Delving into the Latest Updates on Haemophilus b conjugate vaccine(GSK Plc) with Synapse

Overview

Basic Info

Drug Type

Prophylactic vaccine, Toxoid vaccine, Conjugated vaccine

Synonyms

Hib vaccine conjugate(GSK Plc), Hiberix, GSK 208108

Target-

Mechanism

Immunostimulants

Therapeutic Areas

Infectious Diseases

Active Indication

Haemophilus Infections

Inactive Indication

DiphtheriaHepatitis BMeningococcal Infections+ [3]

Originator Organization

GSK Plc

Active Organization

GlaxoSmithKline LLC

Inactive Organization

GSK Plc

Drug Highest PhaseApproved

First Approval Date

US (19 Aug 2009),

Haemophilus Infections

Regulation-

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The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V114 in healthy infants. The primary hypotheses are that: 1) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes between V114 and Prevnar 13™ based on response rates at 30 days following Dose 3; 2) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on the response rate of the 2 unique V114 serotypes compared with the lowest response rate of any of the shared serotypes in Prevnar 13™, excluding serotype 3, at 30 days following Dose 3; 3) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes based on anti-pneumococcal polysaccharide (PnPs) serotype-specific immunoglobulin g (IgG) geometric mean concentrations (GMCs) at 30 days following Dose 3; 4) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on the anti-PnPs serotype-specific IgG GMCs of the 2 unique V114 serotypes compared with the lowest IgG GMC of any of the shared serotypes in Prevnar 13™, excluding serotype 3, at 30 days following Dose 3; 5) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes between V114 and Prevnar 13™ based on anti-PnPs serotype-specific IgG GMCs at 30 days following Dose 4; and 6) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on anti-PnPs serotype-specific IgG GMCs of the 2 unique V114 serotypes compared with the lowest IgG GMC of any of the shared serotypes in Prevnar 13, excluding serotype 3, at 30 days following Dose 4.

Start Date19 Jun 2019

Sponsor / Collaborator

Merck Sharp & Dohme Corp.

NCT03620162 / CompletedPhase 3

A Phase 3, Multicenter, Randomized, Double-blind Study to Evaluate the Interchangeability of V114 and Prevnar 13™ With Respect to Safety, Tolerability, and Immunogenicity in Healthy Infants (PNEU-DIRECTION)

The goal of this study is to evaluate the safety, tolerability, and immunogenicity of the Pneumococcal Conjugate Vaccines (PCVs) V114 and Prevnar 13™ in healthy infants switched from Prevnar 13™ to V114 during the four-dose PCV immunization schedule.

Start Date18 Oct 2018

Sponsor / Collaborator

Merck Sharp & Dohme Corp.

NCT03621670 / Active, not recruitingPhase 3

Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants

The purpose of this study is to evaluate the safety and immunogenicity of Bexsero (meningococcal group B vaccine-rMenB+OMV NZ) in North American infants 6 weeks through 12 weeks of age, when administered concomitantly with Pneumococcal conjugate vaccine (PCV 13) and other recommended routine infant vaccines(RIV).

Start Date27 Jul 2018

Sponsor / Collaborator

GSK Plc

100 Clinical Results associated with Haemophilus b conjugate vaccine(GSK Plc)

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100 Translational Medicine associated with Haemophilus b conjugate vaccine(GSK Plc)

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100 Patents (Medical) associated with Haemophilus b conjugate vaccine(GSK Plc)

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68

Literatures (Medical) associated with Haemophilus b conjugate vaccine(GSK Plc)

04 May 2018·Human vaccines & immunotherapeuticsQ3 · MEDICINE

Progress toward the global control ofNeisseria meningitidis: 21st century vaccines, current guidelines, and challenges for future vaccine development

Q3 · MEDICINE

Review

Author: Rouphael, N. G. ; Stephens, D. S. ; Dretler, A. W.

