Vaccination safety and immune response in adults with HIV
Safety and Immunogenicity Following Meningococcal and Pneumococcal Immunization Among Adult People Living With HIV: A Single Center, Non-blinded, Randomized Clinical Trial
This study is testing how safe and effective meningococcal and pneumococcal vaccines are for adults with HIV who are on treatment.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 55 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hvidovre University Hospital Academic / other |
| Locations | 1 site (Hvidovre) |
| Trial ID | NCT04875819 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the safety and immunogenicity of meningococcal and pneumococcal vaccinations in adults living with HIV who are on antiretroviral treatment. Participants are randomly assigned to receive either a two-dose regimen of Menveo® and Bexsero® or a prime-boost regimen of Prevenar13® and Pneumovax23®. They will be monitored for immune response through blood samples and adverse events over a five-year period. The study aims to determine the effectiveness of these vaccines in this specific population.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are HIV-1 positive and receiving antiretroviral therapy with controlled viral loads.
Not a fit: Patients who are pregnant, have a history of meningococcal or pneumococcal vaccination, or have active infections or certain health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance vaccination strategies for adults living with HIV, potentially improving their health outcomes.
How similar studies have performed: While there is ongoing research in this area, this specific approach to vaccination in adults with HIV is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.)
Where this trial is running
Hvidovre
- Hvidovre Hospital — Hvidovre, Denmark (Recruiting)
Study contacts
- Principal investigator: Michaela Tinggaard, M.D. — Department of Infectious Diseases, Hvidovre Hospital
- Study coordinator: Michaela Tinggaard, M.D.
- Email: michaela.tinggaard@regionh.dk
- Phone: 22326800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.