Investigating immune response to different COVID-19 booster vaccines using lymph node aspiration
Lymph Node Aspiration to Decipher the Immune Response of Beta-variant Recombinant Protein Booster Vaccine (VidPrevtyn Beta, Sanofi) Compared to a Bivalent mRNA Vaccine (Comirnaty Original/Omicron BA.4-5, BioNTech-Pfizer) in Adults Previously Vaccinated With at Least 3 Doses of COVID-19 mRNA Vaccine. Ancillary of COVIBOOST 2
This study is testing how well two different COVID-19 booster vaccines help the immune system by looking at lymph nodes in a small group of participants after they get vaccinated.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT05951920 on ClinicalTrials.gov |
What this trial studies
This study aims to analyze the immune response generated by two different COVID-19 booster vaccines: a beta-variant recombinant protein vaccine and a bivalent mRNA vaccine. By performing fine needle aspiration of lymph nodes, researchers will assess the presence of specific germinal center B cells that are crucial for long-term immunity. The study will involve six participants from each vaccine group, with aspirations conducted 3 to 6 weeks post-vaccination. This innovative approach allows for a detailed understanding of how different vaccines mobilize immune memory and adapt to new variants of the virus.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have received at least three doses of a COVID-19 mRNA vaccine.
Not a fit: Patients with hypersensitivity to lidocaine or recurrent porphyrias may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance our understanding of vaccine-induced immunity and inform future COVID-19 vaccination strategies.
How similar studies have performed: While the approach of lymph node aspiration for vaccine response analysis is relatively novel, previous studies have shown promising results in understanding immune responses to vaccines.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female aged 18 years and over included in COVIBOOST 2 Exclusion Criteria: * Hypersensitivity to lidocaine, to anaesthetics of the amide type or to any of the excipients * Patient with recurrent porphyrias
Where this trial is running
Paris
- GH Broca-Cochin-Hôtel-Dieu CIC 1417 Cochin-Pasteur — Paris, France (Recruiting)
Study contacts
- Study coordinator: Odile LAUNAY, Pr
- Email: odile.launay@aphp.fr
- Phone: + 33 1 58 41 27 41
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.