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  1. Article ; Online: Coronavirus Vaccine: Light at the End of the Tunnel.

    Ella, Krishna M / Mohan, V Krishna

    Indian pediatrics

    2020  Volume 57, Issue 5, Page(s) 407–410

    Abstract: The world is currently facing an unprecedented global pandemic caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Predicting the next source of the pandemic can be very challenging. As vaccination is the best way to prevent an ... ...

    Abstract The world is currently facing an unprecedented global pandemic caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Predicting the next source of the pandemic can be very challenging. As vaccination is the best way to prevent an infectious disease, the development of an effective vaccine against SARS-CoV-2 can not only reduce the morbidity and mortality associated with it, but can also lessen the economic impact. As the traditional method of vaccine development takes many years for a vaccine to be available to the society, the vaccine development for SARS-CoV-2 should be speeded up using a pandemic approach with fast-track approvals from the regulatory authorities. Various challenges associated with developing a vaccine during the pandemic such as technological hurdles, clinical development pathways, regulatory issues, and support from global funding agencies are expressed here.
    MeSH term(s) Betacoronavirus ; COVID-19 ; COVID-19 Vaccines ; Coronavirus Infections/prevention & control ; Drug Development ; Global Health ; Humans ; Pandemics/prevention & control ; Pneumonia, Viral/prevention & control ; Research Support as Topic ; SARS-CoV-2 ; Viral Vaccines
    Chemical Substances COVID-19 Vaccines ; Viral Vaccines
    Keywords covid19
    Language English
    Publishing date 2020-04-15
    Publishing country India
    Document type Journal Article
    ZDB-ID 402594-5
    ISSN 0974-7559 ; 0019-6061
    ISSN (online) 0974-7559
    ISSN 0019-6061
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article: Coronavirus Vaccines: Light at the End of the Tunnel

    Ella, Krishna M. / Mohan, V. Krishna

    Indian pediatrics

    Abstract: The world is currently facing an unprecedented global pandemic caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Predicting the next source of the pandemic can be very challenging As vaccination is the best way to prevent an ... ...

    Abstract The world is currently facing an unprecedented global pandemic caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Predicting the next source of the pandemic can be very challenging As vaccination is the best way to prevent an infectious disease, the development of an effective vaccine against SARS-CoV-2 can not only reduce the morbidity and mortality associated with it, but can also lessen the economic impact As the traditional method of vaccine development takes many years for a vaccine to be available to the society, the vaccine development for SARS-CoV-2 should be speeded up using a pandemic approach with fast-track approvals from the regulatory authorities Various challenges associated with developing a vaccine during the pandemic such as technological hurdles, clinical development pathways, regulatory issues, and support from global funding agencies are expressed here
    Keywords covid19
    Publisher WHO
    Document type Article
    Note WHO #Covidence: #60460
    Database COVID19

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  3. Article ; Online: Recombinant human epidermal growth factor (REGEN-D 150): effect on healing of diabetic foot ulcers.

    Mohan, V Krishna

    Diabetes research and clinical practice

    2007  Volume 78, Issue 3, Page(s) 405–411

    Abstract: Recombinant human epidermal growth factor (REGEN-D 150), which was cloned and over expressed in E. coli, has shown enhanced healing of chronic diabetic foot ulcers (DFU) by significantly reducing the duration of healing in addition to providing excellent ...

