Safety and Immunogenicity Following Meningococcal and Pneumococcal Immunization Among Adult People Living With HIV
Recruiting
Phase 4
Interventional Study
Hiv
Meningococcal Infections
Pneumococcal Infections
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 55 (estimated)
- Sponsor
- Thomas Benfield · Other
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About This Trial
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…
Trial Locations
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Eligibility Criteria
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 com…
Contacts