U. de Chile to conduct phase III study of rotavirus vaccine
Designed by academics from the Faculty of Medicine at the University of Chile, the phase III study will recruit 5,800 children from across the country to demonstrate the safety, efficacy, and immunogenicity of the Rotavac vaccine from Bharat Biotech Laboratories. This formula has been used in India since 2014 to prevent severe cases of this disease that mainly affects infants, where it has shown excellent results.
Doctors Miguel O’Ryan and Juan Pablo Torres, pediatric infectious disease specialists in charge of the study, explain that “this is the Rotavac vaccine, which has already been administered millions of doses in its country of origin with excellent results in terms of safety and efficacy. However, in order to understand its performance in countries with different socioeconomic realities and to add it to the global strategy for rotavirus control, the World Health Organization asked its producer, Bharat Biotech, for new phase III studies. That’s why experts from the Centers for Disease Control and Prevention in the United States, CDC, contacted us.”
Dr. O’Ryan, currently the dean of our institution and an academic in the Microbiology and Mycology Program at the Institute of Biomedical Sciences, was the principal investigator of the multinational trial of the human rotavirus vaccine produced by GlaxoSmithKline in 2006, which was conducted in more than 60,000 children from 11 Latin American countries and Finland. He also led the Chilean study of the Janssen vaccine against Covid-19 since 2020.
Chile and Uruguay are the only two countries that do not include the rotavirus vaccine in their National Immunization Program, although it is available privately. “Partly because rotavirus is not associated with mortality in our country due to timely access to outpatient and hospital medical care in case a child has this infection. Despite this, it causes a significant burden of disease, meaning a high number of cases. In fact, it is the leading cause of hospitalization for diarrhea in children under five years of age in the public sector,” says Dr. Torres, vice dean of our institution and an academic in the Department of Pediatrics and Pediatric Surgery at the Faculty of Medicine.
In that sense, Dr. O’Ryan adds, “the global estimate is that before vaccination, rotavirus caused 500,000 deaths per year. Currently, about 120 countries have implemented its use, so that figure is between 200,000 and 300,000 deaths per year. In addition, in middle- and high-income countries, the management of children with rotavirus has improved, mainly through hydration, because it is an infection that causes a very intense fever, vomiting, and diarrhea, especially before 24 months of age, whether at home or in the hospital. However, it still causes a significant occupancy of beds. The vaccine not only reduces mortality but also severe illness, hospitalization in intensive care units, and visits to emergency services. That is the importance of analyzing the possible incorporation of a new alternative to the available options.”
What is the study about?
The Rotavac vaccine was created from a naturally attenuated neonatal human strain from India. It emerged when a pediatrician observed that newborns infectedU. de Chile to conduct phase III study of rotavirus vaccine
Designed by academics from the Faculty of Medicine at the University of Chile, the phase III study will recruit 5,800 children throughout the country to demonstrate the safety, efficacy, and immunogenicity of the Rotavac vaccine from Bharat Biotech Laboratories. This formula has been used in India since 2014 to prevent severe cases of this disease that mainly affects infants, where it has shown excellent results.
Doctors Miguel O’Ryan and Juan Pablo Torres, pediatric infectious disease specialists in charge of the study, explain that “this is the Rotavac vaccine, which has already been administered millions of doses in its country of origin with excellent results in terms of safety and efficacy. However, in order to understand its performance in countries with different socioeconomic realities and to add it to the global strategy for rotavirus control, the World Health Organization asked its producer, Bharat Biotech, for new phase III studies. That’s why experts from the Centers for Disease Control and Prevention in the United States, CDC, contacted us.”
Dr. O’Ryan, currently the dean of our institution and an academic in the Microbiology and Mycology Program at the Institute of Biomedical Sciences, was the principal investigator of the multinational trial of the human rotavirus vaccine produced by GlaxoSmithKline in 2006, which was carried out in more than 60,000 children from 11 Latin American countries and Finland. He also led the Chilean study of the Janssen vaccine against Covid-19 since 2020.
