Safety and immunogenicity of Bio Pox™, a live varicella vaccine (Oka strain) in Indian children: A comparative multicentric, randomized phase II/III clinical trial

Dubey, Anand Prakash; Faridi, M. M. A.; Mitra, Monjori; Dabas, Aashima; Choudhury, Jaydeep; Mukherjee, M. K.; Mishra, Devendra

doi:10.1080/21645515.2017.1318236

Cited by 3 publications

(3 citation statements)

References 25 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…India now ranks fifth in global research publication output. Vaccine research and development in India is making steady progress, which is evident in the number of product licensures in the last 7 years and the candidate vaccines that are under development (Bhandari et al, 2014 ; Singh et al, 2015 ; Dubey et al, 2017 ; Kulkarni et al, 2017a , b ; Sutton et al, 2017 ; Ramasamy et al, 2018 ). India now produces more than 60% of the world's vaccines and is a member of the governing council of International Vaccine Institute, with a commitment of US$500,000 every year.…”

Section: Rna Virus Research In Indiamentioning

confidence: 99%

Position Paper on Road Map for RNA Virus Research in India

2018

View full text Add to dashboard Cite

The Indian subcontinent with its population density, climatic conditions, means of subsistence, socioeconomic factors as well as travel and tourism presents a fertile ground for thriving of RNA viruses. Despite being pathogens of huge significance, there is very little focus on research into the biology and pathogenesis of RNA viruses in India. Studies on epidemiology and disease burden, risk factors, the immune response to RNA viruses, circulating virus strains and virus evolution, animal models of disease, antivirals and vaccines are strikingly absent. Emerging RNA viruses such as Zika virus, Nipah virus and Crimean-Congo haemorrhagic fever virus are a matter of grave concern to India. Here we summarize the outcome of the India|EMBO symposium on “RNA viruses: immunology, pathogenesis and translational opportunities” organized at Faridabad, National Capital Region, India, on March 28–30, 2018. The meeting focused on RNA viruses (non-HIV), and both national and international experts on RNA viruses covered topics ranging from epidemiology, immune response, virus evolution and vaccine trials concerning RNA viruses. The aim of the symposium was to create a road map for RNA virus research in India. Both concrete and tentative ideas pointing towards short-term and long-term goals were presented with recommendations for follow-up at government level.

show abstract

Section: Rna Virus Research In Indiamentioning

confidence: 99%

Position Paper on Road Map for RNA Virus Research in India

2018

View full text Add to dashboard Cite

show abstract

“…[10][11][12][13] In India, varicella vaccine for single-dose schedule was studied by a few researchers and proven to be safe and effective in preventing disease, but a second dose is yet not introduced as mandatory in the national immunization schedule. [14][15][16] As per WHO, countries deciding to introduce routine childhood varicella immunization should administer vaccination at an early age of 12-18 months, and two doses are recommended for decreasing mortality and severe morbidity, and to further reduce the number of cases and outbreaks. 17 As per the Indian Academy of Paediatrics (IAP) immunization schedule (2018), the minimum age of administering varicella vaccine is recommended as 12 months with the minimum dosing interval of 3 months for children aged 12 months through 12 years.…”

Section: Introductionmentioning

confidence: 99%

“…In India, varicella vaccine for single-dose schedule was studied by a few researchers and proven to be safe and effective in preventing disease, but a second dose is yet not introduced as mandatory in the national immunization schedule. 14 – 16 As per WHO, countries deciding to introduce routine childhood varicella immunization should administer vaccination at an early age of 12–18 months, and two doses are recommended for decreasing mortality and severe morbidity, and to further reduce the number of cases and outbreaks. 17…”

Section: Introductionmentioning

confidence: 99%

Evaluation of immunogenicity, safety and breakthrough following administration of live attenuated varicella vaccine in two doses three months apart regimen in Indian children

