Typhim vi

Manufactured by Sanofi

Sourced in France, United Kingdom

Typhim Vi is a vaccine manufactured by Sanofi. It is a polysaccharide vaccine designed to prevent typhoid fever caused by Salmonella Typhi bacteria.

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Lab products found in correlation

Menveo, by GlaxoSmithKline (2 mentions) Keyhole limpet hemocyanin (klh), by Merck Group (1 mentions) Gravity flow columns, by Qiagen (1 mentions) Hiprep 26 10, by GE Healthcare (1 mentions) Escherichia coli bl21 de3 plyss, by Promega (1 mentions) Ni nta, by Thermo Fisher Scientific (1 mentions) Histrap nickel affinity column, by GE Healthcare (1 mentions) Kdo2 lipid a, by Avanti Polar Lipids (1 mentions) 96 well flat bottom culture plate, by Corning (1 mentions) Lipopolysaccharides (lps), by Merck Group (1 mentions) Bactec system, by BD (1 mentions)

19 protocols using typhim vi

Transcutaneous Immunization with Vi Polysaccharide

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Purified Vi polysaccharide and DT-conjugated Vi polysaccharide (Vi-DT) (both gifts from the International Vaccine Institute, IVI, in South Korea), and CT (CT; List Biological Laboratories Inc., Campbell, CA) were used for immunizations. Each mouse was transcutaneously immunized with 25 µg of Vi, 25 µg of Vi in Vi-DT conjugate, or 10 µg of CT alone or as an adjuvant with Vi or Vi-DT. Typhim Vi (Sanofi Aventis, Bridgewater, NJ), CT, and keyhole limpet hemocyanin (KLH; Sigma Chemical Co., St. Louis, MO) were used for detection of immunologic responses.

Bhuiyan M.S., Kalsy A., Arifuzzaman M., Charles R.C., Harris J.B., Calderwood S.B., Qadri F, & Ryan E.T. (2020). Transcutaneous Vaccination with Conjugate Typhoid Vaccine Vi-DT Induces Systemic, Mucosal, and Memory Anti-Polysaccharide Responses. The American Journal of Tropical Medicine and Hygiene, 103(3), 1032-1038.

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Vi-TT Vaccine Efficacy Trial in Typhoid Challenge

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Samples for this work were obtained from a randomized, controlled, phase 2b clinical trial centered in Oxford, UK evaluating the efficacy of Vi-TT in deliberately infected volunteers (ClinicalTrials.gov identifier: NCT02324751). Details of the study protocol and inclusion criteria were published previously (8 (link)). Healthy adults received a Vi-tetanus toxoid conjugate vaccine (Vi-TT: Typbar-TCV, Bharat Biotech), or a Vi plain polysaccharide vaccine (Vi-PS: TYPHIM Vi, Sanofi Pasteur). Participants were monitored in an outpatient setting and serial blood samples were collected at baseline (D0), and 7 (D7), 10 (D10), and 28 (D28) days post-vaccination. Participants were challenged orally approximately 28 days post-vaccination with 1–5 x 10⁴ colony forming units (CFU) of S. Typhi Quailes strain. In context of the current manuscript, all samples were collected before the participants were challenged. Informed written consent was obtained from all volunteers before enrolment.

Cross D.L., Verheul M.K., Leipold M.D., Obermoser G., Jin C., Jones E., Starr J.S., Mohorianu I., Blohmke C.J., Maecker H.T., Napolitani G., Hill J, & Pollard A.J. (2020). Vi-Vaccinations Induce Heterogeneous Plasma Cell Responses That Associate With Protection From Typhoid Fever. Frontiers in Immunology, 11, 574057.

