NCT04239430

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

Evaluation of the Immunogenicity of Meningococcal B (4CMenB) and Meningococcal ACWY (MenACWY Conjugate) Vaccination in a Population With HIV at 18 and 30 Months After Two Doses of Vaccine

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 55 (estimated)
• Sponsor: St George's, University of London · Academic / Other
• Sex: All
• Age: 18 Years – 47 Years
• Healthy volunteers: Accepted

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

• HIV/AIDS
• Meningococcal Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-11-26
• Primary completion: 2022-04-01
• Completion: 2022-04-01
• First posted: 2020-01-27
• Last updated: 2022-02-02

Locations

1 site across 1 country: United Kingdom