Mitra

Chowdhury

Basu

et al. 2020

Therapeutic Advances in Vaccines and Immunotherapy

Self Cite

View full text Add to dashboard Cite

Background: In India, where varicella outbreaks are reported at a younger age, a two-dose vaccine schedule administered at an early age could be highly efficacious in preventing varicella infection. The aim of this study was to evaluate the immunogenicity and safety of live attenuated varicella vaccine (VR 795 Oka strain) in a two-dose, 3 months apart regimen. Methodology: Healthy children (⩾ 12 months and ⩽12 years; mean age: 4.4 years) of either sex were included. Geometric mean titers (GMT) were measured at baseline and 28 days post first- and second-dose, and seroprotection rates were measured 28 days post first and second dose. The incidence of breakthrough (BT) infections post vaccination was determined from 42 days post first and second dose of vaccine up to 12 months. Adverse events (AEs) were monitored and recorded throughout the study period. Results: Of 305 subjects enrolled, 217 were seronegative. The seroconversion rate (a change from a seronegative to a seropositive condition) was 93.3% post first-dose and 100% post two-doses. High levels (9 times) of GMT were reported since post first-dose to post second-dose in children aged 12–18 months, 18–60 months (99.43%); and in and above 60 months (99.02%). The extent of rise of anti-VZV IgG antibody titer post 28 days of first-dose at two-fold, three-fold and four-fold rise was 93.39%, 90.56% and 80.66%, respectively and 100% 4-fold rise post second-dose. A single case, a day after the first-dose of vaccination of mild BT infection, was observed after close contact with a severe case. AEs were mild and none of the serious AEs were related to the study drug. Conclusion: The two-dose schedule of varicella vaccine was safe and immunogenic when given 3 months apart. However, further comparative studies and follow up for both dosing schedules are needed to validate the advantage of early dosing.

show abstract

Vaccination With Live Attenuated Vaccines in Four Children With Chronic Myeloid Leukemia While on Imatinib Treatment

et al. 2020

View full text Add to dashboard Cite

Chronic myeloid leukemia (CML) in childhood and adolescence is a rare malignancy that can successfully be treated with the tyrosine kinase inhibitor (TKI) imatinib. According to the current experience, treatment is necessary for years and, in the majority of cases, a lifelong approach is required to control the malignant disease. To what extent imatinib causes immunosuppression in different age cohorts is a controversial discussion. According to general medical recommendations, live vaccines are contraindicated in individuals treated with imatinib. However, a recent increase in the number of globally reported cases of measles has been observed and continues to rise. Due to the high contagiousness of the virus, near-perfect vaccination coverage (herd immunity of 93 to 95%) is required to effectively protect against measles resurgence-a scenario that is not realistic in many countries. When four teenagers with CML (median age 13 years, range 12-15) who were enrolled into pediatric trial CML-paed II while on imatinib treatment (median treatment duration 36 months, range 11-84) were identified without protective measles and/or varicella titers, we carefully balanced the risks of a live vaccination under immunosuppressive TKI medication against the benefit of being protected. The patients underwent live vaccination with the live attenuated vaccines MM -RVAX Pro R and Varivax R simultaneously (Patient #1), Priorix R and Varilix R consecutively (Patient #2), and Priorix R (Patients #3 and #4). While the first three patients were vaccinated while receiving TKI therapy, treatment with imatinib was interrupted in patient #4 for 1 week prior and 2 weeks after vaccination. Patients #1 and #3 reacted with stable long-term seroconversion. In Patient #2, serum titer conversion against measles and varicella could not be demonstrated and thus revaccination with Priorix R and Varilix R was performed 3 years later. However, protective titers did not develop or were lost again. Patient #4 also lost protective titers against measles when assessed 10 months after vaccination, but revaccination resulted in stable seroprotective titers over 12 months after the last vaccination during ongoing imatinib treatment. We conclude that in all patients, the safety of live vaccines could be documented, as

show abstract

Safety and immunogenicity of Bio Pox™, a live varicella vaccine (Oka strain) in Indian children: A comparative multicentric, randomized phase II/III clinical trial

Cited by 3 publications

References 25 publications

Position Paper on Road Map for RNA Virus Research in India

Position Paper on Road Map for RNA Virus Research in India

Evaluation of immunogenicity, safety and breakthrough following administration of live attenuated varicella vaccine in two doses three months apart regimen in Indian children

Vaccination With Live Attenuated Vaccines in Four Children With Chronic Myeloid Leukemia While on Imatinib Treatment

Contact Info

Product

Resources

About