NCT03682939

Evaluation of Safety and Immunogenicity of Meningococcal B and Meningococcal ACWY Vaccine in at Risk Population

Evaluation of Safety and Immunogenicity of Meningococcal B and Meningococcal ACWY Vaccine in at Risk Population (ProPositive Study)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: St George's, University of London · Academic / Other
• Sex: All
• Age: 10 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the immunogenicity, safety and tolerability of co-administration of vaccinations for meningitis B (Bexsero®) and meningitis ACWY (Menveo®) in adults and children aged 10-45 years living with HIV. All participants will be vaccinated with both Menveo® and Bexsero® on days 0 and 30. Immunogenicity will be determined on venous blood sampled at days 0 and 60. Adverse effects will be recorded to evaluate safety.

Conditions

• Hiv
• Meningitis, Meningococcal
• HIV Infections

Interventions

Type	Name	Description
BIOLOGICAL	Bexsero® (meningitis B vaccine)	Bexsero® 0.5ml IM vaccine administered into non-dominant arm of participant
BIOLOGICAL	Menveo® (meningitis ACWY vaccine)	Menveo® 0.5ml IM vaccine administered into dominant arm of participant

Timeline

• Start date: 2019-02-21
• Primary completion: 2020-06-01
• Completion: 2021-03-01
• First posted: 2018-09-25
• Last updated: 2019-04-10

Locations

1 site across 1 country: United Kingdom