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

This study has been completed.
Sponsor:
Information provided by:
National Institute of Hygiene and Epidemiology, Vietnam
ClinicalTrials.gov Identifier:
NCT01375907
First received: May 19, 2011
Last updated: June 16, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention Phase
Diarrhea
Vomit
Fever
Nausea
Irritability
Drug: Rotavin
Phase 1

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by National Institute of Hygiene and Epidemiology, Vietnam:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 29
Study Start Date: August 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rotavin
Rotavin-M1 vaccine, 10e6.3FFU/dose, 2 doses, 1 month between doses
Drug: Rotavin
Rotavin-M1, 10e6.3FFU/dose, 2 doses, 1-month between doses
Other Name: Rotavin-M1

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01375907

Locations
Vietnam
Preventive Medicine Center
Thanh Son, Phu Tho, Vietnam
Sponsors and Collaborators
National Institute of Hygiene and Epidemiology, Vietnam
Investigators
Principal Investigator: Anh D Dang, PhD National Institute of Hygiene and Epidemiology, Vietnam
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dang Duc Anh/ Deputy Director,, The National Institute of Hygiene and Epidemiology
ClinicalTrials.gov Identifier: NCT01375907     History of Changes
Other Study ID Numbers: Rotavin01
Study First Received: May 19, 2011
Last Updated: June 16, 2011
Health Authority: Vietnam: Ministry of Health

Keywords provided by National Institute of Hygiene and Epidemiology, Vietnam:
blood cell counts
BUN
ALT
AST
diarrhea
fever
vomit
nausea
loss of appetite
irritability

Additional relevant MeSH terms:
Diarrhea
Fever
Nausea
Signs and Symptoms, Digestive
Signs and Symptoms
Body Temperature Changes

ClinicalTrials.gov processed this record on April 15, 2014