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FinOM Efficacy Trial of 7Valent Pneumococcal Conjugate Vaccine

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Otorhinolaryngology. Biostatistics. Data management. Virology. Study clinic personnel ... evaluated efficacy of two 7-valent pneumococcal (Pnc) conjugate vaccines for ... – PowerPoint PPT presentation

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Title: FinOM Efficacy Trial of 7Valent Pneumococcal Conjugate Vaccine


1
FinOM Efficacy Trial of 7-Valent Pneumococcal
Conjugate Vaccine
  • Terhi Kilpi
  • National Public Health Institute (KTL)
  • Finland

2
FinOM Study Group
FinOM Vaccine Trial
  • Principal investigator
  • Study coordination
  • Bacteriology
  • Immunology
  • Otorhinolaryngology
  • Biostatistics
  • Data management
  • Virology
  • Study clinic personnel
  • Senior adviser
  • Juhani Eskola, Terhi Kilpi
  • Arto Palmu , Kari S Lankinen
  • Elja Herva, Maija Leinonen
  • Helena Käyhty, Heidi Åhman
  • Pekka Karma
  • Jukka Jokinen, Mika Lahdenkari, Jouko Verho
  • Jaason Haapakoski, Esa Ruokokoski, Marko Grönholm
  • Tapani Hovi
  • Wilhelm Bredenberg, Heljä Savolainen, Ritva
    Syrjänen
  • P Helena Mäkelä

3
FinOM Vaccine Trial
  • evaluated efficacy of two 7-valent pneumococcal
    (Pnc) conjugate vaccines for prevention of AOM
    due to vaccine serotypes in children less than 2
    years of age
  • clinical phase from December 1995 to March 1999
  • 2 497 children enrolled (55 of the birth
    cohort) in Tampere area

4
Study design
FinOM Vaccine Trial
  • All children were randomized to receive PncCRM
    (Prevnar, Prevenar), PncOMPC, or control (HBV)
    vaccine at 2, 4, 6, and 12 mo
  • Follow-up from 2 to 24 mo at the study clinic
  • All respiratory infections requiring medical
    attention were evaluated and treated at the study
    clinic

5
Definition of AOM
FinOM Studies
  • Symptoms
  • At least one of the following fever, earache,
    irritability, diarrhea, vomiting, acute otorrhea
    not caused by otitis externa, or other symptoms
    of respiratory infection
  • Signs
  • A visually abnormal tympanic membrane (in regard
    of color, position and/or mobility) suggesting
    middle ear effusion

6
Acute Otitis Media (AOM)
FinOM Studies
  • Myringotomy with aspiration performed in AOM with
    effusion
  • Middle ear fluid (MEF) sample for bacterial
    culture, pneumococcal serotyping and pneumolysin
    PCR
  • AOM episode defined to start at diagnosis and to
    last for 30 days

7
Efficacy of PncCRM against AOM
FinOM Vaccine Trial
  • Primary
  • All AOM episodes due to vaccine serotypes
  • Secondary
  • First and subsequent AOM episodes due to vaccine
    serotypes
  • Other
  • All Pnc AOM episodes
  • All AOM episodes
  • Recurrent AOM

8
Efficacy of PncCRM against AOM
FinOM Vaccine Trial
  • Post Hoc
  • AOM episodes due to vaccine related serotypes
    (6A, 9N, 18B, 19A, 23A)
  • AOM episodes due to serotypes unrelated to
    vaccine types
  • AOM episodes due to individual serotypes

9
Disposition of subjects
FinOM Vaccine Trial
10
All AOM episodes due to vaccine serotypes
Primary analysis
FinOM Vaccine Trial
Per protocol follow-up from 6.5 to 24 months of
age
Vaccine efficacy 57 (95 CI 44 to 67)
11
First and subsequent AOM episodes due to vaccine
serotypes
Secondary analysis
FinOM Vaccine Trial
Per protocol follow-up
Per person-year
12
Summary of efficacy results
FinOM Vaccine Trial
Acute Otitis Media
Per protocol follow-up from 6.5 to 24 months of
age
13
Summary of efficacy results
FinOM Vaccine Trial
Acute Otitis Media
Intention to treat follow-up from 2 to 24 months
of age
14
Pneumococcal AOM episodes
FinOM Vaccine Trial
Acute Otitis Media
Per protocol follow-up from 6.5 to 24 months of
age
15
PCR counts in MEF of Pnc Ply PCR positive AOM
FinOM Vaccine Trial
GM (95 CI)
PCR counts
Pnc culture positive
Pnc culture negative
16
Individual vaccine serotypes
FinOM Vaccine Trial
Acute Otitis Media
Per protocol follow-up
17
Vaccine, vaccine-related and other serotypes
FinOM Vaccine Trial
Acute Otitis Media
Per protocol follow-up
18
Vaccine-related serotypes
FinOM Vaccine Trial
Acute Otitis Media
Per protocol follow-up
19
PncCRM
FinOM Vaccine Trial
Conclusions
  • is efficacious against
  • culture-confirmed, vaccine serotype specific AOM
    (VE 57)
  • culture-confirmed AOM due to vaccine-related
    serotypes (VE 51)
  • culture-confirmed pneumococcal AOM (VE 34)