The control of meningitis, meningococcemia and other infections caused by Neisseria meningitidis is a significant global health challenge. Substantial progress has occurred in the last twenty years in meningococcal vaccine development and global implementation. Meningococcal protein-polysaccharide conjugate vaccines to serogroups A, C, W, and Y (modeled after the Haemophilus influenzae b conjugate vaccines) provide better duration of protection and immunologic memory, and overcome weak immune responses in infants and young children and hypo-responsive to repeated vaccine doses seen with polysaccharide vaccines. ACWY conjugate vaccines also interfere with transmission and reduce nasopharyngeal colonization, thus resulting in significant herd protection. Advances in serogroup B vaccine development have also occurred using conserved outer membrane proteins with or without OMV as vaccine targets. Challenges for meningococcal vaccine research remain including developing combination vaccines containing ACYW(X) and B, determining the ideal booster schedules for the conjugate and MenB vaccines, and addressing issues of waning effectiveness.

01 Oct 2017·The Pediatric infectious disease journalQ4 · MEDICINE

Cardio-respiratory Events and Inflammatory Response After Primary Immunization in Preterm Infants < 32 Weeks Gestational Age: A Randomized Controlled Study

Q4 · MEDICINE

Article

Author: Germain, Nathalie ; Martin, Brigitte ; Lebel, Marc H. ; Pladys, Patrick ; Nuyt, Anne Monique ; Hernández, Alfredo I. ; Cloutier, Anik ; Sutherland, Megan R. ; Ben Jmaa, Wissal ; Lachance, Christian

Background::

Inflammation may depress respiration in neonates. This study aimed to establish a link between postimmunization inflammation and cardio-respiratory events (CREs).

Methods::

Randomized double-blind controlled study of infants born < 32 weeks gestation receiving the 2 months vaccine, which comprised diphtheria and tetanus toxoids and acellular pertussis adsorbed combined with inactivated poliomyelitis vaccines and Haemophilus b conjugate and the pneumococcal conjugate 10-valent vaccines. Infants were randomized to ibuprofen treatment or a placebo group (n = 28/group). C-reactive protein (CRP) and prostaglandins E2 (PgE2) levels were assessed before and after immunization. CREs were recorded for 72 hours. Heart rate variability was assessed by polysomnography.

Results::

In the placebo group, immunization was associated with significantly increased CRP levels and an increase in CRE (8.6 ± 11.1 before versus 14.0 ± 12.8 after), which did not reach statistical significance (P = 0.08), and no change in PgE2. The increase in CRP was correlated with changes in CRE (r = 0.4: P < 0.05). In the ibuprofen group, immunization significantly increased CRP levels but was not associated with change in CRE (6.7 ± 7.7 before versus 6.8 ± 9.7 after) and PgE2 levels. Comparing the groups, variation in CRE (ΔCRE before versus after immunization) was significantly lower in the ibuprofen group (0.1 ± 7.9 versus 5.4 ± 10.0 ΔCRE; P < 0.05).

Conclusion::

The first immunization of infants born < 32 weeks was associated with an increase in CRP. Ibuprofen treatment significantly attenuated the variation (Δ) in CRE following first immunization in these infants but the current study could not demonstrate an impact on CRP and PgE2 levels. The impact of anti-inflammatory treatment on antigenicity must be evaluated before their clinical use aiming at reducing CRE after immunization in preterm infants.

01 Mar 2013·The American journal on addictionsQ4 · MEDICINE

Spontaneous Development of IgM Anti‐Cocaine Antibodies in Habitual Cocaine Users: Effect on IgG Antibody Responses to a Cocaine Cholera Toxin B Conjugate Vaccine

Q4 · MEDICINE

Article

Author: Wu, Yan ; Orson, Frank M. ; Lopez, Angel Y. ; Rossen, Roger D. ; Kosten, Thomas R. ; Shen, Xiaoyun

Background and Objectives:

In cocaine vaccine studies, only a minority of subjects made strong antibody responses. To investigate this issue, IgG and IgM antibody responses to cocaine and to cholera toxin B (CTB—the carrier protein used to enhance immune responses to cocaine) were measured in sera from the 55 actively vaccinated subjects in a Phase IIb randomized double‐blind placebo‐controlled trial (TA‐CD 109).