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Evaluation of Salmonella and Pneumococcal Vaccines

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We conducted a prospective cohort study in 100 healthy volunteers. The study was approved by the Ethics committee of University Hospitals Leuven, Belgium. Volunteers aged 2–55 years were included when they did not meet any of the following exclusion criteria: (i) previous vaccination with an unconjugated polysaccharide salmonella vaccine or pneumococcal vaccine within 5 years prior to study participation, (ii) previous allergic reaction to any vaccine, and (iii) medical history suggestive of PID. After obtaining full informed and written consent, a blood sample was drawn for pre-vaccination serum, allohemagglutinins (AHA), and blood group. Typhim Vi™ (Sanofi Pasteur, Lyon, France) and Pneumovax 23™ (Merck Sharp en Dohme B.V., Haarlem, the Netherlands) vaccines were administered by intramuscular injection at two distinct sites (right and left deltoid muscle). Information on the clinical history and potential previous contact with S. typhi was obtained by a medical doctor and noted in a case report form. Three to four weeks after vaccination, a second blood sample was obtained for postvaccination antibody concentrations. Pre- and postvaccination blood was separated by centrifugation and serum was stored at −20°C until simultaneous analysis of specific IgG.

Schaballie H., Bosch B., Schrijvers R., Proesmans M., De Boeck K., Boon M.N., Vermeulen F., Lorent N., Dillaerts D., Frans G., Moens L., Derdelinckx I., Peetermans W., Kantsø B., Jørgensen C.S., Emonds M.P., Bossuyt X, & Meyts I. (2017). Fifth Percentile Cutoff Values for Antipneumococcal Polysaccharide and Anti-Salmonella typhi Vi IgG Describe a Normal Polysaccharide Response. Frontiers in Immunology, 8, 546.

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Immunogenic Polysaccharide Protocols in Mice

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Two-and-a-half micrograms of Vi Polysaccharide (ViPS) (Typhim Vi^®; Sanofi Pasteur Inc., Swiftwater, PA; or purified ViPS, Lot 5, U.S. Food and Drug Administration), dissolved in 100 μl Dulbecco’s phosphate-buffered saline [(DPBS); Mediatech, Herndon, VA] were used to immunize mice intraperitoneally (i.p.). Previously, immunization with ViPS in the range of 0.25 - 50 μg in 100 μl PBS was shown to induce comparable anti-ViPS antibody response (25 (link), 26 (link)). For dextran immunizations, 50 μg of α1-6 dextran (B512; MP Biomedicals, LLC, Solon, OH) or 50 μg of α1-3 dextran (B1355; A gift from Dr. A. Jeanes) dissolved in 100 μl DPBS were used to immunize mice i.p. For whole bacterial immunization, mice were injected i.p. with 3×10⁸ heat-killed Escherichia coli strain W3110 pDC5, which expresses ViPS (27 (link)), or 10⁸ heat-killed, paraformaldehyde-fixed Enterobacter cloacae strain MK7, which expresses α1-3 dextran. Blood samples were obtained 0, 7, 14, 21, and 28 days following immunization.

Dickinson G.S., Levenson E.A., Walker J.A., Kearney J.F, & Alugupalli K.R. (2018). Interleukin-7 enables antibody responses to bacterial polysaccharides by promoting B cell antigen receptor diversity. Journal of immunology (Baltimore, Md. : 1950), 201(4), 1229-1240.

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Purification of Bacterial Virulence Factors

Cited 2 times

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Lipopolysaccharide (O9:LPS) was from Sigma-Aldrich, UK (L2387, >99% free of protein) and Vi capsular polysaccharide was from Sanofi Pasteur, UK (Typhim Vi^®). Flagellin (H) was purified from a flagellin-deficient S. Enteritidis strain that expresses S. Typhi H:d from a plasmid (University of Maryland, USA) (14 (link), 20 (link)). Cytolethal distending toxin B (CdtB) and pilus control protein L (PilL) coding sequences lacking transmembrane domains were PCR-amplified from S. Typhi CT18 strain genomic DNA, cloned into plasmid pET28b(+) (Novagen, UK) and expressed in Escherichia coli BL21(DE3)pLysS (Promega, WI, USA). Recombinant His-tagged CdtB and PilL were purified by tagging with nickel-coated agarose beads (Ni-NTA, Invitrogen) and elution from gravity flow columns (Qiagen, Germany). CdtB was renatured in 50-mM sodium phosphate solution and 500-mM NaCl. hlyE was PCR-amplified from Ty21a, cloned into pET21a vector (Novagen, UK), and expressed in an LPS-modified E. coli BL21 strain to produce endotoxin free proteins (Lucigen, ClearCoil BL21 cells). Recombinant His-tagged hemolysin E (HlyE) was purified using HisTrap nickel-affinity column (GE Healthcare) followed by desalting on a HiPrep 26/10 (GE Healthcare).

