Delving into the Latest Updates on Hepatitis A inactivated & hepatitis B (recombinant) vaccine(GlaxoSmithKline Plc) with Synapse

Overview

Basic Info

Drug Type

Inactivated vaccine, Prophylactic vaccine

Synonyms

Ambirix, Hepatitis A-hepatitis B vaccine, Twinrix Adult

+ [6]

Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesDigestive System Disorders

Active Indication

Hepatitis AHepatitis B

Inactive Indication-

Originator Organization

GSK Plc

Active Organization

GlaxoSmithKline Biologicals SAGlaxoSmithKline LLCGlaxoSmithKline Australia Pty Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

European Union (19 Sep 1996),

Hepatitis AHepatitis B

Regulation-

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Structure/Sequence

Sequence Code 160473134

Previous studies have shown that 5-10% of Hepatitis B Virus vaccine recipients produce none or to few antibodies after a standard immunization with 3 vaccines. These individuals are defined as non-responders. The investigators wish to investigate if mounting another kind of immune response, called the cellular immune (CMI) response, protects these non-responders.
Aim/Hypothesis
Primary aims:
To estimate the CMI response in serologic non-responders after receiving a standard course of HBV immunization
Secondary aims:
To establish the prevalence of serological non-responders after a standard course of HBV vaccination.
To assess the safety of the vaccine.
Evaluate predictors of serologic non-response in young, healthy individuals receiving a standard course of HBV immunization
To compare the immunological profile before and after a standard HBV vaccination regimen on non-responders and responders
Establish a rapid test for measuring CMI after being HBV vaccinated.
A total of 400 healthy volunteers receive a standard course of immunization with a combined hepatitis A and B vaccine (Twinrix®) at 0, 1, and 6 months. Blood is drawn at 0 and 8 months from all participants. The blood will be analysed to see if there is antibodies or/and if there is mounted a cellular immune response by measuring on parameters called cytokines.

Start Date01 Oct 2011

Sponsor / Collaborator

University of Aarhus

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100 Clinical Results associated with Hepatitis A inactivated & hepatitis B (recombinant) vaccine(GlaxoSmithKline Plc)

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100 Translational Medicine associated with Hepatitis A inactivated & hepatitis B (recombinant) vaccine(GlaxoSmithKline Plc)

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100 Patents (Medical) associated with Hepatitis A inactivated & hepatitis B (recombinant) vaccine(GlaxoSmithKline Plc)

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106

Literatures (Medical) associated with Hepatitis A inactivated & hepatitis B (recombinant) vaccine(GlaxoSmithKline Plc)

01 Nov 2023·The Lancet Infectious Diseases

Malaria transmission-blocking vaccines Pfs230D1-EPA and Pfs25-EPA in Alhydrogel in healthy Malian adults; a phase 1, randomised, controlled trial

Article

Author: Muratova, Olga ; Fintzi, Jonathan ; Samake, Yacouba ; Gorres, J Patrick ; Healy, Sara A ; Doumbo, Ogobara K ; Hume, Jen C C ; Imeru, Alemush ; Mohan, Rathy ; Kone, Mamady ; Duffy, Patrick E ; Doucoure, M'Bouye ; Sylla, Daman ; Kwan, Jennifer L ; O'Connell, Elise M ; MacDonald, Nicholas J ; Niaré, Karamoko ; Sagara, Issaka ; Salazar-Miralles, Fernando ; Diarra, Balla ; Thera, Ismaila ; Jones, David S ; Sissoko, Kourane ; Narum, David L ; Rausch, Kelly M ; Zaidi, Irfan ; Duan, Junhui ; Swihart, Bruce J ; Zhu, Daming ; Assadou, Mahamadoun H ; Morrison, Robert D ; Traore, Sekou F ; Coulibaly, Mamadou B ; Neal, Jillian ; Kamate, Bourama ; Guindo, Merepen A ; Anderson, Charles F ; Wu, Yimin ; Dolo, Amagana

BACKGROUNDMalaria transmission-blocking vaccines target mosquito-stage parasites and will support elimination programmes. Gamete vaccine Pfs230D1-EPA/Alhydrogel induced superior activity to zygote vaccine Pfs25-EPA/Alhydrogel in malaria-naive US adults. Here, we compared these vaccines in malaria-experienced Malians.METHODSWe did a pilot safety study then double-blind, block-randomised, comparator-controlled main-phase trial in malaria-intense Bancoumana, Mali. 18-50-year-old healthy non-pregnant, non-breastfeeding consenting adult residents were randomly assigned (1:1:1:1) to receive four doses at months 0, 1, 4·5, and 16·5 of either 47 μg Pfs25, 40 μg Pfs230D1 or comparator (Twinrix or Menactra)-all co-administered with normal saline for blinding-or 47 μg Pfs25 plus 40 μg Pfs230D1 co-administered. We documented safety and tolerability (primary endpoint in the as-treated populations) and immunogenicity (secondary endpoint in the as-treated populations: ELISA, standard-membrane-feeding assay, and mosquito direct skin feed assay). This trial is registered at ClinicalTrials.gov, NCT02334462.FINDINGSBetween March 19, and June 2, 2015, we screened 471 individuals. Of 225 enrolled for the pilot and main cohorts, we randomly assigned 25 participants to pilot safety cohort groups of five (20%) to receive a two-dose series of Pfs25-EPA/Alhydrogel (16 μg), Pfs230D1-EPA/Alhydrogel (15 μg) or comparator, followed by Pfs25-EPA/Alhydrogel (16 μg) plus Pfs230D1-EPA/Alhydrogel (15 μg) or comparator plus saline. For the main cohort, we enrolled 200 participants between May 11 and June 2, 2015, to receive a four-dose series of 47 μg Pfs25-EPA/Alhydrogel plus saline (n=50 [25%]; Pfs25), 40 μg Pfs230D1-EPA/Alhydrogel plus saline (n=49 [25%]; Pfs230D1), 47 μg Pfs25-EPA/Alhydrogel plus 40 μg Pfs230D1-EPA/Alhydrogel (n=50 [25%]; Pfs25 plus Pfs230D1), or comparator (Twinrix or Menactra) plus saline (n=51 [25%]). Vaccinations were well tolerated in the pilot safety and main phases. Most vaccinees became seropositive after two Pfs230D1 or three Pfs25 doses; peak titres increased with each dose thereafter (Pfs230D1 geometric mean: 77·8 [95% CI 56·9-106·3], 146·4 [108·3-198·0], and 410·2 [301·6-558·0]; Pfs25 geometric mean 177·7 [130·3-242·4] and 315·7 [209·9-474·6]). Functional activity (mean peak transmission-reducing activity) appeared for Pfs230D1 (74·5% [66·6-82·5]) and Pfs25 plus Pfs230D1 (68·6% [57·3-79·8]), after the third dose and after the fourth dose (88·9% [81·7-96·2] for Pfs230D1 and 85·0% [78·4-91·5] Pfs25 plus Pfs230D1) but not for Pfs25 (58·2% [49·1-67·3] after the third dose and 58·2% [48·5-67·9] after the fourth dose). Pfs230D1 transmission-reducing activity (73·7% [64·1-83·3]) persisted 10 weeks after the fourth dose. Transmission-reducing activity of 80% was estimated at 1659 ELISA units for Pfs25, 218 for Pfs230D1, and 223 for Pfs230D1 plus Pfs25. After 3850 direct skin feed assays, 35 participants (12 Pfs25, eight Pfs230D1, five Pfs25 plus Pfs230D1, and ten comparator) had transmitted parasites at least once. The proportion of positive assays in vaccine groups (Pfs25 33 [3%] of 982 [-0·013 to 0·014], Pfs230D1 22 [2%] of 954 [-0·005 to 0·027], and combination 11 [1%] of 940 [-0·024 to 0·002]) did not differ from that of the comparator (22 [2%] of 974), nor did Pfs230D1 and combination groups differ (-0·024 to 0·001).INTERPRETATIONPfs230D1 but not Pfs25 vaccine induces durable serum functional activity in Malian adults. Direct skin feed assays detect parasite transmission to mosquitoes but increased event rates are needed to assess vaccine effectiveness.FUNDINGIntramural Research Program of the National Institute of Allergy and Infectious Diseases and US National Institutes of Health.

01 Sep 2020·VaccineQ3 · MEDICINE

Safety evaluation of adverse events following vaccination with Havrix, Engerix-B or Twinrix during pregnancy

