Immunogenicity and Reactogenicity of the 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

NCT05749926 | Unknown Phase 3

• 2 other identifiers: APHP2207752022-002715-38
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this trial is to compare the immunogenicity and the safety of the Beta-variant recombinant protein booster vaccine (VidPrevtyn® Beta, Sanofi) 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. The results will provide important data for the future COVID 19 vaccine strategy. A biobank will also be set up to evaluate the protection conferred by one or other of these vaccines as booster in the event of the emergence of new variants in the future.

Conditions

Vaccine Reaction; COVID-19

Keywords

COVID 19; mRNA vaccines; Immunulogy; Sub-unit vaccine; Booster

Outcome Measures

Primary Outcomes (1)

• Neutralizing antibody titers against the SARS-CoV-2 variant of most prominent public health interest and against one of the variant targeted by the vaccines

  Title : Neutralizing antibody titers against the SARS-CoV-2 variant of most prominent public health interest and against one of the variant targeted by the vaccines Time Frame : 28 Days Description: There will be a coprimary endpoint : Neutralizing antibody titers against the SARS-CoV-2 variant of most prominent public health interest according to pandemic evolution (among D614G, B.1.351, Omicron sub-variants BA.4-5, BQ1.1 and XBB or another recent variant) and against one of the variant targeted by the vaccines. The two variants will be specified in the statistical analysis plan before D28 data base lock. Neutralizing antibody titers will be measured by a microneutralization technique 28 days after the booster dose.

  28 Days

Secondary Outcomes (5)

• Humoral immune response against SARS-CoV-2 variants

  Day0, Day15, Day28, 3 Months, 6 Months and 12 Months

• Number and intensity of local and systemic adverse

  7 and 28 days

• Factors of interest

  Day 0

• Cellular immune response

  Day 0, Day 7, Day 15, Month 3

• Number of Covid 19 cases

  Day 7 up to Month 12

Study Arms (2)

Comirnaty® BNT162b2 /Omicron BA.4-5 vaccine (Pfizer-BioNTech)

ACTIVE COMPARATOR

Length of use : 1 day

Biological: Comirnaty® BNT162b2 /Omicron BA.4-5 vaccine (Pfizer-BioNTech)

VidPrevtyn® Beta vaccine (Sanofi/GSK)

EXPERIMENTAL

Length of use : 1 day

Biological: VidPrevtyn® Beta vaccine (Sanofi/GSK)

Interventions

Comirnaty® BNT162b2 /Omicron BA.4-5 vaccine (Pfizer-BioNTech) BIOLOGICAL

A single administration of COVID-19 vaccine will be performed at D0, depending on randomization

Comirnaty® BNT162b2 /Omicron BA.4-5 vaccine (Pfizer-BioNTech)

VidPrevtyn® Beta vaccine (Sanofi/GSK) BIOLOGICAL

A single administration of COVID-19 vaccine will be performed at D0, depending on randomization

VidPrevtyn® Beta vaccine (Sanofi/GSK)

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
• Adult in a healthy condition or with a stable health status, determined by medical history, targeted physical examination and clinical judgement of the investigator to be in stable state of health. Participants with pre-existing stable chronic medical conditions defined as condition not requiring significant change in therapy or hospitalization for worsening disease within 4 weeks from enrollment can be included at the discretion of the investigator.
• Confirmed receipt of at least three doses of COVID-19 mRNA vaccine the last dose at least 6 months prior to study vaccine
• Understands and agrees to comply with the study procedures
• Written informed consent signed by both the participant and the investigator
• Subject affiliated to the French Social Security System.

You may not qualify if:

• Acute febrile infection (body temperature ≥ 38.0°C) within the previous 72 hours and/or presenting symptoms suggestive of COVID-19 within the previous 28 days
• Confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection \< 3 months prior to the study vaccine dose.
• Any medical condition, such as cancer, that might impair the immune response.
• Use of experimental immunoglobulins, experimental monoclonal antibodies or convalescent plasma is not permitted during the study.
• Pregnancy or breastfeeding currently ongoing
• History of severe adverse events following vaccine administration including anaphylactic reaction and associated symptoms such as rash, breathing problems, angioedema, and abdominal pain, or a history of allergic reaction that could be triggered by a component of the SARS-COV-2 vaccine at the time of the first vaccine injection:
• Any bleeding disorder considered as a contraindication to an intramuscular injection,
• Subject under legal protection (e.g. guardianship)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• IREIVAC/COVIREIVAC Network: collaborator

Study Sites (1)

CIC 1417 Cochin-Pasteur

Paris, 75679, France

Location

MeSH Terms

Conditions

COVID-19

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: March 1, 2023
• Study Start: May 16, 2023
• Primary Completion: July 12, 2023
• Study Completion: July 12, 2024
• Last Updated: June 29, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)