Preclinical immunogenicity studies were conducted in rhesus monkeys to dete
rmine whether there is immune interference in the response to one or more c
omponents of a hexavalent vaccine (Hexavac(TM)) that contains antigens from
Haemophilus influenzae (Hib), hepatitis B (HB), diphtheria (D), tetanus (T
), acellular pertussis (aP) and inactivated polio virus (IPV). Antibody res
ponses were measured following co-administration of the components at three
separate anatomical sites or administration as a hexavalent combination in
a single site. After three injections of the hexavalent vaccine, the peak
antibody responses to each component of the vaccine were > 100-fold above p
re-immune titers and persisted at levels > 10-fold above pre-immune titers
at approximate to1 year. Immune interference was observed in the peak respo
nse to HE, D and pertussis toxin, but was not seen at later time points. Th
e results indicate that the rhesus monkey model may be useful for pre-clini
cal evaluation of combination vaccines. (C) 2000 Elsevier Science Ltd. All
rights reserved.