Scholarlink

Background <p>Mpox disease is endemic to several regions of sub-Saharan Africa, with transmission occurring through close contact with infected animals or humans. Increasing case numbers in East Africa led the African Centre for Disease Control and Prevention to declare a Public Health Emergency of Continental Security on 13th August 2024 related to a new virus variant (clade 1b). The Mpox CARE study aims to establish clinical and epidemiology data to develop innovative immunodiagnostic tests, facilitating models for sub-clinical disease exposure, transmission and future vaccine strategies (Part A). Furthermore, we aim to evaluate and optimize vaccine cold-chain (VCC) systems to support Mpox vaccine deployment while ensuring the continued provision of childhood immunizations (Part B).</p> Methods <p>This study will recruit up to 650 participants to three study groups according to Mpox exposure status and/or vaccination in Rwanda. All enrolled participants will be asked to provide demographic information, relevant medical history, up to 20mLs of venous blood and a dried blood spot capillary blood sample. For Part A of the study, samples will undergo testing for quantitative analysis of total serum antibody to Mpox specific proteins using an enzyme-linked immunosorbent assay (ELISA) and test a novel point-of-care (POC) lateral flow test to determine positive/negative qualitative serostatus. For Part B, we will collect data on VCC equipment, inventories and methods of vaccine distribution. The results of this project aim to (a) validate a blood-based ELISA assay for the detection of Mpox immunity in a target population of Rwanda, (b) generate an estimate of sero-positivity to Mpox in Rwanda, (c) evaluate the clinical performance of a novel POC lateral flow test for Mpox serostatus and (d) understand the VCC requirements for additional vaccine deployment for disease control.</p> Discussion <p>Detecting antibodies for sub-clinical Mpox cases improves disease mapping and transmission patterns in endemic African regions. Novel POC immunodiagnostics can enhance community healthcare and decentralise efforts to understand Mpox seroepidemiology. Understanding VCC requirements for deployment of genetic vaccines, alongside regular vaccine provision to pregnant women, and children offers insights for management of future vaccine-preventable disease outbreaks.</p> Trail registration <p>Clinicaltrials.gov trial registration number NCT06887556, registered 20th March 2025. </p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Mpox comprehensive assessment for responsive immunisation in emergency outbreaks (MpoxCARE): study protocol

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年2月13日

查看全文
  • Karishma Gokani,
  • Herve Semukunzi,
  • Gilbert Rukundo,
  • Jenny Clarke,
  • Sian E. Faustini,
  • Jean Pierre Musabyimana,
  • Siobhan Roche,
  • Scott Jones,
  • Ashley David Otter,
  • Alex Richter,
  • Claude Muvunyi,
  • Jennifer Heaney,
  • Christopher Aird Green,
  • Leopold Bitunguhari,
  • Prosper Ingabire,
  • William Iradukunda,
  • Gerard Izuwayo,
  • Emmanuel Kabalisa,
  • Hin Fai Kowk,
  • Leon Mutesa,
  • Leonce Rukundo,
  • Charles Simugomwa,
  • Chloe Tanner,
  • Jean Marie Vianney Uwimana,
  • Philemon Uwishema

摘要

Background

Mpox disease is endemic to several regions of sub-Saharan Africa, with transmission occurring through close contact with infected animals or humans. Increasing case numbers in East Africa led the African Centre for Disease Control and Prevention to declare a Public Health Emergency of Continental Security on 13th August 2024 related to a new virus variant (clade 1b). The Mpox CARE study aims to establish clinical and epidemiology data to develop innovative immunodiagnostic tests, facilitating models for sub-clinical disease exposure, transmission and future vaccine strategies (Part A). Furthermore, we aim to evaluate and optimize vaccine cold-chain (VCC) systems to support Mpox vaccine deployment while ensuring the continued provision of childhood immunizations (Part B).

Methods

This study will recruit up to 650 participants to three study groups according to Mpox exposure status and/or vaccination in Rwanda. All enrolled participants will be asked to provide demographic information, relevant medical history, up to 20mLs of venous blood and a dried blood spot capillary blood sample. For Part A of the study, samples will undergo testing for quantitative analysis of total serum antibody to Mpox specific proteins using an enzyme-linked immunosorbent assay (ELISA) and test a novel point-of-care (POC) lateral flow test to determine positive/negative qualitative serostatus. For Part B, we will collect data on VCC equipment, inventories and methods of vaccine distribution. The results of this project aim to (a) validate a blood-based ELISA assay for the detection of Mpox immunity in a target population of Rwanda, (b) generate an estimate of sero-positivity to Mpox in Rwanda, (c) evaluate the clinical performance of a novel POC lateral flow test for Mpox serostatus and (d) understand the VCC requirements for additional vaccine deployment for disease control.

Discussion

Detecting antibodies for sub-clinical Mpox cases improves disease mapping and transmission patterns in endemic African regions. Novel POC immunodiagnostics can enhance community healthcare and decentralise efforts to understand Mpox seroepidemiology. Understanding VCC requirements for deployment of genetic vaccines, alongside regular vaccine provision to pregnant women, and children offers insights for management of future vaccine-preventable disease outbreaks.

Trail registration

Clinicaltrials.gov trial registration number NCT06887556, registered 20th March 2025.