Delving into the Latest Updates on Typhoid Vi polysaccharide vaccine(Sanofi) with Synapse

Overview

Basic Info

Drug Type

Inactivated vaccine, Prophylactic vaccine

Synonyms

Purified Vi Polysaccharide Typhoid Vaccine, Typhoid vaccine Vi polysaccharide

+ [2]

Target-

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesOther Diseases

Active Indication

Typhoid Fever

Inactive Indication

Depressive Disorder, MajorEncephalitis, JapaneseMeningitis, Meningococcal+ [2]

Originator Organization

Sanofi

Active Organization

Sanofi PasteurSanofi KK

Inactive Organization

GSK PlcNovartis Pharma AGJanssen Pharmaceutical Unlimited Co.

Drug Highest PhaseApproved

First Approval Date

US (04 Feb 2000),

Typhoid Fever

Regulation-

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Iron deficiency (ID) anemia (IDA) is a global public health problem, with the highest prevalence in Africa. Vaccines often underperform in low- and middle- income countries (LMIC), and undernutrition, including ID, likely plays a role. Recent studies have shown the importance of iron status in vaccine response. Intravenous iron given at time of vaccination improved response to yellow fever and COVID-19 vaccines in IDA Kenyan women. Whether oral iron treatment would have a similar beneficial effect on vaccine response is uncertain. Also, timing of oral iron treatment needs further investigation.
The co-primary objectives of this study are to assess 1) whether IDA in Kenyan women impairs vaccine response, and whether oral iron treatment improves their response; 2) the timing of oral iron treatment to improve vaccine response (prior to vaccination vs at time of vaccination).
We will conduct a double-blind randomized controlled trial in southern Kenya to assess the effects of iron supplementation on response to three single-shot vaccines: Johnson & Johnson COVID- 19 (JJ COVID-19), the quadrivalent meningococcal vaccine (MenACWY) and the typhoid Vi polysaccharide vaccine (Typhim Vi). Women with IDA will be recruited and randomly assigned to three study groups: group 1 (pre- treatment) will receive 100 mg oral iron as ferrous sulfate (FeSO4) daily on days 1-56; group 2 (simultaneous treatment) will receive matching placebo daily on days 1-28, and 200 mg oral iron as FeSO4 daily on days 29-56; and group 3 (control) will receive matching placebo daily on days 1-56. Women in all groups will receive the JJ COVID-19 vaccine, the MenACWY and the Typhim Vi vaccine on day 28. Cellular immune response and serology will be measured at 28 days after vaccination in all groups.

Start Date01 Jul 2023

Sponsor / Collaborator

Jomo Kenyatta University of Agriculture & Technology

[+2]

NCT05346302 / CompletedEarly Phase 1IIT

Persistent Readiness Through Early Prediction Immunization Study

This study will enroll volunteers in an open-format (outside hospital) setting, to complete novel data collection/analysis of biomarkers, facial images, and audio-recording to establish an optimal set of parameters to predict emergent cases of infection via an early warning score, along with actionable personalized information.

Start Date08 Feb 2022

Sponsor / Collaborator

Texas A&M University

[+1]

ACTRN12621001059853 / Active, not recruitingPhase 4IIT

Evaluating Vi-polysaccharide vaccine responses in specific antibody deficiency patients receiving immunoglobulin replacement.

Start Date18 Jan 2022

Sponsor / Collaborator-

100 Clinical Results associated with Typhoid Vi polysaccharide vaccine(Sanofi)

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100 Translational Medicine associated with Typhoid Vi polysaccharide vaccine(Sanofi)

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100 Patents (Medical) associated with Typhoid Vi polysaccharide vaccine(Sanofi)

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305

Literatures (Medical) associated with Typhoid Vi polysaccharide vaccine(Sanofi)

31 Dec 2024·Human Vaccines & Immunotherapeutics

Safety and immunogenicity of conjugate vaccine for typhoid (Vi-DT): Finding from an observer-blind, active-controlled, randomized, non-inferiority, phase III clinical trial among healthy volunteers

