Delving into the Latest Updates on Hepatitis A vaccine, inactivated(GlaxoSmithKline Plc) with Synapse

Overview

Basic Info

Drug Type

Inactivated vaccine, Prophylactic vaccine

Synonyms

Havrix Junior, Havrix Monodose, Hepatitis A vaccine inactivated

+ [1]

Target-

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesDigestive System Disorders

Active Indication

Hepatitis A

Inactive Indication

Human Papillomavirus Infection

Originator Organization

GSK Plc

Active Organization

GlaxoSmithKline LLC

Inactive Organization

GSK Plc

Drug Highest PhaseApproved

First Approval Date

US (22 Feb 1995),

Hepatitis A

Regulation-

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The hepatitis A virus (HAV) is a significant global public health concern. The hepatitis A virus is transmitted primarily by the faecal-oral route, leading to acute hepatitis. Symptoms include low-grade fever, anorexia, jaundice, and typically resolve without complications.
However, HAV infection in patients with chronic liver disease, especially those over 50 years old, may result in more severe outcomes, including fulminant hepatitis, with a higher mortality rate compared to the general population
HAV vaccination is a cornerstone of prevention, especially in high-risk groups. Currently, there is a recommendation to vaccinate patients with chronic liver disease against HAV infection. However, these patients often have compromised immune responses, leading to lower vaccine efficacy compared to the general population.
The goal of this randomized controlled trial is to compare the efficacy and safety of the standard 2-dose (0, 6 months) hepatitis A vaccination regimen with an intensive 3-dose (0, 1, 6 months) schedule in patients with advanced fibrosis and cirrhosis.
The main questions it aims to answer are:
Compared the seroconversion rate of the standard 2-dose (0, 6 months) hepatitis A vaccination regimen versus the intensive 3-dose (0, 1, 6 months) hepatitis A vaccination regimen in patients with advanced fibrosis and cirrhosis.
Compared the antibody levels against the hepatitis A virus (Anti-HAV IgG) of the standard 2-dose (0, 6 months) hepatitis A vaccination regimen versus the intensive 3-dose (0, 1, 6 months) hepatitis A vaccination regimen in patients with advanced fibrosis and cirrhosis.

Start Date29 Feb 2024

Sponsor / Collaborator

Mahidol University

NCT05778357 / CompletedNot ApplicableIIT

The Effect of the Covid 19 Pandemic Process on the Neuromotor Developments of 6-24 Month-old Babies: A Cross-sectional Study From Turkey

Development; It covers the areas of physical, mental, emotional and social development. Development in one area affects other areas as well. Infancy is the period in which children grow and develop the fastest. Babies need many environmental factors and stimulants in order to have a healthy developmental process. For the Covid 19 pandemic, many restrictions have been made in Turkey to reduce the spread of the epidemic and to maintain social distance between people. It has been suggested that individuals practice their own social isolation. It has also caused babies who spend their time at home during the pandemic process to be deprived of environmental stimuli. In current studies in the literature, it has been reported that the COVID-19 pandemic affects infant and child development significantly and negatively. It has been reported that the risk of delay in children who have experienced the COVID-19 pandemic is especially in the fine motor and communication areas. There is a limited number of studies in the literature on this subject. No study was found in Turkey. The aim of this study is to evaluate the neuromotor development of infants in early childhood (6-24 months) in the Covid-19 pandemic and to reveal the effects of the pandemic process. Denver II Developmental Screening Test was used to evaluate the neuromotor development of healthy infants aged 6-24 months, who applied to the healthy pediatric outpatient clinic of Acıbadem Altunizade Hospital, and Alberta Infant Motor Scale was used to evaluate gross motor functions.

