Results of The Gambia Pneumococcal Vaccine Trial

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Results of The Gambia Pneumococcal Vaccine Trial

• netSPEAR 3rd Annual Conference
• November 14-15, 2005

Cutts et al, Lancet 20053651139-1146
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Pneumococcus causes a variety of diseases, each
of which can be caused by other organisms

• INVASIVE
• Meningitis
• Bacteraemia (sepsis)
• Bacteraemic pneumonia
• Peritonitis
• Septic arthritis

• NON-INVASIVE
• Non-bacteraemic pneumonia
• Sinusitis
• Otitis media

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Incidence of Invasive Pneumococcal Disease in
Children lt2 Years by Population
Sources Robinson KA JAMA 2001 Davidson M JID
1994 ODempsey TJ PIDJ 1996 Levine MM PIDJ
1998Torzillo PJ. Med J Austr 1995 Eskola J
JAMA 1992 Berkley NEJM 2005
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Bacterial infections contribute to a
disproportionately high number of ALRI deaths
Strategies such as vaccination and case
management are aimed at preventing cases of
deaths due to bacterial ALRI
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Earlier studies have established the high
efficacy of the conjugate vaccine against vaccine
type invasive disease
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DefinitionsEnd point consolidation

• End point consolidation A dense opacity that may
  be (a) a fluffy consolidation of a portion or
  whole of a lobe or of the entire lung, often
  containing air-bronchograms and sometimes
  associated with pleural effusion.
• Atelectasis of an entire lobe that produces a
  dense opacity and a positive silhouette sign with
  the mediastinal border will be considered to be
  an end point consolidation.

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Pneumococcal Conjugate Vaccine Prevents CXR
Confirmed Pneumonia (all cause)
Refs Black et al PIDJ 2001 Klugman et al NEJM
2003 Black et al. ISPPD4 abstract
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The Gambia Pneumococcal Vaccine TrialStudy end
points

• Primary
• Radiologically confirmed pneumonia (WHO)
• Secondary
• Clinical and severe clinical pneumonia
• Invasive pneumococcal disease
• All-cause hospital admissions
• Safety
• Other a-priori analysis
• All-cause mortality
• Admissions with potential IPD-related clinical
  syndromes

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Schematic of study area, The Gambia
Study area
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The Gambia Pneumococcal Vaccine TrialStudy
methods overview

• Children enrolled at 110 govt vaccination
  clinics
• Vaccine Pneumo vaccine or placebo mixed with
  DTP-Hib (Tetramune) given according to EPI
  schedule
• Home visits every 3 months till age 30 months or
  30 April 2004 for mortality surveillance
• Surveillance for pneumonia and invasive
  pneumococcal disease at Basse health centre (URD)
  and Bansang hospital (CRD), with referrals of
  children from peripheral health centres to
  hospitals.

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General information

• Recruitment dates 18/08/00 07/02/03
• Vaccination dates 18/08/00 30/04/03
• Follow-up to age 30 months/death/withdrawal/
  30th April 2004
• 22,170 children screened
• 17,437 (79) participated
• 16,344 (94) entered per-protocol analysis
• Median age at dose 1 11 weeks
• Median age at dose 3 24 weeks

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Summary of efficacy results
Per-protocol analysis
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Estimated costs and benefits from pneumococcal
vaccination in The Gambia
Sinha A, Lieu T Personal communication
(preliminary data, work in progress)
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Conclusions

• Pneumococcal disease represents a significant
  burden in terms of childhood morbidity in The
  Gambia.
• Pneumococcal vaccine can prevent a large
  proportion of these illnesses and can
  significantly reduce mortality among children in
  a typical rural African setting, especially in
  hard-to-reach populations.