Tests meningococcal and pneumococcal vaccines in adults living with HIV
Compares two vaccine schedules in adults with HIV to see how they respond.
Plain-language title generated from the registry record
Registry title: Safety and Immunogenicity Following Meningococcal and Pneumococcal Immunization Among Adult People Living With HIV
Key facts
- Where
- Frederiksberg and Hvidovre, DenmarkSee the 2 sites
- Phase
- Phase 4
Where in Denmark
- GCP-enheden ved Københavns UniversitetshospitalFrederiksberg, DenmarkTaking people
- Hvidovre HospitalHvidovre, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Thomas Benfield
- Trial code
- NCT04875819EU 2024-516961-35-01
- Record updated
- 6 May 2021
- Original description
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.Read full original descriptionShow less
Safety and Immunogenicity Following Meningococcal and Pneumococcal Immunization Among Adult People Living With HIV: A Single Center, Non-blinded, Randomized Clinical Trial
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.
Inclusion: Age ≥ 18 years; Seropositive for HIV-1; Recipient of ART; Plasma HIV-RNA < 500 copies/ml; Patients written consent obtained.
Exclusion: Previous known or suspected disease caused by N. meningitidis; History of meningococcal or pneumococcal vaccination; Allergies towards any of the vaccine components; Sign of bacterial infection; Active AIDS associated illness; Active malignancy; End-stage renal or liver disease; Bleeding disorder; Use of immunosuppressive agents (corticosteroids, cancer chemotherapeutic agents etc.); Pregnancy or breastfeeding; Temperature > 38 ᵒC; Recipient of any blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation within the last month.