Methods:

Isotype specific ELISAs were used to measure IgG and IgM anti‐cocaine and anti‐CTB antibody in serial samples collected prior to and at intervals after immunization. We assessed IgG anti‐cocaine responses of patients with pre‐vaccination IgM anti‐cocaine antibodies. Competitive inhibition ELISA was used to evaluate antibody specificity.

Results and Conclusions:

Before immunization, 36/55 subjects had detectable IgM antibodies to cocaine, and 9 had IgM levels above the 95% confidence limit of 11 μg/ml. These nine had significantly reduced peak IgG anti‐cocaine responses at 16 weeks, and all were below the concentration (40 μg/ml) considered necessary to discourage recreational cocaine use. The IgG anti‐CTB responses of these same subjects were also reduced.

Scientific Significance:

Subjects who develop an IgM antibody response to cocaine in the course of repeated recreational exposure to this drug are significantly less likely to produce high levels of IgG antibodies from the cocaine conjugate vaccine. The failure may be due to recreational cocaine exposure induction of a type 2 T‐cell independent immune response. Such individuals will require improved vaccines and are poor candidates for the currently available vaccine. (Am J Addict 2013;22:169‐174)

100 Deals associated with Haemophilus b conjugate vaccine(GSK Plc)

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	J07AG51	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Haemophilus Infections	US	GlaxoSmithKline LLC	19 Aug 2009

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Streptococcal Infections	Phase 3	KR	GSK Plc	10 Jun 2008
Diphtheria	Phase 3	PH	GSK Plc	16 Jun 2005
Diphtheria	Phase 3	TH	GSK Plc	16 Jun 2005
Hepatitis B	Phase 3	PH	GSK Plc	16 Jun 2005
Hepatitis B	Phase 3	TH	GSK Plc	16 Jun 2005
Meningococcal Infections	Phase 3	PH	GSK Plc	16 Jun 2005
Meningococcal Infections	Phase 3	TH	GSK Plc	16 Jun 2005
Tetanus	Phase 3	PH	GSK Plc	16 Jun 2005
Tetanus	Phase 3	TH	GSK Plc	16 Jun 2005
Whooping Cough	Phase 3	PH	GSK Plc	16 Jun 2005

