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.

COVID-19 Clinical Trial

— LymphoBOOST  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05951920
• Other study ID #: APHP230684
• Secondary ID: 2023-A01335-40
• Status: Recruiting
• Phase: Early Phase 1
• Start date: July 5, 2023
• Est. completion date: September 2023

Study information

• Verified date: July 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Odile LAUNAY, Pr
• Phone: + 33 1 58 41 27 41
• Email: odile.launay[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In order to investigate whether a germinal center response occurs following vaccine boost and to characterize it based on the type of vaccine received, we aim to analyze Spike and/or RBD-specific germinal center B cells within the draining lymph nodes.

To achieve this, we will perform lymph node fine needle aspiration of the draining lymph node in 6 subjects in each study arm, 3 to 6 weeks after the booster vaccine injection.

Description:

Lymph nodes are secondary lymphoid organs essential for the establishment of the germinal center reaction, allowing the generation of long-lived B cell memory and high-affinity antibodies. In order to investigate whether a germinal center response occurs following vaccine boost and to characterize it based on the type of vaccine received, we aim to analyze Spike and/or RBD-specific germinal center B cells within the draining lymph nodes. Accessing germinal center through fine needle aspirations under ultrasound guidance has recently emerged as an innovative strategy in the United States to investigate vaccine response. This procedure under local anesthesia is well-tolerated, and no major side effects have been reported in a hundred patients who underwent fine needle aspiration. The technical details for performing this examination are now well-described.

Our previous work has highlighted the importance of repertoire diversity in responding to new variants of SARS-CoV-2. We thus aim to investigate whether a booster dose with mRNA or protein-based vaccine mobilizes memory B cells or naive cells, thereby contributing to a greater diversity of the Memory B cell comportment. To preserve the diversity of the memory B cell pool is absolutely essential for our immune system to adapt against variants.

To achieve this, we will perform lymph node fine needle aspiration of the draining lymph node in 6 subjects in each study arm, 3 to 6 weeks after the booster vaccine injection. Indeed, it has been shown that the response of germinal centers in response to a booster vaccination was detectable at 2- and 8-weeks post-injection vaccination.

This outpatient procedure will be performed by a radiologist under ultrasound guidance, aiming to collect 4 fine needle aspirations from 4 axillary draining lymph nodes under local anesthesia. Concurrently, a 35 mL blood sample will be collected from the subject to correlate the response in secondary lymphoid organs with the circulating response.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: September 2023
• Est. primary completion date: July 22, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Procedure:
• Lymph node aspiration / Blood sampling
Lymph node aspiration / Blood sampling

Locations

Country	Name	City	State
France	GH Broca-Cochin-Hôtel-Dieu CIC 1417 Cochin-Pasteur	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Spike and/or RBD-specific germinal center B cell response	As part of an ancillary study of COVIBOOST2 to analyse the percentage of Hu-1, Delta or Omicron Spike and RBD-specific germinal center B cells in draining lymph nodes 3-8 weeks after the Beta-variant recombinant protein booster vaccine (VidPrevtyn®Beta, Sanofi) or the 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, the last dose received at least 6 months prior the inclusion in the study.	Day 1
Primary	The Spike and/or RBD-specific germinal center B cell repertoire	As part of an ancillary study of COVIBOOST2 to analyse the percentage of Hu-1, Delta or Omicron Spike and RBD-specific germinal center B cells in draining lymph nodes 3-8 weeks after the Beta-variant recombinant protein booster vaccine (VidPrevtyn®Beta, Sanofi) or the 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, the last dose received at least 6 months prior the inclusion in the study.	Day 1
Secondary	The repertoire of the cellular germinal center B immune response in the two arms.	To determine the number of somatic hypermutations in the immunoglobulin heavy chain of each single Hu-1, Delta or Omicron Spike/RBD-specific germinal center cells. To determine the number of clonal relationships between Spike/RBD- specific germinal center B cells in draining lymph nodes with memory B cells in peripheral blood.	Day 1