Delving into the Latest Updates on SARS-CoV-2 vaccine (Sanofi Pasteur) with Synapse

Overview

Basic Info

Drug Type

Prophylactic vaccine

Synonyms-

Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesRespiratory DiseasesOther Diseases

Active Indication-

Inactive Indication

COVID-19Severe Acute Respiratory Syndrome

Originator Organization

Sanofi Pasteur

Active Organization-

Inactive Organization

GSK Plc

Sanofi Pasteur

Drug Highest PhasePendingPhase 1/2

First Approval Date-

Regulation-

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The primary objectives of the study were:
To describe the neutralizing antibody profile at Day 1, Day 22, and Day 36 of each study intervention group.
To describe the safety profile of all participants in each age group and each study intervention group up to 12 months post-last injection.
The secondary objectives of the study are:
To describe binding antibody profile at Day 1, Day 22, Day 36, Day 181 (Cohort 1) or Day 202 (Cohort 2), and Day 366 (Cohort 1) or Day 387 (Cohort 2) of each study intervention group.
To describe the neutralizing antibody profile at Day 181 (Cohort 1) or Day 202 (Cohort 2) and at Day 366 (Cohort 1) and Day 387 (Cohort 2) of each study intervention group.
To describe the occurrence of virologically-confirmed coronavirus disease (COVID-19)-like illness and serologically-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
To evaluate the correlation / association between antibody responses to SARS-CoV-2 Recombinant Protein and the risk of virologically-confirmed COVID-19-like illness and/or serologically-confirmed SARS-CoV-2 infection.

Start Date03 Sep 2020

Sponsor / Collaborator

Sanofi Pasteur

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100 Clinical Results associated with SARS-CoV-2 vaccine (Sanofi Pasteur)

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100 Translational Medicine associated with SARS-CoV-2 vaccine (Sanofi Pasteur)

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100 Patents (Medical) associated with SARS-CoV-2 vaccine (Sanofi Pasteur)

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2,310

Literatures (Medical) associated with SARS-CoV-2 vaccine (Sanofi Pasteur)

31 Dec 2025·Expert Review of Vaccines

Sustained immunogenicity of bivalent protein COVID-19 vaccine SCTV01C against antigen matched and mismatched variants

Article

Author: Dai, Yuyang ; Zhao, Xiuli ; Wang, Qian ; Ren, Yanping ; Xie, Liangzhi ; Fu, Yongpan ; Shi, Rui ; Zhang, Miaomiao ; Cui, Yimin ; Liang, Yufei ; Liu, Dongfang ; Tian, Qingyun ; Zhao, Kexin ; Wang, Yanchao ; Hu, Zhongyu ; Chen, Zhisong ; Ni, Siyang ; Xie, Zekang ; Zhao, Xuedan ; He, Peng ; Yang, Xinjie ; Wang, Guiqiang ; Han, Ying ; Li, Yanhua ; Zhang, Yun ; Pan, Jing ; Zhang, Chao ; Zhang, Tianzuo ; Li, Jing

BACKGROUNDThe development of bivalent or multivalent vaccines offers a promising strategy for combating SARS-CoV-2 mutations.RESEARCH DESIGN AND METHODSIn this phase 2 trial, conducted from 1 December 2021, to 25 July 2023, 392 unvaccinated adults aged ≥18 years were randomized to receive a primary series of two doses and a booster dose of SCTV01C, a bivalent protein SARS-CoV-2 vaccine.RESULTSGeometric mean titers (GMTs) of neutralizing antibodies (nAb) against live Alpha, Beta, Delta, and Omicron showed 85.4-, 100.0-, 32.1-, and 9.8-fold increase from baseline on 28 days, and 49.4-, 55.3-, 5.7-fold increase against live Alpha, Beta, and Omicron on 90 days after primary series. At Day 28 and Day 90 following the booster dose, GMTs of nAb against Beta, BA.2 and BA.5 variants showed 12.1- and 8.8-, 13.8- and 7.1-, 18.7-, and 11.9-fold of increase from baseline, respectively. Reactogenicity was generally mild, with one adverse event of special interest (AESI) and 9 ≥Grade 3 treatment-related adverse events (TRAEs); all recovered within 3 days.CONCLUSIONSSCTV01C, when administered as both a primary series and a booster vaccination, exhibited encouraging sustained immunogenicity against both antigen-matched and antigen-mismatched variants, with no significant safety concerns.CLINICAL TRIAL REGISTRATIONwww.clinicaltrials.gov identifier is NCT05148091.