Juel H.B., Thomaides-Brears H.B., Darton T.C., Jones C., Jones E., Shrestha S., Sie R., Eustace A., Galal U., Kurupati P., Van T.T., Thieu N.T., Baker S., Blohmke C.J, & Pollard A.J. (2018). Salmonella Typhi Bactericidal Antibodies Reduce Disease Severity but Do Not Protect against Typhoid Fever in a Controlled Human Infection Model. Frontiers in Immunology, 8, 1916.

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Safety and Immunogenicity of Vi-DT Typhoid Vaccine

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This was a randomized, observer-blinded, Phase I study to assess the safety and immunogenicity of 25 µg Vi-DT typhoid conjugate vaccine (Test vaccine) compared with Vi polysaccharide typhoid vaccine (25 µg) (Typhim Vi®, Sanofi Pasteur) (Comparator vaccine). Since Test and Comparator vaccines differ in their presentation, the study was observer-blinded (safety evaluators and other trial staff remained blinded with the exception of the vaccine administrator) to ensure evaluator’s blinding to prevent bias in assessment of adverse events. This study was conducted at RITM, Manila, the Philippines, from May 2016 to Feb 2017. Healthy Filipino participants aged 2–45 years were enrolled into 3 cohorts of 18–45, 6–17, and 2–5 years in an age de-escalation manner.
The primary objective of the study was to evaluate the safety of Vi-DT, while the secondary objectives were to assess the immunogenicity of Vi-DT comparatively to Typhim Vi®.

Capeding M.R., Teshome S., Saluja T., Syed K.A., Kim D.R., Park J.Y., Yang J.S., Kim Y.H., Park J., Jo S.K., Chon Y., Kothari S., Yang S.Y., Ham D.S., Ryu J.H., Hwang H.S., Mun J.H., Lynch J.A., Kim J.H., Kim H., Excler J.L, & Sahastrabuddhe S. (2018). Safety and immunogenicity of a Vi-DT typhoid conjugate vaccine: Phase I trial in Healthy Filipino adults and children. Vaccine, 36(26), 3794-3801.

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Typhoid Vaccine Efficacy Study

Cited 1 time

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Samples were obtained from consenting adult volunteers participating in a phase IIb, participant-observer blinded, randomized, controlled, Vi-vaccine efficacy study conducted at the Centre for Clinical Vaccinology and Tropical Medicine (Churchill Hospital, Oxford, UK; ClinicalTrials.gov: NCT02324751), as previously described (Jin et al., 2017 (link)). Briefly, participants were randomized and vaccinated with Vi-TT (Typbar-TCV; Bharat Biotech), Vi-PS (Typhim Vi; Sanofi Pasteur), or meningococcal-ACWY conjugate vaccine (MENVEO; GlaxoSmithKline). Approximately 28 days after vaccination, participants ingested ∼10⁴ CFU of S. Typhi (Quailes strain). Blood and stool cultures were sampled daily over the 14-d challenge period; oral temperatures (recorded two to three times a day) and symptoms were reported for a total of 21 days after challenge. Typhoid fever was diagnosed in participants with positive S. Typhi bacteremia or fever ≥38°C for ≥12 h.
Humoral responses were evaluated for Vi vaccinees. Serum samples were collected before vaccination (baseline), on the day of challenge (day 28), and 4 months (day 118 ± 14) and 7 months (day 208 ± 28) after vaccination and stored at −80°C.

Jin C., Hill J., Gunn B.M., Yu W.H., Dahora L.C., Jones E., Johnson M., Gibani M.M., Spreng R.L., Alam S.M., Nebykova A., Juel H.B., Dennison S.M., Seaton K.E., Fallon J.K., Tomaras G.D., Alter G, & Pollard A.J. (2020). Vi-specific serological correlates of protection for typhoid fever. The Journal of Experimental Medicine, 218(2), e20201116.

