Review of the epidemiology, diagnosis and management of invasive meningococcal disease in Vietnam

Nguyen, Phung Nguyen The; Hưng, Nguyễn Thành; Mathur, G P; Pinto, Thatiana de Jesus Pereira; Nguyen, Minh

doi:10.1080/21645515.2023.2172922

Cited by 4 publications

(2 citation statements)

References 41 publications

(96 reference statements)

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“…There were no clinically signi cant changes in clinical laboratory tests and vital signs before and after the administration of the study drugs. Headache 2 (6.7) [2] .…”

Section: Safety and Tolerabilitymentioning

confidence: 99%

Safety, tolerability, and immunogenicity of a pentavalent meningococcal conjugate vaccine containing serogroups A, C, W-135, X, and Y in healthy adults: A randomized, single-center, active-controlled, double-blind, phase 1 study

Oh,

Kim,

Bae

et al. 2024

Preprint

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Introduction Invasive meningococcal disease is a significant health threat, especially in sub-Saharan Africa, and it often results in outbreaks and severe epidemics. However, existing meningococcal vaccines lack protection against the emerging serogroup X, which has been on the rise since 2010. To address this gap, EuNmCV-5, a pentavalent meningococcal conjugate vaccine targeting serogroups A, C, W-135, X, and Y is newly developed. Methods A randomized, single-center, active-controlled, double-blind, first-in-human, phase 1 study was conducted in healthy Korean adults to evaluate the safety, tolerability, and immunogenicity of EuNmCV-5. The test drug, a pentavalent vaccine targeting serogroups A, C, W-135, X, and Y, was compared with the reference drug, a quadrivalent vaccine containing serogroups A, C, W-135, and Y. After obtaining written informed consent, sixty subjects were randomly assigned in a 1:1 ratio to receive a single intramuscular dose of either the test or reference drug. Safety assessment included monitoring anaphylactic reactions for 30 minutes, recording solicited adverse events for 7 days post-vaccination, unsolicited adverse events for 28 days post-vaccination, and serious adverse events over 180 days. Blood samples were collected before vaccination and 28 days after vaccination for immunogenicity assessment using a rabbit complement-dependent serum bactericidal antibody (rSBA) assay. Immunogenicity parameters, including seroconversion, seroprotection rates, geometric mean titers (GMT), and GMT ratio were compared between the two drugs. Result A total of sixty subjects completed the study as planned, and none of them reported anaphylactic reactions or life-threatening adverse events. The incidence rate and severity of adverse events were comparable between the test and reference drug. Following a single vaccination, the test drug induced seroconversion in over 85% of subjects and achieved a seroprotection rate exceeding 96.7% for all the targeted serogroups. The test drug showed higher seroconversion rates against serogroups A and C than the reference drug (p = 0.0016 and 0.0237, respectively) and maintained seroconversion rates greater than 90% for serogroups W-135 and Y. The GMT ratios (test to the reference drug) with corresponding 95% confidence intervals were 5.5 (2.3–13.2), 9.0 (2.5–32.4), 6.1 (2.2–16.7), 397.1 (161.8-974.4), and 5.0 (2.1–12.0) for serogroup A, C, W-135, X, and Y, respectively. Conclusion A single dose of EuNmCV-5 was safe and well-tolerated in healthy Korean adults. It elicited high seroconversion and seroprotection rates, along with a substantial increase in GMT for all targeted serogroups. ClinicalTrials.gov identifier: NCT05739292

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“…There were no clinically signi cant changes in clinical laboratory tests and vital signs before and after the administration of the study drugs. Headache 2 (6.7) [2] .…”

Section: Safety and Tolerabilitymentioning

confidence: 99%

Safety, tolerability, and immunogenicity of a pentavalent meningococcal conjugate vaccine containing serogroups A, C, W-135, X, and Y in healthy adults: A randomized, single-center, active-controlled, double-blind, phase 1 study

