Safety of an Inactivated Enterovirus Type 71 Vaccine in Healthy Adults

Sinovac

Status and phase: Completed; Phase 1

Conditions: Infection; Viral, Enterovirus

Treatments: Other: Placebo; Biological: Inactivated Enterovirus Type 71 Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01273233

EV71-1001-Ia

Details and patient eligibility

About

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

Full 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

Enrollment: 36 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 4 patient groups, including a placebo group

Group 1: 200U EV71 vaccine

Experimental group

Description:

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

Treatment:

Biological: Inactivated Enterovirus Type 71 Vaccine

Group 2: 400U EV71 vaccine

Experimental group

Description:

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

Treatment:

Biological: Inactivated Enterovirus Type 71 Vaccine

Group 1: Placebo

Placebo Comparator group

Description:

6 adults received 3 doses of placebo 14 days apart

Treatment:

Other: Placebo

Group 2: Placebo

Placebo Comparator group

Description:

6 adults received 3 doses of placebo 14 days apart

Treatment:

Other: Placebo