    Abstract Recombinant human epidermal growth factor (REGEN-D 150), which was cloned and over expressed in E. coli, has shown enhanced healing of chronic diabetic foot ulcers (DFU) by significantly reducing the duration of healing in addition to providing excellent quality of wound healing and reepithelization. Post-marketing surveillance (PMS) study of REGEN-D 150 in 135 patients of DFU in India was compared with Phase III clinical trial data of REGEN-D 150 in India. Statistical analysis of study data determined that the empirical survival probability distribution, in terms of non-healing of ulcers, was lowest in the case of PMS study, better than that for Phase III; more DFU patients were healed in PMS study. Percentage of patients cured in any given week (e.g., in week 10) is above 90% in PMS study, as compared to 69% in Phase III clinical trial; this percentage was around 18% for the control group with placebo in the Phase III trial. The average wound healing time was significantly lower in PMS study, 4.8 weeks, while it was 9 weeks in Phase III clinical trials while the average wound healing with REGEN-D 150 was found to be 86% in this study. REGEN-D 150 has been found to result in healthy granulation and stimulate epithelization, thus leading to final wound closure. The PMS study has established the efficacy of REGEN-D 150 in faster healing of diabetic foot ulcers.
    MeSH term(s) Adolescent ; Adult ; Aged ; Aged, 80 and over ; Child ; Clinical Trials, Phase II as Topic ; Diabetic Foot/drug therapy ; Diabetic Foot/physiopathology ; Epidermal Growth Factor/adverse effects ; Epidermal Growth Factor/therapeutic use ; Female ; Follow-Up Studies ; Humans ; Male ; Middle Aged ; Patient Selection ; Recombinant Proteins/adverse effects ; Recombinant Proteins/therapeutic use ; Retrospective Studies ; Wound Healing/drug effects ; Wound Healing/physiology
    Chemical Substances Recombinant Proteins ; Epidermal Growth Factor (62229-50-9)
    Language English
    Publishing date 2007-12
    Publishing country Ireland
    Document type Journal Article
    ZDB-ID 632523-3
    ISSN 1872-8227 ; 0168-8227
    ISSN (online) 1872-8227
    ISSN 0168-8227
    DOI 10.1016/j.diabres.2007.06.004
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Neutralization of VUI B.1.1.28 P2 variant with sera of COVID-19 recovered cases and recipients of Covaxin an inactivated COVID-19 vaccine.

    Sapkal, Gajanan / Yadav, Pragya D / Ella, Raches / Abraham, Priya / Patil, Deepak Y / Gupta, Nivedita / Panda, Samiran / Mohan, V Krishna / Bhargava, Balram

    Journal of travel medicine

    2021  Volume 28, Issue 7

    MeSH term(s) Antibodies, Neutralizing ; COVID-19 ; COVID-19 Vaccines ; Humans ; Neutralization Tests ; SARS-CoV-2
    Chemical Substances Antibodies, Neutralizing ; COVID-19 Vaccines
    Language English
    Publishing date 2021-05-17
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 1212504-0
    ISSN 1708-8305 ; 1195-1982
    ISSN (online) 1708-8305
    ISSN 1195-1982
    DOI 10.1093/jtm/taab077
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Neutralization of Variant Under Investigation B.1.617.1 With Sera of BBV152 Vaccinees.

    Yadav, Pragya D / Sapkal, Gajanan N / Abraham, Priya / Ella, Raches / Deshpande, Gururaj / Patil, Deepak Y / Nyayanit, Dimpal A / Gupta, Nivedita / Sahay, Rima R / Shete, Anita M / Panda, Samiran / Bhargava, Balram / Mohan, V Krishna

    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

    2021  Volume 74, Issue 2, Page(s) 366–368

    MeSH term(s) Antibodies, Neutralizing ; Antibodies, Viral ; Humans ; Neutralization Tests
    Chemical Substances Antibodies, Neutralizing ; Antibodies, Viral
    Language English
    Publishing date 2021-05-10
    Publishing country United States
    Document type Letter ; Research Support, Non-U.S. Gov't
    ZDB-ID 1099781-7
    ISSN 1537-6591 ; 1058-4838
    ISSN (online) 1537-6591
    ISSN 1058-4838
    DOI 10.1093/cid/ciab411
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article ; Online: Neutralization of Beta and Delta variant with sera of COVID-19 recovered cases and vaccinees of inactivated COVID-19 vaccine BBV152/Covaxin.

    Yadav, Pragya D / Sapkal, Gajanan N / Ella, Raches / Sahay, Rima R / Nyayanit, Dimpal A / Patil, Deepak Y / Deshpande, Gururaj / Shete, Anita M / Gupta, Nivedita / Mohan, V Krishna / Abraham, Priya / Panda, Samiran / Bhargava, Balram

    Journal of travel medicine

    2021  Volume 28, Issue 7

    MeSH term(s) Antibodies, Neutralizing ; COVID-19 ; COVID-19 Vaccines ; Humans ; SARS-CoV-2
    Chemical Substances Antibodies, Neutralizing ; COVID-19 Vaccines
    Language English
    Publishing date 2021-07-06
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 1212504-0
    ISSN 1708-8305 ; 1195-1982
    ISSN (online) 1708-8305
    ISSN 1195-1982
    DOI 10.1093/jtm/taab104
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article ; Online: Evaluation of safety and immunogenicity of HNVAC, an MDCK-based H1N1 pandemic influenza vaccine, in Phase I single centre and Phase II/III multi-centre, double-blind, randomized, placebo-controlled, parallel assignment studies.

