Infectious diseases and therapy · 2026
Immunogenicity and Safety of Single-Dose MenACYW Conjugate Vaccine in Vietnamese Participants Aged ≥ 12 Months: A Phase III, Open-Label Study.
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Thiem Vu Dinh, Janicot Stephane, Syrkina Olga, Ha Vu Hai, Long Pham Dinh, Nguyen Dao Trung, Zocchetti Céline
Аннотация
INTRODUCTION: Invasive meningococcal disease (IMD) is a progressive condition commonly presenting as septicemia and meningitis, with significant mortality and morbidity. Vietnam reports high incidence rates among military populations and young infants. Despite this burden and unpredictable outbreaks, meningococcal vaccination in Vietnam is offered primarily to high-risk individuals and travelers rather than as routine childhood immunization. MenACYW-TT, a quadrivalent meningococcal polysaccharide tetanus toxoid-conjugate vaccine with licensure in > 80 countries, is approved for toddlers aged ≥ 12 months and for infants aged ≥ 6 weeks. This Phase III, open-label study evaluated the immunogenicity and safety of a single dose of MenACYW-TT in healthy Vietnamese participants aged ≥ 12 months.
METHODS: This study (NCT06228586) was conducted in Vietnam among healthy participants aged ≥ 12 months (five age groups) who received a single dose of MenACYW-TT. Functional antibody activity against all four meningococcal serogroups was measured using serum bactericidal assay with human complement (hSBA) at baseline (Day 1) and after vaccination (Day 31). Safety data were collected up to 30 days (+ 14 days) after vaccination.
RESULTS: Among the 447 enrolled participants, seroprotection rates (hSBA titers ≥ 1:8) were high and comparable across all age groups for each serogroup, i.e., 88.8% for serogroup A to 100% for serogroup C. Overall, the seroresponse rates were high for serogroups C: 98.6%, Y: 96.0%, W: 95.0%, and A: 73.6%, with higher seroresponse to serogroup A in the 12- to 23-month group (81.5%) versus the ≥ 24-month group (66.5%). No safety concerns or vaccine-related serious adverse events were observed.
CONCLUSIONS: A single dose of MenACYW-TT induced robust immunogenicity against all four serogroups and demonstrated an acceptable safety profile across all age groups of Vietnamese participants. Given the high burden of meningococcal disease in Vietnam, these findings support the potential inclusion of MenACYW-TT in Vietnam's National Expanded Program on Immunization.
TRIAL REGISTRATION: clinicaltrials.gov, NCT06228586.
METHODS: This study (NCT06228586) was conducted in Vietnam among healthy participants aged ≥ 12 months (five age groups) who received a single dose of MenACYW-TT. Functional antibody activity against all four meningococcal serogroups was measured using serum bactericidal assay with human complement (hSBA) at baseline (Day 1) and after vaccination (Day 31). Safety data were collected up to 30 days (+ 14 days) after vaccination.
RESULTS: Among the 447 enrolled participants, seroprotection rates (hSBA titers ≥ 1:8) were high and comparable across all age groups for each serogroup, i.e., 88.8% for serogroup A to 100% for serogroup C. Overall, the seroresponse rates were high for serogroups C: 98.6%, Y: 96.0%, W: 95.0%, and A: 73.6%, with higher seroresponse to serogroup A in the 12- to 23-month group (81.5%) versus the ≥ 24-month group (66.5%). No safety concerns or vaccine-related serious adverse events were observed.
CONCLUSIONS: A single dose of MenACYW-TT induced robust immunogenicity against all four serogroups and demonstrated an acceptable safety profile across all age groups of Vietnamese participants. Given the high burden of meningococcal disease in Vietnam, these findings support the potential inclusion of MenACYW-TT in Vietnam's National Expanded Program on Immunization.
TRIAL REGISTRATION: clinicaltrials.gov, NCT06228586.