Vidprevtyn (GSK4353001A) / Sanofi, GSK - LARVOL DELTA

A 3-week pause versus continued Bruton tyrosine kinase inhibitor use during COVID-19 vaccination in individuals with chronic lymphocytic leukaemia (IMPROVE trial): a randomised, open-label, superiority trial. (PubMed, Lancet Haematol) - "Although the study was slightly underpowered, the results suggest that pausing BTKi around the time of vaccination is not beneficial for immunity and should not be recommended in clinical practice."

Head-to-Head • Journal • Chronic Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Novel Coronavirus Disease • Oncology • Respiratory Diseases

VAT00008: Study of Monovalent and Bivalent Recombinant Protein Vaccines Against COVID-19 in Adults 18 Years of Age and Older (clinicaltrials.gov) - P3 | N=23726 | Completed | Sponsor: Sanofi Pasteur, a Sanofi Company | Active, not recruiting ➔ Completed | Trial completion date: Jan 2025 ➔ Aug 2024 | Trial primary completion date: Jan 2025 ➔ Aug 2024

Trial completion • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD4

Boosting the cutaneous chronicle of the COVID-19 vaccine: it's not over yet (BAD 2024) - "She was commenced on acitretin (10 mg daily) and intravenous piperacillin-tazobactam to cover for skin impetiginization. Initial skin improvement was slow, but antibiotic-induced pancytopenia and renal impairment precluded a switch to ciclosporin...It is imperative for clinicians to remain vigilant, recognizing that COVID-19 vaccination, while increasingly common, should not falsely reassure based on a negative history of numerous COVID vaccines in the past. Thoroughly assessing vaccination history is essential in clinical practice."

Dermatology • Hematological Disorders • Immunology • Infectious Disease • Novel Coronavirus Disease • Psoriasis • Pustular Psoriasis • Renal Disease • Respiratory Diseases

Analysis of Allergy and Hypersensitivity Reactions to COVID-19 Vaccines According to the EudraVigilance Database. (PubMed, Life (Basel)) - "The overall frequency of potential serious allergic reactions to COVID-19 is very rare. Therefore, COVID-19 vaccines seem to be safe for human use. The lowest frequency of allergic reaction was observed for Comirnaty and the highest for Vaxzevria."

Journal • Allergy • Immunology • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

VAT00002: Study of Recombinant Protein Vaccines With Adjuvant as a Primary Series and as a Booster Dose Against COVID-19 in Adults 18 Years of Age and Older (clinicaltrials.gov) - P2/3 | N=3385 | Completed | Sponsor: Sanofi Pasteur, a Sanofi Company | Active, not recruiting ➔ Completed | Trial completion date: Jul 2024 ➔ Jun 2023 | Trial primary completion date: Jul 2024 ➔ Jun 2023

Trial completion • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD4

Effectiveness of the Sanofi/GSK (VidPrevtyn Beta) and Pfizer-BioNTech (Comirnaty Original/Omicron BA.4-5) bivalent vaccines against hospitalisation in England. (PubMed, EClinicalMedicine) - "The finding that the adjuvanted vaccine targeting the distant Beta strain had similar effectiveness to the bivalent mRNA vaccine targeting more closely matched Omicron sub-lineages is notable and highlights the need for further real-world studies into the effectiveness of vaccines from different vaccine platforms and formulations in the presence of matched and unmatched strains. No external funding."

Journal • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases

Efficacy of a monovalent (D614) SARS-CoV-2 recombinant protein vaccine with AS03 adjuvant in adults: a phase 3, multi-country study. (PubMed, EClinicalMedicine) - P3 | "This study was funded in whole or in part by Sanofi and by federal funds from the Biomedical Advanced Research and Development Authority, part of the office of the Administration for Strategic Preparedness and Response at the U.S. Department of Health and Human Services under contract number HHSO100201600005I, and in collaboration with the U.S. Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense under contract number W15QKN-16-9-1002. The views presented here are those of the authors and do not purport to represent those of the Department of the Army, the Department of Health and Human Services, or the U.S. government."

Journal • P3 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Efficacy of a bivalent (D614 + B.1.351) SARS-CoV-2 recombinant protein vaccine with AS03 adjuvant in adults: a phase 3, parallel, randomised, modified double-blind, placebo-controlled trial. (PubMed, Lancet Respir Med) - P3 | "The bivalent variant vaccine conferred heterologous protection against symptomatic SARS-CoV-2 infection in the epidemiological context of the circulating contemporary omicron variant. These findings suggest that vaccines developed with an antigen from a non-predominant strain could confer cross-protection against newly emergent SARS-CoV-2 variants, although further investigation is warranted."

