2023-510354-16-00RecruitingPhase 4
The impact of vaccine platform, age and HIV infection on germinal centre formation.
Using lymph nOde fine needle aspiration to assess the effeCt of pnEumococcal vAcciNe platform, Age and HIV infection on Germinal cEntre formation (OCEAN-AGE)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 31 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The primary objective of the trial will be to compare germinal centre formation after pneumococcal vaccination between different populations (health young vs healthy older adults; healthy young vs people living with HIV) as well as between different vaccine platforms.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 75 (estimated)
- First submitted
- 3 Oct 2024
- Start date
- 6 Mar 2025
- Lead sponsor
- Academisch Ziekenhuis Leiden
- Diseases
- HIV
- EU CT number
- 2023-510354-16-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 75
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for generally healthy adults aged 20-40 or over 60, and adults aged 20-40 living with HIV whose virus is controlled by treatment.
- Age
- 20 - 40 years, or over 60 years (HIV group: 20 - 40 years)
- Sex
- Men and women can join.
- Disease stage
- HIV group: documented HIV infection with the virus under control (HIV copies < 200/ml).
- Earlier treatment
- HIV group: must be on active anti-retroviral therapy. No earlier pneumococcal vaccination and no earlier pneumococcal infection.
- Biomarker or test result
- HIV group: HIV copies < 200/ml.
Main reasons for not taking part
- Pregnancy at time of inclusion, or breastfeeding during the study
- Use of immunosuppressive medication
- Use of blood thinners such as DOACs or vitamin K antagonists
- Known hypersensitivity to vaccine components
- A primary immune disorder or primary coagulopathy
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of immunosuppressive medication
- Use of direct acting anticoagulant drugs (DOACs) or vitamin K antagonists
- Recent (past month) surgery in axillar area or major surgery elsewhere
- Chronic nasal corticosteroid use (> 3 months)
- Vaccination < 1 month before inclusion
- Prior documented pneumococcal vaccination
- Prior pneumococcal infection
Other illness
- Known hypersensitivity to vaccine components
- History of severe nose bleeds
- Documented primary immune disorder or primary coagulopathy
Other
- Pregnancy at time of inclusion
- Fever at time of inclusion
- Inability to provide informed consent
- Inability to visit the LUMC for study procedures.
- Breastfeeding during the course of the study
Who the study is looking for
- Age between 20 - 40 years or age > 60 years.
- Generally Healthy
- For PLWH group: aged 20 - 40 years, with documented HIV infection on active anti-retroviral therapy resulting in viral supression ( HIV copies < 200/ml)
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Leids Universitair Medisch Centrum (LUMC) | Leiden | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.