Safety of Russian-Backbone Trivalent, Live Attenuated Seasonal Influenza Vaccine in Healthy Subjects: Open-Label, Non-randomized Phase 4 Study

Nigwekar, Prashant; Kumar, Anuj; Padbidri, Vikram; Choudhury, Amlan; Chaudhari, Amol; Kulkarni, Prasad S.

doi:10.1007/s40264-017-0605-3

Cited by 7 publications

(3 citation statements)

References 17 publications

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“… 146 Another intranasal live attenuated vaccine, Nasovac-S, has been approved in India, as its safety and efficacy were confirmed after administration to a large population. 147 …”

Section: Licensed In Vaccinesmentioning

confidence: 99%

Noninvasive vaccination against infectious diseases

Zheng

Díaz-Arévalo

Guan

et al. 2018

Human Vaccines & Immunotherapeutics

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The development of a successful vaccine, which should elicit a combination of humoral and cellular responses to control or prevent infections, is the first step in protecting against infectious diseases. A vaccine may protect against bacterial, fungal, parasitic, or viral infections in animal models, but to be effective in humans there are some issues that should be considered, such as the adjuvant, the route of vaccination, and the antigen-carrier system. While almost all licensed vaccines are injected such that inoculation is by far the most commonly used method, injection has several potential disadvantages, including pain, cross contamination, needlestick injury, under- or overdosing, and increased cost. It is also problematic for patients from rural areas of developing countries, who must travel to a hospital for vaccine administration. Noninvasive immunizations, including oral, intranasal, and transcutaneous administration of vaccines, can reduce or eliminate pain, reduce the cost of vaccinations, and increase their safety. Several preclinical and clinical studies as well as experience with licensed vaccines have demonstrated that noninvasive vaccine immunization activates cellular and humoral immunity, which protect against pathogen infections. Here we review the development of noninvasive immunization with vaccines based on live attenuated virus, recombinant adenovirus, inactivated virus, viral subunits, virus-like particles, DNA, RNA, and antigen expression in rice in preclinical and clinical studies. We predict that noninvasive vaccine administration will be more widely applied in the clinic in the near future.

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“… 146 Another intranasal live attenuated vaccine, Nasovac-S, has been approved in India, as its safety and efficacy were confirmed after administration to a large population. 147 …”

Section: Licensed In Vaccinesmentioning

confidence: 99%

Noninvasive vaccination against infectious diseases

Zheng

Díaz-Arévalo

Guan

et al. 2018

Human Vaccines & Immunotherapeutics

View full text Add to dashboard Cite

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“…LAIVs based on Len/17-MDV or B/USSR/60/69 have been used for decades in Russia and since 2011 in India. Vaccines generated using these two backbones have been shown to be safe and effective [3], [4], [5], [6]. In some studies, superior efficacy of LAIV over inactivated vaccines has been observed for both antigenically well-matched and drifted viruses [7].…”

Section: Introductionmentioning

confidence: 99%

Evaluation of A(H1N1)pdm09 LAIV vaccine candidates stability and replication efficiency in primary human nasal epithelial cells

et al. 2019

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The recent reduction of live attenuated influenza vaccine (LAIV) effectiveness in multivalent formulations was particularly associated with the A(H1N1)pdm09 component. In the 2017 the WHO vaccine composition committee changed its recommendations for the A(H1N1)pdm09 component to include an A/Michigan/45/2015-like virus. We evaluated effectiveness and quality of newly developed and previous A(H1N1)pdm09 LAIV reassortants through assessment of their thermal and pH stability, receptor binding specificity and replication fitness in primary human airway epithelial cells of nasal origin (hAECN). Our analysis showed that LAIV expressed hemagglutinin (HA) and neuraminidase (NA) from an A/Michigan/45/2015-like strain A/New York/61/2015 (A/New York/61/2015-CDC-LV16A, NY-LV16A), exhibit higher thermal and pH stability compared to the previous vaccine candidates expressing HA and NA from A/California/07/2009 and A/Bolivia/559/2013 (A17/Cal09 and A17/Bol13). Reassortants A/South Africa/3626/2013-CDC-LV14A (SA-LV14A) and NY-LV16A showed preferential binding to α2,6 sialic acid (SA) receptors and replicated at higher titers and more extensively in hAECN compared to A17/Cal09 and A17/Bol13, which had an α2,3 SA receptor binding preference. Our data analysis supports selection of A/New York/61/2015-CDC-LV16A for LAIV formulation and the introduction of new assays for LAIV characterization.

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“…Finally, reversion of an Ann Arbor-backbone LAIV (FluMist™) to a phenotype capable of inducing disease in mice following serial passage of the vaccine virus at increasing temperatures 58 highlights the need to consider alternative LAIV backbones for future LAIV formulations. Indeed, a Leningrad-based LAIV developed by the Institute of Experimental Medicine (Russia) and subsequently sublicensed via a World Health Organization influenza technology transfer initiative 59 has been demonstrated to be safe and well tolerated in human clinical trials 59 , 60 .…”

Section: Discussionmentioning

confidence: 99%

Intranasal powder live attenuated influenza vaccine is thermostable, immunogenic, and protective against homologous challenge in ferrets

et al. 2021

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Influenza viruses cause annual seasonal epidemics and sporadic pandemics; vaccination is the most effective countermeasure. Intranasal live attenuated influenza vaccines (LAIVs) are needle-free, mimic the natural route of infection, and elicit robust immunity. However, some LAIVs require reconstitution and cold-chain requirements restrict storage and distribution of all influenza vaccines. We generated a dry-powder, thermostable LAIV (T-LAIV) using Preservation by Vaporization technology and assessed the stability, immunogenicity, and efficacy of T-LAIV alone or combined with delta inulin adjuvant (Advax™) in ferrets. Stability assays demonstrated minimal loss of T-LAIV titer when stored at 25 °C for 1 year. Vaccination of ferrets with T-LAIV alone or with delta inulin adjuvant elicited mucosal antibody and robust serum HI responses in ferrets, and was protective against homologous challenge. These results suggest that the Preservation by Vaporization-generated dry-powder vaccines could be distributed without refrigeration and administered without reconstitution or injection. Given these significant advantages for vaccine distribution and delivery, further research is warranted.

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Safety of Russian-Backbone Trivalent, Live Attenuated Seasonal Influenza Vaccine in Healthy Subjects: Open-Label, Non-randomized Phase 4 Study

Abstract: Clinical Trials Registry of India (CTRI/2015/08/006074).

Cited by 7 publications

References 17 publications

Noninvasive vaccination against infectious diseases

Noninvasive vaccination against infectious diseases

Evaluation of A(H1N1)pdm09 LAIV vaccine candidates stability and replication efficiency in primary human nasal epithelial cells

Intranasal powder live attenuated influenza vaccine is thermostable, immunogenic, and protective against homologous challenge in ferrets

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