AN EXTENSION OF BBIL/CTP/04/2010 PHASE 3 CLINICAL TRIAL OF TYPBAR TCVÂ®: To DETERMINE THE LEVEL OF ANTI-SALMONELLA TYPHI VI POLYSACCHARIDE IGG ANTIBODIES AT THE END OF APPROXIMATELY 7 YEARS AND FOLLOW UP OF A BOOSTER DOSE OF TYPBAR TCVÂ® DOSE IN THOSE WHO HAVE LOWER LEVEL OF ANTIBODIES (BELOW CORRELATE OF PROTECTION) IN HEALTHY PRIMED AND BOOSTER DOSE RECEIVED CHILDREN AND ADULTS - Typbar TCVÂ® 7 years followup study

Start Date15 Apr 2019

Sponsor / Collaborator

Bharat Biotech International Ltd.

100 Clinical Results associated with Typhoid vaccine Vi polysaccharide(Bharat Biotech International Ltd.)

100 Translational Medicine associated with Typhoid vaccine Vi polysaccharide(Bharat Biotech International Ltd.)

100 Patents (Medical) associated with Typhoid vaccine Vi polysaccharide(Bharat Biotech International Ltd.)

Literatures (Medical) associated with Typhoid vaccine Vi polysaccharide(Bharat Biotech International Ltd.)

01 Dec 2023·Journal of Affective Disorders

Inflamed but not impulsive: Acute inflammatory cytokine response does not impact prepotent response inhibition

Article

Author: Noonan, Anne M ; Lustberg, Maryam ; Kiecolt-Glaser, Janice K ; Reinbolt, Raquel E ; Madison, Annelise A ; Wesolowski, Robert ; Renna, Megan E ; Cherian, Mathew A ; Sardesai, Sagar D ; Andridge, Rebecca ; Ramaswamy, Bhuvaneswari ; Sheridan, John F ; Williams, Nicole O ; Malarkey, William B

BACKGROUNDPrior evidence has linked inflammation with impulsivity, but most of this evidence is cross-sectional. In this study, we provoked an acute inflammatory cytokine response to see whether it lowered prepotent response inhibition on three cognitive tasks.METHODThis study features secondary analyses from a randomized crossover trial in which 171 postmenopausal breast cancer survivors (Stage I-IIIA) each received a typhoid capsular polysaccharide vaccination and a saline placebo injection in a random sequence at two separate visits at least one month apart. Participants completed the Stroop Color-Discrepant Task, the 2-back, and the Conners Continuous Performance Test (CPT) on the computer between 5 and 7 h after the injections. They had their blood drawn once before and repeatedly after the injection to measure interleukin-1 receptor antagonist and interleukin-6 responses.RESULTSWomen committed marginally fewer errors on the Stroop color-discrepant trials after the typhoid vaccine (M = 0.36, SE = 0.08), compared to placebo (M = 0.54, SE = 0.09, p = .076). Injection type did not predict 2-back accuracy (p = .80) or CPT commission errors (p = .47). Inflammatory cytokine responses were also unrelated to the outcomes of interest (ps>.16).CONCLUSIONWe found no evidence that an acute inflammatory cytokine response provokes response disinhibition - an important facet of impulsivity. In fact, our only marginally non-significant result suggested that women were better able to inhibit their prepotent responses on the Stroop after receiving the typhoid vaccine, compared to placebo. Further experimental tests of the acute inflammatory cytokine response's effect on other aspects of impulsivity are warranted.LIMITATIONSThe sample was female, primarily White, highly educated cancer survivors, and recruitment was not premised on impulsive traits or diagnosis with an impulsive-related disorder. Also, there are many facets of impulsivity, and this study only measured response inhibition.

