Immunogenicity of single dose live attenuated hepatitis A vaccine

Bhave, Sheila; Bavdekar, Ashish; Sapru, Amita; Bawangade, Seema; Pandit, Anand

doi:10.1007/s13312-011-0039-4

Cited by 10 publications

(12 citation statements)

References 4 publications

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“…Because of this, they produce lifelong immunity with the primary dose compared to most inactivated vaccines that require a booster dose. 2,7,8 Previous studies with this live attenuated vaccine conducted in the People's Republic of China and India have shown remarkable long-term immunogenicity with a single dose of the vaccine. [9][10][11] The present study was a regulatory requirement of the Drugs Controller General of India (DCGI) due to a change in the manufacturing facility (in the People's Republic of China) and the addition of new inactive stabilizers.…”

Section: Introductionmentioning

confidence: 99%

Immunogenicity and safety of live attenuated hepatitis A vaccine (Biovac-A™) in healthy Indian children

Bhave¹,

Ghosh²,

Sapru³

et al. 2013

VDT

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Introduction:The World Health Organization (WHO) recommends either inactivated or live attenuated vaccine against the hepatitis A virus (HAV) infection in countries with high incidence. Live attenuated vaccines against HAV infection have been developed and used exclusively in the People's Republic of China and have shown promising results. This is the first study conducted outside the People's Republic of China to evaluate the immunogenicity and safety of live attenuated hepatitis A vaccine (Biovac-A™) in healthy Indian children. Material and methods:This was an open-labeled, 8-week (July 2012 to October 2012), noncomparative, non-randomized, confirmatory study conducted at two centers (Kolkata and Pune) in India. A total of 140 healthy Indian children aged 12 months to 12 years were administered live attenuated hepatitis A vaccine at the two centers. Overall, 137 subjects (female: 66, mean age: 4.09±2.5 years) completed the study. The subjects were vaccinated (subcutaneous over the deltoid muscle of the upper arm) with 0.5 mL of live attenuated H2 strain hepatitis A vaccine. Results: Eight weeks after a single dose of the vaccine, 136 subjects from both the centers developed protective immunoglobulin (IgM) G antibodies $20 mIU/mL. The overall seroconversion rate was 99% (Kolkata: 100%, Pune: 98%). The hematological and biochemical parameters remained within normal limits. All the adverse events were non-serious and mild in severity. Conclusion: Live attenuated H2 strain hepatitis A vaccine is immunogenic and safe in Indian children.

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Section: Introductionmentioning

confidence: 99%

Immunogenicity and safety of live attenuated hepatitis A vaccine (Biovac-A™) in healthy Indian children

Bhave¹,

Ghosh²,

Sapru³

et al. 2013

VDT

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“…The incidence of Hepatitis A reduced dramatically in the Chinese regions where the vaccine was used in mass and routine public immunization programs 27,46 . Biovac–A (Zhepu) has been used in China from a long time, and has shown remarkable safety, immunogenicity, and long-term protection to millions of subjects 47 .…”

Section: Discussionmentioning

confidence: 99%

“…(2000) 44 1 years421–15100 Bhave et al. (2011) 27 30 months1431–1287.8 Bhave et al. (2015) 37 10 years1431–1298.15 Bhave et al.…”

Section: Discussionmentioning

confidence: 99%

A review of immunogenicity and tolerability of live attenuated Hepatitis A vaccine in children

Rao

Mao

Motlekar

et al. 2016

Human Vaccines & Immunotherapeutics

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Changing epidemiology of Hepatitis A virus (HAV) has led to an increased susceptibility of adolescents and adults to the infection. Vaccination can remarkably reduce the incidence and associated morbidity of HAV infection. This review is focused on the safety and efficacy of H2 strain derived live attenuated Hepatitis A vaccine. We found the vaccine to be highly immunogenic with minimal or negligible safety issues. Moreover, a single dose of live attenuated vaccine persists a long term immune response and can be a preferred option for developing countries. In 2014, Indian Academy of Paediatrics (IAP) also updated their recommendations for H2 vaccine as a single dose as against the previous 2 dose schedule. A focused approach to include the vaccine in national immunization program should be explored.

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“…This retrospective study was approved by the human ethics committee of Bharati Vidyapeeth University (deemed to be), Pune, India and utilized stored serum samples (aliquots at −80°C) collected in 2017. These included (a) 1065 samples collected during a cross‐sectional, stratified, facility‐based, multistage cluster sampling‐based survey at Pune city, described earlier . Municipal Corporation hospitals provide medical care at no/very low cost, and those accessing such facilities were classified as lower/LMSS strata while those getting paid treatment at private clinics were grouped as HSS category.…”

Section: Methodsmentioning

confidence: 99%

Age‐stratified anti‐HAV positivity in Pune, India after two decades: Has voluntary vaccination impacted overall exposure to HAV?

Arankalle

Tiraki

Kulkarni

et al. 2019

Journal of Viral Hepatitis

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Summary The degree of transmission of hepatitis A virus (HAV) is inversely proportional to the socioeconomic status of a community. Serosurveys conducted at Pune, India during 1982‐98 documented significant reduction in HAV exposure of paediatric, higher socioeconomic status (HSS) population. Anti‐HAV positivity (ELISA) in age‐stratified Pune population representing HSS and lower middle socioeconomic status (LMSS) (n = 1065) and infants till the age of 15 months (n = 690) was determined in 2017. Anti‐HAV positivity in the LMSS population decreased significantly in 2017 while an increase was seen in the HSS category. The surprising rise in anti‐HAV positivity in the HSS population reflected vaccine‐ and infection‐induced antibodies while only infection‐induced antibodies were present in the LMSS category. Lowest antibody prevalence in infants was at 12 months, the recommended age for hepatitis A vaccination. Improved hygiene and selective immunization practices impacted HAV exposure of the LMSS population. The data emphasize the need for hepatitis A vaccination irrespective of socioeconomic status.

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Immunogenicity of single dose live attenuated hepatitis A vaccine

Cited by 10 publications

References 4 publications

Immunogenicity and safety of live attenuated hepatitis A vaccine (Biovac-A™) in healthy Indian children

Immunogenicity and safety of live attenuated hepatitis A vaccine (Biovac-A™) in healthy Indian children

A review of immunogenicity and tolerability of live attenuated Hepatitis A vaccine in children

Age‐stratified anti‐HAV positivity in Pune, India after two decades: Has voluntary vaccination impacted overall exposure to HAV?

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Immunogenicity of single dose live attenuated hepatitis A vaccine

Cited by 10 publications

References 4 publications

Immunogenicity and safety of live attenuated hepatitis A vaccine (Biovac-A&trade;) in healthy Indian children

Immunogenicity and safety of live attenuated hepatitis A vaccine (Biovac-A&trade;) in healthy Indian children

A review of immunogenicity and tolerability of live attenuated Hepatitis A vaccine in children

Age‐stratified anti‐HAV positivity in Pune, India after two decades: Has voluntary vaccination impacted overall exposure to HAV?

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Immunogenicity and safety of live attenuated hepatitis A vaccine (Biovac-A™) in healthy Indian children

Immunogenicity and safety of live attenuated hepatitis A vaccine (Biovac-A™) in healthy Indian children