Delving into the Latest Updates on Meningococcal groups C and Y and Haemophilus b tetanus toxoid conjugate vaccine(GlaxoSmithKline Plc) with Synapse

Overview

Basic Info

Drug Type

Prophylactic vaccine, Toxoid vaccine, Conjugated vaccine

Synonyms

Hib-MenCY-TT vaccine, Hib-meningococcal vaccine groups C and Y conjugate, HibMenCY-TT

+ [2]

Target-

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesNervous System Diseases

Active Indication-

Inactive Indication

Haemophilus InfectionsMeningitisMeningococcal Infections

Originator Organization

GSK Plc

Active Organization-

Inactive Organization

GSK PlcGlaxoSmithKline LLC

Drug Highest PhaseWithdrawn

First Approval Date

US (14 Jun 2012),

Haemophilus InfectionsMeningococcal Infections

Regulation-

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The purpose of the study is to characterize the immunogenicity & safety of a booster dose of GSK Biologicals' meningococcal vaccine 134612 given at 12-15 months of age or at 15-18 months of age (co-administered with Infanrix®) in healthy toddlers primed with GSK Biological's Hib-meningococcal vaccine 792014. This study is single-blinded for the primary phase and open-label for the booster phase.

Start Date13 Feb 2008

Sponsor / Collaborator

GSK Plc

NCT00345683 / CompletedPhase 3

Single-blind, Randomized, Controlled, Multinational Study for the Evaluation of Safety of GSK Biologicals' Hib-MenCY-TT Vaccine Compared to Monovalent Hib Control Vaccine in Healthy Infants at 2, 4, 6, and 12 to 15 Months of Age.

The booster phase of the study will evaluate the safety of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine at 12 to 15 months of age.
This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00345579).
No new recruitment will take place during this booster phase of the study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Start Date01 Jul 2007

Sponsor / Collaborator

GSK Plc

100 Clinical Results associated with Meningococcal groups C and Y and Haemophilus b tetanus toxoid conjugate vaccine(GlaxoSmithKline Plc)

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100 Translational Medicine associated with Meningococcal groups C and Y and Haemophilus b tetanus toxoid conjugate vaccine(GlaxoSmithKline Plc)

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100 Patents (Medical) associated with Meningococcal groups C and Y and Haemophilus b tetanus toxoid conjugate vaccine(GlaxoSmithKline Plc)

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67

Literatures (Medical) associated with Meningococcal groups C and Y and Haemophilus b tetanus toxoid conjugate vaccine(GlaxoSmithKline Plc)

02 Sep 2021·Human Vaccines & ImmunotherapeuticsQ3 · MEDICINE

Risk factors for delay in starting age-appropriate vaccinations among infants in urban slums of Bangladesh

Q3 · MEDICINE

Article

Author: Khanam, Afsana ; Ahmad, Shaikh Meshbahuddin ; Afsar, Md. Nure Alam ; Alam, Md Jahangir

Age-appropriate vaccination is crucial for infants, protecting them from vaccine-preventable diseases. Delaying in starting initial immunization may result in incomplete or non-vaccination in early life. However, limited vaccine coverage data are available regarding the starting age of vaccination. In this study, we determined the factors associated with the delay in infant immunization. We carried out a cross-sectional study at three maternal-child health clinics in Dhaka city. Mothers visited these clinics for their infant immunization were surveyed with structured questionnaires. A multivariate logistic regression model was used to estimate the significant influencing factors on untimely vaccination. A total of 548 mother-infant pairs were surveyed. 46.5% of mothers did not receive Tetanus (TT) vaccines, and mothers who had a previous pregnancy were less likely to receive TT-vaccine (p < .01). 41.2% of infants did not receive BCG vaccines within 1-week of birth. Mothers working outside the home showed a negative impact on BCG vaccination (p < .05). Among the infants' born in-clinic facilities, 39% were BCG unvaccinated, and 69% had c-section delivery. The median age of infants for starting vaccination was 6.57 wks (95% CI: 6.43-7.14); however, 17.3% infants received vaccination at ≥8 wks of age. Mother's schooling-years and infant normal body-weight positively associated with vaccination at <8 wks, whereas sickness after birth increased the age to start vaccination program recommended at 6 wks. Our analysis suggests the need for specific interventions based on potential maternal determinants, such as educating mothers about the timing and the importance of infant immunization, and addressing programmatic barriers to timely vaccination among infants in Bangladesh.

