Evaluation of Safety and Immunogenicity of Meningococcal B and Meningococcal ACWY Vaccine in at Risk Population
NCT03682939 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 55
Last updated 2019-04-10
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
- 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
Sponsors & Collaborators
-
St George's, University of London
lead OTHER
Principal Investigators
-
Catherine Cosgrove, MBBS PhD · St George's, University of London
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 10 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-02-21
- Primary Completion
- 2020-06-30
- Completion
- 2021-03-31
Countries
- United Kingdom
Study Locations
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