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03207750 (CTgov)	Phase 3	Rotavirus Infections \| Viral gastroenteritis due to Rotavirus	1,280	human rotavirus (HRV) vaccine+Hiberix+Prevnar-13+Pediarix (HRV Porcine Circovirus (PCV)-Free Liquid Group)	gwcbzidtiv(fawwbtgvra) = ffqjwdwtsa hiffcylqwe (xdkcheqnpx, fdpuzuespp - rrpkgyltcm) View more	-	31 Oct 2019
				human rotavirus (HRV) vaccine+Hiberix+Prevnar-13+Pediarix (HRV Lyophilized Group)	gwcbzidtiv(fawwbtgvra) = adukdkaqdt hiffcylqwe (xdkcheqnpx, uhdrdzfnjt - iufdliztvv) View more
NCT01098474 (CTgov)	Phase 2	Tuberculosis	301	GSK's investigational vaccine 692342 (SB692342 2 Dose Group)	zlybsqzfve(cajedfxivm) = rzvxvonhua frmqiizacb (otfbpvugob, zsudlscatg - nkjxpybgfb) View more	-	27 Nov 2018
				GSK's investigational vaccine 692342 (SB692342 1 Dose Group)	zlybsqzfve(cajedfxivm) = sylcvuawim frmqiizacb (otfbpvugob, srhxrwgxhu - shtyxwzdnz) View more
NCT00291343 (CTgov)	Phase 3	Meningococcal Infections	296	Hib-MenAC+Tritanrix-HepB+Mencevax ACWY (Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group)	poyhqweudr(lwgqohnjky) = ohmoeoisov iocjwchipf (mrjtzumqfk, tzmckmtwuk - qlnkhehypr) View more	-	03 Aug 2017
				Tritanrix-HepB+Hiberix+Mencevax ACWY (Tritanrix-HepB/Hiberix+Mencevax ACWY Group)	poyhqweudr(lwgqohnjky) = gujflaydkc iocjwchipf (mrjtzumqfk, wmbguzwxut - vgebieanfx) View more
NCT00317109 (CTgov)	Phase 3	Meningococcal Infections	168	Tritanrix-HepB+Hiberix (Tritanrix-HepB/Hiberix Group)	puhkmojoqr(ohaxuwnxkg) = xfrtrqqufa qcpglrzyyq (eqjaqaoplq, lbrbgkknfu - tmoyxxsboc) View more	-	01 Mar 2017
				Hiberix-Mencevax AC+Tritanrix-HepB (Tritanrix-HepB/Hiberix-Mencevax AC Group)	puhkmojoqr(ohaxuwnxkg) = zwrqreoafd qcpglrzyyq (eqjaqaoplq, jnneexsyvb - omhrynzzwb) View more
NCT01000974 (CTgov)	Phase 3	Haemophilus Infections	4,003	GSK Biologicals' Haemophilus influenzae type b vaccine (GSK 208108)+Infanrix™+Rotarix™+Prevnar 13™+Pediarix™ (Hiberix Group)	vonruwkkrb(zothvooidl) = iktvairguh ulqdrjjssn (mwwfkxnzcd, gqbejtwlnl - ganimbsnrt) View more	-	19 Aug 2013
				ActHIB™+Infanrix™+Rotarix™+Prevnar 13™+Pediarix™ (ActHIB Group)	vonruwkkrb(zothvooidl) = pcdgruxaie ulqdrjjssn (mwwfkxnzcd, zuumyzxgob - kkyrxamlmh) View more
NCT00911144 (CTgov)	Phase 3	Streptococcal Infections	450	GSK Biologicals' Synflorix™ (Pneumococcal vaccine GSK1024850A)+GSK Biologicals' Hiberix™ (Synflorix Group)	lenfwphnws(zttkloqond) = rizqodsgwq ayugshnmpe (ejwrvpjdau, dqijaxwrrs - iqthdgtlep) View more	-	19 Jan 2011
				Wyeth-Lederle's Prevenar™+GSK Biologicals' Hiberix™ (Prevenar Group)	lenfwphnws(zttkloqond) = mteycdhsiq ayugshnmpe (ejwrvpjdau, qstnakmzgw - qdhnmoongu) View more
NCT00680914 (CTgov)	Phase 3	Streptococcal Infections	503	Pneumococcal vaccine GSK1024850A (Synflorix)+GSK Biologicals' Hiberix™ (Synflorix Group)	yjlkaxkqvb(rxmsfqwvyx) = dlupkakwgk nfmewieezb (nccujsatmt, mioapfqolt - ugtynqofjj) View more	-	14 Jun 2010
				GSK Biologicals' Hiberix™+Prevenar (Prevenar Group)	yjlkaxkqvb(rxmsfqwvyx) = ybzufouteb nfmewieezb (nccujsatmt, tmvrenizoz - xmthhefdav) View more
NCT00696423 (CTgov)	Phase 3	Diphtheria \| Whooping Cough \| Tetanus	467	Hiberix™+Infanrix™ (Infanrix/Hib Single Injection Group)	pvjkqiltxj(rasxeizpaz) = vlfhzpqqqs vjeymarwve (hoosjassne, doeqancndx - nlmrpxrxdt) View more	-	26 Aug 2009
				Hiberix™+Infanrix™ (Infanrix + Hiberix Separate Injection Group)	pvjkqiltxj(rasxeizpaz) = dufnivtazy vjeymarwve (hoosjassne, hyzowfuipj - ozufzdquyd) View more