Oh,

Kim,

Bae

et al. 2024

Preprint

View full text Add to dashboard Cite

show abstract

“…Invasive meningococcal disease (IMD), caused by Neisseria meningitidis , is an acute infection and contagious respiratory illness. The disease is severe, often progresses extremely rapidly, and, if not treated promptly, has a high risk of mortality (4–20% within 48 h) and of sequelae in 10–20% of survivors (e.g., amputation of limbs, hearing loss, and learning difficulties) [ 1 ].…”

Section: Introductionmentioning

confidence: 99%

4CMenB Vaccination to Prevent Meningococcal B Disease in Vietnam: Expert Review and Opinion

Nguyen,

Thai,

Dien

et al. 2024

Infect Dis Ther

Self Cite

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An advisory board meeting was held with experts in Vietnam (Hanoi, August 2022), to review the evidence on invasive meningococcal disease (IMD) epidemiology, clinical management, and meningococcal vaccines to reach a consensus on recommendations for meningococcal vaccination in Vietnam. IMD is a severe disease, with the highest burden in infants and children. IMD presents as meningitis and/or meningococcemia and can progress extremely rapidly. Almost 90% of deaths in children occur within the first 24 h, and disabling sequelae (e.g., limb amputations and neurological damage) occur in up to 20% of survivors. IMD patients are often hospitalized late, due to mild and nonspecific early symptoms and misdiagnosis. Difficulties related to diagnosis and antibiotic misuse mean that the number of reported IMD cases in Vietnam is likely to be underestimated. Serogroup B IMD is predominant in many regions of the world, including Vietnam, where 82% of IMD cases were due to serogroup B (surveillance data from 2012 to 2021). Four component meningococcal B vaccine (4CMenB) is used in many countries (and is part of the pediatric National Immunization Program in 13 countries), with infant vaccination starting from two months of age, and a 2 + 1 dosing schedule. Experts recommend 4CMenB vaccination as soon as possible in Vietnam, starting from two months of age, with a 2 + 1 dosing schedule, and at least completing one dose before 6 months of age. Supplementary Information The online version contains supplementary material available at 10.1007/s40121-023-00905-y.

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A randomized study to evaluate the safety and immunogenicity of a pentavalent meningococcal vaccine

Kim,

Bae,

et al. 2024

npj Vaccines

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A randomized, active-controlled, double-blind, first-in-human, phase 1 study was conducted in healthy Korean adults to evaluate the safety, tolerability, and immunogenicity of EuNmCV-5, a new pentavalent meningococcal vaccine targeting serogroups A, C, W, X, and Y. Sixty participants randomly received a single dose of either EuNmCV-5 or MenACWY-CRM, a quadrivalent vaccine containing serogroups A, C, W, and Y. Safety was assessed through monitoring anaphylactic reactions, adverse events for 28 days, and serious adverse events over 180 days. Immunogenicity was assessed via rabbit complement-dependent serum bactericidal antibody (rSBA) assay. EuNmCV-5 was safe, well-tolerated, and elicited a substantial antibody titer increase. The seroprotection rates exceeded 96.7%, and the seroconversion rates were over 85% for all the targeted serogroups. It showed higher seroconversion rates against serogroups A and C (p = 0.0016 and 0.0237, respectively) and elicited a substantial increase in GMT for all targeted serogroups compared to the MenACWY-CRM.ClinicalTrials.gov identifier: NCT05739292.

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Review of the epidemiology, diagnosis and management of invasive meningococcal disease in Vietnam

Cited by 4 publications

References 41 publications

Safety, tolerability, and immunogenicity of a pentavalent meningococcal conjugate vaccine containing serogroups A, C, W-135, X, and Y in healthy adults: A randomized, single-center, active-controlled, double-blind, phase 1 study

Safety, tolerability, and immunogenicity of a pentavalent meningococcal conjugate vaccine containing serogroups A, C, W-135, X, and Y in healthy adults: A randomized, single-center, active-controlled, double-blind, phase 1 study

4CMenB Vaccination to Prevent Meningococcal B Disease in Vietnam: Expert Review and Opinion

A randomized study to evaluate the safety and immunogenicity of a pentavalent meningococcal vaccine

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