Safety Study of a Rotavirus Vaccine (Rotavin-M1) Among Healthy Adults

Study Overview
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Brief Summary
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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.

Detailed Description
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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[8] strain and attenuating it through serial

Official Title
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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

Conditions
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Diarrhea, Vomit, Fever, Nausea, Irritability

Intervention / Treatment
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* Drug: Rotavin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At dose 1 Healthy male or female, 18 to 40 years of age, Free of disease, Written informed consent obtained from subjects. At dose 2 Received dose 1. Oral informed consent obtained from subject for continuing participate the study. Exclusion Criteria: At dose 1 Pregnant woman or planning to be pregnant during the study period. Has a chronic disease (cardiovascular, liver, kidney disease). Acute disease at the time of enrolment. Administering corticosteroids (> 1mg/kg/day). Received any immunosuppressive therapy within 4 week before vaccination (Administration of immunoglobulins and/or any blood product or corticosteroids for >2 weeks). Immunosuppressive or immunodeficient condition. Allergic or reaction with any component of vaccine, includes anaphylactic and shock with any antibiotic. Fever (axillary temperature >38oC) within 3 days before or on the day of vaccination. Has any type of blood disorder, leukemia, or malignant tumor which can affect the bone marrow or lymph system. Use of any investigational or non-registered product (unlicensed drug or vaccine) other than the study vaccine during the study period. At dose 2 Pregnant woman or planning to be pregnant in next 1 month. Acute disease at the time of 2nd dose. Administering corticosteroids (> 1mg/kg/day). Received any immunosuppressive therapy within 4 week before vaccination (administration of immunoglobulins and/or any blood product or corticosteroids for >2 weeks). Immunosuppressive or immunodeficient condition. History of allergic disease or reactions likely to be exacerbated by any component of the study vaccine. Fever (axillary temperature >38oC) within 3 days before or on the day of vaccination. Has any type of blood disorder, leukemia, or malignant tumor which can affect the bone marrow or lymph system. Use of any investigational or non-registered product (unlicensed drug or vaccine) other than the study vaccine during the study period.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rotavin<br>Rotavin-M1 vaccine, 10e6.3FFU/dose, 2 doses, 1 month between doses | Drug: Rotavin<br>* Rotavin-M1, 10e6.3FFU/dose, 2 doses, 1-month between doses<br>* Other names: Rotavin-M1;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of Rotavin-M1 vaccine in healthy adult volunteers | To evaluate the safety of 2 doses Rotavin-M1 vaccine (10e6.3FFU/dose, 1-month interval between doses) in healthy adult volunteers. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reactogenicity of Rotavin-M1 in healthy adult volunteer | To evaluate immediate reactions (30 minutes) after administration of each dose | 3 months | 
| Change in blood cell counts, serum transaminase and urea nitrogen concentration in adults after vaccination with Rotavin-M1 | 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 | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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blood cell counts, BUN, ALT, AST, diarrhea, fever, vomit, nausea, loss of appetite, irritability