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Development and clinical use of an oral heat-inactivated whole cell pertussis vaccine
Insights
An oral pertussis vaccine is safe and effective in newborns, inducing an early immune response and reducing illness. Field trials showed significantly lower pertussis morbidity in orally vaccinated infants up to one year old.
Area of Science:
- Immunology
- Vaccinology
- Pediatrics
Background:
- Pertussis (whooping cough) remains a significant public health concern, necessitating effective vaccination strategies.
- Traditional parenteral pertussis vaccines have limitations, prompting research into alternative administration routes.
- Development of an orally administered, killed whole-cell pertussis vaccine has been explored for improved accessibility and immune response.
Purpose of the Study:
- To evaluate the safety and immunogenicity of an orally administered, killed whole-cell pertussis vaccine in newborns.
- To assess the efficacy of the oral pertussis vaccine in reducing pertussis-related morbidity in infants.
- To compare the immune response elicited by oral versus parenteral vaccination routes.
Main Methods:
- A killed whole-cell pertussis vaccine was administered orally to newborns on days 2-5 post-birth, with a booster at six weeks.
- Safety was assessed through monitoring side effects in over 20,000 newborns.
- Immunogenicity was evaluated by measuring anti-pertussis IgG in serum and IgA in saliva, and specific mitogen stimulation.
- Efficacy was determined by comparing pertussis morbidity in 11,192 orally vaccinated infants versus 3,496 unvaccinated infants up to one year.
Main Results:
- The oral pertussis vaccine was well-tolerated with no reported side effects in over 20,000 newborns.
- Oral vaccination induced a specific immune response, including serum IgG and salivary IgA, significantly earlier than parenteral vaccination.
- Salivary anti-pertussis antibodies were not induced by parenteral vaccination.
- Pertussis morbidity was significantly lower in orally vaccinated infants up to one year of age.
- No significant difference was observed in pertussis hospitalization or verified infection after one year between oral and non-oral vaccination groups.
Conclusions:
- The orally administered killed whole-cell pertussis vaccine is safe and potent in newborns.
- Oral vaccination elicits an early and specific immune response, including mucosal immunity, which may contribute to reduced morbidity.
- Further research is warranted to optimize oral pertussis vaccination strategies for long-term protection.
Abstract:
An orally administered, killed whole cell pertussis vaccine was developed which proved to be safe and potent in animal experiments. This vaccine was studied in limited field trials in Austria. In these field trials 1 X 10(12) bacterial cells were given orally on days 2, 3, 4, and 5 after birth with an oral booster of 1 X 10(12) cells given at six weeks. This vaccine was tolerated without side effects in more than 20,000 newborns, did induce a specific immune response including anti-pertussis IgG in serum, anti-pertussis IgA in saliva and specific pertussis mitogen stimulation. This immune response occurred significantly earlier in the orally but not in the parenterally vaccinated group. In addition, anti-pertussis antibodies in saliva were not induced in the parenterally vaccinated group. Pertussis morbidity in 11,192 orally vaccinated infants was compared to 3496 infants who did not receive oral vaccination and was found to be significantly lower for up to one year. There was no overall difference between orally and non-orally vaccinated infants as far as pertussis hospitalization and verified pertussis infection after one year was concerned.