Safety and Immunogenicity Following Meningococcal and Pneumococcal Immunization Among Adult People Living With HIV: A Single Center, Non-blinded, Randomized Clinical Trial

Who is this study for? Patients with Human Immunodeficiency Virus, Meningococcal, Pneumococcal Infections
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years

• Seropositive for HIV-1

• Recipient of ART

• Plasma HIV-RNA \< 500 copies/ml

• Patients written consent obtained

Locations
Other Locations
Denmark
Hvidovre Hospital
RECRUITING
Hvidovre
Contact Information
Primary
Michaela Tinggaard, M.D.
michaela.tinggaard@regionh.dk
22326800
Time Frame
Start Date: 2021-04-28
Estimated Completion Date: 2026-12
Participants
Target number of participants: 55
Treatments
Experimental: Menveo + Bexsero
Experimental: Prevenar13 + Pneumovax23
Related Therapeutic Areas
Sponsors
Leads: Thomas Benfield

This content was sourced from clinicaltrials.gov

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