Vaccination safety and immune response in adults with HIV

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.