Clinical trial NCT04875819: Safety and Immunogenicity Following Meningococcal and Pneumococcal Immunization Among Adult People Living With HIV
Official title: Safety and Immunogenicity Following Meningococcal and Pneumococcal Immunization Among Adult People Living With HIV: A Single Center, Non-blinded, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Hiv
Meningococcal Infections
Pneumococcal Infections
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2021-05-06
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


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 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.)

Primary outcomes:
measure: Change in immunogenic response from baseline, Menveo
timeFrame: Day 30 and year 1, 2, 3, 4, and 5 post-vaccination
measure: Change in immunogenic response from baseline, Bexsero
timeFrame: Day 30 and year 1, 2, 3, 4, and 5 post-vaccination
measure: Change in immunogenic response from baseline, Prevenar13/Pneumovax23
timeFrame: Day 30 and year 1, 2, 3, 4, and 5 post-vaccination
Secondary outcomes:
measure: Number of participants with immediate adverse events
timeFrame: 30 minutes post-vaccination
measure: Number of participants with short term adverse events
timeFrame: Day 5 post vaccination
measure: Number of participants with long term adverse events
timeFrame: Day 90 post-vaccination
measure: Streptococcus pneumoniae carriage rates
timeFrame: Baseline and day 30 post-vaccination
measure: Neisseria meningitidis carriage rates
timeFrame: Baseline and day 30 post-vaccination
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
Study officials:
affiliation: Department of Infectious Diseases, Hvidovre Hospital
name: Michaela Tinggaard, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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