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

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.

Study Overview

• Status: Recruiting
• Conditions: HIV/AIDS; Meningococcal Disease
• Intervention / Treatment: Diagnostic test: Serum Bactericidal Assays

• Study Type: Observational
• Enrollment (Anticipated): 55

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Recruiting
    • St George's University of London
    • Contact: Catherine Cosgrove, PhD; Phone Number: 02087253887; Email: ccosgrov@sgul.ac.uk
    • Sub-Investigator: Alberto San Francisco Ramos, LMS
    • Principal Investigator: Catherine Cosgrove, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 47 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population is the same as for the original Propositive study. This study will follow up the same cohort of participants.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum bacteridical Assay responses against relevant MenB strains at 18 and 30 months post two doses Bexsero (administered concomitantly with Menveo)	Geometric Mean Titres against relevant MenB strains at 18 and 30 months post two doses of Bexsero; 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; The proportion of subjects with "protective" hSBA titres >4 against relevant MenB strains at 18 months and 30 months post two doses of 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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum bactericidal Assay responses against relevant MenACWY strains at 18 and 30 months post two doses Menveo (administered concomitantly with Bexsero)	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.	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

Collaborators and Investigators

• Sponsor: St George's, University of London
• Collaborators: Public Health England

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 26, 2020
• Primary Completion (ANTICIPATED): April 1, 2022
• Study Completion (ANTICIPATED): April 1, 2022

Study Registration Dates

• First Submitted: January 20, 2020
• First Submitted That Met QC Criteria: January 20, 2020
• First Posted (ACTUAL): January 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 2, 2022
• Last Update Submitted That Met QC Criteria: January 27, 2022
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Neisseriaceae Infections; Meningococcal Infections
• Other Study ID Numbers: 2019.0374

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No