A Phase 4 interventional study of Neisseria meningitidis oligosaccharide conjugate vaccine and recombinant protein-based vaccine and 13 valent pneumococcal conjugate vaccine and 23 valent pneumococcal polysaccharide vaccine in Hiv, Meningococcal Infections and Pneumococcal Infections, sponsored by Thomas Benfield. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-06.
Sponsored by Thomas Benfield · Phase 4, Interventional, and Prevention
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 55 is below the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Thomas Benfield is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Neisseria meningitidis oligosaccharide conjugate vaccine and recombinant protein-based vaccine
Drug: 13 valent pneumococcal conjugate vaccine and 23 valent pneumococcal polysaccharide vaccine
One dose (0.5 ml) of conjugate vaccine against meningococcal serogroups ACWY (Menveo®) and one dose of a recombinant protein-based vaccine against meningococcal serogroup B (Bexsero®) at day 0 followed by another dose (0.5 ml) of each vaccine at day 60.
Also known as: Menveo® and Bexsero®
One dose (0.5 ml) of pneumococcal conjugate vaccine (Prevenar13®) at day 0 and one dose (0.5 ml) of pneumococcal polysaccharide vaccine (Pneumovax23®) at day 60.
Also known as: Prevenar13® and Pneumovax23®
Change in immunogenic response from baseline, Menveo
A ≥4-fold rise in rabbit complement source (rSBA) for the four serogroups A, C, Y, and W-135. Seroprotection is defined as an rSBA titre ≥1:8 and patients will be classified as previously immune if baseline rSBA is ≥1:8.
Time frame: Day 30 and year 1, 2, 3, 4, and 5 post-vaccination
Change in immunogenic response from baseline, Bexsero
A ≥4-fold rise in antibody titers against a panel of four meningococcal serogroup B reference strains between pre-vaccination and post-vaccination timepoints, or a post-vaccination antibody titre ratio of ≥1:4 for individuals who were seronegative before vaccination.
Time frame: Day 30 and year 1, 2, 3, 4, and 5 post-vaccination
Change in immunogenic response from baseline, Prevenar13/Pneumovax23
A ≥2-fold rise in serum anti-capsular IgG GMC for 12 shared pneumococcal polysaccharides (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F)
Time frame: Day 30 and year 1, 2, 3, 4, and 5 post-vaccination
Number of participants with immediate adverse events
Time frame: 30 minutes post-vaccination
Number of participants with short term adverse events
Time frame: Day 5 post vaccination
Number of participants with long term adverse events
Time frame: Day 90 post-vaccination
Streptococcus pneumoniae carriage rates
Proportion of study subject with a culture or PCR positive pharyngeal swab sample
Time frame: Baseline and day 30 post-vaccination
Neisseria meningitidis carriage rates
Proportion of study subject with a culture or PCR positive pharyngeal swab sample
Time frame: Baseline and day 30 post-vaccination
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