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.
BACKGROUND:Rotavirus Gastroenteritis (RVGE) is an important global public health problem. Recently a Lyophilized Pentavalent HumanBovine 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.