20
Extended follow-up
FinOM Vaccine Trial
21
Objectives
FinOM Follow-up Study
  • To assess long-term effects of PncCRM on
  • pneumococcal carriage
  • antibody persistence
  • surgery due to OM in the routine practice after
    the Vaccine Trial

22
Methods
FinOM Follow-up Study
  • Single follow-up visit at the age of 4 to 5 years
    in spring 2001
  • Collection of data
  • Parental interview
  • Pneumatic otoscopy
  • Medical records
  • Nasopharyngeal, blood and saliva samples

23
Inclusion criteria
FinOM Follow-up Study
24
Study flow
FinOM Vaccine Trial and Follow-up Study
Children, N
Hospital tympanostomy data available
Eligible children Analysis population 2
Fully evaluated children Analysis population 1
Age, months
Start of long-term follow-up
25
Case ascertainment for tube placement
FinOM Follow-up Study
  • Fully evaluated children (Analysis population 1)
  • Parental interview
  • Hospital records from Tampere University
    Hospital, three district hospitals (78)
  • Medical records from private physician offices
    for verification (22)
  • Eligible children (Analysis population 2)
  • Hospital records from Tampere University
    Hospital, three district hospitals

26
Tube placement during the Vaccine Trial
FinOM Studies
  • Included in the study services
  • Close follow-up in the study clinics, active
    treatment strategy, specific criteria for
    referral in the SOP
  • Tampere University Hospital
  • Free of charge
  • Within 4 to 8 weeks of referral

27
Tube placement after the Vaccine Trial
FinOM Studies
  • Public hospitals
  • Nominal charge
  • Waiting time 3 to 4 months
  • 78
  • Private medical centers and hospitals
  • Charge 10 x public sector charge
  • No waiting time
  • 22

28
Incidence of tube placement
/ 100 person-years


Age, years
National hospital discharge register and
national sick insurance reimbursement database
29
Study flow
FinOM Vaccine Trial and Follow-up Study
Children, N
Eligible children Analysis population 2
Fully evaluated children Analysis population 1
Age, months
Start of long-term follow-up
30
Tympanostomy tube placement in fully evaluated
children
FinOM Vaccine Trial and Follow-up Study
Intention to treat follow-up
Per 100 person-years
Analysis population 1
31
Tympanostomy tube placement in all eligible
children
FinOM Vaccine Trial and Follow-up Study
Intention to treat follow-up
Per 100 person-years
Analysis population 2
32
Cumulative hazard of tympanostomy tube placement
FinOM Vaccine Trial and Follow-up Study
Cumulative hazard
HBV
PncCRM
Fully evaluated children
Start of long-term follow-up
33
Cumulative hazard of tympanostomy tube placement
FinOM Vaccine Trial and Follow-up Study
Cumulative hazard
HBV
PncCRM
All eligible children
Start of long-term follow-up
34
Kinetics of anti-23F
FinOM Vaccine Trial and Follow-up Study
?g/ml
PncCRM
HBV
Start of long-term follow-up
35
Kinetics of anti-19F
FinOM Vaccine Trial and Follow-up Study
?g/ml
PncCRM
HBV
Start of long-term follow-up
36
Kinetics of anti-6B
FinOM Vaccine Trial and Follow-up Study
?g/ml
PncCRM
HBV
Start of long-term follow-up
37
Long-term effect on otitis media and carriage
FinOM Follow-up Study
P0.05
38
PncCRM
FinOM Follow-up Study
Conclusions
  • PncCRM reduces tube placement due to OM
  • Vaccine efficacy against OM persists for several
    years

39
Thank you
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