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

Launched by THOMAS BENFIELD · May 5, 2021

Keywords

ClinConnect Summary

This clinical trial, called MENPI, is studying how safe and effective two different vaccination regimens are for adults living with HIV. Specifically, it looks at vaccines for meningococcal and pneumococcal infections in people who are receiving treatment for HIV. Participants will be randomly assigned to receive either a series of two specific meningococcal vaccines or a different combination of pneumococcal vaccines. After the initial doses, participants will switch to the other vaccine regimen after 90 days. The goal is to see how well these vaccines work and if there are any side effects over time.

To join the trial, participants must be at least 18 years old, have a confirmed HIV infection, and be on antiretroviral treatment with controlled virus levels. They should not have had recent vaccinations for these infections or certain health conditions that could complicate the study. During the trial, participants will have regular check-ups, including blood tests and monitoring for any health issues. This study is important because it aims to improve vaccination strategies for people living with HIV, ensuring they are protected against serious infections.

Gender

ALL

Eligibility criteria

• 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.)