01 Jan 2023·Brain, Behavior, and Immunity

Typhoid vaccine does not impact feelings of social connection or social behavior in a randomized crossover trial among middle-aged female breast cancer survivors

Article

Author: Sheridan, John ; Noonan, Anne M ; Rosie Shrout, M ; Lustberg, Maryam ; Sardesai, Sagar D ; Stover, Daniel G ; Ratner, Kyle G ; Madison, Annelise A ; Malarkey, William B ; VanDeusen, Jeffrey B ; Kiecolt-Glaser, Janice K ; Way, Baldwin ; Peng, Juan ; Reinbolt, Raquel E ; Wesolowski, Robert ; Renna, Megan ; Williams, Nicole O ; Ramaswamy, Bhuvaneswari ; Cherian, Mathew A ; Andridge, Rebecca

BACKGROUNDInflammation can have social consequences, which may be relevant to inflammation's link with depression. The current study tests whether a typhoid vaccine increases feelings of social disconnection and avoidance behavior.METHODIn two full-day visits at least three weeks apart, 172 postmenopausal breast cancer survivors (Stage I-IIIA) each received a typhoid capsular polysaccharide vaccination and a saline placebo injection in a random sequence. Blood was drawn prior to the injection, as well as every 90 min thereafter for 8 h to assess the inflammatory response (interleukin-6, IL-6; interleukin-1 receptor antagonist, IL-1Ra). At both visits, women completed the Social Connection Scale at 0 and 8.5 h post-vaccination as well as implicit and explicit social avoidance tasks at 7 h post-vaccination.RESULTSThe typhoid vaccine triggered rises in both inflammatory markers (ps < 0.01), but it did not impact feelings of social connection (p = .32), or performance on the implicit (p = .34) or explicit tasks (p = .37). Inflammatory rises did not predict feelings of social connection (ps > 0.64) or performance on explicit (ps > 0.73) or implicit (ps > 0.88) social avoidance tasks.CONCLUSIONMilder inflammatory stimuli may not affect social processes. Higher levels of inflammation or, relatedly, more sickness symptoms may be necessary to recapitulate prior findings of social avoidance.

30 Nov 2022·Human Vaccines & ImmunotherapeuticsQ3 · MEDICINE

A multicenter, single-blind, randomized, phase-2/3 study to evaluate immunogenicity and safety of a single intramuscular dose of biological E’s Vi-capsular polysaccharide-CRM ₁₉₇ conjugate typhoid vaccine (TyphiBEV ^TM ) in healthy infants, children, and adults in comparison with a licensed comparator

Q3 · MEDICINE

Article

Author: Matur, Ramesh ; Turaga, Kishore ; GV, Subba Reddy ; Paradkar, Vikram ; Thuluva, Subhash

The current scenario of typhoid fever warrants early prevention with typhoid conjugate vaccines in susceptible populations to provide lifelong protection. We conducted a multicenter, single-blind, randomized, Phase 2/3 study to assess the immunogenicity and safety of Biological E's Typhoid Vi-CRM₁₉₇ conjugate vaccine (TyphiBEV^TM) compared to Vi-TT conjugate vaccine manufactured by Bharat Biotech International Limited (Typbar-TCV; licensed comparator) in healthy infants, children, and adults from India. The study's primary objective was to assess the non-inferiority of TyphiBEV^TM in terms of the difference in the proportion of subjects seroconverted with a seroconversion threshold value of ≥2.0 µg/mL against Typbar-TCV. A total of 622 healthy subjects (311 each in both vaccine groups) were randomized and received the single dose of the study vaccine. The TyphiBEV^TM group demonstrated noninferiority compared to the Typbar-TCV group at Day 42. The lower 2-sided 95% confidence interval limit of the group difference was -.34%, which met the non-inferiority criteria of ≥10.0%. The geometric mean concentration (24.79 µg/mL vs. 26.58 µg/mL) and proportion of subjects who achieved ≥4-fold increase in antiVi IgG antibody concentrations (96.95% vs. 97.64%) at Day 42 were comparable between the TyphiBEV^TM and Typbar-TCV vaccine groups. No apparent difference was observed in the safety profile between both vaccine groups. All adverse events reported were mild or moderate in intensity in all age subsets. This data demonstrates that TyphiBEV^TM is non-inferior to TypbarTCV in terms of immunogenicity, and the overall safety and reactogenicity in healthy infants, children, and adults studied from India was comparable.

100 Deals associated with Typhoid vaccine Vi polysaccharide(Bharat Biotech International Ltd.)

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