    Basavaraj, V H / Sampath, G / Hegde, Nagendra R / Mohan, V Krishna / Ella, Krishna M

    Vaccine

    2014  Volume 32, Issue 35, Page(s) 4592–4597

    Abstract: The clinical evaluation of the MDCK-based H1N1 pandemic influenza vaccine HNVAC in adults aged 18-65 years is reported. In the Phase I randomized, double-blind, placebo-controlled, single-centre study, 160 subjects were parallelly assigned 3:1 to vaccine: ...

    Abstract The clinical evaluation of the MDCK-based H1N1 pandemic influenza vaccine HNVAC in adults aged 18-65 years is reported. In the Phase I randomized, double-blind, placebo-controlled, single-centre study, 160 subjects were parallelly assigned 3:1 to vaccine:placebo groups (n=60:20) with both the aluminium hydroxide adjuvanted and non-adjuvanted vaccine formulations. A single dose of both the formulations containing 15 μg of haemagglutinin protein showed minimal adverse reactions, the most common of which were pain at injection site (11.67%) and fever (10.00%). Both formulations produced 74-81% seroprotection (SRP: titre of ≥40), 67-70% seroconversion (SRC: four-fold increase in titres between days 0 and 21), and a four-fold increase in geometric mean titres (GMT). Aluminium hydroxide did not have a significant effect either on immunogenicity or on reactogenicity. Nevertheless, based on its recognized positive effects on the stability and immunogenicity of many vaccines, and its marginal benefit in both pre-clinical and Phase I studies of HNVAC, alum adjuvanted HNVAC was further tested in a staggered Phase II/III randomized, double-blind, placebo-controlled, multi-centre study of 200 and 195 subjects, respectively, parallelly assigned 4:1 to adjuvanted vaccine and placebo groups. In these studies, the most common adverse reactions were pain at injection site (6.88% and 5.77% in Stage 1 and Stage 2, respectively) and fever (7.50% and 7.05%, respectively), and a single dose resulted in 87-90% SRP, 85-86% SRC, and a nearly six-fold increase in GMT, meeting or exceeding licensing criteria. It is concluded that HNVAC is safe and immunogenic to adults of 18-65 years.
    MeSH term(s) Adjuvants, Immunologic/administration & dosage ; Adolescent ; Adult ; Aged ; Aluminum Hydroxide/administration & dosage ; Antibodies, Viral/blood ; Double-Blind Method ; Drug-Related Side Effects and Adverse Reactions/epidemiology ; Drug-Related Side Effects and Adverse Reactions/pathology ; Female ; Humans ; Influenza A Virus, H1N1 Subtype/immunology ; Influenza Vaccines/administration & dosage ; Influenza Vaccines/adverse effects ; Influenza Vaccines/immunology ; Influenza Vaccines/isolation & purification ; Influenza, Human/epidemiology ; Influenza, Human/prevention & control ; Male ; Middle Aged ; Pandemics/prevention & control ; Placebos/administration & dosage ; Vaccines, Synthetic/administration & dosage ; Vaccines, Synthetic/adverse effects ; Vaccines, Synthetic/immunology ; Vaccines, Synthetic/isolation & purification ; Young Adult
    Chemical Substances Adjuvants, Immunologic ; Antibodies, Viral ; Influenza Vaccines ; Placebos ; Vaccines, Synthetic ; Aluminum Hydroxide (5QB0T2IUN0)
    Language English
    Publishing date 2014-05-21
    Publishing country Netherlands
    Document type Clinical Trial, Phase I ; Clinical Trial, Phase II ; Clinical Trial, Phase III ; Journal Article ; Multicenter Study ; Randomized Controlled Trial
    ZDB-ID 605674-x
    ISSN 1873-2518 ; 0264-410X
    ISSN (online) 1873-2518
    ISSN 0264-410X
    DOI 10.1016/j.vaccine.2014.05.039
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  8. Article ; Online: Neutralization against B.1.351 and B.1.617.2 with sera of COVID-19 recovered cases and vaccinees of BBV152