01 Mar 2020·VaccineQ3 · MEDICINE

Higher mass meningococcal group C-tetanus toxoid vaccines conjugated with carbodiimide correlate with greater immunogenicity

Q3 · MEDICINE

Article

Author: Eastwood, David ; Gao, Fang ; Francis, Robert J ; Derrick, Jeremy P ; Bolgiano, Barbara ; Stebbings, Richard ; Lockyer, Kay ; Khatri, Bhagwati

To examine the link between meningococcal C (MenC) vaccine size and immunogenic response, a panel of MenC glycoconjugate vaccines were prepared differing in chain length, molar mass and hydrodynamic volume. The preparations consisted of different lengths of MenC polysaccharide (PS) covalently linked to monomeric purified tetanus toxoid (TT) carrier protein using the coupling reagent ethylcarbodiimide hydrochloride (EDC). Size exclusion chromatography with multi-angle light scattering (SEC-MALS) and viscometry analysis confirmed that the panel of MenC-TT conjugates spanned masses of 191,500 to 2,348,000 g/mol, and hydrodynamic radii ranging from 12.1 to 47.9 nm. The two largest conjugates were elliptical in shape, whereas the two smallest conjugates were more spherical. The larger conjugates appeared to fit a model described by multiple TTs with cross-linked PS, typical of lattice-like networks described previously for TT conjugates, while the smaller conjugates were found to fit a monomeric or dimeric TT configuration. The effect of vaccine conjugate size on immune responses was determined using a two-dose murine immunization. The two larger panel vaccine conjugates produced higher anti-MenC IgG1 and IgG2b titres after the second dose. Larger vaccine conjugate size also stimulated greater T-cell proliferative responses in an in vitro recall assay, although cytokines indicative of a T-helper response were not measurable. In conclusion, larger MenC-TT conjugates up to 2,348,000 g/mol produced by EDC chemistry correlate with greater humoral and cellular murine immune responses. These observations suggest that conjugate size can be an important modulator of immune response.

01 Jun 2019·Pediatric Infectious Disease JournalQ4 · MEDICINE

Immunogenicity and Safety of a Quadrivalent Meningococcal ACWY-tetanus Toxoid Conjugate Vaccine 6 Years After MenC Priming as Toddlers

Q4 · MEDICINE

Article

Author: Jastorff, Archana ; Marshall, Helen S ; Ziegler, John B ; Richmond, Peter ; Booy, Robert ; Baine, Yaela ; Nolan, Terry ; Nissen, Michael ; Van der Wielen, Marie ; Traskine, Magali

Background:We assessed immunogenicity, antibody persistence and safety of the meningococcal serogroups A, C, W and Y-tetanus toxoid (TT) conjugate vaccine (MenACWY-TT) in children primed as toddlers with MenC vaccine.Methods:This open, multicenter extension study enrolled children 84–95 months of age who had received one dose of the combined Haemophilus influenzae type b (Hib)-MenC-TT conjugate vaccine (HibMenC group) or Hib-TT and monovalent MenC (MCC)-CRM197 vaccines (Hib+MCC group) at 12–18 months of age, in the primary study. All participants received one dose of MenACWY-TT. We assessed immunogenicity against MenA, MenC, MenW and MenY at 1 month and 2 years postvaccination by serum bactericidal assay using baby rabbit complement (rSBA). Safety and reactogenicity were evaluated.Results:Six years post-MenC vaccination, <20% of children retained rSBA-MenC titers ≥1:8. At 1 month post-MenACWY-TT vaccination, vaccine response rates against all serogroups were high for both groups with ≥97.1% of children having rSBA ≥1:8. Two years postvaccination, ≥63.6% of children retained rSBA-MenA ≥1:8, and ≥87.9% for other serogroups. Geometric mean titers for all serogroups declined at 2 years post-MenACWY-TT vaccination, but remained ≥13 times higher than prevaccination levels. For both groups, pain (≤58.5%), redness (≤51.4%) and fatigue (≤27.0%) were the most frequently reported adverse events. No serious adverse events were reported.Conclusions:One dose of MenACWY-TT boosts protection against MenC in primed children, is safe and extends protection against MenA, MenW and MenY. Immunogenicity and safety were comparable in infants vaccinated with conjugated vaccine (HibMenC-TT) or the separate vaccines (Hib-TT and MCC-CRM197).

