Safety of an Inactivated Enterovirus Type 71 Vaccine in Healthy Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sinovac Biotech Co., Ltd
ClinicalTrials.gov Identifier:
NCT01273233
First received: January 7, 2011
Last updated: March 13, 2013
Last verified: March 2013
  Purpose

A blind, randomized and placebo-controlled clinical trial with Inactivated Enterovirus Type 71 Vaccines in healthy adults


Condition Intervention Phase
Infection; Viral, Enterovirus
Biological: Inactivated Enterovirus Type 71 Vaccine
Other: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Blinded, Randomized and Controlled Clinical Trial of An Inactivated Enterovirus Type 71 Vaccine in Healthy Adults

Further study details as provided by Sinovac Biotech Co., Ltd:

Primary Outcome Measures:
  • To evaluate the safety and tolerability of the inactivated Enterovirus Type 71 Vaccine in adults by different doses [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 36
Study Start Date: December 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1: 200U EV71 vaccine
12 adults received 3 doses of 200U EV71 vaccine 14 days apart
Biological: Inactivated Enterovirus Type 71 Vaccine
A Sinovac EV71 vaccine contains inactivated EV71 virus, aluminum hydroxide, sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate and injection water. The EV71 vaccine is supplied in one mono-dose vial containing 0.5 mL of viral suspension with EV71 virus antigen of 200U and 400U (Elisa unit)
Other Name: EV71 Vaccine
Experimental: Group 2: 400U EV71 vaccine
12 adults received 3 doses of 400U EV71 vaccine 14 days apart
Biological: Inactivated Enterovirus Type 71 Vaccine
A Sinovac EV71 vaccine contains inactivated EV71 virus, aluminum hydroxide, sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate and injection water. The EV71 vaccine is supplied in one mono-dose vial containing 0.5 mL of viral suspension with EV71 virus antigen of 200U and 400U (Elisa unit)
Other Name: EV71 Vaccine
Placebo Comparator: Group 1: Placebo
6 adults received 3 doses of placebo 14 days apart
Other: Placebo
Placebo is suspension with a little ivory precipitation, composition of which is aluminum hydroxide diluents.
Other Name: EV71 Vaccine
Placebo Comparator: Group 2: Placebo
6 adults received 3 doses of placebo 14 days apart
Other: Placebo
Placebo is suspension with a little ivory precipitation, composition of which is aluminum hydroxide diluents.
Other Name: EV71 Vaccine

Detailed Description:

A total of 36 eligible subjects aged from 18 to 49 years will be enrolled in the study, they will be randomized to receive two different dosage of vaccine candidate or placebo to evaluate the safety of this vaccine in adults

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy males and females, aged from 18 to 49 years old. Health is determined by medical history, physical examination, laboratory examination and clinical judgment of the investigator
  2. Provided legal identification for the sake of recruitment.
  3. Subjects are able to understand and sign informed consents.

Exclusion Criteria:

  1. Histroy of Hand-foot-mouth Disease
  2. Women of lactation, pregnancy or about to be pregnant in 60 days
  3. Subject that has allergic history of vaccine, or allergic to any ingredient of vaccine
  4. Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
  5. Congenital malformations or developmental disorders, genetic defects, or severe malnutrition
  6. Epilepsy, seizures or convulsions history, or family history of mental illness
  7. Autoimmune disease or immunodeficiency, or parents, brothers and sisters have autoimmune diseases or immunodeficiency
  8. History of asthma, angioedema, diabetes or malignancy
  9. History of thyroidectomy or thyroid disease that required medication within the past 12 months
  10. Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
  11. Asplenia, functional asplenia or any condition resulting in the absence or removal the spleen
  12. Acute illness or acute exacerbation of chronic disease within the past 7 days
  13. Any history of immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis)
  14. History of any blood products within 3 months
  15. Administration of any live attenuated vaccine within 28 days
  16. Administration of subunit or inactivated vaccines ,e.g., pneumococcal vaccine, or allergy treatment within 14 days
  17. Axillary temperature > 37.0 centigrade before vaccination
  18. Abnormal laboratory parameters before vaccination
  19. Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01273233

Locations
China, Guangxi
GuangXi Center for Diseases Control and Prevention
Nanning, Guangxi, China
Sponsors and Collaborators
Sinovac Biotech Co., Ltd
Investigators
Principal Investigator: Yan-ping Li, MD Guangxi Centers for Disease Control and Prevention
  More Information

No publications provided by Sinovac Biotech Co., Ltd

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sinovac Biotech Co., Ltd
ClinicalTrials.gov Identifier: NCT01273233     History of Changes
Other Study ID Numbers: EV71-1001-Ia
Study First Received: January 7, 2011
Last Updated: March 13, 2013
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Enterovirus Infections
Virus Diseases
Picornaviridae Infections
RNA Virus Infections

ClinicalTrials.gov processed this record on September 18, 2014