Evaluation of the Antibody Persistence Beyond Five Years After Immunization With MenFiveTM (NmCV-5), a Pentavalent Meningococcal ACYWX Conjugate Vaccine
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Meningoccocal Disease. Basic parameters: 7 years — 36 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Mali, The Gambia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the Antibody Persistence in African Participants Beyond Five Years After Immunization With MenFiveTM (NmCV-5), a Pentavalent Meningococcal ACYWX Conjugate Vaccine
Overview
This study will measure immune persistence of the NmCV-5 more than 5 years after a single dose vaccination in participants 2-29 years of age in Mali and The Gambia.
Detailed description
This non-interventional long-term follow-up study will involve one telephonic contact in all 1800 former participants from study ACYWX-03 followed by one visit beyond five years after vaccination in a subset of 450 participants. This subset will be randomly selected to participate in a follow-on immune persistence evaluation. To document the duration of the immune response and any requirement of booster dose in the target population, this study is intended to explore antibody persistence.
Primary outcome measures
- Geometric mean titers (GMTs) measured by rSBA against serogroups A, C, Y, W and X [Time frame: five-six years after vaccination.]
Secondary outcome measures (2)
- Percentage of participants with rSBA titers ≥ 8 [Time frame: five-six years after vaccination.]
- Percentage of participants with rSBA titers ≥ 128 [Time frame: five-six years after vaccination]
Eligibility criteria
Inclusion criteria
- Written informed consent and assent (if applicable)
Exclusion criteria
- Current or previous, confirmed disease caused by Neisseria meningitidis at any given time since meningococcal vaccination
- Any condition or criteria that in the opinion of the investigator might compromise the well-being of the participant or the compliance with study procedures or interfere with the outcome of the study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Mali · 1 center
- Centre pour le Développement des Vaccins du Mali, ex-Institut Marchoux, Ministry of Health — Bamako
The Gambia · 1 center
- Medical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medici — Banjul
Identifiers
NCT: NCT07379151 · PERS-ACYWX-03