Start Date25 Jun 2022

Sponsor / Collaborator

Istanbul University

NCT04422340 / Unknown statusNot ApplicableIIT

A Multicentric Survey on Patients Over 60 Admitted to Intensive Care for Severe Forms of COVID Infection: Search for Prognostic Criteria Associated With Survival

With the spread of COVID-19 epidemic since 2019 in Wuhan, China health plans have to be adapted continuously in response to the emergency. The first publications from the Chinese experience demonstrate an increase in the incidence of COVID-19 infections in patients over 60 years of age, a higher frequency of severe forms of the disease and therefore theoretical indications of orientation towards resuscitative care.
However, the first published data from Hubei province suggest a low benefit of resuscitation for patients between 70 and 80 years of age and null in patients over 80 years of age. These data question the individual benefit / risk balance of an orientation towards resuscitation for this category of patients, their quality of life and the concept of unreasonable obstinacy.
Among the covariates associated with resuscitation mortality described in the data published to date, cardiovascular comorbidities, certain biological covariates (LDH, creatinine, lymphocytes, neutrophils, TP, D-dimers, etc.), the time between the first symptoms and the entry into resuscitation have been identified.
The objective of this multicentric observational study is to determine the clinical and biological covariates predictive of mortality in the population of patients over 60 years of age admitted in intensive care unit, in particular by integrating functional and nutritional data from patients 1 month before COVID-19 infection.

Start Date01 Apr 2020

Sponsor / Collaborator

Hospices Civils de Lyon

100 Clinical Results associated with Hepatitis A vaccine, inactivated(GlaxoSmithKline Plc)

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100 Translational Medicine associated with Hepatitis A vaccine, inactivated(GlaxoSmithKline Plc)

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100 Patents (Medical) associated with Hepatitis A vaccine, inactivated(GlaxoSmithKline Plc)

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106

Literatures (Medical) associated with Hepatitis A vaccine, inactivated(GlaxoSmithKline Plc)

08 Dec 2023·Emerging microbes & infections

Durability of serologic responses to inactivated hepatitis A virus vaccination among people living with HIV following acute hepatitis A outbreak: a 5-year follow-up study

Article

Author: Lin, Kuan-Yin ; Sun, Hsin-Yun ; Liu, Wang-Da ; Hsieh, Szu-Min ; Huang, Sung-Hsi ; Hung, Chien-Ching ; Chen, Guan-Jhou ; Huang, Yu-Shan

Serologic responses to hepatitis A virus (HAV) vaccination may wane among immunocompromised populations. To evaluate the long-term seroresponses to 2-dose HAV vaccination, we retrospectively included people living with HIV (PLWH) who had achieved seroconversion within 12 months after vaccination at a university hospital during an outbreak of acute hepatitis A between 2015 and 2017. PLWH included in the study received either Havrix or Vaqta. The seroresponses were evaluated 60 months after the second dose of vaccination and estimated by the intention-to-treat (ITT) with last-observation-carried-forward (LOCF) and per-protocol (PP) analyses. Overall, 986 PLWH (median age, 34 years and CD4 count, 587 cells/µL) were included. The rates of PLWH with persistent seroprotection at month 60 of vaccination were 90.7% (894/986) and 97.4% (748/768) in the ITT with LOCF and PP analyses, respectively. PLWH with persistent seroprotection had achieved higher peak anti-HAV IgG titers after vaccination and had a slower decline in antibody levels compared with those with seroreversion. In the multivariable analysis, seroreversion at month 60 was associated with a higher body-mass index (per 1-kg/m² increase, AOR, 1.10; 95% CI, 1.04-1.17), lowest-ever CD4 count (per 10-cell/µL increase, AOR 0.98; 95% CI, 0.97-1.00), plasma HIV RNA <200 copies/ml at vaccination (AOR, 0.28; 95% CI, 0.14-0.59), and having received Vaqta as the first dose of HAV vaccination (AOR, 0.44; 95% CI, 0.27-0.70). The seroprotection against HAV remained high in the long-term follow-up among PLWH on antiretroviral therapy after 2-dose HAV vaccination. Regular monitoring of seroresponses and timely administration of HAV vaccines are warranted to maintain seroprotection.

06 Oct 2023·Vaccine

Immunogenicity and safety of Havisure^TM vaccine developed by Human Biologicals Institute in healthy subjects of 12 months to 49 years of age: A phase II/III, randomized, single blind, non-inferiority study.

Article

Author: Palkar, Sonali ; Kanakasapapathy, Anand Kumar ; Gupta, Madhu ; Sandhya, G ; Sahoo, Devi Prasad ; Rajendra, L ; Siva Ram Prasad, K ; Ravi, M D ; Dhongade, Ashish Ramachandra ; Pradeep, N ; Satish, M ; Rajapantula, Vasudev ; Susarla, Sai Krishna ; Rajashakar, B C ; Uttam, Kheya Ghosh

BACKGROUND:

Hepatitis A is an inflammation of the liver caused by the hepatitis A virus (HAV). It is transmitted mainly because of poor personal hygiene via the faecal/oral route through ingestion of contaminated food or water or through the direct contact with an infectious person. Though most of the infected individuals recover from the infection, a few may develop fatal fulminant hepatitis. In this randomized, multicenter study, immunogenicity and safety of Havisure™ vaccine of Human Biologicals Institute was compared with Havrix® vaccine.