1

News (Medical) associated with Meningococcal groups C and Y and Haemophilus b tetanus toxoid conjugate vaccine(GlaxoSmithKline Plc)

15 Jun 2023

·www.globenewswire.com

AltruBio to Present at the Federation of Clinical Immunology Societies (FOCIS) 2023 Annual Meeting

SAN FRANCISCO, June 15, 2023 (GLOBE NEWSWIRE) -- AltruBio Inc. (“AltruBio” or “the Company”), a clinical stage biotech company dedicated to the development of novel therapeutics for the treatment of immunological diseases with high unmet medical needs, today announced that the company will be giving an oral presentation on its immune checkpoint enhancer (ICE), ALTB-268, as well as feature a poster on ICE ALTB-168 at the 2023 Federation of Clinical Immunology Societies (FOCIS) Annual Meeting, which is being held June 20-23, 2023 in Boston, Massachusetts. “We’re pleased to share some of the foundational work that continue to support the advancement of our novel ICEs in development to restore immune balance by downregulating T cell effector function for the treatment of human inflammatory diseases," said David Lin, M.D. Ph.D., Vice President of Research of AltruBio. “Our mission is to bring safer, more durable biologic treatments to improve the lives of patients, and we believe selective inhibition or depletion of activated T cells by leveraging an agonistic pathway of the immune checkpoint protein PSGL-1 is a promising therapeutic approach. We look forward to sharing further progress as we continue to evaluate our ICEs in clinical trials.” Oral PresentationSession: Mechanisms of AutoimmunityTitle: ALTB-268, a tetravalent anti-PSGL-1 antibody derived from ALTB-168, shows enhanced potency in treating T cell mediated inflammatory diseases allowing for subcutaneous administration.Presenter: Yu-Chin Lin, MSc, Senior Scientist, AltruBioOral presentation: Wednesday June 21, 2023, 4:30-4:45 pm ESTPoster Presentation: Wednesday June 21, 2023, 6:15-7:30 pm EST Poster Number: W201 Yu-Chin Lin will discuss in vitro and in vivo data on AltruBio’s second anti-P-selectin glycoprotein ligand 1 (PSGL-1) agonist, ALTB-268, which demonstrates enhanced potency and excellent bioavailability, enabling its formulation for subcutaneous (sc) delivery. ALTB-268 is engineered to be a tetravalent version of its predecessor ALTB-168 and has a similar mechanism of action. Data highlights include: ALTB-268, a tetravalent version of ALTB-168 demonstrated greater than 10-fold higher potency in in vitro T cell activation inhibition assays compared to ALTB-168.When compared in a human-mouse trans-vivo delayed type hypersensitivity (DTH) study as well as in a non-human primate (NHP) DTH study, greater than 3-fold higher potency was observed for ALTB-268.Increased potency is likely related to differences in stoichiometry and increased avidity rather than increased affinity, as a single ALTB-268 molecule can bind to more PSGL-1 compared to a single ALTB-168 molecule, while similar affinity for both ALTB-168 and ALTB-268 was measured by surface plasmon resonance or ELISA.A similar safety profile as ALTB-168 was observed for ALTB-268 in NHP toxicology assessments, with a NOAEL of 120 mg/kg in a definitive 28-day weekly repeat-dose toxicity study, and a bioavailability of 70% by sc route. Poster PresentationSession: Exhibit & Poster Opening ReceptionTitle: ALTB-168, an Immune Checkpoint Enhancer (ICE) targeting P-selectin glycoprotein-1 (PSGL-1), is effective in treating T-cell mediated inflammatory diseasesPresenter: Evelyn Chiang, Ph.D., Principal Scientist, AltruBioPoster Presentation: Tuesday, June 20, 2023, 6:00 p.m. – 7:45 p.m. ESTPoster Number: Tu221 The preclinical data will highlight a new role for PSGL-1 as a novel immune