GESSNER BD; HIB STUDY GROUP; Interscience Conference on Antimicrobial Agents and Chemotherapy (43rd: 2003: Chicago, Ill.).

Abstr Intersci Conf Antimicrob Agents Chemother Intersci Conf Antimicrob Agents Chemother. 2003 Sep 14-17; 43: abstract no. G-2054a.

AMP, Paris, France.

BACKGROUND: In part because most studies in Asia have found low Hib disease incidence, few Asian countries use Hib vaccine in routine immunization programs. It is unclear if Hib is truly rare in Asia or if unmeasured disease exists. METHODS: During 1998-2002, we conducted a randomized, controlled, double-blind trial comparing pneumonia and meningitis outcomes among children <2 years of age who were immunized according to the World Health Organization (WHO) schedule with DTP or DTP-PRP-T (Hib conjugate) vaccine. Randomization to vaccine group was based on residence in one of 818 hamlets. The primary outcome was radiologically confirmed alveolar infiltrate based on standard WHO criteria. Outcomes were identified at village clinics and the three major local hospitals. We conducted an intention to treat analysis with enrollment defined as receipt of >/= 1 dose of study vaccine. RESULTS: We enrolled 55,073 children. We found no significant effect on radiologically confirmed pneumonias (vaccine efficacy [VE], -4.6%; p=0.56), hospitalized severe pneumonias (VE, 4.3%; p=0.23), or pneumonia deaths (VE, 9.1%; p=0.34) but a modest effect on all clinically defined pneumonias (VE, 2.9%; p=0.013). Vaccine was efficacious against confirmed Hib meningitis (VE, 86%; p=0.053), meningitis with cerebrospinal fluid findings consistent with a bacterial etiology (VE, 50%; p=0.0044), and clinical meningitis (VE, 22%; p=0.0070) and had a non-significant effect on meningitis mortality (VE, 10%; p=0.28). Based on observed differences in rates of clinical meningitis between groups, we estimated that the Hib meningitis incidence was 154/100,000/year. CONCLUSIONS: DTP-PRP-T had a large effect on meningitis outcomes but prevented a small proportion, if any, of measured pneumonia outcomes. The high vaccine-preventable disease burden may justify use of Hib conjugate vaccine in immunization programs in this region.

Publication Types:

• Meeting Abstracts

Keywords:

• Asia
• Child
• Diphtheria-Tetanus-Pertussis Vaccine
• Double-Blind Method
• Haemophilus Vaccines
• Haemophilus influenza type b polysaccharide vaccine-tetanus toxin conjugate
• Haemophilus influenzae type b
• Haemophilus influenzae type b polysaccharide vaccine
• Humans
• Immunization
• Immunization Programs
• Incidence
• Indonesia
• Meningitis, Haemophilus
• Pneumonia
• Pneumonia, Bacterial
• Polysaccharides, Bacterial
• Tetanus Toxoid
• Vaccination
• Vaccines, Conjugate
• immunology

Other ID:

• GWAIDS0025793

UI: 102265417

From Meeting Abstracts