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Immunogenicity and safety of Vero cell culture-derived Japanese encephalitis vaccine: a phase 3 study in Chinese infants
- Source :
- Expert Review of Vaccines, Vol 23, Iss 1, Pp 958-965 (2024)
- Publication Year :
- 2024
- Publisher :
- Taylor & Francis Group, 2024.
-
Abstract
- Background Japanese encephalitis (JE) is a severe infectious disease of the central nervous system. Vaccination with Vero cell culture-derived vaccines may effectively reduce JE incidence.Research Design and Methods In this single-center, randomized, blinded, positive-controlled clinical trial in China involving 600 healthy infants aged 6–11 months, participants were divided into experimental and control groups administered JEV-PI and JEV-LI, respectively. Antibody titers were determined after 0- and 7-day immunization schedules. A booster dose followed 12 months later.Results After primary vaccination and before booster vaccination, the positive conversion rate, geometric mean titer (GMT), and geometric mean increase (GMI) of JEV-PI-neutralizing antibodies exceeded those of JEV-LI. After booster immunization, the GMT and GMI of JEV-PI were higher than those of JEV-LI. After primary immunization, the local, systemic, and overall adverse reactions were of grades 1 and 2, with a low incidence of grade 3. After booster immunization, these differences were mainly grades 1 and 2, with no differences between JEV-PI and JEV-LI.Conclusion JEV-PI is a promising vaccine as infants acquired long-lasting and highly neutralizing immune antibodies after inoculation with JEV-PI.Trial Registration The trial was registered in the Chinese Clinical Trial Registry (https://www.chictr.org.cn/showproj.html?proj = 203130; registration number: ChiCTR2300074692; registration date: 14/08/2023).
- Subjects :
- Infection
Japanese encephalitis
vaccine
Vero cells
virus
Internal medicine
RC31-1245
Subjects
Details
- Language :
- English
- ISSN :
- 14760584 and 17448395
- Volume :
- 23
- Issue :
- 1
- Database :
- Directory of Open Access Journals
- Journal :
- Expert Review of Vaccines
- Publication Type :
- Academic Journal
- Accession number :
- edsdoj.9c584e7da1d944338b1b8e3f0b8be2c5
- Document Type :
- article
- Full Text :
- https://doi.org/10.1080/14760584.2024.2404633