Q3 · MEDICINE

Review

Author: Ibrahimi, Abdelilah ; Celzo, Froilan ; Buyse, Hubert ; Welby, Sarah

BACKGROUNDVaccination of pregnant women against hepatitis A virus (HAV) or hepatitis B virus (HBV) may benefit the mother and the fetus but is not routinely recommended. However, the risk associated with vaccination should be weighed against the risk of HAV or HBV infection. Data on safety profiles after hepatitis A, B or combined AB immunization during pregnancy are limited.METHODSWe searched the GSK Worldwide Safety Database for adverse events (AEs) following immunization of pregnant women with HAV (Havrix, GSK), HBV (Engerix-B, GSK) or the combined hepatitis AB (Twinrix, GSK) vaccine since market authorization through 31 January 2018, covering at least 25 years. AE reports (spontaneous, post-marketing surveillance and clinical trial cases) in the GSK Worldwide Safety Database were identified using a systematic search and were reviewed by clinicians to ascertain pregnancy status at time of vaccination and characterize adverse pregnancy outcomes, including pregnancy-related AEs and AEs in infants regardless of the causality assessment.RESULTSOverall, 613, 700 and 363 pregnancies with exposure to Havrix, Engerix-B and Twinrix, respectively, were reported. Of these, 378, 339 and 194 were analyzed. The most frequently identified pregnancy outcomes were live infants (288, 223 and 151), spontaneous abortions (43, 57 and 26) and elective terminations (25, 24 and 9). A total of 19, 29 and 10 cases of congenital anomalies were reported. Of these, 17, 20 and 7 were major birth defects. The most commonly reported pregnancy-related AE and AE in infants were premature delivery (28) and jaundice (11), respectively. No maternal deaths were reported. Congenital anomalies were reported in all recorded infant deaths.CONCLUSIONSThis review did not indicate any concerning pattern of adverse pregnancy outcomes following exposure to any of the 3 vaccines during pregnancy.

02 Mar 2020·Military MedicineQ4 · MEDICINE

Latex content in adult vaccines

Q4 · MEDICINE

Article

Author: Smith, Derek ; Gomez, Robert ; Davenport, Julie

AbstractIntroductionHypersensitivity reactions to natural rubber latex are well-characterized occupational concerns for health care personnel. Health care providers are at increased risk for exposure and possibly transmission of vaccine preventable diseases. Therefore, many health care facilities require providers to be vaccinated against these diseases to maintain employment. Mandatory vaccination for these health care providers presents potential challenges and safety concerns.Materials and MethodsUsing a commercial Latex Allergen ELISA Assay kit for Hev b 1, we evaluated the latex content of HAVRIX, ENGERIX-B, TWINRIX, and BOOSTRIX all manufactured by GlaxoSmithKline.ResultsThese data demonstrate undetectable Hev b 1 content among all of the vaccines tested. This study provides the first known data regarding natural rubber latex content in adult vaccines.ConclusionsOur study revealed undetectable levels of Hev b 1 natural rubber latex content in the tested adult vaccines. These data provide evidence for prospective studies into the safety of vaccinating latex allergic patients.

100 Deals associated with Hepatitis A inactivated & hepatitis B (recombinant) vaccine(GlaxoSmithKline Plc)

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External Link

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R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Hepatitis A	Liechtenstein	GlaxoSmithKline Biologicals SA	19 Sep 1996
Hepatitis A	European Union	GlaxoSmithKline Biologicals SA	19 Sep 1996
Hepatitis A	Norway	GlaxoSmithKline Biologicals SA	19 Sep 1996
Hepatitis A	Iceland	GlaxoSmithKline Biologicals SA	19 Sep 1996
Hepatitis B	Liechtenstein	GlaxoSmithKline Biologicals SA	19 Sep 1996
Hepatitis B	Norway	GlaxoSmithKline Biologicals SA	19 Sep 1996
Hepatitis B	European Union	GlaxoSmithKline Biologicals SA	19 Sep 1996
Hepatitis B	Iceland	GlaxoSmithKline Biologicals SA	19 Sep 1996

