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

NCT01375907 | Completed Phase 1 DMC

• 1 other identifier: Rotavin01
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diarrhea; Vomit; Fever; Nausea; Irritability

Keywords

blood cell counts; BUN; ALT; AST; diarrhea; fever; vomit; nausea; loss of appetite; irritability

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Reactogenicity of Rotavin-M1 in healthy adult volunteer

  3 months

• Change in blood cell counts, serum transaminase and urea nitrogen concentration in adults after vaccination with Rotavin-M1

  3 months

Study Arms (1)

Rotavin

EXPERIMENTAL

Rotavin-M1 vaccine, 10e6.3FFU/dose, 2 doses, 1 month between doses

Drug: Rotavin

Interventions

Rotavin DRUG

Rotavin-M1, 10e6.3FFU/dose, 2 doses, 1-month between doses

Also known as: Rotavin-M1

Rotavin

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• National Institute of Hygiene and Epidemiology, Vietnam: lead
• Center for Research and Production of Vaccines and Biologicals: collaborator

Study Sites (1)

Preventive Medicine Center

Thanh Sơn, Phu Tho, Vietnam

Location

Related Publications (7)

• 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. doi: 10.1097/01.inf.0000195635.05186.52.

  PMID: 16395100 BACKGROUND

• 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. doi: 10.1086/431501.

  PMID: 16088796 BACKGROUND

• 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.

  PMID: 19931725 BACKGROUND

• 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. doi: 10.1002/jmv.20857.

  PMID: 17385670 BACKGROUND

• 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.

  PMID: 19159483 BACKGROUND

• 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.

  PMID: 19931712 BACKGROUND

• Dang DA, Nguyen VT, Vu DT, Nguyen TH, Nguyen DM, Yuhuan W, Baoming J, Nguyen DH, Le TL; Rotavin-M1 Vaccine Trial Group. A dose-escalation safety and immunogenicity study of a new live attenuated human rotavirus vaccine (Rotavin-M1) in Vietnamese children. Vaccine. 2012 Apr 27;30 Suppl 1:A114-21. doi: 10.1016/j.vaccine.2011.07.118.

  PMID: 22520120 DERIVED

MeSH Terms

Conditions

Diarrhea; Vomiting; Fever; Nausea; Anorexia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Temperature Changes

Study Officials

• Anh D Dang, PhD

  National Institute of Hygiene and Epidemiology, Vietnam

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: May 19, 2011
• First Posted: June 17, 2011
• Study Start: August 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: July 4, 2016

Record last verified: 2016-07

Locations

VN (1)