Status:
RECRUITING
Safety and Immunogenicity Following Meningococcal and Pneumococcal Immunization Among Adult People Living With HIV
Lead Sponsor:
Thomas Benfield
Conditions:
Hiv
Meningococcal Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 receiv...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Seropositive for HIV-1
- Recipient of ART
- Plasma HIV-RNA \< 500 copies/ml
- Patients written consent obtained
Exclusion
- 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.)
Key Trial Info
Start Date :
April 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT04875819
Start Date
April 28 2021
End Date
December 1 2026
Last Update
May 6 2021
Active Locations (1)
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1
Hvidovre Hospital
Hvidovre, Denmark, 2650