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Tests treatment safety and results for Hiv
Official title Safety and Immunogenicity Following Meningococcal and Pneumococcal Immunization Among Adult People Living With HIV
ClinicalTrials.gov ID: NCT04875819
What this study is testing
What is Neisseria meningitidis oligosaccharide conjugate vaccine and recombinant protein-based vaccine?
Neisseria meningitidis oligosaccharide conjugate vaccine and recombinant protein-based vaccine is an investigational medicine, being studied as a potential treatment for hiv.
Also referred to as Menveo® and Bexsero®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years
- Seropositive for HIV-1
- Recipient of ART
- Plasma HIV-RNA \< 500 copies/ml
- Patients written consent obtained
You likely can't join if
- 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
See the full eligibility criteria
- Age ≥ 18 years
- Seropositive for HIV-1
- Recipient of ART
- Plasma HIV-RNA \< 500 copies/ml
- Patients written consent obtained
- 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.)
The study team makes the final eligibility decision.
Where it's taking place
- Hvidovre, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hvidovre, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.