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Propositive (Protecting Positive People From Meningococcal Infection) Follow-up Study

NCT04239430 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 55

Last updated 2022-02-02

No results posted yet for this study

Summary

The need for and timing of booster doses of meningococcal vaccines in People Living with HIV (PLWHIV) is currently unknown. As such it is impossible for clinicians to recommend booster doses or to know if and when these might be necessary.We propose to follow up a group of participants from the Propositive study who received two doses of both MenB (Bexsero) and MenACWY (Menveo). This was a group of PLWHIV between the ages 18-45 years. We propose following up these participants at 18 and 30 months post completion of two doses of vaccine and investigating their immunological response.

Conditions

Interventions

DIAGNOSTIC_TEST

Serum Bactericidal Assays

Blood samples will be taken from participants at two time points in the study. Serum Bactericidal Assays from participant serum using relevant MenB and MenACWY strains will be undertaken at 18 and 30 months post two doses of 4CMenB (Bexsero, GSK) and MenACWY-conjugate (Menveo, GSK) vaccine. The Vaccines were given to participants during an earlier clinical trial (Propositive). This trisal is a follow up study.

Sponsors & Collaborators

  • Public Health England

    collaborator OTHER_GOV

  • St George's, University of London

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
47 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-26
Primary Completion
2022-04-30
Completion
2022-04-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04239430 on ClinicalTrials.gov