Study of acellular pertussis vaccine and its effect on whooping cough colonization in healthy adults using controlled human infection
- Participants:Adults · Healthy volunteers
Rare diseases
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Inactivated poliovirus vaccines contain killed virus particles that cannot cause disease but can still trigger an immune response. When injected, the immune system recognises the viral proteins and produces antibodies against poliovirus type 3, providing protection without infection. The molecular basis of attenuation in the related Sabin strain of poliovirus type 3 has been studied to understand how weakened viruses behave differently from wild-type strains.[3] The WHO notes that the three wild poliovirus strains are immunologically distinct, meaning each must be targeted separately by vaccines.[4]
The substance is formulated as a suspension for injection and is administered by injection.[1] In the REVAXIS product, it is part of a fixed combination with diphtheria toxoid, tetanus toxoid, poliovirus type 1 (inactivated) and poliovirus type 2 (inactivated), given as a 0.5 ml dose.[1] A related pentavalent vaccine, Pentacel, is approved in the United States as a four-dose series in children aged 6 weeks through 4 years, with doses at 2, 4, 6 and 15–18 months of age.[2]
One completed clinical trial included poliovirus type 3 (inactivated) as part of the comparison vaccine. The study was a Phase 3 randomised vaccination trial in 99 healthy adults investigating the effects of acellular pertussis vaccine on colonisation with Bordetella pertussis using controlled human infection.[1] The trial compared a Tdap-IPV booster vaccine (containing diphtheria, tetanus, acellular pertussis and inactivated poliovirus components) against a Td-IPV control vaccine (containing diphtheria, tetanus and inactivated poliovirus components, including poliovirus type 3).[1] The primary outcome measured Bordetella pertussis colonisation rate, defined as any positive culture from nasal wash samples at any time point between day 3 and day 28 after challenge.[1]
According to the prescribing information for Pentacel, a related vaccine containing inactivated poliovirus, a severe allergic reaction (anaphylaxis) after a previous dose of the vaccine or any of its ingredients is a contraindication.[2] The label does not list additional side effects in the provided excerpt. No side effect data specific to the REVAXIS product are available from the provided sources.
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