checkpoint regulator that modulates T cell homeostasis. The poster presents data demonstrating that PSGL-1 is upregulated in activated T cells compared to naïve T cells, providing rationale for AltruBio’s first anti-PSGL-1 agonistic antibody, ALTB-168, to act as an ICE to downregulate early T cell receptor mediated signaling, T cell proliferation and cytokine secretion, which is independent of the migration function of PSGL-1 as ALTB-168 does not interfere with the binding of P-selectin to PSGL-1. Data highlights: ALTB-168 treatment in a pre-clinical graft-versus-host disease (GvHD) model resulted in increased population of apoptotic CD3 T cells, reduced severity of GvHD and prolonged survival of mice.In a trans-vivo DTH study where human peripheral blood mononuclear cells (PBMCs), previously sensitized with tetanus toxoid (TT), were implanted in the mouse footpad together with TT, the induration of the mouse footpad was reduced by ALTB-168 in a dose-dependent manner.DTH studies performed in NHP also showed that ALTB-168 inhibited skin induration as well as the inflammation of the lesion site.ALTB-168 treatment does not impact the development of T cell dependent antibody production, suggesting a marginal impact in primary T cells and represents a significant safety advantage in clinical development.To date more than 200 subjects have been treated with ALTB-168 and no significant adverse events have been reported.ALTB-168 has been clinically validated for safety, tolerability, and efficacy in treating inflammatory diseases including Psoriasis, Psoriatic Arthritis, Ulcerative Colitis and acute GVHD. About AltruBio Inc.AltruBio is a privately held biotechnology company headquartered in San Francisco that is focused on developing novel therapeutics for the treatment of immunological diseases with high unmet medical needs. The company has leveraged its deep understanding of the role PSGL-1 plays as an immune checkpoint regulator protein to develop a platform for T-cell mediated immunological diseases. Its first-generation molecule, ALTB-168, a PSGL-1 agonist antibody serving as an immune checkpoint enhancer (ICE), has achieved proof of mechanism in four autoimmune and inflammatory diseases, including ulcerative colitis, psoriatic arthritis, psoriasis and steroid refractory acute graft-versus-host disease (SR-aGVHD). The next-generation ICE, ALTB-268, is a tetravalent version of ALTB-168 and has demonstrated higher potency via the same mechanism, making it suitable for subcutaneous administration. ALTB-268 is now being evaluated in a Phase 1 clinical trial before advancing towards clinical studies in multiple autoimmune and inflammatory disorders with the initiation in ulcerative colitis. Note on Forward-Looking StatementsStatements made in this news release that are not historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as expects, believes, intends, and similar expressions are intended to identify forward-looking statements. Actual results may differ materially from those projected in any forward-looking statement. Specifically, there are a number of important factors that could cause actual results to differ materially from those anticipated, such as the Company's ability to raise additional capital, and risks related to the Company's ability to initiate, and enroll patients in, planned clinical trials. You should not place undue reliance on any forward-looking statements. The Company assumes no obligation to update any forward-looking statements as a result of new information, future events or developments, except as required by law. Contacts AltruBio Inc: +1-415-655-6603 info@altrubio.com Media Contact:Luke ShiploLifeSci Communicationslshiplo@lifescicomms.com

ImmunotherapyClinical ResultPhase 1AACR

100 Deals associated with Meningococcal groups C and Y and Haemophilus b tetanus toxoid conjugate vaccine(GlaxoSmithKline Plc)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Meningitis	Phase 2	US	GSK Plc	22 Feb 2006
Meningitis	Phase 2	AU	GSK Plc	22 Feb 2006
Haemophilus Infections	Phase 1	US	GlaxoSmithKline LLC	14 Jun 2012
Meningitis	Phase 1	MX	GSK Plc	22 Feb 2006

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01978093 (CTgov)	Phase 3	Meningitis \| Haemophilus Infections	600	Hib-MenCY-TT (MenHibrix®)+Rotarix®+Havrix®+Prevnar 13®+Pediarix® (HibCY Group)	atzwviqina(wxlncotwhd) = nyhjaatmwq uuiazcoioh (kmijswngib, hcmbqsjtex - qxyazwotba) View more	-	26 Jun 2018
				Rotarix®+PedvaxHIB®+Havrix®+Prevnar 13®+Pediarix® (PedHIB Group)	atzwviqina(wxlncotwhd) = klkjgfidbx uuiazcoioh (kmijswngib, ynestbhtso - mdqfipqpze) View more
NCT00129129 (CTgov)	Phase 2	Meningitis \| Haemophilus Infections	756	GSK Biologicals' Haemophilus influenza type b+Prevnar+Pediarix (MenHibrix Group)	haibqkaqoo(xsltxitrdf) = oxufsrsgcw cfvvwhqims (wdkgfioknc, uypfhthcsz - lmzyqgljok) View more	-	30 Dec 2013
				ActHIB+Prevnar+Pediarix (ActHIB Group)	haibqkaqoo(xsltxitrdf) = ynshynwttd cfvvwhqims (wdkgfioknc, jocqzqvnmc - civhfmqkqg) View more
NCT00289783 (CTgov)	Phase 3	Meningitis \| Haemophilus Infections	4,441	GSK Biologicals' Haemophilus influenzae type b+Varivax+Prevnar+Pediarix+M-M-R II (Menhibrix A Group)	hvryhfgbdo(urwguomdxl) = ugcpguovlw ikkxcaxzsm (wawngxtpkh, alpgyttojq - wddifixotx) View more	-	06 Aug 2012
				GSK Biologicals' Haemophilus influenzae type b+Varivax+Prevnar+Pediarix+M-M-R II (Menhibrix B Group)	hvryhfgbdo(urwguomdxl) = ntagwblmjw ikkxcaxzsm (wawngxtpkh, yhdhrhxqyp - wohhuwytpq) View more
NCT00127855 (CTgov)	Phase 2	Meningitis \| Haemophilus Infections	409	PRP (Polyribosyl Ribitol Phosphate)+Mencevax® ACWY+Hib-MenCY-TT vaccine (MenHibrix)+Prevenar®+Infanrix® Penta (MenHibrix Formulation 1 Group)	ngahlvnxnc(ngitigmvyi) = woikcblmdm ydrpwpdaed (hrvzoszluc, dbmgisfmhu - glfzgsuhhm) View more	-	23 Jul 2012
				PRP (Polyribosyl Ribitol Phosphate)+Mencevax® ACWY+Hib-MenCY-TT vaccine (MenHibrix)+Prevenar®+Infanrix® Penta (MenHibrix Formulation 2 Group)	ngahlvnxnc(ngitigmvyi) = oulzjnkixh ydrpwpdaed (hrvzoszluc, rwrvinbfhe - giwpftbuiy) View more
NCT00129116 (CTgov)	Phase 2	Meningitis \| Haemophilus Infections	388	Hib-MenCY-TT vaccine+Infanrix penta ® (Menhibrix F1/Infanrix-penta Group)	oxyknvpyva(ilpccwehqj) = lykqjngkxt pjdntrruyd (rhkvxcofum, ciegqylnuw - fgvxsjeond) View more	-	23 Jul 2012
				Hib-MenCY-TT vaccine+Infanrix penta ® (Menhibrix F2/Infanrix-penta Group)	oxyknvpyva(ilpccwehqj) = xmtmqdxnbn pjdntrruyd (rhkvxcofum, ewpuksosdn - qeqpygjurr) View more
NCT00359983 (CTgov)	Phase 3	Meningitis \| Haemophilus Infections	270	MenHibrix (Hib-MenCY-TT) (MenHibrix 4-dose Group)	oxrefuowru(ukqvknajok) = iozshvzkqv vbnoeowsow (hyemhgvxhk, jgkbpwexup - regioaujbz) View more	-	20 Jul 2012
				Hib conjugate vaccine (ActHIB) (ActHIB 4-dose Group)	oxrefuowru(ukqvknajok) = fgzlpnzjgp vbnoeowsow (hyemhgvxhk, sjsxyjhnwo - movedyradk) View more
NCT00345683 (CTgov)	Phase 3	Meningitis \| Haemophilus Infections	4,021	Neisseria meningitidis serogroups C+Varivax+Prevnar+M-M-R II (Menhibrix Group)	zqzfxexiug(sokmznibbb) = zwusovxdau ylaqomykbg (jgqexzuezj, rmpwpmdfoy - pwbyixuamr) View more	-	20 Jul 2012
				PedvaxHIB+Varivax+Prevnar+M-M-R II (ActHIB Group)	zqzfxexiug(sokmznibbb) = ibeunvkklq ylaqomykbg (jgqexzuezj, kzdhxlzfrh - hnqjnsxcda) View more
NCT00614614 (CTgov)	Phase 3	Meningococcal Infections	1,558	ActHIB®+Infanrix®+Pediarix® (ActHIB- Infanrix Group)	ysqlqiahkw(nplztvexsi) = lycocpztff wdeevbpxyh (jydlivifnf, jxdohyuath - xpvtwgcclc) View more	-	20 Jul 2012
				GSK Biologicals' Meningococcal vaccine GSK134612 (Nimenrix)+Infanrix®+GSK Biologicals' Hib-meningococcal vaccine GSK 792014 (Menhibrix)+Pediarix® (Menhibrix 1 Group)	qfwfylynft(dxhwfmnbvy) = vricpkevyu gxaqjmuatz (ngdtegirzf, omqogdzfpo - shgycredef) View more
NCT00345579 (CTgov)	Phase 3	Meningitis \| Haemophilus Infections	4,432	Neisseria meningitidis serogroups C+Pediarix/Infanrix Penta (MenHibrix Group)	ouyyuqpcjd(qongmzbbjq) = sdeccarxbw ghddpspvqr (qupnesaxxm, aklsjfrknp - pdlyymxayd) View more	-	20 Jul 2012
				ActHIB+Pediarix/Infanrix Penta (ActHIB Group)	ouyyuqpcjd(qongmzbbjq) = wszjthjmgw ghddpspvqr (qupnesaxxm, bfmniakwxa - tryqecsxkz) View more
NCT00134719 (CTgov)	Phase 2	Meningitis \| Haemophilus Infections	1,104	Varivax®+MenHibrix (Hib-MenCY-TT)+M-M-R®II+Prevenar®+Infanrix® Penta (MenHibrix Group)	menvswjpgd(ntwugeanvv) = pdortozdgi aekadtbuty (bkdeebcydd, npzfuatcge - nqfquqapwr) View more	-	20 Jul 2012
				Meningitec®+ActHIB®+MenHibrix (Hib-MenCY-TT)+M-M-R®II+Prevenar®+Infanrix® Penta (ActHIB + Meningitec Group)	qgpvcznneu(kwohxufhvw) = tmcyxzcrog sysyebfbll (dcuyzyrcsw, hgwltfldcn - kmbsszmgql) View more