Delving into the Latest Updates on Shigella sonnei vaccine (GlaxoSmithKline) with Synapse

Overview

Basic Info

Drug Type

Prophylactic vaccine

Synonyms

1790GAHB vaccine, GVGH Shigella sonnei 1790GAHB vaccine

+ [1]

Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesDigestive System DisordersOther Diseases

Active Indication-

Inactive Indication

Dysentery, Bacillary

Originator Organization

Novartis AG

Active Organization-

Inactive Organization

GSK Vaccines Institute for Global Health Srl

GSK Plc

License Organization-

Drug Highest PhasePendingPhase 2

First Approval Date-

Regulation-

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A Phase 1, Open Label, Non-randomized, Single Center Study to Evaluate the Safety and Immunogenicity of 1 Booster Vaccination With (GVGH Shigella Sonnei 1790GAHB) Vaccine Administered Intramuscularly in Healthy Adults Previously Primed With Three Doses of the Same Vaccine in Study H03_01TP Compared to 1 Vaccination With (1790GAHB) Administered Intramuscularly Either to Subjects Who Received Placebo in the H03_01TP Study or naïve Subjects Who Were Not Part of H03_01TP Study

GVGH Shigella Sonnei 1970GAHB is a vaccine aimed at preventing the disease caused by Shigella sonnei.
A post-hoc analysis of subjects who participated in the parent study showed significantly different responses in subjects with detectable versus undetectable antibody titres at baseline, suggesting the possibility that the vaccine might not be sufficiently immunogenic in completely naïve adults.
This study was then designed to further characterize the immunogenicity profile of the vaccine and to evaluate whether it was able to induce an immunological memory response.

Start Date16 Mar 2017

Sponsor / Collaborator

GSK Plc

NCT02676895

/ CompletedPhase 2

A Phase 2a, Observer Blind, Randomized, Controlled, Single Center Study To Evaluate The Safety, Reactogenicity And Immunogenicity Of 2 Doses Of The GVGH 1790GAHB Vaccine Against Shigella Sonnei, Administered Intramuscularly In Adult Subjects From A Country Endemic For Shigellosis

The purpose of this study is to evaluate the safety and the immunogenicity of two different doses of the GVGH S. sonnei vaccine in healthy adults and represents the first step towards testing of the GMMA vaccine in the vaccine target population of children from developing countries where shigellosis is endemic.

Start Date08 Aug 2016

Sponsor / Collaborator

GSK Plc

100 Clinical Results associated with Shigella sonnei vaccine (GlaxoSmithKline)

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100 Translational Medicine associated with Shigella sonnei vaccine (GlaxoSmithKline)

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100 Patents (Medical) associated with Shigella sonnei vaccine (GlaxoSmithKline)

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25

Literatures (Medical) associated with Shigella sonnei vaccine (GlaxoSmithKline)

01 Apr 2022·Infectious Diseases and TherapyQ3 · MEDICINE

GMMA Technology for the Development of Safe Vaccines: Meta-Analysis of Individual Patient Data to Assess the Safety Profile of Shigella sonnei 1790GAHB Vaccine in Healthy Adults, with Special Focus on Neutropenia

Q3 · MEDICINE

ArticleOA

Author: Conti, Valentino ; De Ryck, Iris ; Auerbach, Joachim ; Nakakana, Usman ; Vella, Venanzio ; Sarakinou, Eleanna ; Podda, Audino ; Cilio, Giulia Luna ; Granada, Juan-Paolo ; Ndiaye, Augustin