Chile and Uruguay are the only two countries that do not include the rotavirus vaccine in their National Immunization Program, although it is available privately. “Partly because rotavirus is not associated with mortality in our country due to timely access to outpatient and hospital medical care in case a child has this infection. Despite this, it causes a significant burden of disease, meaning a high number of cases. In fact, it is the leading cause of hospitalization for diarrhea in children under five years of age in the public sector,” says Dr. Torres, vice dean of our institution and an academic in the Department of Pediatrics and Pediatric Surgery at the Faculty of Medicine.
In that sense, Dr. O’Ryan adds, “the global estimate is that before vaccination, rotavirus caused 500,000 deaths per year. Currently, about 120 countries have implemented its use, so that figure is between 200,000 and 300,000 deaths per year. In addition, in middle- and high-income countries, the management of children with rotavirus has improved, mainly through hydration, because it is an infection that causes a very intense fever, vomiting, and diarrhea, especially before 24 months of age, whether at home or in the hospital. However, it still causes a significant occupancy of beds. The vaccine not only reduces mortality but also severe illness, hospitalization in intensive care units, and visits to emergency services. That is the importance of analyzing the possible incorporation of a new alternative to the available options.”
What is the study about?
The Rotavac vaccine was created from a naturally attenuated neonatal human strain from India. It emerged when a pediatrician observed that newborns infected with the virusU. de Chile to Conduct Phase III Study of Rotavirus Vaccine
The University of Chile will conduct a phase III study of the Rotavac vaccine, designed by academics from the Faculty of Medicine. The study aims to recruit 5,800 children nationwide to demonstrate the safety, efficacy, and immunogenicity of the vaccine, which is produced by Bharat Biotech Laboratories. The Rotavac vaccine has been used in India since 2014 to prevent severe cases of rotavirus, a disease that primarily affects infants, and has shown excellent results.
According to Dr. Miguel O’Ryan and Dr. Juan Pablo Torres, pediatric infectious disease specialists leading the study, the Rotavac vaccine has already been administered in millions of doses in India with excellent safety and efficacy results. However, the World Health Organization (WHO) has requested new phase III studies from Bharat Biotech to assess its performance in countries with different socioeconomic realities. As a result, experts from the Centers for Disease Control and Prevention (CDC) in the United States have been contacted to collaborate on the study.
Dr. O’Ryan, who was the principal investigator of a multinational trial of a rotavirus vaccine in 11 countries in Latin America and Finland, explains that Chile and Uruguay are the only countries that do not include the rotavirus vaccine in their National Immunization Programs. This is partly because rotavirus is not associated with mortality in Chile due to timely access to medical care. However, it still causes a significant burden of disease, being the leading cause of hospitalization for diarrhea in children under five years old in the public sector.
Globally, rotavirus was responsible for 500,000 deaths annually before the introduction of vaccination. Currently, around 120 countries have implemented rotavirus vaccination, reducing the annual death toll to between 200,000 and 300,000. The vaccine not only decreases mortality but also reduces severe illness, hospitalizations in intensive care units, and emergency room visits.
The Rotavac vaccine is an oral formulation developed from a naturally attenuated human neonatal strain of rotavirus. It was initially developed through collaboration between Indian and American researchers and completed by Bharat Biotech International in 2014. The vaccine is indicated for the active immunization of infants from six weeks of age to prevent severe rotavirus gastroenteritis. It consists of three doses administered at two, four, and six months of age and has been shown to reduce hospitalizations and the need for oral rehydration therapy.
The Rotavac study is being conducted by the Faculty of Medicine at the University of Chile, with the support of the Institute of Complex Engineering Systems and IQVIA, a multinational company that provides clinical trial services. The study began recruiting participants in July and aims to enroll 5,800 healthy volunteers from various cities in Chile. The participants will be randomly assigned to receive either three doses of Rotavac or a placebo alongside their routine vaccinations. A subgroup of 300 children will be included in the immunogenicity cohort to assess antibody response to the vaccine.
