Non-pertussis components of combination vaccines: problems with potency testing.
Vaccines comprising combinations of diphtheria, tetanus and pertussis (DTP) with Haemophilus influenzae type b polysaccharide-protein conjugate (Hib), inactivated poliomyelitis virus (IPV) and hepatitis B virus (HBV) are already available, and new combinations using acellular pertussis components in a triple vaccine (DTaP) are under development. Evidence to date has shown that control of the efficacy, safety and stability of combination vaccines cannot be based on information already available on the individual components or existing licensed formulations. Several examples of immunological interference between components of a combination vaccine have been observed both in clinical trials and in laboratory tests. Examples of these for D, T and Hib components in DTP and DTaP combinations have been investigated.
Sesardic
D
D
Division of Bacteriology, National Institute for Biological Standards and Control, Potters Bar, Hertfordshire, EN6 3QG, U.K.
Dawes
C S
CS
Mclellan
K
K
Durrani
Z
Z
Yost
S E
SE
Corbel
M J
MJ
D000818:Animals; D016667:Bacterial Capsules; D002986:Clinical Trials as Topic; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000276:immunology; D018073:Haemophilus Vaccines / Q000276:immunology; D006801:Humans; D011054:Poliovirus Vaccine, Inactivated / Q000276:immunology; D011135:Polysaccharides, Bacterial / Q000276:immunology; D017778:Vaccines, Combined / Q000276:immunology
D015721:Diphtheria-Tetanus-Pertussis Vaccine; D018073:Haemophilus Vaccines; C044237:Haemophilus influenzae type b polysaccharide vaccine; D011054:Poliovirus Vaccine, Inactivated; D011135:Polysaccharides, Bacterial; D017778:Vaccines, Combined