Evaluation of the Antibody Persistence Beyond Five Years After Immunization With MenFiveTM (NmCV-5), a Pentavalent Meningococcal ACYWX Conjugate Vaccine

Evaluation of the Antibody Persistence in African Participants Beyond Five Years After Immunization With MenFiveTM (NmCV-5), a Pentavalent Meningococcal ACYWX Conjugate Vaccine

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07379151

Acronym

PERS-ACYWX-03

Enrollment

450

Registered

2026-01-30

Start date

2026-05-05

Completion date

2026-12-01

Last updated

2026-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Meningoccocal Disease

Keywords

Seropersistence, Meningococcal

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

7 Years to 36 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Geometric mean titers (GMTs) measured by rSBA against serogroups A, C, Y, W and X	five-six years after vaccination.

Secondary

Measure	Time frame
Percentage of participants with rSBA titers ≥ 8	five-six years after vaccination.
Percentage of participants with rSBA titers ≥ 128	five-six years after vaccination

Countries

Mali, The Gambia

Contacts

CONTACTDr Prasad Kulkarni, MD, FRCP

drpsk@seruminstitute.com+91-20-71946820

Outcome results