Abhijeet Dharmadhikari

Safety and Preliminary Efficacy of Dengue Monoclonal Antibody in Adult Patients

Prasad S. Kulkarni, Anirudha Vyankatesh Potey, Sandeep Kumar Gupta, Dr Aparna Kodre et autres

Importance: Dengue outbreaks are increasing in frequency and intensity. In the absence of any specific treatment, a pan-serotype recombinant monoclonal antibody (Dengue-mAb) was tested in adult patients with dengue as a therapeutic option. Objective: To assess the safety and effect of a …

in, us, nl (code pays fourni par la source)

Phase II multicentre double-blind randomised controlled trial of a Bivalent VaccInation against Salmonella Typhi and Paratyphi A (BiVISTA) using a controlled human infection model of paratyphoid A infection: study protocol

Margarete Paganotti Vicentine, Naina McCann, Oisin Hennigan, Noshi Maria et autres

INTRODUCTION: Paratyphi A (SPA), is endemic mainly in South Asia, disproportionately affecting school-age children. Although typhoid conjugate vaccines (TCVs) are effective and implemented in many countries, no licensed vaccine exists against paratyphoid A. Bivalent vaccines targeting both S. Typhi and SPA may …

gb, us, in (code pays fourni par la source)

Safety and immunogenicity of a pentavalent meningococcal conjugate vaccine versus a quadrivalent meningococcal conjugate vaccine in adults in India: an observer-blind, randomised, active-controlled, phase 2/3 study

Prasad S. Kulkarni, Anand Kawade, Sunil Kohli, Renuka Munshi et autres

in, us, ca (code pays fourni par la source)

The safety and immunogenicity of a bivalent conjugate vaccine against Salmonella enterica Typhi and Paratyphi A in healthy Indian adults: a phase 1, randomised, active-controlled, double-blind trial

Prasad S. Kulkarni, Anirudha Vyankatesh Potey, Sandesh Bharati, Anil Kunhihitlu et autres

in (code pays fourni par la source)

Seropersistence of SII-ChAdOx1 nCoV-19 (COVID-19 vaccine): 6-month follow-up of a randomized, controlled, observer-blind, phase 2/3 immuno-bridging study in Indian adults

Prasad S. Kulkarni, Chandrasekaran Padmapriyadarsini, Johan Vekemans, Ashish Bavdekar et autres

AZD1222 (ChAdOx1 nCoV-19) is a replication-deficient adenoviral vectored coronavirus disease-19 (COVID-19) vaccine that is manufactured as SII-ChAdOx1 nCoV-19 by the Serum Institute of India Pvt Ltd following technology transfer from Oxford University/AstraZeneca. The non-inferiority of SII-ChAdOx1 nCoV-19 with AZD1222 was previously demonstrated …

in, se, br, vn, us, il (code pays fourni par la source)

A Phase 3, randomized, non-inferiority study of a heterologous booster dose of SARS CoV-2 recombinant spike protein vaccine in adults

Prasad S. Kulkarni, Bhagwat Gunale, Sunil Kohli, Sanjay Lalwani et autres

Due to waning immunity following primary immunization with COVID-19 vaccines, booster doses may be required. The present study assessed a heterologous booster of SII-NVX-CoV2373 (spike protein vaccine) in adults primed with viral vector and inactivated vaccines. In this Phase 3, observer-blind, randomized, …

in, us (code pays fourni par la source)

Post-marketing safety surveillance of the rotavirus vaccine in India

Gagandeep Kang, Anand Lakhkar, Chetanraj Bhamare, Abhijeet Dharmadhikari et autres

Background: ROTASIIL, an oral live attenuated bovine-human reassortant pentavalent rotavirus vaccine, was approved in 2017. This post-marketing surveillance (PMS) was conducted to collect real-world data on the safety of ROTASIIL in India. Methods: Observational, active PMS was conducted in approximately 10,000 infants …

in (code pays fourni par la source)

Safety and Immunogenicity of SARS-CoV-2 Recombinant Spike Protein Vaccine in Children and Adolescents in India

Bhagwat Gunale, Dhananjay Kapse, Sonali Kar, Ashish Bavdekar et autres

Importance: The recombinant COVID-19 vaccine NVX-CoV2373 has demonstrated efficacy of approximately 90% in adults; however, its safety and efficacy in children is unknown. Objective: To assess the noninferiority of SII-NVX-CoV2373 in children and adolescents compared to adults and to evaluate its safety …

in, us (code pays fourni par la source)

Active safety surveillance of rabies monoclonal antibody and rabies vaccine in patients with category III potential rabies exposure

Gagandeep Kang, Anand Lakhkar, Chetanraj Bhamare, Abhijeet Dharmadhikari et autres

Background: A vero cell-based inactivated Rabies Vaccine (Rabivax-S) and Rabies Human Monoclonal Antibody (Rabishield) have been approved since 2016. A post-marketing surveillance was conducted in India from 2020 to 2021 to gather real world safety data on Rabivax-S and Rabishield. Methods: This …

in (code pays fourni par la source)

A randomized, controlled study to evaluate the safety and immunogenicity of a heterologous booster dose of an adjuvanted SARS CoV-2 recombinant spike protein vaccine in adults

Prasad S. Kulkarni, Bhagwat Gunale, Sunil Kohli, Sanjay Lalwani et autres

in, us (code pays fourni par la source)

Safety and immunogenicity of SII-NVX-CoV2373 (COVID-19 vaccine) in adults in a phase 2/3, observer-blind, randomised, controlled study

Prasad S. Kulkarni, Abhijit N. Kadam, Sheela Godbole, Varsha Bhatt et autres

NVX-CoV2373, a Covid-19 vaccine was developed in the USA with ∼90% efficacy. The same vaccine is manufactured in India after technology transfer (called as SII-NVX-CoV2373), was evaluated in this phase 2/3 immuno-bridging study. This was an observer-blind, randomised, phase 2/3 study in …

in, us, au (code pays fourni par la source)

A Phase 2/3 observer-blind, randomized, controlled study to determine the safety and immunogenicity of SARS-CoV-2 recombinant spike protein vaccine in Indian children and adolescents aged 2 to 17 years

Bhagwat Gunale, Dhananjay Kapse, Sonali Kar, Ashish Bavdekar et autres

Abstract Background A recombinant, adjuvanted COVID-19 vaccine, SII-NVX-CoV2373 was manufactured in India and evaluated in Indian children and adolescents to assess safety and immunogenicity. Methods This was a Phase 2/3 observer-blind, randomized, controlled immuno-bridging study in children and adolescents aged 2 to …

in, us (code pays fourni par la source)