Safety of an Inactivated Enterovirus Type 71 Vaccine in Healthy Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-02-28

Brief Summary

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

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Detailed Description

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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

Conditions

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Infection; Viral, Enterovirus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group 1: 200U EV71 vaccine

12 adults received 3 doses of 200U EV71 vaccine 14 days apart

Group Type EXPERIMENTAL

Inactivated Enterovirus Type 71 Vaccine

Intervention Type BIOLOGICAL

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)

Group 2: 400U EV71 vaccine

12 adults received 3 doses of 400U EV71 vaccine 14 days apart

Group Type EXPERIMENTAL

Inactivated Enterovirus Type 71 Vaccine

Intervention Type BIOLOGICAL

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)

Group 1: Placebo

6 adults received 3 doses of placebo 14 days apart

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo is suspension with a little ivory precipitation, composition of which is aluminum hydroxide diluents.

Group 2: Placebo

6 adults received 3 doses of placebo 14 days apart

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo is suspension with a little ivory precipitation, composition of which is aluminum hydroxide diluents.

Interventions

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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)

Intervention Type BIOLOGICAL

Placebo

Placebo is suspension with a little ivory precipitation, composition of which is aluminum hydroxide diluents.

Intervention Type OTHER

Other Intervention Names

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EV71 Vaccine EV71 Vaccine

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes