Safety Study of a Rotavirus Vaccine (Rotavin-M1) Among Healthy Adults
The purpose of this study is to evaluate the safety of Rotavin-M1 produced by the Center for Research and Production of Vaccines and Biologicals (POLYVAC) in adult volunteers in Vietnam.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||A Phase 1 Study to Evaluate Safety and Reactogenicity of a Vietnamese Rotavirus Vaccine (Rotavin-M1 at 10e6.3FFU/Dose) Among Healthy Adults in Vietnam|
- Safety of Rotavin-M1 vaccine in healthy adult volunteers [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]To evaluate the safety of 2 doses Rotavin-M1 vaccine (10e6.3FFU/dose, 1-month interval between doses) in healthy adult volunteers.
- Reactogenicity of Rotavin-M1 in healthy adult volunteer [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]To evaluate immediate reactions (30 minutes) after administration of each dose
- Change in blood cell counts, serum transaminase and urea nitrogen concentration in adults after vaccination with Rotavin-M1 [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]to assess change in blood cell counts (red blood cells, white blood cells, platelets), blood urea nitrogen concentration, serum transaminase levels (AST, ALT) in adult volunteer after each dose of Rotavin-M1 10e6.3FFU/dose
|Study Start Date:||August 2009|
|Study Completion Date:||October 2009|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
Rotavin-M1 vaccine, 10e6.3FFU/dose, 2 doses, 1 month between doses
Rotavin-M1, 10e6.3FFU/dose, 2 doses, 1-month between doses
Other Name: Rotavin-M1
Rotavirus (RV) is the most important cause of acute gastroenteritis in children worldwide. In Vietnam rotavirus causes an estimated 122,000-140,000 hospitalizations and 2900-5400 deaths per year among children under 5 years of age (1). Over the past 13 years, sentinel hospital surveillance identified rotavirus in 44%-62% of children admitted for the treatment of acute diarrhea in Vietnam (2-4). Such a high burden of disease justified accelerated development of a new and locally manufactured vaccine against rotavirus in Vietnam. It is estimated that if a vaccine was introduced in the current childhood immunization schedule, it could reduce severe rotavirus disease by about 60% or more given current vaccine efficacies and coverage (5).
The Government of Vietnam has pursued a policy to encourage local vaccine production so the country could be self-reliant with affordable vaccines for its population (6). Over the past decades, several locally produced vaccines for poliomyelitis, cholera, Japanese encephalitis, and Diphtheria-Pertussis-Tetanus have contributed to the reduction in the prevalence of these diseases and to the eradication of polio over the past decade. While two commercial rotavirus vaccines, RotarixTM (GSK, Belgium) and RotaTeq® (Merck), have both been tested in Vietnam, neither is currently available at an affordable cost for the national program. Therefore, the candidate vaccine, Rotavin-M1, was developed in order to fill this need for a more affordable vaccine for Vietnamese children (6). This vaccine is similar to RotarixTM, and was developed by selecting a common G1P strain and attenuating it through serial
Please refer to this study by its ClinicalTrials.gov identifier: NCT01375907
|Preventive Medicine Center|
|Thanh Son, Phu Tho, Vietnam|
|Principal Investigator:||Anh D Dang, PhD||National Institute of Hygiene and Epidemiology, Vietnam|