MENPI: Safety and immunogenicity following meningococcal and pneumococcal immunization among adult people living with HIV. A single center, non-blinded, randomized clinical trial

Not yet recruiting

• Conditions: HIV

• Registration Number: 2024-516961-35-01
• Lead Sponsor: Hvidovre Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-10-11
• Last Update Posted: 2024-10-11

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

•Pregnancy or breastfeeding
•History of meningococcal or pneumococcal vaccination
•Allergies towards any of the vaccine components
•Temperature > 38 ?C
•Sign of bacterial infection
•Previous known or suspected disease caused by N. meningitidis
•Active AIDS associated illness
•Active malignancy
•End-stage renal or kidney 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.)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Trial Locations

Locations (2)

Hvidovre Hospital; 🇩🇰 Hvidovre, Denmark

GCP-enheden ved Københavns Universitetshospital; 🇩🇰 Frederiksberg, Denmark

Hvidovre Hospital

🇩🇰Hvidovre, Denmark

Michaela Tinggaard

Site contact

22326800

michaela.tinggaard@regionh.dk