A Clinical Trial for Inactivated Vaccine(Vero Cell) Against EV71 in Chinese Healthy Young Adults and Children

Hand, Foot and Mouth Disease Clinical Trial

Official title:

A Phase Ia Clinical Trial for Inactivated Vaccine(Vero Cell) Against EV71 in Chinese Healthy Young Adults and Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01267903
• Other study ID #: JSVCT003
• Status: Completed
• Phase: Phase 1
• First received: December 28, 2010
• Last updated: June 9, 2011
• Start date: January 2011
• Est. completion date: June 2011

Study information

• Verified date: January 2011
• Source: Jiangsu Province Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Hand, foot, and mouth disease (HFMD) is a common viral illness in infants and children caused by viruses that belong to the enterovirus genus of the picornavirus family. Although most HFMD cases do not result in serious complications, outbreaks of HFMD caused by enterovirus 71 (EV71) can present with a high rate of neurological complications, including meningoencephalitis, pulmonary complications, and can even cause infant death. HFMD caused by EV71 has become a major emerging infectious disease in Asia and the highly pathogenic potential of EV71 clearly requires the attention of world medical community.

The development of vaccine against EV71 is active and ongoing in Asian countries now. Several studies have examined the effectiveness of inactivated viral vaccines against EV71 in animal model. A wide range of experimental EV71 vaccine approaches have been studied including heat-inactivated or formaldehyde-inactivated virion, EV71 virus-like particles (VLP) , VP1 recombinant protein ,VP1 DNA vaccine , VP1 peptide-based vaccine targeting the neutralizing domain, bacterial or viral vector expressing VP1, and a Vero cell-adapted live attenuated virus. Furthermore, neutralizing antibodies against EV71 have been suggested as one of the most important factors in prevention of the severe EV71 infection. Recently, an inactivated vaccine(vero cell) against EV71 has been licensed by SFDA in China, this clinical trial phase Ia is armed to evaluate safety and tolerance in Chinese healthy adults and children.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 22 Years

Eligibility

Inclusion Criteria:

• Healthy subjects aged from 5 to 22 years old as established by medical history and clinical examination

• The subjects or their guardians are able to understand and sign the informed consent

• Had never received the vaccine against EV71

• Subjects who can and will comply with the requirements of the protocol

Exclusion Criteria:

• Subject that has a medical history of HFMD

• subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine

• Family history of seizures or progressive neurological disease

• Family history of congenital or hereditary immunodeficiency

• Women of pregnancy, lactation or about to be pregnant in 60 days

• Autoimmune disease or immunodeficiency

• Bleeding disorder diagnosed by a doctor or significant bruising or bleeding difficulties with IM injections or blood draws

• Any prior administration of administration of immunoglobulins

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hand, Foot and Mouth Disease
• Mouth Diseases

Intervention

Biological:
• vaccine against EV71 of 320U/0.5ml
inactivated vaccine(vero cell) against EV71 of 320U/0.5ml on day0,28,modern medicines
• vaccine against EV71 of 640U/0.5ml
inactivated vaccine(vero cell) against EV71 of 640U/0.5ml on day0,28
• vaccine against EV71 of 160U/0.5ml
inactivated vaccine(vero cell) against EV71 of 160U/0.5ml on 0,28 day
• vaccine against EV71 of 320U/0.5ml
inactivated vaccine(vero cell) against EV71 of 320U/0.5ml on day0,28
• vaccine against EV71 of 640U/0.5ml
inactivated vaccine(vero cell) against EV71 of 640U/0.5ml on day0,28

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Jiangsu Province Centers for Disease Control and Prevention	Bejing Vigoo Biological Co., LTD

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to evaluate the safety of EV71 vaccine in Chinese healthy adults and children	to evaluate the Adverse reactions of EV71 vaccine in Chinese healthy adults and children	28 days after the first vaccination	Yes
Primary	to evaluate the safety of EV71 vaccine in Chinese healthy adults and children	to evaluate the Adverse reactions of EV71 vaccine in Chinese healthy adults and children	28 days after the second vaccination	Yes
Secondary	to evaluate the seroconversion rate of Antinuclear antibodies in serum after first vaccination	to evaluate the seroconversion rate of Antinuclear antibodies in serum 28 days after first vaccination	28 days after the first vaccination	Yes
Secondary	to evaluate the seroconversion rate of Antinuclear antibodies in serum after second vaccination	to evaluate the seroconversion rate of Antinuclear antibodies in serum 28 days after second vaccination	28 days after second vaccination	Yes
Secondary	to evaluate the abnormity change of live and kidney function indexes in serum after first vaccination	to evaluate the abnormity change of live and kidney function indexes in serum 3 days after first vaccination	3 days after first vaccination	Yes
Secondary	to evaluate the abnormity change of live and kidney function indexes in serum after second vaccination	to evaluate the abnormity change of live and kidney function indexes in serum 3 days after second vaccination	3 days after second vaccination	Yes