Safety and Immunogenicity Following Meningococcal and Pneumococcal Immunization Among Adult People Living With HIV

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 Criteria:

• Age ≥ 18 years
• Seropositive for HIV-1
• Recipient of ART
• Plasma HIV-RNA < 500 copies/ml
• Patients written consent obtained

Exclusion Criteria:

• Pregnancy or breastfeeding
• History of meningococcal or pneumococcal vaccination
• Allergies towards any of the vaccine components
• Temperature > 38 ᵒC
• Sign of bacterial infection
• Previous known or suspected disease caused by N. meningitidis
• Active AIDS associated illness
• Active malignancy
• End-stage renal or liver disease
• Bleeding disorder
• Recipient of any blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation within the last month
• Use of immunosuppressive agents (corticosteroids, cancer chemotherapeutic agents etc.)