01 Apr 2025·The Laryngoscope

Neighborhood Socioeconomic Disadvantage Increases Risk of Severe Acute Respiratory Syndrome Coronavirus 2‐Mediated Otologic Dysfunction

Article

Author: Harris, Jeffrey P. ; Matsuoka, Akihiro ; Baker, Omer ; Kocharian, Elida ; Moshtaghi, Omid ; Naugle, Kendyl ; de Cos, Víctor ; Dixon, Peter R.

ObjectivesWe aim to use the Area Deprivation Index (ADI) to investigate the correlations between neighborhood socioeconomic disadvantage (NSD), SARS‐CoV‐2 vaccination rates, infection severity, and subsequent audiovestibular symptoms.MethodsIn this retrospective cohort study, surveys were administered to participants ≥18 years of age who received a SARS‐CoV‐2 vaccination and/or tested positive for SARS‐CoV‐2 infection between January 2020 and September 2022. ADI scores were calculated for each patient to quantify NSD. Statistical analyses were performed to compare demographic and clinical characteristics between ADI quintiles.ResultsOf 2415 participants, the majority were female (62.8%) and White (87%), with a mean age of 60.8 years. Individuals in ADI Quintile 5 were less likely to receive second booster doses than those in Quintile 1 (58% vs. 71%, p < 0.0001). Among those infected with SARS‐CoV‐2, those in ADI Quintile 5 were 2.5 times more likely to be hospitalized (relative risk = 2.46, 95% confidence interval [1.03, 5.88]) than those in Quintile 1. Symptoms more likely to be experienced by participants in ADI Quintile 5 than those in Quintile 1 immediately following SARS‐CoV‐2 infection included headaches (28% vs. 21%, p = 0.02), aural fullness (14% vs. 6%, p < 0.0001), change of hearing (8% vs. 4%, p = 0.01), dizziness (15% vs. 8%, p < 0.01), and otalgia (8% vs. 4%, p < 0.01).ConclusionsIndividuals experiencing greater NSD were found to have lower SARS‐CoV‐2 vaccine booster rates, higher rates of postinfection hospitalization, and increased rates of certain otologic and neurotologic symptoms following infection.Level of Evidence3 Laryngoscope, 135:1472–1477, 2025

01 Mar 2025·High Altitude Medicine & Biology

Death Risk Response of High-Altitude Resident Populations to COVID-19 Vaccine: A Retrospective Cohort Study

Article

Author: Vásquez-Velásquez, Cinthya ; Gonzales, Gustavo F. ; Fano-Sizgorich, Diego

