NCT04875819RecruitingPhase 4
Safety and Immunogenicity Following Meningococcal and Pneumococcal Immunization Among Adult People Living With HIV
Safety and Immunogenicity Following Meningococcal and Pneumococcal Immunization Among Adult People Living With HIV: A Single Center, Non-blinded, Randomized Clinical Trial
Source: ClinicalTrials.gov · Last updated 6 May 2021 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 55 (estimated)
- First submitted
- 12 Apr 2021
- Start date
- 28 Apr 2021
- Primary completion date
- Dec 2026
- Lead sponsor
- Thomas Benfield
- Diseases
- HIV
- NCT number
- NCT04875819
- EU CT number
- 2024-516961-35-01
- EudraCT number
- 2020-000863-22
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 55
- From 28 Apr 2021 to the primary completion date, Dec 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous known or suspected disease caused by N. meningitidis
Other illness
- History of meningococcal or pneumococcal vaccination
- Allergies towards any of the vaccine components
- Sign of bacterial infection
- Active AIDS associated illness
- Active malignancy
- End-stage renal or liver disease
- Bleeding disorder
- Use of immunosuppressive agents (corticosteroids, cancer chemotherapeutic agents etc.)
Other
- Pregnancy or breastfeeding
- Temperature \> 38 ᵒC
- Recipient of any blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation within the last month
Who the study is looking for
- Age ≥ 18 years
- Seropositive for HIV-1
- Recipient of ART
- Plasma HIV-RNA \< 500 copies/ml
- Patients written consent obtained
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| GCP-enheden ved Københavns Universitetshospital Coordinator of this site? Confirm its status | Frederiksberg | Denmark | Not yet recruiting |
| Hvidovre Hospital Coordinator of this site? Confirm its status | Hvidovre | Denmark | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.