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Background: This first in human study was designed as an open label clinical trial to assess safety and tolerability of Serum Institute of India Pvt. Ltd. (SIIPL) quadrivalent HPV (qHPV) vaccine., Methods: A total of 48 healthy male and female (24 each) adult volunteers were administered a 0.5 ml single dose of SIIPL qHPV vaccine intramuscularly, and were followed for one month for safety outcomes viz., immediate, solicited, unsolicited and serious adverse events., Results: 47 subjects completed the study in compliance with protocol. One subject had pain immediately after immunization which was recovered without treatment. None of the participants experienced any other local or systemic solicited AEs and serious AE., Conclusion: qHPV vaccine manufactured by SIIPL was found to be safe and well tolerable in adults. Further clinical development should continue to assess safety and immunogenicity, in the target population following recommended 2 and 3-dose schedule. Clinical Trial Registration - CTRI/2017/02/007785., Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: The authors HS, SP, PP, SS, SD, HR, SG and US are employees of Serum Institute of India Pvt. Ltd., Pune, India. AK, RLM, JP, AE are employees of Syngene International Ltd., Bangalore., (© 2023 The Authors.)

Background: This first in human study was designed as an open label clinical trial to assess the safety and tolerability of Serum Institute of India Pvt. Ltd. (SIIPL) Tdap vaccine in healthy adult volunteers, aged 18-45 years., Methods: A total of 24 healthy adults were administered a 0.5 ml single dose of SIIPL Tdap vaccine intramuscularly, and were followed for one month for safety outcomes viz., immediate, solicited, unsolicited and serious adverse events., Results: 23 subjects completed the study in compliance with the study protocol. None of the participants experienced any immediate adverse events or any local or systemic solicited adverse events., Conclusion: Tdap vaccine manufactured by Serum Institute of India Pvt. Ltd. is safe and well tolerable in adults. It was concluded that further clinical development of this vaccine should continue to assess its safety and immunogenicity, in the target population. Clinical Trial Registration - CTRI/2017/03/008003., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2020. Published by Elsevier Ltd.)

Reticulocyte invasion by Plasmodium vivax requires interaction of the Duffy-binding protein (PvDBP) with host Duffy antigen receptor for chemokines (DARCs). The binding domain of PvDBP maps to a cysteine-rich region referred to as region II (PvDBPII). Blocking this interaction offers a potential path to prevent P. vivax blood-stage growth and P. vivax malaria. This forms the rationale for development of a vaccine based on PvDBPII. Here we report results of a Phase I randomized trial to evaluate the safety and immunogenicity of recombinant PvDBPII formulated with glucopyranosyl lipid adjuvant-stable emulsion (GLA-SE). Thirty-six malaria-naive, healthy Indian male subjects aged 18-45 years were assigned into three cohorts corresponding to doses of 10, 25 and 50 µg of PvDBPII formulated with 5 µg of GLA-SE. Each cohort included nine PvDBPII/GLA-SE vaccinees and three hepatitis B control vaccine recipients. Each subject received the assigned vaccine intramuscularly on days 0, 28 and 56, and was followed up till day 180. No serious AE was reported and PvDBPII/GLA-SE was well-tolerated and safe. Analysis by ELISA showed that all three doses of PvDBPII elicited antigen-specific binding-inhibitory antibodies. The 50 µg dose elicited antibodies against PvDBPII that had the highest binding-inhibitory titres and were most persistent. Importantly, the antibody responses were strain transcending and blocked receptor binding of diverse PvDBP alleles. These results support further clinical development of PvDBPII/GLA-SE to evaluate efficacy against sporozoite or blood-stage challenge in controlled human malaria infection (CHMI) models and against natural P. vivax challenge in malaria endemic areas., Competing Interests: D.C.K. is an inventor on patents that relate to DNA segments encoding the Duffy receptor of Plasmodium parasite, including recombinantly produced Duffy receptor. C.E.C. is an inventor on patents that relate to binding domains of erythrocyte binding proteins of Plasmodium parasites including PvDBP. S.R. and D.C. are inventors on patents covering the adjuvant GLA-SE. None of the other authors have any competing interests.

Background: Rotavirus Gastroenteritis (RVGE) is an important global public health problem. Recently a Lyophilized Pentavalent Human Bovine Reassortant Rotavirus vaccine (BRV-PV, Rotasiil) was licensed in India. A Liquid formulation of the same vaccine (LBRV-PV) was tested in a Phase I clinical trial., Methods: Total 20 healthy adults were given a single oral dose of LBRV-PV and were followed for one month for safety outcomes: immediate reactions, solicited reactions, unsolicited adverse events and serious adverse events., Results: All 20 adults completed the study without any major protocol deviations. No immediate reaction, solicited reactions and unsolicited adverse events were reported during the study. No clinically significant changes were seen in the vital parameters and safety laboratory test results., Conclusions: LBRV-PV developed in India was safe and well tolerated in adults. Further clinical development of this vaccine in infants should be undertaken. Trial Registration - CTRI/2015/11/006,384., (Copyright © 2018 Elsevier Ltd. All rights reserved.)