Actively Recruiting
Safety and Immunogenicity Following Meningococcal and Pneumococcal Immunization Among Adult People Living With HIV
Led by Thomas Benfield · Updated on 2021-05-06
55
Participants Needed
1
Research Sites
291 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Safety and Immunogenicity Following Meningococcal and Pneumococcal Immunization Among Adult People Living With HIV
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Confirmed positive test for HIV-1
- Currently receiving antiretroviral treatment
- Plasma HIV-RNA levels below 500 copies/ml
- Provided written consent to participate
You will not qualify if you...
- Pregnant or breastfeeding
- Previous meningococcal or pneumococcal vaccination
- Allergic to any vaccine components
- Fever with temperature over 38 DC
- Signs of bacterial infection
- History of disease caused by Neisseria meningitidis
- Active AIDS-related illness
- Active cancer
- End-stage kidney or liver disease
- Bleeding disorders
- Received blood products or immunoglobulins within the last month
- Use of immunosuppressive medications such as corticosteroids or chemotherapy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hvidovre Hospital
Hvidovre, Denmark, 2650
Actively Recruiting
Research Team
M
Michaela Tinggaard, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
PREVENTION
Number of Arms
2
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