Journal • P3 data • Allergy • Cardiovascular • CNS Disorders • Hematological Disorders • Immunology • Infectious Disease • Inflammation • Novel Coronavirus Disease • Respiratory Diseases • Thrombocytopenia • Thrombosis

Safety and immunogenicity of a variant-adapted SARS-CoV-2 recombinant protein vaccine with AS03 adjuvant as a booster in adults primed with authorized vaccines: a phase 3, parallel-group study. (PubMed, EClinicalMedicine) - P2/3 | "Adults, previously primed with mRNA (BNT162b2, mRNA-1273), adenovirus-vectored (Ad26.CoV2.S, ChAdOx1nCoV-19) or protein (CoV2 preS dTM-AS03 [monovalent D614; MV(D614)]) vaccines were enrolled between 29 July 2021 and 22 February 2022. CoV2 preS dTM-AS03 boosters demonstrated acceptable safety and elicited robust neutralizing antibodies against multiple variants, regardless of priming vaccine. Sanofi and Biomedical Advanced Research and Development Authority (BARDA)."

Journal • P3 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

"Hey, how about an XBB version of your Vidprevtyn vaccine?" (@RolandSB13)

Clinical

LymphoBOOST: 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. (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: Assistance Publique - Hôpitaux de Paris

New P1 trial • Infectious Disease • Novel Coronavirus Disease • IGH

LymphoBOOST: 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. (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: Assistance Publique - Hôpitaux de Paris | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Novel Coronavirus Disease • IGH

CoviBOOST 2: 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 (clinicaltrials.gov) - P3 | N=248 | Active, not recruiting | Sponsor: Assistance Publique - Hôpitaux de Paris | Recruiting ➔ Active, not recruiting

Enrollment closed • Head-to-Head • Infectious Disease • Novel Coronavirus Disease • CD4 • CD8 • IL2

"My Dad collapsed and died suddenly today, less than 48hrs after having a COVID booster @sanofi #VidPrevtyn" (@h11725916)

Novel Coronavirus Disease

CoviBOOST 2: 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 (clinicaltrials.gov) - P3 | N=236 | Recruiting | Sponsor: Assistance Publique - Hôpitaux de Paris | Not yet recruiting ➔ Recruiting

Enrollment open • Head-to-Head • Infectious Disease • Novel Coronavirus Disease • CD4 • CD8 • IL2

"So ist es, Vidprevtyn Beta ein weiterer hervorragender Impfstoff (nicht mRNA) v .@sanofi, den ich als 5/5 vor 14 Tagen erhielt. Es geht blendend." (@padrealex)

"Hab neulich Vidprevtyn bekommen; u.a. deshalb, weil kein Wildtyp mehr enthalten ist" (@Sebastian_hurra)

"Gratuliere! 5. kommt jetzt, nach 4 "traditionellen" Impfungen [ohne mRNA] bis heute alles bestens, und die 5. wird Vidprevtyn Beta v .@sanofi" (@padrealex)

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: A non-inferiority multicenter single-blinded, randomized trial (clinicaltrialsregister.eu) - P4 | N=236 | Ongoing | Sponsor: Assistance Publique – Hôpitaux de Paris (AP-HP)

Head-to-Head • New P4 trial • Infectious Disease • Novel Coronavirus Disease • CD4 • CD8 • IL2

"VidPrevtyn Beta" (@GK09887)

CoviBOOST 2: 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 (clinicaltrials.gov) - P3 | N=236 | Not yet recruiting | Sponsor: Assistance Publique - Hôpitaux de Paris

Head-to-Head • New P3 trial • Infectious Disease • Novel Coronavirus Disease • CD4 • CD8 • IL2

VAT00002: Study of Recombinant Protein Vaccines With Adjuvant as a Primary Series and as a Booster Dose Against COVID-19 in Adults 18 Years of Age and Older (clinicaltrials.gov) - P2/3 | N=3385 | Active, not recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Trial completion date: Jul 2023 ➔ Jul 2024 | Trial primary completion date: Jul 2023 ➔ Jul 2024

Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD4

VAT00008: Study of Monovalent and Bivalent Recombinant Protein Vaccines Against COVID-19 in Adults 18 Years of Age and Older (clinicaltrials.gov) - P3 | N=23726 | Active, not recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Trial completion date: Jun 2024 ➔ Jan 2025 | Trial primary completion date: Jun 2024 ➔ Jan 2025

Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD4

"VidPrevtyn ist monovalent (Beta): https://t.co/b9zQLodFDo" (@Papa_impft)

"4⃣ Le VidPrevtyn, vaccin de @sanofi et de @GSK contre le Covid-19, n’est toujours pas disponible en pharmacie 💉 https://t.co/SrZpxVSvIO" (@usinenouvelle)

Infectious Disease • Novel Coronavirus Disease