Article

Author: Tamrakar, Rajendra ; Gupta, Birendra Prasad ; Khadgi, Amit ; Tamrakar, Dipesh ; Shrestha, Anmol ; Rai, Ganesh Kumar ; Saluja, Tarun ; Thapa, Pragya ; Poudel, Pranodan ; Madhup, Surendra ; Singh, Srijana ; Shrestha, Rajeev ; Sahastrabuddhe, Sushant ; Thapa, Sameera

Typhoid fever is a significant public health concern with most of the sufferers between 15 and 25 y of age in Nepal. We undertook this study to demonstrate Vi polysaccharide conjugated with diphtheria toxoid (Vi-DT) conjugate vaccine which is non-inferior to Typbar typhoid conjugate vaccine, a Vi polysaccharide vaccine conjugated with tetanus toxoid (Vi-TT) with a focus on the adult population from Dhulikhel Hospital which was one of the total four sites in Nepal. In this study, we assigned the eligible participants in 1:1:1:1 ratio by block randomization, and stratified into three age groups (6 months to less than 2 y, 2 y to less than 18 y, and 18 y to 45 y), allotted to Group A, B, C, and D. Group A, B, and C received 25 μg (0.5 mL) of Vi-DT study vaccine and participants in Group D received 25 μg (0.5 mL) Vi-TT vaccine. We descriptively analyzed safety in all the participants receiving one dose of the investigational vaccine. The anti-Vi-IgG seroconversion rate in Vi-DT recipients was 99.71% (97.5% CI 98.04-99.96; 344 of 345 participants) and 99.13% (94.27-99.87; 114 of 115) in Vi-TT recipients which indicates that Vi-DT vaccine is non-inferior to Vi-TT vaccine. In safety aspect, 16.81% of total subject had at least one solicited adverse reaction and 22.61% of the Vi-TT participants experienced at least one solicited adverse reaction with most of them being local adverse reactions. None of the enrolled participants reported serious adverse events. Our study shows that a single dose of the Vi-DT vaccine is immunogenic, safe to administer and non-inferior to the Vi-TT vaccine four weeks after vaccination.

01 Dec 2024·Vaccine

A randomized, triple-blinded, placebo-controlled clinical trial evaluating immune responses of Typhim Vi and PPSV23 vaccines in healthy adults: The PREP study

Article

Author: McFarlane, Daniel ; Deutz, Nicolaas E.P. ; Engelen, Mariёlle P K J ; Deutz, Nicolaas E P ; Silva, Ikaro ; Conroy, Bryan ; Ruebush, Laura E. ; Ruebush, Laura E ; Mariani, Sara ; Cote, Gerard L. ; Damiano, Robert J. ; Engelen, Mariёlle P.K.J. ; Liu, Luoluo ; Borhani, Soheil ; Wang, Chunxue ; Cote, Gerard L ; Damiano, Robert J

Rapid and early identification of emergent infections is essential for delivering prompt clinical care. To advance the development of algorithms for the clinical management of infection identification, we performed a vaccination clinical trial to investigate the potential of using vaccination as a model for studying mild inflammation responses associated with different infections (NCT05346302). We collected data at various time points over 4 weeks from blood samples, wearable devices, and questionnaires. Following a 2-week baseline period, 210 healthy participants, aged 18-40 years, were administered either a Pneumococcal Polysaccharide vaccine (PPSV23), Typhoid Vi Polysaccharide vaccine (Typhim Vi), or placebo. In longitudinal analyses of blood biomarkers, we found that CRP was significantly higher at 2 days post-vaccination, whereas basophils, IL-10, IL-12p40, and MIG were significantly higher at 7 days post-vaccination in the PPSV23 group compared to both other groups (all p < 0.05). MIP-1β was significantly lower in the PPSV23 group than in the placebo group, while monocytes and MPV were significantly lower in the Typhim Vi group than in the placebo group at 7 days post-vaccination (all p < 0.05). The PPSV3 group showed a higher inflammatory profile, suggesting that PPSV23 induces a stronger immune response compared to Typhim Vi. The distinct immune responses induced by the two vaccines indicate the potential for utilizing vaccines as models for studying inflammation responses associated with different infectious pathogens.

