RecruitingPhase 4NCT04875819

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

Sponsor

Thomas Benfield

Enrollment

55 participants

Start Date

Apr 28, 2021

Study Type

INTERVENTIONAL

Conditions

HIV Pneumococcal Infections Meningococcal Infections

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates the safety and immune response to meningococcal and pneumococcal vaccines in adults living with HIV who are on antiretroviral therapy (ART) and have well-controlled HIV. People with HIV may have weaker immune responses to vaccines, so researchers want to understand the best way to vaccinate this group. **You may be eligible if...** - You are 18 or older and HIV-positive - You are currently on antiretroviral therapy (ART) - Your viral load is less than 500 copies/mL (HIV is well controlled) - You have given written consent **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have previously received a meningococcal or pneumococcal vaccine - You are allergic to any component of these vaccines - You have a fever, active bacterial infection, or active AIDS-related illness - You have an active cancer, severe kidney or liver disease, or a bleeding disorder - You have received blood products or immunosuppressive drugs recently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNeisseria 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.

DRUG13 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.