The development of a new heptavalent diphtheria–tetanus–whole cell pertussis–hepatitis B–Haemophilus influenzae type b–Neisseria meningitidis serogroups A and C vaccine: a randomized dose-ranging trial of the conjugate vaccine components

Research Institute for Tropical Medicine, Alabang, Muntinlupa, Philippines.
International Journal of Infectious Diseases (Impact Factor: 1.86). 05/2008; 12(3):278-88. DOI: 10.1016/j.ijid.2007.08.007
Source: PubMed


To assess immunogenicity, antibody persistence, immune memory, and reactogenicity of a novel heptavalent DTPw-HBV/Hib-MenAC (diphtheria, tetanus, whole cell pertussis-hepatitis B virus/Haemophilus influenzae type b-Neisseria meningitidis serogroups A and C) vaccine.
This was an open, randomized study in the Philippines, with DTPw-HBV/Hib-MenAC administered at 6, 10, and 14 weeks of age. Three different polysaccharide contents of the conjugate vaccine components were assessed with conjugated PRP (polyribosylribitol phosphate), MenA, and MenC polysaccharides at the following doses: 2.5 microg of each, 5 microg of each, or 2.5 microg of PRP and 5 microg each of MenA and MenC. Controls received licensed DTPw-HBV and Hib or DTPw-HBV/Hib and MenC conjugate vaccines separately. Immune memory was evaluated via plain polysaccharide challenge administered to half of the subjects at 10 months of age.
After primary vaccination, at least 97.7% of DTPw-HBV/Hib-MenAC recipients had serum bactericidal antibody (SBA)-MenA and SBA-MenC titers > or =1:8, and at least 99% had anti-PRP antibody concentrations > or =0.15 microg/ml. Immune responses to DTPw-HBV components were not impaired by the lowest dose of Hib-MenAC vaccine. Plain polysaccharide challenge induced marked increases in Hib, MenA, and MenC antibodies in primed subjects, indicative of immune memory. All of the experimental vaccines were well tolerated.
The lowest dose of DTPw-HBV/Hib-MenAC polysaccharide conjugate vaccine was well tolerated, immunogenic, had good persistence of antibodies, and demonstrated immune memory, and consequently was selected for further development.

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    • "Vaccine Study Phase Country Target group Schedule N Publication NCT00317174 Phase II Philippines Infants 6, 10, 14 weeks PS challenge at 10 months 524 217 Gatchalian et al., 2008 [59] * DTPw-HBV/Hib- MenAC ISRCTN35754083 Phase II Ghana Infants 6, 10, 14 weeks PS challenge at 12 months 280 260 Hodgson et al., 2008 [60] NCT00317161 and NCT00317187 Phase III Philippines, Thailand Infants 2, 4, 6 months 1780 Kerdpanich et al., 2008 [61] NCT00135486 and NCT00135564 Phase II Germany Infants 2, 3, 4 months PS challenge at 12–15 months 520 Schmitt et al., 2007 [70] NCT00323050 and NCT00322335 Phase III Spain Infants 2, 4, 6 months 13-14 months 237 358 Tejedor et al., 2007 [62] "
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