INTRODUCTIONShigellosis is a major health concern among children < 5 years of age from developing countries, and there are no widely available vaccines to prevent it. The GMMA-based 1790GAHB investigational vaccine against Shigella sonnei was well tolerated and immunogenic in phase 1 and 2 studies conducted in healthy adults from Shigella endemic and non-endemic populations. Based on pooled data of five individual trials, we assessed the association between vaccine administration and the risk of neutropenia as well as the overall safety profile of 1790GAHB.METHODSThe risk ratio (RR) of neutropenia was evaluated between participants receiving 1790GAHB (vaccinees) and active comparator/placebo (controls) using different ethnicity-specific absolute neutrophil count (ANC) thresholds established to define neutropenia. Safety was assessed in terms of solicited, unsolicited, and serious adverse events (AEs).RESULTSOf the 279 participants, 11 (5.5%) vaccinees and 4 (5.0%) controls had ANC below the appropriate threshold within 7 days post-vaccination. RR was 0.96 [95% confidence interval (CI) 0.54-1.70]. When neutrophil counts of participants of African descent were measured against an ethnicity non-specific threshold, they resulted in neutropenia episodes in 30 (37.0%) vaccinees and 16 (30.2%) controls, while only 2 (2.5%) vaccinees and 1 (1.9%) control had neutropenia when the ethnicity-specific threshold was applied. RRs were 0.98 (95% CI 0.75-1.28) and 1.30 (95% CI 0.1-17.6), respectively. Solicited and unsolicited AEs were slightly more frequent among vaccinees than controls. No serious AEs, other than neutropenia cases, were recorded in the vaccine group.CONCLUSIONBy applying the appropriate threshold, no increased risk of neutropenia was identified in vaccinees compared with the controls. The frequency of neutropenia events varied drastically when ethnicity-appropriate thresholds were applied. This observation highlights the importance of selecting appropriate cut-off values according to the correct population reference. Overall, the 1790GAHB vaccine demonstrated an acceptable safety profile.

20 Dec 2021·The Journal of Infectious DiseasesQ2 · MEDICINE

Functional Antibodies and Innate Immune Responses to WRSS1, a Live Oral Shigella sonnei Vaccine Candidate, in Bangladeshi Adults and Children

Q2 · MEDICINE

Article

Author: Mily, Akhirunnesa ; Wierzba, Thomas F ; Sarker, Protim ; Ara, Anjuman ; Walker, Richard I ; Haque, Farjana ; Venkatesan, Malabi M ; Raqib, Rubhana ; Maier, Nicole

AbstractBackgroundWe demonstrated in a randomized placebo-controlled trial that WRSS1, a live oral Shigella sonnei vaccine candidate, is safe in Bangladeshi adults and children, and elicits antigen-specific antibodies. Here, we describe functional antibody and innate immune responses to WRSS1.MethodsAdults (18–39 years) and children (5–9 years) received 3 doses of 3 × 105 or 3 × 106 colony forming units (CFU) of WRSS1 or placebo, 4 weeks apart; children additionally received 3 × 104 CFU. Blood and stool were collected at baseline and 7 days after each dose. Functional antibodies were measured using serum bactericidal antibody (SBA) assay. Cytokine/chemokine concentrations were measured in lymphocyte cultures. Host defense peptides LL-37, HBD-1, and HD-5 were analyzed in plasma and stool.ResultsChildren showed increased SBA titers over baseline after the third dose of 3 × 106 CFU (P = .048). Significant increases of Th-17 and proinflammatory cytokines (TNF-α, G-CSF, MIP-1β), and reduction of anti-inflammatory and Th2 cytokines (IL-10, IL-13, GM-CSF) were observed in children. Plasma HBD-1 and LL-37 decreased in children after vaccination but were increased/unchanged in adults.ConclusionsFunctional antibodies and Th1/Th17 cytokine responses in children may serve as important indicators of immunogenicity and protective potential of WRSS1.Clinical Trials Registration: NCT01813071.

