NCT04875819 Safety and Immunogenicity Following Meningococcal and Pneumococcal Immunization Among Adult People Living With HIV
| NCT ID | NCT04875819 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Thomas Benfield |
| Condition | Hiv |
| Study Type | INTERVENTIONAL |
| Enrollment | 55 participants |
| Start Date | 2021-04-28 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 55 participants in total. It began in 2021-04-28 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.)
Contact & Investigator
Michaela Tinggaard, M.D.
PRINCIPAL INVESTIGATOR
Department of Infectious Diseases, Hvidovre Hospital
Frequently Asked Questions
Who can join the NCT04875819 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hiv. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04875819 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04875819 currently recruiting?
Yes, NCT04875819 is actively recruiting participants. Contact the research team at michaela.tinggaard@regionh.dk for enrollment information.
Where is the NCT04875819 trial being conducted?
This trial is being conducted at Hvidovre, Denmark.
Who is sponsoring the NCT04875819 clinical trial?
NCT04875819 is sponsored by Thomas Benfield. The principal investigator is Michaela Tinggaard, M.D. at Department of Infectious Diseases, Hvidovre Hospital. The trial plans to enroll 55 participants.
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