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

NCT04239430 UNKNOWN

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.

Details

Lead sponsor	St George's, University of London
Status	UNKNOWN
Enrolment	55
Start date	2020-11-26
Completion	2022-04

Conditions

• HIV/AIDS
• Meningococcal Disease

Interventions

• Serum Bactericidal Assays

Primary outcomes

• 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

Countries

United Kingdom