The study will follow participants for one year after the first dose, monitoring for any adverse reactions and episodes of gastroenteritis. The efficacy of the vaccine will be determined by comparing the number of episodes between the vaccine and control groups.
So far, the Rotavac study has had a success rate of approximately 21% in enrolling participants, with 60 children already enrolled. No serious adverse effects related to the vaccine have been reported.
The results of this phase III study will provide valuable information on the potential inclusion of the Rotavac vaccine in Chile’s National Immunization Program, contributing to the global strategy for rotavirus control.
What are the objectives of the phase III study conducted by the University of Chile on the Rotavac vaccine?
E global strategy for rotavirus control, the World Health Organization asked its producer, Bharat Biotech, for new phase III studies. That’s why experts from the Centers for Disease Control and Prevention in the United States, CDC, contacted us.”
Dr. O’Ryan, currently the dean of the institution and an academic in the Microbiology and Mycology Program at the Institute of Biomedical Sciences, was the principal investigator of the multinational trial of the human rotavirus vaccine produced by GlaxoSmithKline in 2006, which was conducted in more than 60,000 children from 11 Latin American countries and Finland. He also led the Chilean study of the Janssen vaccine against Covid-19 since 2020.
Chile and Uruguay are the only two countries that do not include the rotavirus vaccine in their National Immunization Program, although it is available privately. “Partly because rotavirus is not associated with mortality in our country due to timely access to outpatient and hospital medical care in case a child has this infection. Despite this, it causes a significant burden of disease, meaning a high number of cases. In fact, it is the leading cause of hospitalization for diarrhea in children under five years of age in the public sector,” says Dr. Torres, vice dean of the institution and an academic in the Department of Pediatrics and Pediatric Surgery at the Faculty of Medicine.
In that sense, Dr. O’Ryan adds, “the global estimate is that before vaccination, rotavirus caused 500,000 deaths per year. Currently, about 120 countries have implemented its use, so that figure is between 200,000 and 300,000 deaths per year. In addition, in middle- and high-income countries, the management of children with rotavirus has improved, mainly through hydration, because it is an infection that causes a very intense fever, vomiting, and diarrhea, especially before 24 months of age, whether at home or in the hospital. However, it still causes a significant occupancy of beds. The vaccine not only reduces mortality but also severe illness, hospitalization in intensive care units, and visits to emergency services. That is the importance of analyzing the possible incorporation of a new alternative to the available options.”
What is the study about?
The Rotavac vaccine was created from a naturally attenuated neonatal human strain from India. It emerged when a pediatrician observed that newborns infected with this strain did not fall ill with rotavirus diarrhea. Extensive research and development were carried out to turn this observation into a safe and effective vaccine.
The phase III study conducted by the University of Chile aims to evaluate the safety, efficacy, and immunogenicity of the Rotavac vaccine in Chilean children. The study will recruit 5,800 children from across the country and will assess the vaccine’s ability to prevent severe cases of rotavirus disease. The results of this study will provide valuable data on the vaccine’s performance in a different socioeconomic context and will contribute to the global efforts for rotavirus control.
The researchers leading the study, Dr. O’Ryan and Dr. Torres, are experienced pediatric infectious disease specialists who have conducted similar studies in the past. Their expertise and knowledge in the field will ensure the study is conducted rigorously and effectively.
The study’s findings will be crucial in informing health authorities and policymakers in Chile regarding the potential inclusion of the rotavirus vaccine in the national immunization program. By demonstrating the vaccine’s safety and efficacy in the Chilean population, the study may pave the way for improved healthcare outcomes and reduced burden of rotavirus disease in the country.
Overall, the phase III study conducted by the University of Chile is a significant step towards expanding the options for rotavirus control and prevention. By evaluating the Rotavac vaccine in a new population, the study will provide valuable insights that can contribute to global efforts in reducing the burden of rotavirus disease.