METHODS:

The study was carried out in 528 eligible healthy subjects, in two age groups across eight centres in India. Group A included subjects of 19-49 years and Group B subjects of 12 months to below 19 years of age. All subjects received two doses of either Havisure™ vaccine or Havrix® vaccine as per randomization at six months interval. Blood samples for antibody titre estimation were collected before vaccination and 4-6 weeks after 2nd dose of vaccination. Immunogenicity was assessed by estimating seroconversion rate, seroprotection rate, and geometric mean titres of antibodies. Safety was evaluated by collection and analysis of data on solicited and unsolicited adverse events.

RESULTS:

Of 528 enrolled subjects, 493 subjects completed the study. There was 100% seroconversion and seroprotection in both the vaccine arms. There was no statistical difference in the geometric mean titres between the two vaccine arms. Pain and swelling at the site of injection were the most common local adverse events whereas fever and headache were the most common systemic adverse events observed in both vaccine arms. No serious adverse event was reported in the study.

CONCLUSION:

The study results indicate that the Havisure™ vaccine is immunogenic and safe when administered to healthy subjects of 12 months to 49 years of age, and is non-inferior to Havrix® Vaccine.

01 Aug 2023·Human vaccines & immunotherapeutics

Immunogenicity persistence of hepatitis A vaccines Healive® and Havrix® among children:15 years follow-up and long-term prediction

Article

Author: Xu, Li ; Hu, Yuansheng ; Wang, Xiaoli ; Zhang, Ying ; Yao, Hui ; Wang, Yalong ; Xu, Wenguo ; Ma, Minhua

Healive® was the only Chinese WHO-prequalified inactivated vaccine for the hepatitis A virus, which has been widely used in national immunization programs in China. Long-term follow-up studies are needed to estimate the persistence of vaccine-induced antibody levels and the necessity for booster vaccines. During the trial, geometric mean concentrations (GMCs) and seroconversion rates (SRs) of anti-HAV antibodies were compared based on two different inactivated hepatitis A vaccines, Healive® and Havrix®. Four hundred children were randomly assigned to receive two doses of Healive® or Havrix® at 0 and 6 months. The current study assessed antibody persistence for both vaccines 15 years post-immunization. A mixed linear model was used to predict long-term antibody persistence. The GMCs were significantly higher for Healive® compared to Havrix® at 1, 6, 7, 66, 138 months (P < .001) and 186 months (P = .004 < .05) post-vaccination. Healive® and Havrix® reached a GMC of 164.8 mIU/ml and 105.7 mIU/ml post-15 years of vaccination, respectively. The seroconversion rates of both vaccines showed no statistically significant differences (97.9% for Healive® and 94.7% for Havrix®, P = .20). The prediction showed that Healive® would provide protection for a minimum of 30 years following immunization, with a lower limit of the 95% confidence intervals for GMCs greater than 20mIU/mL. Compared to Havrix®, the vaccine Healive® showed a stronger protective effect and better persistence among children at 15 years post-full immunization. Prediction indicated at least 30 years of antibody persistence for Healive® and at least 25 years for Havrix®.

100 Deals associated with Hepatitis A vaccine, inactivated(GlaxoSmithKline Plc)

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External Link

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hepatitis A	US	GlaxoSmithKline LLC	22 Feb 1995

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Human Papillomavirus Infection	Phase 3	-	GSK Plc	01 Feb 2015