    Yadav, Pragya D / Sapkal, Gajanan / Ella, Raches / Sahay, Rima R / Nyayanit, Dimpal A / Patil, Deepak Y / Deshpande, Gururaj / Shete, Anita M / Gupta, Nivedita / Mohan, V Krishna / Abraham, Priya / Panda, Samiran / Bhargava, Balram

    bioRxiv

    Abstract: Recently, multiple SARS-CoV-2 variants have been detected across the globe.The recent emergence of B.1.617 lineage has created serious public health problem in India. The high transmissibility was observed with this lineage which has led to daily ... ...

    Abstract Recently, multiple SARS-CoV-2 variants have been detected across the globe.The recent emergence of B.1.617 lineage has created serious public health problem in India. The high transmissibility was observed with this lineage which has led to daily increase in the number of SARS-CoV-2 infections. Apparently, the sub-lineage B.1.617.2 has slowly dominated the other variants including B1617.1, B.617.3 and B.1.1.7. With this, World Health Organization has described B.1.617.2 as variant of concern. Besides this, variant of concern B.1.351 has been also reported from India, known to showreducedefficacyfor many approved vaccines. With the increasing threat of the SARS-CoV-2 variants, it is imperative to assess the efficacy of the currently available vaccines against these variants. Here, we have evaluated the neutralization potential of sera collected from COVID-19 recovered cases (n=20) and vaccinees with two doses of BBV152 (n=17) against B.1.351 and B.1.617.2 compared to the prototype B.1 (D614G) variant.The finding of the study demonstrated a reduction in neutralization titers with sera of COVID-19 recovered cases(3.3-fold and 4.6-fold) and BBV152 vaccinees (3. 0 and 2.7 fold) against B.1.351 and B.1.617.2 respectively. Although, there is reduction in neutralization titer, the whole-virion inactivated SARS-CoV-2 vaccine (BBV152) demonstrates protective response against VOC B.1351 and B.1.617.2.
    Keywords covid19
    Language English
    Publishing date 2021-06-07
    Publisher Cold Spring Harbor Laboratory
    Document type Article ; Online
    DOI 10.1101/2021.06.05.447177
    Database COVID19

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  9. Article ; Online: Neutralization of UK-variant VUI-202012/01 with COVAXIN vaccinated human serum

    Sapkal, Gajanan N / Yadav, Pragya / Ella, Raches / Deshpande, Gururaj / Sahay, Rima / Gupta, Nivedita / Mohan, V Krishna / Abraham, Priya / Panda, Samiran / Bhargava, Balram

    bioRxiv

    Keywords covid19
    Language English
    Publishing date 2021-01-27
    Publisher Cold Spring Harbor Laboratory
    Document type Article ; Online
    DOI 10.1101/2021.01.26.426986
    Database COVID19

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  10. Article ; Online: Neutralization of variant under investigation B.1.617 with sera of BBV152 vaccinees

    Yadav, Pragya / Sapkal, Gajanan N / Abraham, Priya / Ella, Raches / Deshpande, Gururaj / Patil, Deepak Y / Nyayanit, Dimpal / Gupta, Nivedita / Sahay, Rima R / Shete, Anita M / Panda, Samiran / Bhargava, Balram / Mohan, V Krishna

    bioRxiv

    Abstract: The drastic rise in the number of cases in Maharashtra, India has created a matter of concern for public health experts. Twelve isolates of VUI lineage B.1.617 were propagated in VeroCCL81 cells and characterized. Convalescent sera of the COVID-19 cases ... ...

    Abstract The drastic rise in the number of cases in Maharashtra, India has created a matter of concern for public health experts. Twelve isolates of VUI lineage B.1.617 were propagated in VeroCCL81 cells and characterized. Convalescent sera of the COVID-19 cases and recipients of BBV152 (Covaxin) were able to neutralize VUI B.1.617.
    Keywords covid19
    Language English
    Publishing date 2021-04-23
    Publisher Cold Spring Harbor Laboratory
    Document type Article ; Online
    DOI 10.1101/2021.04.23.441101
    Database COVID19

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