Birunu Nivio
Papua New Guinea Institute of Medical Research, Goroka, Papua New Guinea
Title: 10-Valent And 13-Valent Pnemococcal Conjugate Vaccine Trial In High Risk Children In Papua New Guinea
Biography
Biography: Birunu Nivio
Abstract
Introduction: Pneumococcal pneumonia is the most common cause of childhood death worldwide; including Papua New Guinea (PNG). Prior to introduction of 13-valent pneumococcal conjugate vaccine Prevenar13 (PCV13) into PNG’s EPI program in 2014 we began an open randomized controlled trial to determine the safety, immunogenicity and impact on carriage of two PCVs with or without a pneumococcal polysaccharide vaccine (PPV) booster.
Methods: 265 babies at birth were consented into PCV 10 and 13 trial recruited from Goroka General Hospital’s labor ward, villages around Goroka town and Asaro valley. Between November, 2011 and April, 2014 eligible children were randomized to receive Synflorix (PCV10) or Prevnar (PCV13) at ages 1, 2 and 3 months. At 9 months, they were again randomized to receive PPV (Pneumovax23) or no PPV. At 23 months, all received 0.1ml PPV challenge dose to assess immunological safety. Bloods and per nasal swabs (PNS) were collected at ages 1, 4, 9, 10, 23 and 24 months.
Results 262 children were randomized to receive PCV10 (131) or PCV13 (131). 176 (67%) completed 24 months of follow up (91 PCV10, 85 PCV13) with 82-96% of vaccination and specimen collection completed according to protocol. There were 25 migrations, 25 lost to follow-up, 20 withdrawals of consent, 8 deaths and 8 protocol violations, half before age 6 months. Successful collection of specimens were taken from >98% of attendees. 781 illness episodes were documented (396 PCV10, 385 PCV13); 79 (PCV10) and 88 (PCV13) were mild pneumonia, 72 and 48 moderate or severe pneumonia respectively. 78 (44 PCV10, 34 PCV13) serious adverse events recorded, none due to study vaccines. 21 participants experienced reactions to vaccines (all fever and/or irritability), none hospitalized.
Conclusion: Prevenar 13 was included in the EPI program in PNG to be given to infants at 1, 2 and 3 months with other scheduled vaccines. As PCV13 coverage increases over time, reduction in PCV serotype carriage is anticipated in vaccinated and unvaccinated children. An ongoing aetiology study will assist in evaluating the universal PCV13 programme.