Hiv, Meningococcal Infections, Pneumococcal Infections
Conditions
Brief 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.
Interventions
DRUGNeisseria meningitidis oligosaccharide conjugate vaccine and recombinant protein-based 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.
DRUG13 valent pneumococcal conjugate vaccine and 23 valent pneumococcal polysaccharide vaccine
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.
Sponsors
Thomas Benfield
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 components * Temperature \> 38 ᵒC * Sign of bacterial infection * Previous known or suspected disease caused by N. meningitidis * Active AIDS associated illness * Active malignancy * End-stage renal or liver disease * Bleeding disorder * Recipient of any blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation within the last month * Use of immunosuppressive agents (corticosteroids, cancer chemotherapeutic agents etc.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in immunogenic response from baseline, Menveo | Day 30 and year 1, 2, 3, 4, and 5 post-vaccination | 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. |
| Change in immunogenic response from baseline, Bexsero | Day 30 and year 1, 2, 3, 4, and 5 post-vaccination | 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. |
| Change in immunogenic response from baseline, Prevenar13/Pneumovax23 | Day 30 and year 1, 2, 3, 4, and 5 post-vaccination | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with long term adverse events | Day 90 post-vaccination | — |
| Streptococcus pneumoniae carriage rates | Baseline and day 30 post-vaccination | Proportion of study subject with a culture or PCR positive pharyngeal swab sample |
| Neisseria meningitidis carriage rates | Baseline and day 30 post-vaccination | Proportion of study subject with a culture or PCR positive pharyngeal swab sample |
| Number of participants with immediate adverse events | 30 minutes post-vaccination | — |
| Number of participants with short term adverse events | Day 5 post vaccination | — |
Countries
Denmark
Contacts
Primary ContactMichaela Tinggaard, M.D.
Outcome results
None listed