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

Thomas Benfield

Status and phase: Enrolling; Phase 4

Conditions: Meningococcal Infections; Pneumococcal Infections; Hiv

Treatments: Drug: Neisseria meningitidis oligosaccharide conjugate vaccine and recombinant protein-based vaccine; Drug: 13 valent pneumococcal conjugate vaccine and 23 valent pneumococcal polysaccharide vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT04875819

H-19001166

2020-000863-22 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 55 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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55 participants in 2 patient groups

Menveo + Bexsero

Experimental group

Treatment:

Drug: Neisseria meningitidis oligosaccharide conjugate vaccine and recombinant protein-based vaccine

Prevenar13 + Pneumovax23

Experimental group

Treatment:

Drug: 13 valent pneumococcal conjugate vaccine and 23 valent pneumococcal polysaccharide vaccine