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

NCT04239430 | Unknown

• 1 other identifier: 2019.0374
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV/AIDS; Meningococcal Disease

Outcome Measures

Primary Outcomes (1)

• Serum bacteridical Assay responses against relevant MenB strains at 18 and 30 months post two doses Bexsero (administered concomitantly with Menveo)

  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

  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 Outcomes (1)

• 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

Interventions

Serum Bactericidal Assays DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 18 Years - 47 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• Unwilling or unable to comply with study requirements

Sponsors & Collaborators

• St George's, University of London: lead
• Public Health England: collaborator

Study Sites (1)

St George's University of London

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Meningococcal Infections

Interventions

Serum Bactericidal Antibody Assay

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Serologic Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2020
• First Posted: January 27, 2020
• Study Start: November 26, 2020
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: February 2, 2022

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)