Comparison of three different recombinant hepatitis B vaccines: GeneVac-B, Engerix B and Shanvac B in high risk infants born to HBsAg positive mothers in India

Vijayakumar, V.; Nandakumar, Subhadra; Saravanan, S.; Jadhav, Suresh; Kulkarni, Prasad S.; Thyagarajan, Sadras Panchatcharam

doi:10.3748/wjg.v13.i22.3084

Cited by 26 publications

(24 citation statements)

References 29 publications

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“…We find that AEs due to HepB vaccination are notified to occur rarely and AEs rate in 10 mg-HepB group is not higher than that in the other group. No serious AEs are attributed to HepB, whatever 10 mg-HepB or 5 mg-HepB, which is similar to those types of adverse events illustrated by Kojouharova et al 18 Our survey showed that AEs rate of infants in 10 mg-HepB vaccination was lower than Bulgarian and India, 18,19,28 which could be considered the difference in methods, technology of vaccine-manufacture and sample size. A group of data about HepB AEs summarized through a large database of reported adverse events following immunization (AEFI) during 10 years in Rondonia (a state of Brazil) is nearly to us.…”

Section: Discussionsupporting

confidence: 85%

“…Thirdly, in method, we take measures to avoid AEs restricted to target vaccines being confused by other vaccines, which was not mentioned in other papers. 18,19 However the shortcomings are existent in the present study. Although the similar articles about Chinese infants are not searched, the timeliness of our manuscript is limited with the usage of safety and coverage results in practice since 2010.…”

Section: Discussionmentioning

confidence: 80%

“…Although many studies researching safety and coverage of HepB-derived from Saccharomyces Cerevisiae Yeast or hamster ovary cell have been reported, 15,18,19 this is the first time to perform the safety of 10 mg HepB-HPY (HepB derived from Hansenula polymorpha Yeast) in Chinese newborns. Sun reported the efficacy of HepB-HPY in the population aged greater than or equal to 16 years in China in 2010, which demonstrated that the safety of 10 mg HepB-HPY had been supported in adults.…”

Section: Discussionmentioning

confidence: 99%

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Safety, immunization coverage and determinants of a new kind of Hepatitis B vaccine firstly applied in Ningbo, China

Yang

et al. 2015

Human Vaccines & Immunotherapeutics

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Evaluate safety and immunization coverage of a new kind of recombinant Hepatitis B vaccine (HepB) in Ningbo city, China. Two groups were carried out in 2 of 11 randomly selected countries in Ningbo in 2009. All of the infants born from July 1 to December 31, 2009 were enrolled as subjects and received 3 doses of HepB at 0, 1, 6 month. Control group (N D 3452) received current HepB derived from Saccharomyces Cerevisiae Yeast (HepB made by recombinant DNA techniques in Saccharomyces Cerevisiae Yeast, HepB-SCY; 5 mg/0.5 ml per dose) and experimental group (N D 5104) received the new kind of HepB derived from Hansenula polymorpha Yeast (HepB made by recombinant DNA techniques in Hansenula polymorpha Yeast, HepB-HPY; 10 mg/0.5 ml per dose). 3-dose and timely birth dose (TBD) coverage were available and compared between 2 groups. Standard structured questionnaires were applied to record information from parents and hospitals for selecting determinants of coverage. The data were analyzed using stepwise multiple logistic regression models. After each dose, HepB-related adverse events (AEs) and recta-temperature were recorded for 7 days. 3-dose coverage in control group (89.98%) was higher than that in experimental group (x2 D 575.1173, P < 0.0001). TBD coverage in control and experimental group were 98.41% and 98.53%, respectively. No statistically significant difference in TBD coverage was found between 2 groups (x2 D 0.0623, P D 0.8029). A total of 9 local AEs were reported, 4 for control group and 5 for experimental group. The percentages of subjects reporting AEs were similar across the 2 vaccination groups. No serious or immediate reactions were found in this study. From logistic models, receiving 10 mg vaccine (odds ratio [OR]:0.38; 95% confidence interval [95%CI]: 0.34-0.44) and mother migrating from other cities (OR: 0.45; 95%CI: 0.42-0.47) were the determinants for non-acceptance of 3 doses of HepB; infants born from low grade hospitals and native mothers contributed to administrate the TBD.

