Safety and Immunogenicity Following Meningococcal and Pneumococcal Immunization Among Adult People Living With HIV
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorThomas Benfield
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 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 criteria
Qualifiers
Age ≥ 18 years
Seropositive for HIV-1
Recipient of ART
Plasma HIV-RNA < 500 copies/ml
Disqualifiers
Pregnancy or breastfeeding
History of meningococcal or pneumococcal vaccination
Allergies towards any of the vaccine components
Temperature > 38 ᵒC
Trial design
Treatments tested in this trial
- Neisseria meningitidis oligosaccharide conjugate vaccine and recombinant protein-based vaccine
- 13 valent pneumococcal conjugate vaccine and 23 valent pneumococcal polysaccharide vaccine
Treatment groups
55 Participants
are divided into 2 treatment groupsSponsors and collaborators
Thomas Benfield
Lead sponsor
Hvidovre University Hospital
Sponsor institution
Source ClinicalTrials.gov