Diarrhea Clinical Trial
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
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.
Status | Completed |
Enrollment | 29 |
Est. completion date | October 2009 |
Est. primary completion date | October 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 40 Years |
Eligibility |
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 1. Pregnant woman or planning to be pregnant during the study period. 2. Has a chronic disease (cardiovascular, liver, kidney disease). 3. Acute disease at the time of enrolment. 4. Administering corticosteroids (> 1mg/kg/day). 5. Received any immunosuppressive therapy within 4 week before vaccination (Administration of immunoglobulins and/or any blood product or corticosteroids for >2 weeks). 6. Immunosuppressive or immunodeficient condition. 7. Allergic or reaction with any component of vaccine, includes anaphylactic and shock with any antibiotic. 8. Fever (axillary temperature >38oC) within 3 days before or on the day of vaccination. 9. Has any type of blood disorder, leukemia, or malignant tumor which can affect the bone marrow or lymph system. 10. Use of any investigational or non-registered product (unlicensed drug or vaccine) other than the study vaccine during the study period. At dose 2 1. Pregnant woman or planning to be pregnant in next 1 month. 2. Acute disease at the time of 2nd dose. 3. Administering corticosteroids (> 1mg/kg/day). 4. Received any immunosuppressive therapy within 4 week before vaccination (administration of immunoglobulins and/or any blood product or corticosteroids for >2 weeks). 5. Immunosuppressive or immunodeficient condition. 6. History of allergic disease or reactions likely to be exacerbated by any component of the study vaccine. 7. Fever (axillary temperature >38oC) within 3 days before or on the day of vaccination. 8. Has any type of blood disorder, leukemia, or malignant tumor which can affect the bone marrow or lymph system. 9. Use of any investigational or non-registered product (unlicensed drug or vaccine) other than the study vaccine during the study period. |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
Vietnam | Preventive Medicine Center | Thanh Son | Phu Tho |
Lead Sponsor | Collaborator |
---|---|
National Institute of Hygiene and Epidemiology, Vietnam | Center for Research and Production of Vaccines and Biologicals |
Vietnam,
Anh DD, Thiem VD, Fischer TK, Canh DG, Minh TT, Tho le H, Van Man N, Luan le T, Kilgore P, von Seidlein L, Glass RI. The burden of rotavirus diarrhea in Khanh Hoa Province, Vietnam: baseline assessment for a rotavirus vaccine trial. Pediatr Infect Dis J. 2006 Jan;25(1):37-40. — View Citation
Kim SY, Goldie SJ, Salomon JA. Cost-effectiveness of Rotavirus vaccination in Vietnam. BMC Public Health. 2009 Jan 21;9:29. doi: 10.1186/1471-2458-9-29. — View Citation
Luan le T, Trang NV, Phuong NM, Nguyen HT, Ngo HT, Nguyen HT, Tran HB, Dang HN, Dang AD, Gentsch JR, Wang Y, Esona MD, Glass RI, Steele AD, Kilgore PE, Nguyen MV, Jiang B, Nguyen HD. Development and characterization of candidate rotavirus vaccine strains derived from children with diarrhoea in Vietnam. Vaccine. 2009 Nov 20;27 Suppl 5:F130-8. doi: 10.1016/j.vaccine.2009.08.086. — View Citation
Ngo TC, Nguyen BM, Dang DA, Nguyen HT, Nguyen TT, Tran VN, Vu TT, Ogino M, Alam MM, Nakagomi T, Nakagomi O, Yamashiro T. Molecular epidemiology of rotavirus diarrhoea among children in Haiphong, Vietnam: the emergence of G3 rotavirus. Vaccine. 2009 Nov 20;27 Suppl 5:F75-80. doi: 10.1016/j.vaccine.2009.08.074. — View Citation
Nguyen TA, Yagyu F, Okame M, Phan TG, Trinh QD, Yan H, Hoang KT, Cao AT, Le Hoang P, Okitsu S, Ushijima H. Diversity of viruses associated with acute gastroenteritis in children hospitalized with diarrhea in Ho Chi Minh City, Vietnam. J Med Virol. 2007 May;79(5):582-90. — View Citation
Van Man N, Luan le T, Trach DD, Thanh NT, Van Tu P, Long NT, Anh DD, Fischer TK, Ivanoff B, Gentsch JR, Glass RI; Vietnam Rotavirus Surveillance Network. Epidemiological profile and burden of rotavirus diarrhea in Vietnam: 5 years of sentinel hospital surveillance, 1998-2003. J Infect Dis. 2005 Sep 1;192 Suppl 1:S127-32. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes |
Secondary | Reactogenicity of Rotavin-M1 in healthy adult volunteer | To evaluate immediate reactions (30 minutes) after administration of each dose | 3 months | Yes |
Secondary | 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 | Yes |
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