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Section: Discussionsupporting

confidence: 85%

Section: Discussionmentioning

confidence: 80%

Section: Discussionmentioning

confidence: 99%

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Safety, immunization coverage and determinants of a new kind of Hepatitis B vaccine firstly applied in Ningbo, China

Yang

et al. 2015

Human Vaccines & Immunotherapeutics

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“…When classified by system organ, the most common ADR/AEs reported were 'body as a whole-general' disorders (n= 197; 66.7%) including death (n=1), oedema (n=2), fever (n=174), pain (n= 4), limb pain (n=1) and crying abnormal (n=15); Skin and appendages (n= 8; 2.7%) including eczema (n=1), pruritis (n=1), rash (n=4) and urticaria (n=2); Musculo-skeletal system including myalgia (n= 3; 1%); neurological disorder (n= 7; 2.3%) including coma (n=1), convulsions (n=2), complex partial seizures (n=1) and febrile convulsions (n=3); Psychiatric disorders (n= 1; 0.3%); Gastro-intestinal disorders (n=10; 3.3%), including diarrhoea (n=8) and vomiting (n=2); Cardiovascular disorders (n=3; 1%), including cardiac arrest (n=1) and cyanosis (n=2); Respiratory system disorder (n=7; 2.3%), including bronchospasm (n=1), coughing (n=1), dyspnoea (n=2), pharyngitis Immunization Programme of the country and other international organizations for newborns, infants, adolescents and high risk adults. 16 In India, National Immunization Schedule recommends hepatitis B vaccine in three doses at zero, 3 weeks and 6 months of age and if not vaccinated at the recommended age, children and adolescents as well as subjects who are, or will be, at increased risk of infection can be vaccinated at recommended intervals. 17 The study showed that maximum number of ICSRs (82.3%) were reported from the age group of 1-4 years, which may support that infant vaccination is good practice as compared to that of vaccination in children.…”

Section: Methodsmentioning

confidence: 99%

Adverse Reactions after Hepatitis B Vaccination: A Retrospective Analysis Using Spontaneous Reports

Kalaivani¹,

Rastogi²,

Kalaiselvan³

et al. 2017

JYP

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Background: Safety of vaccines is more critical because they are used for immunization in children and Hepatitis-B vaccination is included in national immunization schedule for neonates and infants in India. The National Coordination Centre (NCC)-Pharmacovigilance Programme of India (PvPI), Indian Pharmacopoeia Commission (IPC) monitors the adverse drug reactions/Adverse events (ADR/AE) associated with the drugs used in the country through WHO reporting system, VigiFlow. Objective of the study is to analyse ADR/AEs associated with Hepatitis B vaccination reported to NCC-PvPI through VigiFlow database. Methods: Retrospective analysis of the VigiFlow data were extracted and analysed with respect to patient demography, profession of reporter, system organ class (SOC) affected, causality assessment, seriousness of adverse event and year wise analysis of reported ADRs. Results: During the study period 295 ADR/AEs were reported following Hepatitis B vaccination. The adverse reactions following Hepatitis B immunization were primarily reported in infants (55.2 %) in age group 1-2 years. The causality assessment showed that 42.7% of the adverse events are probable/likely associated with Hepatitis B vaccination. Most of the cases were reported by the physician. The two main ADRs were fever 58.9% and injection site pain 11.5%. Conclusion: Data analyzed in our study showed only non-serious reactions were reported due to hepatitis B vaccination. Data also clearly showed that there is a need for reporting ADR/AEs associated with quality of vaccines that may affect safety of the vaccine, which may be possible by amending the suspected adverse drug reaction reporting form of NCC-PvPI. This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms.

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“…Hepatit B Aşılarının Etkinliği Dünya genelinde çok sayıda rekombinan aşı bulunmakta olup bu aşılarla ilgili olarak yapılmış sayısız çalışmada hem çocuklarda hem de erişkinlerde oldukça etkin ve güvenilir oldukları gösterilmiştir (27)(28)(29)(30)(31).…”

Section: Hepatit B Aşılarıunclassified

Hepatit B Virüs Aşılaması

...

2012

Vhd

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Comparison of three different recombinant hepatitis B vaccines: GeneVac-B, Engerix B and Shanvac B in high risk infants born to HBsAg positive mothers in India

Cited by 26 publications

References 29 publications

Safety, immunization coverage and determinants of a new kind of Hepatitis B vaccine firstly applied in Ningbo, China

Safety, immunization coverage and determinants of a new kind of Hepatitis B vaccine firstly applied in Ningbo, China

Adverse Reactions after Hepatitis B Vaccination: A Retrospective Analysis Using Spontaneous Reports

Hepatit B Virüs Aşılaması

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