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Priming with Vi-TT Vaccine and Vi-PS Boost

Cited 2 times

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We analyzed 12 participants, from a completed clinical trial (12 (link)), who were primed with a Vi-TT vaccine (Typbar TCV, Bharat Biotech, Hyderabad, India). Of the 10 participants who completed the study, 40% were female, and the mean age of participants was 39 ± 12 years (±SD). PBMCs were acquired before immunization and 7 days after immunization. Serum was available before immunization and 28 days after immunization with Vi-TT. Five participants were orally challenged with S. Typhi 28 days after receiving the initial immunization. Challenge did not increase antibody responses toward Vi (51 (link)). All participants received a boost with Vi-PS (TYPHIM Vi, Sanofi Pasteur, Lyon, France). The Vi-PS boost was administered between 19 and 23 months after the initial Vi-TT immunization. PBMCs were acquired before immunization and 7 days after immunization, and serum was available 28 days after immunization with Vi-PS.
All volunteers provided written informed consent before enrollment. The study protocol was approved by the sponsor (University of Oxford), the South Central Oxford A Ethics Committee (14/SC/1427), and the Medicines and Healthcare Products Regulatory Agency (Eudract 2014–002978-36).

Dahora L.C., Verheul M.K., Williams K.L., Jin C., Stockdale L., Cavet G., Giladi E., Hill J., Kim D., Leung Y., Bobay B.G., Spicer L.D., Sawant S., Rijpkema S., Dennison S.M., Alam S.M., Pollard A.J, & Tomaras G.D. (2021). Salmonella Typhi Vi capsule prime-boost vaccination induces convergent and functional antibody responses. Science immunology, 6(64), eabj1181.

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Immunogenicity of Vi Polysaccharide Vaccines

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ViPS (lot 5, PDMI 158299) isolated from Citrobacter freundii strain WR7011 was obtained from the U.S. Food and Drug Administration (Silver Spring, MD). ViPS isolated from S. Typhi clinical isolate C652464 was obtained from the International Vaccine Institute (Seoul, Republic of Korea). Typbar TCV was obtained from Bharat Biotech India (Hyderabad, India). Typhim Vi was purchased from Sanofi Pasteur (lot V2A451M). Mice were immunized i.m. with 2.5 μg (50 μl vol) of ViPS in the thigh region of the hindlimb. Blood samples were obtained 0, 7, 14, 21, or 28 d following immunization and stored at −20°C. In some experiments, the phenol-extracted ViPS preparations were admixed with 5 μg of lipid A (Kdo2-lipid A purchased from Avanti Polar Lipids, Alabaster, AL) for immunization.

, & Alugupalli K.R. (2024). TLR4 Ligands in Typhoid Vi Polysaccharide Subunit Vaccines Contribute to Immunogenicity. ImmunoHorizons, 8(1), 29-34.

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Comparison of Vi-DT and Vi-PS Typhoid Vaccines

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Vi-DT vaccine manufactured by BioFarma was used as an investigational product. Each dose of this vaccine (0.5 mL) is composed of 25 µg of a purified Vi capsular polysaccharide of S. Typhi, 5 mg of 2-phenoxyethanol as preservative and 0.5 mL of phosphate buffer solution. IP was stored at a temperature of + 2 °C to + 8 °C and is in the form of multi-dose vials. Licensed Vi-PS vaccine (Typhim Vi® produced by Sanofi) was used as a control. Control was also stored at a temperature of + 2 °C to + 8 °C but is in the form of pre-filled syringes. Both vaccines were administered intramuscularly in the deltoid region.

Koesnoe S., Medise B.E., Rengganis I., Hadinegoro S.R., Puspita M., Sari R.M., Yang J.S., Sahastrabuddhe S., S.o.e.d.j.a.t.m.i.k.o., Gunardi H., Sekartini R., Wirahmadi A., Kekalih A., Mukhi S., Satari H.I, & Bachtiar N.S. (2024). A phase II clinical trial of a Vi-DT typhoid conjugate vaccine in healthy Indonesian adolescents and adults: one-month evaluation of safety and immunogenicity. Tropical Diseases, Travel Medicine and Vaccines, 10, 3.

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