 DERIVED

Study Officials

• Deepali Kumar, BSc, MSc, MD, FRCP(C)

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 7, 2005
• First Posted: September 9, 2005
• Study Start: January 1, 2005
• Study Completion: January 1, 2009
• Last Updated: February 19, 2007

Record last verified: 2005-09

Locations

CA (1)