03 Jun 2019·Human Vaccines & ImmunotherapeuticsQ3 · MEDICINE

A phase I trial of WRSS1, a Shigella sonnei live oral vaccine in Bangladeshi adults and children

Q3 · MEDICINE

Article

Author: Qadri, Firdausi ; Walker, Richard I. ; Venkatesan, Malabi M. ; Alam, Nur Haque ; Fix, Alan ; Suvarnapunya, Akamol E. ; Zaman, K. ; Wierzba, Thomas F. ; Raqib, Rubhana ; Baqui, Abdullah Hel ; Sarker, Protim ; Maier, Nicole ; Talukder, Kaisar

Shigella sonnei live vaccine candidate, WRSS1, which was previously evaluated in US, Israeli and Thai volunteers, was administered orally to Bangladeshi adults and children to assess its safety, clinical tolerability and immunogenicity. In a randomized, placebo-controlled, dose-escalation, age-descending study, 39 adults (18-39 years) and 64 children (5-9 years) were enrolled. Each adult cohort (n = 13) received one dose of 3x10⁴, or three doses of 3 × 10⁵ or 3 × 10⁶ colony forming unit (CFU) of WRSS1 (n = 10) or placebo (n = 3). Each child cohort (n = 16) received one dose of 3x10³, or three doses of 3x10⁴, 3x10⁵, or 3 × 10⁶ CFU WRSS1 (n = 12) or placebo (n = 4). WRSS1 elicited mostly mild and transient reactogenicity events in adults and children. In the 3 × 10⁶ dose group, 50% of the adults shed the vaccine; no shedding was seen in children. At the highest dose, 100% of adults and 40% of children responded with a ≥ 4-fold increase of S. sonnei LPS-specific IgA antibody in lymphocyte supernatant (ALS). At the same dose, 63% of adults and 70% of children seroconverted with IgA to LPS, while in placebo, 33% of adults and 18% of children seroconverted. Both the vaccinees and placebos responded with fecal IgA to LPS, indicating persistent exposure to Shigella infections. In conclusion, WRSS1 was found safe up to 10⁶ CFU dose and immunogenic in adults and children in Bangladesh. These data indicate that live, oral Shigella vaccine candidates, including WRSS1 can potentially be evaluated in toddlers and infants (<2 years of age), who comprise the target population in an endemic environment.

100 Deals associated with Shigella sonnei vaccine (GlaxoSmithKline)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Dysentery, Bacillary	Phase 2	Kenya	GSK Plc	08 Aug 2016

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03089879 (CTgov)	Phase 1	Dysentery, Bacillary	35	GVGH Shigella sonnei 1790GAHB vaccine (Shigella Group)	xrmhaggcmu(weqsgjuear) = byjuapmbjq jgcdxxbpvg (hzhmzrzoya, ixrmumwfig - vcugtdursf) View more	-	07 Mar 2019
				GVGH Shigella sonnei 1790GAHB vaccine (Placebo Group)	xrmhaggcmu(weqsgjuear) = cujbawejzb jgcdxxbpvg (hzhmzrzoya, eztlnwejwg - rzxjwinjvb) View more
NCT02676895 (CTgov)	Phase 2	Dysentery, Bacillary	74	GVGH S. sonnei (1790GAHB) vaccine 25 μg (1790GAHB 25 μg Group)	vxheqpvuei(hozefebbbs) = miepdugsxo dxxergqhti (lqbkraalxy, mzsbcttrhg - wjmhdhzfsh) View more	-	18 Feb 2019
				GVGH S. sonnei (1790GAHB) vaccine 100 μg (1790GAHB 100 μg Group)	vxheqpvuei(hozefebbbs) = oslkugrfcq dxxergqhti (lqbkraalxy, fzmuztfurv - jqbffkjbzq) View more
NCT02017899 (CTgov)	Phase 1	Dysentery, Bacillary	50	S. sonnei 1790GAHB (S. Sonnei 1790GAHB - 1 mcg)	(unwhulhlfl) = lamhhxsfhd ixedfchcuj (inhauxyyrs, kyltlyuysb - vffybhcwrn) View more	-	23 Jan 2019
				S. sonnei 1790GAHB (S. Sonnei 1790GAHB - 5 mcg)	(unwhulhlfl) = kjrjmdpcsi ixedfchcuj (inhauxyyrs, wmmzheqhed - gtowbjygws) View more