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00624819 (CTgov)	Phase 3	Pneumonia, Pneumococcal	524	GSK1024805A+Varilrix+Infanrix hexa+Havrix (Synflorix + Infanrix + Havrix and/or Varilrix Group)	ytklvyoskz(jraobifgws) = sqorslohuk nuuccdxgno (mcgqkcwjzq, dgiehxdkpc - wegrrwtecw) View more	-	18 Mar 2020
NCT00624819 (CTgov)	Phase 3	Pneumonia, Pneumococcal	524	Varilrix+Infanrix hexa+Havrix+Prevenar (Prevenar + Infanrix + Havrix and/or Varilrix Group)	ytklvyoskz(jraobifgws) = ryozbdruer nuuccdxgno (mcgqkcwjzq, prcmdyjcsa - krkzwapkxj) View more	-	18 Mar 2020
NCT01282216 (CTgov)	Phase 2	Neoplasms	120	PCV13+Havrix	lmgtfsaiwg(xfflnulgzt) = teadshdxdg blubgsvvom (ctqqcdhifg, mblnkmwdze - xemjopygkn) View more	-	30 May 2019
NCT02184572 (CTgov)	Phase 3	Rubella \| Mumps \| Measles	1,742	Priorix+Varivax+Havrix+Prevnar 13 (INV_MMR)	jxnhiaotzh(mvzjaxvxjv) = fqhzrscila gmuxaenvzs (okaqhmtecr, wmxriyftkc - htrxnsvktz)	-	03 Jul 2018
NCT02184572 (CTgov)	Phase 3	Rubella \| Mumps \| Measles	1,742	Varivax+Havrix+Prevnar 13+M-M-R II (COM_MMR)	jxnhiaotzh(mvzjaxvxjv) = izvyconawq gmuxaenvzs (okaqhmtecr, dzonzkcquu - ocjpxyfihs)	-	03 Jul 2018
NCT01037114 (CTgov)	Phase 4	Hepatitis A \| Hepatitis B	50	Blood sampling+Engerix-B+Havrix	smakjlpkev(bezspjwsia) = bgaakbrsxi pvgrpdnslj (gxaiezqxgp, mhlcrugxzi - kqeuktacbr) View more	-	27 Apr 2011
NCT01000324 (CTgov)	Phase 4	Hepatitis A \| Hepatitis B	44	Blood sampling+Engerix-B+Havrix	ghwxlqhyvb(rreuqjdutv) = uucbajjykd xwekjypbbz (svoeoijmft, yodvwaajqc - iilqydugom) View more	-	13 Jan 2011
NCT00578175 (CTgov)	Phase 2	Hepatitis A \| Rubella \| Mumps ... View more	1,851	Prevnar+Priorix-Tetra+Havrix (Refrigerator-stored Priorix-Tetra Group)	ytnslrcvbi(byolilloym) = rmfkzdqlly iaiaoujqok (fufmqkajsl, lignguvdsm - xushimakhy) View more	-	26 Aug 2010
NCT00578175 (CTgov)	Phase 2	Hepatitis A \| Rubella \| Mumps ... View more	1,851	Prevnar+Priorix-Tetra+Havrix (Freezer-stored Priorix-Tetra Group)	ytnslrcvbi(byolilloym) = pikktntetf iaiaoujqok (fufmqkajsl, bgtoorfanq - szpnfjucku) View more	-	26 Aug 2010
NCT00291876 (CTgov)	Phase 4	Hepatitis A	135	Havrix™	phfcjjsqrp(xgircpclux) = pchvjdjkve mosnrlszjj (ozduruvffy, edbbsxjcpq - datiburhyn) View more	-	08 Mar 2010
NCT00289757 (CTgov)	Phase 4	Hepatitis A	78	Havrix™	ldgnygmokj(rgsmqsfxhk) = zijpzmpjqe kwyiwbhiwn (corewnnkmg, ffbgfhamhv - kouodljzgg) View more	-	04 Mar 2010
NCT00197236 (CTgov)	Phase 3	Hepatitis A \| Diphtheria \| Whooping Cough ... View more	468	Havrix™ (Havrix Group)	stwumgntey(pzdsngupne) = ybiyowztbg dhwpbdalwm (kotjheqpmc, tctfqbrkhg - tomjebqtic) View more	-	24 Jul 2009
NCT00197236 (CTgov)	Phase 3	Hepatitis A \| Diphtheria \| Whooping Cough ... View more	468	ActHIB™+Infanrix™+Havrix™ (Havrix + Infanrix + ActHIB Group)	stwumgntey(pzdsngupne) = pxlgiabfnk dhwpbdalwm (kotjheqpmc, vwvvarxmwy - lmaprivznb) View more	-	24 Jul 2009