01 Jun 2024·Pulmonary Therapy

Association between Increased Risk of Pneumonia with ICS in COPD: A Continuous Variable Analysis of Patient Factors from the IMPACT Study

Article

Author: van Hasselt, James ; Ong-Dela Cruz, Bernice ; Casas, Alejandro ; Gomes, Mauro ; Jones, Paul ; Aggarwal, Bhumika ; Weng, Stephen ; Juthong, Siwasak ; Litewka, Diego ; Ramirez-Venegas, Alejandra ; Tombs, Lee ; Sayiner, Abdullah ; Levy, Gur ; Compton, Chris

INTRODUCTIONDespite the proven benefits of inhaled corticosteroid (ICS)-containing triple therapy for chronic obstructive pulmonary disease (COPD), clinicians limit patient exposure to ICS due to the risk of pneumonia. However, there are multiple factors associated with the risk of pneumonia in patients with COPD. This post hoc analysis of IMPACT trial data aims to set the risks associated with ICS into a context of specific patient-related factors that contribute to the risk of pneumonia.METHODSThe 52-week, double-blind IMPACT trial randomized patients with symptomatic COPD and ≥1 exacerbation in the prior year 2:2:1 to once-daily fluticasone furoate (FF)/umeclidinium (UMEC)/vilanterol (VI), FF/VI or UMEC/VI. Annual rate of on-treatment pneumonias in the intent-to-treat population associated with age, body mass index (BMI), percent predicted forced expiratory volume in 1 s (FEV₁) and blood eosinophil count (BEC) was evaluated.RESULTSThis analysis revealed that the annual rate of pneumonia showed the lowest risk at the age of 50 years. The 95% confidence intervals (CI) between ICS-containing and non-ICS containing treatments diverged in ages > 63 years, suggesting a significantly increased ICS-related risk in older patients. In contrast, the annual rate of pneumonia rose in both groups below BMI of 22.5 kg/m², but above that, there was no relationship to pneumonia rate and no differential effect between the two groups. The relationship between BEC and pneumonia was flat up to > 300/µL cells with ICS-containing treatment and then rose. In contrast, the rate of pneumonia with non-ICS containing treatment appeared to increase at a lower level of BEC (~ 200/µL).CONCLUSIONSThere was little evidence of a differential effect of older age, lower BMI, lower FEV₁ and BEC on the pneumonia rate between ICS-containing and non-ICS containing treatments. This analysis points to the need for a balanced approach to risk versus benefit in the use of ICS-containing treatments in COPD.CLINICAL TRIAL REGISTRATIONIMPACT ClinicalTrials.gov number, NCT02164513.

100 Deals associated with Typhoid Vi polysaccharide vaccine(Sanofi)

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External Link

KEGG	Wiki	ATC	Drug Bank
-	Typhoid Vi polysaccharide vaccine(Sanofi)	J07AP03	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Typhoid Fever	CZ	Sanofi Pasteur	-

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pulmonary Disease, Chronic Obstructive	Preclinical	US	GSK Plc	17 Dec 2012
Depressive Disorder, Major	Preclinical	BE	Janssen Pharmaceutical Unlimited Co.	01 May 2012
Encephalitis, Japanese	Preclinical	CZ	Novartis Pharma AG	01 Nov 2011
Encephalitis, Japanese	Preclinical	DE	Novartis Pharma AG	01 Nov 2011
Meningitis, Meningococcal	Preclinical	CZ	Novartis Pharma AG	01 Nov 2011
Meningitis, Meningococcal	Preclinical	DE	Novartis Pharma AG	01 Nov 2011
Typhoid Fever	Preclinical	DE	Novartis Pharma AG	01 Nov 2011
Yellow Fever	Preclinical	DE	Novartis Pharma AG	01 Nov 2011
Yellow Fever	Preclinical	CZ	Novartis Pharma AG	01 Nov 2011

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01608815 (CTgov)	Phase 3	Typhoid Fever	200	Typhoid+Typhoid Vi Polysaccharide Vaccine (Adults (Group 1))	aiucfcsbus(kykkiyxdmk) = visuvlgejh smfdyyrxai (upwzzrpoek, wzgnirmrvh - rnwhrfwkuc) View more	-	12 May 2014
				Typhoid+Typhoid Vi Polysaccharide Vaccine (Dolescents (Group 2))	aiucfcsbus(kykkiyxdmk) = tzabqwhjcv smfdyyrxai (upwzzrpoek, ckdtbjymfj - lqjqabpvxc)