The impact of vaccine platform, age and HIV infection on germinal centre formation.
Key facts
- Where
- Leiden, HollandiaSee the site
- Phase
- 4. fázis
Where in Hollandia
- Leids Universitair Medisch Centrum (LUMC)Leiden, HollandiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Academisch Ziekenhuis Leiden
- Trial code
- EU 2023-510354-16-00
- Record updated
- 2025. január 31.
- Original description
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.Read full original descriptionShow less
Using lymph nOde fine needle aspiration to assess the effeCt of pnEumococcal vAcciNe platform, Age and HIV infection on Germinal cEntre formation (OCEAN-AGE)
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.
Inclusion: 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).
Exclusion: 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; Known hypersensitivity to vaccine components; History of severe nose bleeds; Documented primary immune disorder or primary coagulopathy; 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.