Vásquez-Velásquez, Cinthya, Diego Fano-Sizgorich, and Gustavo F Gonzales. Death risk response of high-altitude resident populations to COVID-19 vaccine: Retrospective cohort study. High Alt Med Biol. 00:00-00, 2024. Background: Peru had one of the highest mortality rates caused by the coronavirus disease 2019 (COVID-19) pandemic worldwide. Vaccination significantly reduces mortality. However, the effectiveness of vaccination might differ at different altitudinal levels. The study aimed to evaluate the effect modification of altitude on the association between vaccination and COVID-19 mortality in Peru. Methodology: A retrospective cohort, using open access databases of deaths, COVID-19 cases, hospitalizations, and vaccination was obtained from the Peruvian Ministry of Health. Deaths due to COVID-19 were evaluated in vaccinated and nonvaccinated patients. Crude (RR) and adjusted relative risks (aRR) were calculated using generalized linear models of Poisson family with robust variances. Models were adjusted for age, sex, pandemic wave, and Human Development Index. To evaluate the interaction by altitude, a stratified analysis by this variable was performed. The variable altitude was categorized as, 0-499 m (828,298 cases), 500-1,499 m (64,735 cases), 1,500-2,499 m (106,572 cases), and ≥2,500 m (179,004 cases). The final sample studied included 1,362,350 cases. Results: The vaccine showed a considerable reduction of death risk with the second (aRR: 0.41, 95% confidence interval [CI]: 0.38-0.44) and third doses (aRR: 0.21, 95% CI: 0.20-0.23). In the adjusted and interaction model, it can be observed that medium and high altitude present a higher risk of death compared to sea level (aRR: 2.58 and 2.03, respectively). Likewise, the two doses' group presents an aRR:1.22 for medium altitude (1,500-2,499 m) and 1.6 for high altitude (≥2,500 m), compared with low-altitude population, suggesting that the action of vaccination at high altitude is altered by the effect of the altitude itself. Conclusions: Altitude might modify the protective effect of SARS-CoV-2 vaccine against COVID-19 death.

100 Deals associated with SARS-CoV-2 vaccine (Sanofi Pasteur)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
COVID-19	Phase 2	United States	Sanofi Pasteur	03 Sep 2020
COVID-19	Phase 2	United States	GSK Plc	03 Sep 2020
Severe Acute Respiratory Syndrome	Phase 2	United States	Sanofi Pasteur	03 Sep 2020
Severe Acute Respiratory Syndrome	Phase 2	United States	GSK Plc	03 Sep 2020

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ARVO2023	Not Applicable	Retinal Vascular Occlusion	1,250	BNT162b2(Pfizer-BioNTech)	(ujnkgsmccs) = yrjuwzxmwz rnjtyldpbu (xnuynwhucp )	Positive	01 Jun 2023
				SARS-CoV-2 vaccine (mRNA-1273(Moderna))	(ujnkgsmccs) = rizwvpmdtx rnjtyldpbu (xnuynwhucp )
BNT162b2 (EASL2022)	Not Applicable	Liver transplant rejection Spike-protein (S) \| Nucleocapsid-protein (N)	80	SARS-CoV-2 vaccine (Liver Transplant recipients)	(mtjesosrqy) = rmcpzcnxhb lwlpfuypeg (qujrccboug ) View more	Positive	25 Jun 2022
				SARS-CoV-2 vaccine (Control group)	(pncuoxbdcw) = hlbjitsoje ntiftusovi (dksrnaikux )
Nor-vaC study (EULAR2022)	Not Applicable	Inflammation	-	SARS-CoV-2 vaccines (IMID patients using immunosuppressive medication)	(gcphnktiea) = okiqhvgcfr fxmofblkfq (akoidljngy, 500 - 5062)	-	01 Jun 2022
				SARS-CoV-2 vaccines (Healthy controls)	(gcphnktiea) = esiqctuhvn fxmofblkfq (akoidljngy, 2528 - 9580)
ASN2021	Not Applicable	Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis	-	SARS-CoV-2 Vaccine (BNT162b2)	yznaznoyxt(ywgbgitsrr) = Vaccine associated side effects occurred in 27% of patients after 1st dose, with 39% after the 2nd dose peutwhvcxr (usqiyvbepn )	Negative	27 Oct 2021
				SARS-CoV-2 Vaccine (mRNA-1273)
EULAR2021	Not Applicable	Musculoskeletal Diseases	830	SARS-COV-2 Vaccine (Patients with RMDs)	(ltywqunijb): OR = 11.3 (95% CI, 8 - 15.9) View more	-	02 Jun 2021
				SARS-COV-2 Vaccine (Healthy controls)