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.

NCT05951920 | Completed

• 2 other identifiers: APHP2306842023-A01335-40
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19

Keywords

COVID 19; mRNA vaccines; Immunology; Sub-unit vaccine; Booster; lymph nod; memory B cell

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• The repertoire of the cellular germinal center B immune response in the two arms.

  Day 1

Study Arms (1)

Lymph node aspiration / Blood sampling

EXPERIMENTAL

Procedure: Lymph node aspiration / Blood sampling

Interventions

Lymph node aspiration / Blood sampling PROCEDURE

Lymph node aspiration / Blood sampling

Lymph node aspiration / Blood sampling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged 18 years and over included in COVIBOOST 2

You may not qualify if:

• Hypersensitivity to lidocaine, to anaesthetics of the amide type or to any of the excipients
• Patient with recurrent porphyrias

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

GH Broca-Cochin-Hôtel-Dieu CIC 1417 Cochin-Pasteur

Paris, 75679, France

Location

MeSH Terms

Conditions

COVID-19

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: July 19, 2023
• Study Start: July 5, 2023
• Primary Completion: July 22, 2023
• Study Completion: July 22, 2023
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)