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Safety and Immunogenicity Following Meningococcal and Pneumococcal Immunization Among Adult People Living With HIV
Sponsor: Thomas Benfield
Summary
MENPI is an investigator-initiated single-centre randomized controlled trial which aims to assess the efficacy and safety of meningococcal and pneumococcal vaccination in adults living with HIV receiving antiretroviral treatment. Participants are randomized 1:1 to either a two-dose Menveo® and Bexsero® regimen or a Prevenar13®/Pneumovax23® prime-boost regimen at day 0 and day 60 and cross over on day 90. All participants will follow an identical follow up program including plasma collection, pharyngeal swab, and adverse event registration. Immunogenicity will be determined on venous blood sampled at 30 days post-vaccination and yearly for five years.
Official title: Safety and Immunogenicity Following Meningococcal and Pneumococcal Immunization Among Adult People Living With HIV: A Single Center, Non-blinded, Randomized Clinical Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
55
Start Date
2021-04-28
Completion Date
2026-12
Last Updated
2021-05-06
Healthy Volunteers
No
Interventions
Neisseria meningitidis oligosaccharide conjugate vaccine and recombinant protein-based vaccine
One dose (0.5 ml) of conjugate vaccine against meningococcal serogroups ACWY (Menveo®) and one dose of a recombinant protein-based vaccine against meningococcal serogroup B (Bexsero®) at day 0 followed by another dose (0.5 ml) of each vaccine at day 60.
13 valent pneumococcal conjugate vaccine and 23 valent pneumococcal polysaccharide vaccine
One dose (0.5 ml) of pneumococcal conjugate vaccine (Prevenar13®) at day 0 and one dose (0.5 ml) of pneumococcal polysaccharide vaccine (Pneumovax23®) at day 60.
Locations (1)
Hvidovre Hospital
Hvidovre, Denmark