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

St George's, University of London55 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

HIV/AIDS Meningococcal Disease

Interventions

Serum Bactericidal AssaysDIAGNOSTIC_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.

Outcomes

Primary Outcomes

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

Time frame: 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

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.