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00289731 (CTgov)	Phase 4	Hepatitis A \| Hepatitis B	596	TWINRIX™ (Twinrix Group)	kigtvhhqms(iyicqjizxm) = tkgciijdap jfitxmocxe (pgyvzdhwmk, ysfoensvdu - lcmftumnbc) View more	-	03 Oct 2018
				Engerix™-B+HAVRIX™ (Engerix-B+Havrix Group)	rfawdkqqyo(bwbshaoeqo) = ktdkzdumlv yeutoyocxf (zmgkvgnwpu, zphuwpqdkr - kbepxltbgq) View more
NCT01453348 (CTgov)	Phase 3	Meningitis, Meningococcal	252	HepA/B+MenACWY-CRM (HepA/B+MenACWY-CRM)	uooinwksbh(jfohxgeaum) = brcyzhtlea igkvhwpqsc (ujowwdwpnd, xylvufzndb - otysrnasgi) View more	-	10 Mar 2014
				monovalent hepatitis A vaccine+hepatitis B vaccine+hepatitis A/B vaccine+hepatitis A vaccine (HepA/B)	uooinwksbh(jfohxgeaum) = mzevlnkpcq igkvhwpqsc (ujowwdwpnd, ojyztpbifg - kpvtlipgzg) View more
NCT00106964 (CTgov)	Phase 4	Hepatitis B \| HIV Infections	371	Hepatitis B vaccine (1: Engerix 20 mcg)	lvvqfotlsw(reyzhypdwo) = jhklviqmpv rsgcdmizvx (umegcdjrdh, wifpoqlxwh - pdqczraynt) View more	-	28 Jun 2013
				Hepatitis B vaccine (2: Engerix 40 mcg)	lvvqfotlsw(reyzhypdwo) = gisbfjgpcz rsgcdmizvx (umegcdjrdh, oqbrgorysp - jwxwkljpvj) View more
NCT00465816 (CTgov)	Phase 3	Meningococcal Infections	611	Nimenrix (Meningococcal vaccine 134612)+Twinrix (Nimenrix + Twinrix Group)	jxrqfnmsqw(ayiaiwjbwl) = zmcwqqwbfo zzaipkykuf (omlzosqcif, odiwaxkkfm - omqjwzctnn) View more	-	22 May 2012
				Nimenrix (Meningococcal vaccine 134612) (Nimenrix Group)	jxrqfnmsqw(ayiaiwjbwl) = znqkwmzcaj zzaipkykuf (omlzosqcif, szcylujunt - vdviovsboj) View more
NCT00289770 (CTgov)	Phase 3	Hepatitis A \| Hepatitis B	50	Twinrix	xysaadkebs(qplgyyuskq) = ebxttnihct nrkxtrgkta (rxerbpkrsz, pnszbyyvek - bgbxaudcqp) View more	-	23 Feb 2011
NCT00289718 (CTgov)	Phase 3	Hepatitis A \| Hepatitis B	51	Twinrix™ adult (Twinrix Group)	idsvekitks(fqzznadgjs) = ybbmsoymuz plptqfitfn (sphxjmgmmp, hdnhtoavck - levfbrgpis) View more	-	26 Aug 2010
				Twinrix™ adult (TWINRIX GROUP)	vamypeybud(dsoydemelz) = ksrguwdciq daionpigcd (emuhodmvqk, npmzxmekqn - ltsvdiecaz) View more
NCT00289744 (CTgov)	Phase 3	Hepatitis A \| Hepatitis B	178	TWINRIX™ ADULT (Twinrix Group)	unifchddfm(fvkbdhlvuj) = ehxaqlegze mlghqhwtaj (elrudfyusc, vzkvnimbfm - uncqeeuamc) View more	-	26 Aug 2010
				Engerix TM (Engerix-B Additional Dose (Adult))	tnmkxcrdpm(nuadgsddtg) = egpgvjluoo xxjlamrjhm (gfzljnopab, pemeoskidk - iiuupzwahc) View more
NCT00578227 (CTgov)	Phase 3	Human Papillomavirus Infection	814	Cervarix™+Twinrix ™ Paediatric (Cervarix™ & Twinrix™ Group)	vaqtyspyoh(dlvkxumhpw) = dcuejuezba qvbqgduuqd (xnojqgnrxu, ywnmfboyxb - qubuhgtwaw) View more	-	06 Jan 2010
				Cervarix™ (Cervarix™ Group)	pfmsbhecnt(rhtwlaociu) = bvpbqxpntr dnlcgtsjvk (xyanzfzphz, qmyikmlaol - ywdkbcmyqi) View more
NCT00684671 (CTgov)	Phase 4	Hepatitis A \| Hepatitis B	506	Twinrix (Twinrix Group)	fvoamzrvjq(celfayhoxo) = eqtnrwjsrg wqqjtumbjy (whhmfjefln, isppjtllbz - qmoabasvhs) View more	-	03 Dec 2009
				Engerix-B+Havrix (Engerix + Havrix Group)	fvoamzrvjq(celfayhoxo) = fcidjlyewt wqqjtumbjy (whhmfjefln, trnhdipuub - autmfzpasl) View more
NCT00197119 (CTgov)	Phase 3	Hepatitis A \| Hepatitis B	244	Twinrix™ Junior (Group Twinrix Junior)	lbvgrtqlnq(lcoomgqzvj) = gjegbzxatc msjabyeenu (aactjnqxxk, wkammippzz - iagdiervba) View more	-	14 Aug 2009
				Twinrix™ Adult (Group Twinrix Adult)	lbvgrtqlnq(lcoomgqzvj) = hqgnajuoyz msjabyeenu (aactjnqxxk, vidolevbyr - vhdlyermbd) View more