Abstract | OBJECTIVES: Haemophilus influenzae type b ( Hib) infection remains a major public health problem in the developing world. We evaluated the safety and immunogenicity of a new PRP-CRM197 conjugate Hib vaccine (Vaxem Hib, Chiron Vaccines), compared with the HibTITER vaccine (Wyeth-Lederle 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. Post-immunisation reactions were recorded after each immunisation and at follow-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 vaccinees in the Vaxem Hib group and 70% in the HibTITER group had anti-PRP antibody titres > or = 1.0 microgram/ml, while 96% of the Vaxem Hib group and 90% of the HibTITER group demonstrated anti-PRP antibody titres > or = 0.15 microgram/ml. The geometric mean titre at day 90 was 3.77 micrograms/ml for the Vaxem Hib and 3.0 micrograms/ml 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 HibTITER vaccine. There was no significant difference in vaccine-related elevated temperature (> or = 38 degrees C) between the two groups (p = 0.11). CONCLUSION: Both vaccines showed comparable safety and immunogenicity profiles when administered to South African babies at 6, 10 and 14 weeks of age.
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Authors | 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 |
Journal | South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde
(S Afr Med J)
Vol. 94
Issue 1
Pg. 43-6
(Jan 2004)
ISSN: 0256-9574 [Print] South Africa |
PMID | 14971232
(Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
- Haemophilus Vaccines
- Haemophilus influenzae type b polysaccharide vaccine
- Polysaccharides, Bacterial
- Vaccines, Conjugate
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Topics |
- Bacterial Capsules
- Developing Countries
- Enzyme-Linked Immunosorbent Assay
- Female
- Haemophilus Infections
(prevention & control)
- Haemophilus Vaccines
(administration & dosage)
- Haemophilus influenzae type b
- Humans
- Infant
- Male
- Polysaccharides, Bacterial
(administration & dosage, immunology)
- Safety
- South Africa
(epidemiology)
- Vaccination
- Vaccines, Conjugate
(administration & dosage)
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