Evaluation of Neonatal Immunisation with Pneumococcal Conjugate Vaccine

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Evaluation of Neonatal Immunisation with
Pneumococcal Conjugate Vaccine
Dr. A. Warira KEMRI/ Wellcome Trust, Kilifi,
Kenya
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Background

• WHO estimates Invasive Pneumococcal Disease (IPD)
  causes 1 million deaths each year in developing
  countries
• WER, WHO JUNE 1999
• 7-valent pneumococcal conjugate vaccine use in
  USA has lead to 94 decrease in IPD in children lt
  5 yrs
• CDC,MMWR Sept 2005

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Why vaccinate at an earlier age?

• Disease occurs at earlier age
• In Kilifi in the first 3 months of life
• - 20 of illness in age lt 2 years
• - 21 of deaths in age lt 2 years

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Age distribution of IPD in Kilifi
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Age distribution of IPD deaths in Kilifi
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Developing world bridging studies

• WHO supporting research of alternatives
• Maternal vaccination
• Neonatal vaccination

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Objectives- phase A

• To evaluate
• - safety
• -immunogenicity
• of a 7 valent pneumococcal conjugate vaccine
  when the first dose is given at birth
• To compare the effect of a pneumococcal conjugate
  vaccine schedule at birth, 10 and 14 weeks with a
  standard EPI schedule at 6,10 and 14 weeks, on
  the antibody level achieved 4 weeks after the
  third dose of vaccine

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Recruitment
?
?
KDH ANC
KDH MATERNITY
KEMRI OPD
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Vaccine and sampling schedules- newborn
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Vaccine and sampling schedules- EPI
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Safety evaluations

• Active after 1st vaccine dose
• - 1 hour review
• - 2 day review
• Passive
• - visit to KEMRI OPD
• - admission at KDH paediatric ward

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Recruitment in phase A
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Randomisation and follow-up

• 49 recruited
• -newborn n26
• -EPI n23
• 2 lost to follow-up after moving from study area
• 1 withdrawal of consent

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Safety report

• 1 SAE reported in the EPI group

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IgG measured by ELISA from sera collected 4 weeks
after 3 doses of PCV-7
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Proportion achieving putative protective
concentration
putative threshold reference level of 0.35 µg/ml
of IgG
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Conclusions of phase A

• No evidence of AE in the 23 vaccinated at birth
• 94 of those vaccinated at birth produce
  antibody levels that are thought to be protective
  against invasive pneumococcal disease.