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

• Conditions: Meningococcal Disease; HIV/AIDS

• Registration Number: NCT04239430
• Lead Sponsor: St George's, University of London

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-20
• Study First Submitted QC: 2020-01-20
• Study First Posted: 2020-01-27
• Study Start: 2020-11-26
• Status Verified: 2021-07
• Last Update Submitted: 2022-01-27
• Last Update Posted: 2022-02-02
• Primary Completion: 2022-04
• Study Completion: 2022-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• Received vaccination with Bexsero and Menveo during Propositive study
• Able to sign fully informed consent
• Able to comply with study requirements

Exclusion Criteria

• Unwilling or unable to comply with study requirements

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum bacteridical Assay responses against relevant MenB strains at 18 and 30 months post two doses Bexsero (administered concomitantly with Menveo)	The 18 month blood test is taken 548 days (+/-60 days) from completion of vaccination during the Propositive study and the 30 month blood test is taken 912 days (+/- 60 days) after completion of vaccination	1. Geometric Mean Titres against relevant MenB strains at 18 and 30 months post two doses of Bexsero; 2. The proportion of subjects with at least 4 fold increase in hSBA against relevant MenB strains from baseline compared to 18 month and 30 months post two doses of Bexsero; 3. The proportion of subjects with "protective" hSBA titres \>4 against relevant MenB strains at 18 months and 30 months post two doses of Bexsero

Secondary Outcome Measures

Name	Time	Method
Serum bactericidal Assay responses against relevant MenACWY strains at 18 and 30 months post two doses Menveo (administered concomitantly with Bexsero)	The 18 month blood test is taken 548 days (+/-60 days) from completion of vaccination during the Propositive study and the 30 month blood test is taken 912 days (+/- 60 days) after completion of vaccination	4. rSBA GMTs for MenACWY antigens at 18 and 30 months.; 5. The proportion of subjects with at least 4 fold increase in rSBA against relevant MenACWY serogroups from baseline compared to at 18 and 30 months.; 6. The proportion of subjects with "protective" rSBA titres \>8 against relevant MenACWY serogroups at 18 and 30 months.

Trial Locations

Locations (1)

St George's University of London; 🇬🇧 London, United Kingdom