Comparison of Western Immunobloting to an Enzyme-Linked Immunosorbent Assay for the Determination of Anti-Bordetella pertussis Antibodies

Merrigan, Stephen D.; Welch, Ryan J.; Litwin, Christine M.

doi:10.1128/cvi.00450-10

Cited by 3 publications

(1 citation statement)

References 24 publications

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“…For pertussis no serological correlate of protection has been established 12 . PT is the exclusive antigen for B. Pertussis and is important for pathogenicity 13 , 14 . The antibodies against PT mainly contribute to protection against pertussis and WHO recommends the assessment of PT response by ELISA with wP based vaccine also 10 .…”

Section: Discussionmentioning

confidence: 99%

A phase III randomized-controlled study of safety and immunogenicity of DTwP-HepB-IPV-Hib vaccine (HEXASIIL®) in infants

Sharma,

Parekh,

Pujari

et al. 2024

npj Vaccines

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A fully liquid hexavalent containing Diphtheria (D), Tetanus (T) toxoids, whole cell Pertussis (wP), Hepatitis B (Hep B), type 1, 2, 3 of inactivated poliovirus (IPV) and Haemophilus influenzae type b (Hib) conjugate vaccine (DTwP-HepB-IPV-Hib vaccine, HEXASIIL®) was tested for lot-to-lot consistency and non-inferiority against licensed DTwP-HepB-Hib + IPV in an open label, randomized Phase II/III study. In Phase III part, healthy infants received DTwP-HepB-IPV-Hib or DTwP-HepB-Hib + IPV vaccines at 6, 10 and 14 weeks of age. Blood samples were collected prior to the first dose and 28 days, post dose 3. Non inferiority versus DTwP-HepB-Hib + IPV was demonstrated with 95% CIs for the treatment difference for seroprotection/seroconversion rates. For DTwP-HepB-IPV-Hib lots, limits of 95% CI for post-vaccination geometric mean concentration ratios were within equivalence limits (0.5 and 2). Vaccine was well-tolerated and no safety concerns observed.Clinical Trial Registration – CTRI/2019/11/022052

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Section: Discussionmentioning

confidence: 99%