Development of RV3 Rotavirus Vaccine by Bio Farma
Established in 1890, Bio Farma is a state-owned enterprise with 900 employees, specializing in the development of vaccines. They have implemented an integrated management system and are WHO prequalified for various vaccines, including those targeting rotaviruses. Rotaviruses are a major cause of diarrheal disease in young children worldwide, leading to significant mortality. The RV3 rotavirus vaccine candidate, derived from a naturally attenuated human neonatal strain, shows promise in providing protection against severe rotavirus infections. This project is a collaboration with the Murdoch Children Research Institute in Melbourne, Australia.
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DEVELOPMENT OF RV3 ROTAVIRUS VACCINE Mahendra Suhardono Production Director 11th Annual Meeting of DCVMN, 16 September 2010, Hyderabad, India
BIO FARMA Established in Aug 6, 1890 State-owned enterprise Number of employee : 900 Implemented Integrated management system GMP, ISO9001, ISO14001, OHSAS18001, GCG, ERM WHO prequalified vaccine ( DTP, DT, TT, DTP-HB, tOPV, mOPV, Measles, TT, HB in Uniject), Td, bOPV
Rotaviruses Rotaviruses are the most common cause of severe diarrhoeal disease in young children throughout the world According to 2004 estimates by WHO, 527 000 children aged <5 years die each year from vaccine-preventable rotavirus infections; most of these children live in low-income countries.
WHO recommendation WHO recommends that rotavirus vaccine for infants should be included in all national immunization programmes. In countries where diarrhoeal deaths account for 10% of mortality among children aged <5 years, the introduction of the vaccine is strongly recommended. Weekly epidemiological record, 18 Dec 2009
Rotavirus vaccines Preventing gastrointestinal disease caused by rotaviruses Two oral, live, attenuated rotavirus vaccines commercially available: GSK, Belgium Merck & co, USA
Rotavirus vaccine candidate RV3 A naturally attenuated human neonatal strain A serotype G3 strain, RV3, was found causing endemic, asymptomatic infection, healthy newborn infants, in Melbourne hospital in the 1970s. Neonates infected with RV3 were protected for their first 3 years of life, against severe disease naturally caused by community strains of rotavirus, including serotypes G1 and G2. RV3 has been prepared as a vaccine candidate.
Structure for RV3 Rotavirus Vaccine Development Project in Indonesia
MCRI Murdoch Children Research Institute, Melbourne-Australia Development & production of rotavirus vaccine: Know-how on technology for the production Quality Control testing Seed lot, based on rotavirus strain RV3 Technical assistance
PATH Vero cell : to grant Bio Farma a sublicense under the ATCC License Field of use: development, production, manufacture, sale and distribution of rotavirus vaccine.
Gajah Mada University PI for clinical trial phase II-B Meridian Labs USA: Provide clinical lot vaccine for CT phase II-B
RV3 Rotavirus Vaccine Development Program: MCRI RV3 Rotavirus Vaccine Program Indonesia Phase IIb Clinical Trial + RV3 Vaccine development Australia New Zealand Phase IIa Clinical Trial Phase I Clinical Trial + Other RV3 Vaccine development projects
Phase II b Trial A Phase IIb, double-blind, randomized placebo-controlled study to compare the immunogenicity, safety, and efficacy of oral RV3 Rotavirus Vaccine with Placebo Study procedure: Vaccine Neonatal Group: 0-7 days, 6-8 and 10-12 week Placebo Group Vaccine Infant Group: 6-8, 10-12 and 14-16 week 1920 participants will be randomized to the study
Primary Objectives: To compare efficacy and vaccine response the neonatal and infant vaccine groups with the placebo group. Study site: Yogyakarta, Sardjito Hospital Interventions: RV3 oral 1ml ~8x106 fcfu/ml doses (range 5x106 1x107 fcfu/ml dose) Placebo 1ml doses (identical in appearance, taste and smell to the study vaccine)
Study procedure Vaccine Neonatal Group Vaccine Infant Group Placebo Group N=640 N=640 N=640 Dose 1 0-7 days (V) Dose 1 0-7 days (P) Dose 1 0-7 days (P) Dose 2 6-8 wks (V) Dose 2 6-8 weeks (P) Dose 2 6-8 weeks (V) Dose 3 10-12 wks (V) Dose 3 10-12 wks (P) Dose 3 10-12 wks (V) Dose 4 14-16 wks (P) Dose 4 14-16 wks (P) Dose 4 14-16 wks (V) Study end 18 months Study end 18 months Study end 18 months
Study Duration: Recruitment period: 12 months duration. Each participant: recruited at birth (day 0-7) and followed to 18 months of age. Total study duration: 30 months
Outcomes and Measures Severe rotavirus gastroenteritis Safety and tolerability RV3 vaccine response Immunogenicity of co-administered vaccines
