Incidences of vaccine-preventable Haemophilus influenzae type b pneumonia and meningitis in Indonesian children: hamlet-randomised vaccine-probe trial.

Abstract

BACKGROUND:

Most studies of Haemophilus influenzae type b (Hib) disease in Asia have found low rates, and few Asian countries use Hib vaccine in routine immunisation programmes. Whether Hib disease truly is rare or whether many cases remain undetected is unclear.

METHODS:

To estimate incidences of vaccine-preventable Hib pneumonia and meningitis among children younger than 2 years in Lombok, Indonesia, during 1998-2002, we undertook a hamlet-randomised, controlled, double-blind vaccine-probe study (818 hamlets). Children were immunised (WHO schedule) with diphtheria, tetanus, pertussis (DTP) or DTP-PRP-T (Hib conjugate) vaccine. Vaccine-preventable disease incidences were calculated as the difference in rates of clinical outcomes between DTP and DTP-PRP-T groups. Analyses included all children who received at least one vaccine dose.

FINDINGS:

We enrolled 55073 children: 28147 were assigned DTP-PRP-T and 26926 DTP. The proportion of pneumonia outcomes prevented by vaccine ranged from less than 0 to 4.8%. Calculated incidences of vaccine-preventable Hib disease (per 10(5) child-years of observation) for outcome categories were: substantial alveolar consolidation or effusion, less than zero (-43 [95% CI -185 to 98]); all severe pneumonia, 264 (95% CI less than zero to 629); all clinical pneumonia, 1561 (270 to 2853); confirmed Hib meningitis, 16 (1.4 to 31); meningitis with cerebrospinal-fluid findings consistent with a bacterial aetiology, 67 (22 to 112); and admission for suspected meningitis or presenting to a clinic with convulsions, 158 (42 to 273).

INTERPRETATION:

Hib vaccine did not prevent the great majority of pneumonia cases, including those with alveolar consolidation. These results do not support a major role for Hib vaccine in overall pneumonia-prevention programmes. Nevertheless, the study identified high incidences of Hib meningitis and pneumonia; inclusion of Hib vaccine in routine infant immunisation programmes in Asia deserves consideration.

• Authors: Bradford D Gessner, Agustinus Sutanto, Mary Linehan, I Gusti Gede Djelantik, Tracy Fletcher, I Komang Gerudug, Ingerani, David Mercer, Vanda Moniaga, Lawrence H Moulton, Lawrence H Moulton, Kim Mulholland, Carib Nelson, Soewignjo Soemohardjo, Mark Steinhoff, Anton Widjaya, Philippe Stoeckel, James Maynard, Soemarjati Arjoso
• Journal: Lancet (London, England) (Lancet) 2005 Jan 1-7 Vol. 365 Issue 9453 Pg. 43-52 ISSN: 1474-547X [Electronic] England
• PMID: 15643700 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, Non-P.H.S.)

Chemical References

• Diphtheria-Tetanus-Pertussis Vaccine
• Haemophilus Vaccines
• Haemophilus influenza type b polysaccharide vaccine-tetanus toxin conjugate
• Haemophilus influenzae type b polysaccharide vaccine
• Polysaccharides, Bacterial
• Tetanus Toxoid
• Vaccines, Conjugate

Topics

• Bacterial Capsules
• Diphtheria-Tetanus-Pertussis Vaccine (administration & dosage)
• Double-Blind Method
• Female
• Haemophilus Infections (epidemiology, prevention & control)
• Haemophilus Vaccines (administration & dosage)
• Humans
• Immunization Programs
• Incidence
• Indonesia (epidemiology)
• Infant
• Male
• Meningitis, Haemophilus (epidemiology, prevention & control)
• Pneumonia, Bacterial (epidemiology, prevention & control)
• Polysaccharides, Bacterial
• Tetanus Toxoid (administration & dosage)
• Vaccines, Conjugate