PROMOTING ACCESS TO AFRICAN RESEARCH

South African Medical Journal

Log in or Register to get access to full text downloads.

Remember me or Register



Safety and immunogenicity of two Haemophilus influenzae type b conjugate vaccines

Maila J Matjila, Thabo C Phohu, Angelika Banzhoff, Simonetta Viviani, Anwar A Hoosen, Massimo Bianchini, Pantaleo Nacci, Chapman W Palweni, Audino Podda, Michael Whitfield, Sanet Aspinall

Abstract


Objectives. Haemophilus influenzae type b (Hib) infection remains a major public health problem inthe developing world. We evaluated the safety and immunogenicity of a new PRP-CRM197 conjugate Hib vaccine (Vaxem Hib, Chiron Vacdnes), compared with theHibTITER vaccine (WyethLederle Vaccines), following the World Health Organisation (WHO)'s accelerated schedule which allows 4-week intervals between doses.
Study design. A phase II, observer-blind, multicentre, randomised, controlled, non-inferiority study.
Methods. In total, 331 babies were immunised with either Vaxem Hib (N = 167) or HibTITER (N = 164) vaccine at 6, 10 and 14 weeks of age, in parallel with oral polio, diphtheriatetanus- pertussis and hepatitis B vaccines. Postimmunisation reactions were recorded after each immunisation and arfollow-up visits. Anti-polyribosylribitol phosphate (PRP) antibodies were measured using enzyme-linked immunosorbent assays (ELISAs) before and 1 month after the third immunisation.
Results. Overall, there was no significant difference in the anti-PRP levels between the two groups .. One month after the third immunisation, 76% of vacdnees in the Vaxem Hib group and 70% in the HibTITER group hadanti-PRP antibody mres i:: 1.0 vg/ tnl, while 96% of the Vaxem l-Iib group and.90% of the HibTITER gn;mp d.e!l}onstrated a),lt1- PRP antibody titres;:: 0.15 vg/ml. The geometric me<t:ntitre at day 90 was 3.77 pg/ml for the VaxemHib and 3.0 Jlg/Inl for the HibTITER groups. Although the Vaxem Hib vaccine produced more redness (6% versus 1 %; p = 0.006) and swelling (5% versus 1%, p = 0.037), overall it was well tolerated compared with the B:ibTITER vaccine. There wa~ no significant difference in vaccine-relateq elevated temperature (;:: 38°(:) between the two groups (p = 0. 11), 
Conclusion. Both vaccines showed comparable safety llJ:\d immunogenicity profiles when administered to SouthAfrican babies at 6, 10 and 14weeks of age.




AJOL African Journals Online