Immunogenicity and safety of an interchangeable vaccination schedule of two inactivated Japanese encephalitis vaccines: a multicentric, phase IV, open-label, randomized controlled trial.
Обработка статьи · этапы, ошибки и управление
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Vivian Thangaraj Jeromie Wesley, Reddy Himabindu, Sapkal Gajanan N, Velusamy Saravana Kumar, Jain Manish A, Dwibedi Bhagirathi, Kanungo Suman, Kundapur Rashmi, Pandey Sanjay, Deshpande Gururaj Rao, Saritha Ala, Kadavath Vishnunath, Kanagasabai Kaliaperumal, Maliye Chetna, Parida Swayam Pragyan, Majumdar Agniva, Reddy Mounika, Singh Chandramani, Lade Archana R, Samanta Sandip, Singh Arvind Kumar, Chawan Sunil Kumar, Pati Binod Kumar, Srivastava Rashi, Panda Sanjay Kumar, Saha Jayanta, Kamble Bhushan, Salunke Asha, Kumar Pardeep, Ramasamy Sabarinathan, Narayanan Muthulakhsmi Mugunthan, Bondre Vijay P, George Leyanna Susan, Gupta Nivedita, Kathiresan Jeyashree, Murhekar Manoj V
Аннотация
METHODS: In this multicentric, open-label, phase 4, non-inferiority randomized trial conducted during November 11, 2023-September 2, 2025, infants aged 9-12 months were assigned (1:1:1:1) to JENVAC-JEEV, JENVAC-JENVAC, JEEV-JENVAC, or JEEV-JEEV. Second dose was given at the age of 16-24 months. The primary outcome was seroconversion assessed by 50% plaque reduction neutralization test titer against wild-type JE virus 28 days after dose-2. The secondary outcomes included frequency of solicited and unsolicited adverse events, and serious adverse events following JE vaccine schedules. Non-inferiority was concluded if the lower bound of the 95% CI for difference in seroconversion proportion between the mixed and same-product vaccine schedule exceeded -10% and was less than 0%. Registered with Clinical Trials Registry-India (CTRI/2023/07/055155).
FINDINGS: Between November 11, 2023, and June 8, 2024, 911 infants were randomly assigned (1:1:1:1) to JENVAC-JEEV (n = 228), JENVAC-JENVAC (n = 228), JEEV-JENVAC (n = 227), and JEEV-JEEV (n = 228). In modified intention-to-treat analysis, seroconversion after second dose was 89.8% (194/216), 90.2% (184/204), 90.9% (189/208), and 89.2% (190/213) respectively. The difference in seroconversion between mixed-product and same-product vaccine schedules was -0.38% (95% CI -6.1 to 5.4) among JENVAC-primed and 1.66% (-4.1 to 7.4) among JEEV-primed infants. The corresponding estimates in per-protocol analysis were -1.11% (95% CI -6.7 to 4.5) and 0.89% (-4.9 to 6.6) respectively. Solicited adverse events occurred in 35.5-37.9% infants across the study groups. None of the serious adverse events was vaccine related.
INTERPRETATION: Mixed-product JENVAC and JEEV schedules were non-inferior to same-product schedules for short-term neutralizing antibody seroconversion and showed no safety signals. These findings support programme flexibility when children cannot complete JE vaccination with the same-product.
FUNDING: The trial was funded by Indian Council of Medical Research, New Delhi, India.