Thiem Dinh Vu1, Quang Dang Nguyen2, Huong Thi Ai Tran3, Valérie Bosch-Castells4, Céline Zocchetti4, Guy Houillon4. 1. National Institute of Hygiene and Epidemiology, 1 Yersin St., Hanoi 10000, Viet Nam. Electronic address: vdt@nihe.org.vn. 2. National Institute of Hygiene and Epidemiology, 1 Yersin St., Hanoi 10000, Viet Nam. 3. Hoa Binh Provincial Preventive Medicine Centre, Hoa Binh Province, Viet Nam. 4. Sanofi Pasteur, 2 Pont Pasteur, 69007 Lyon, France.
Abstract
OBJECTIVE: To describe the immunogenicity and safety of the Japanese encephalitis chimeric virus vaccine (JE-CV) in children and adults in Vietnam. METHODS: In this prospective, open-label, single-center, single-arm study, 250 healthy participants aged 9 months to 60 years received a single dose of JE-CV (IMOJEV®). JE neutralizing antibody titers were assessed at baseline and 28days after vaccination using the 50% plaque reduction neutralization test (PRNT50). Safety and reactogenicity were assessed through solicited and unsolicited adverse events. FINDINGS: Seroconversion (titer ≥10 [1/dil] in participants JE seronegative [titer <10] at baseline [per protocol analysis], or a 4-fold rise from a baseline titer ≥10) and seroprotection (titer ≥10 [1/dil]) rates 28days after vaccination were both 98.5% (132/134) in the per protocol analysis, and 82.4% (201/244) and 98.8% (242/245), respectively, in the full analysis set. Geometric mean titers (GMTs) increased in all age groups from Day 0 to Day 28; Day 28/Day 0 GMT ratios were 55.3 (95% confidence interval [CI] 38.4-79.8), 348 (95% CI 211-572), 296 (95% CI 152-576) and 194 (95% CI 13.1-2870) in those aged 9 months to 4 years, 5-11 years, 12-17 years and 18-60 years, respectively, in the per protocol analysis. There were no safety concerns during the study. CONCLUSION: A single dose of JE-CV in children and adults aged 9 months to 60 years in Vietnam elicited a protective immune response and was well tolerated with no safety concerns. Registered at www.clinicaltrials.gov (NCT02492165).
OBJECTIVE: To describe the immunogenicity and safety of the Japanese encephalitis chimeric virus vaccine (JE-CV) in children and adults in Vietnam. METHODS: In this prospective, open-label, single-center, single-arm study, 250 healthy participants aged 9 months to 60 years received a single dose of JE-CV (IMOJEV®). JE neutralizing antibody titers were assessed at baseline and 28days after vaccination using the 50% plaque reduction neutralization test (PRNT50). Safety and reactogenicity were assessed through solicited and unsolicited adverse events. FINDINGS: Seroconversion (titer ≥10 [1/dil] in participants JE seronegative [titer <10] at baseline [per protocol analysis], or a 4-fold rise from a baseline titer ≥10) and seroprotection (titer ≥10 [1/dil]) rates 28days after vaccination were both 98.5% (132/134) in the per protocol analysis, and 82.4% (201/244) and 98.8% (242/245), respectively, in the full analysis set. Geometric mean titers (GMTs) increased in all age groups from Day 0 to Day 28; Day 28/Day 0 GMT ratios were 55.3 (95% confidence interval [CI] 38.4-79.8), 348 (95% CI 211-572), 296 (95% CI 152-576) and 194 (95% CI 13.1-2870) in those aged 9 months to 4 years, 5-11 years, 12-17 years and 18-60 years, respectively, in the per protocol analysis. There were no safety concerns during the study. CONCLUSION: A single dose of JE-CV in children and adults aged 9 months to 60 years in Vietnam elicited a protective immune response and was well tolerated with no safety concerns. Registered at www.clinicaltrials.gov (NCT02492165).