A Phase II Clinical Trial for Inactivated Vaccine (Vero Cell) Against EV71 in Chinese Children and Infants

NCT01399853 | Completed Phase 2 DMC

• 1 other identifier: JSVCT005
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief 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 phase I study of inactivated vaccine (vero cell) against EV71 has completed last month in Jiangsu Province in China. The data from the phase I study suggested that the inactivated EV71 vaccine had a clinically acceptable safety and good immunogenicity for healthy Chinese children and infants. In order to provide more evidence for the immunogenicity of the vaccine, to further explore the probable immunizing dose and the safety profile of this vaccine, a phase II clinical trial is planed to conduct.

Conditions

Immunogenicity; Safety

Keywords

immunogenicity; safety; inactivated EV71 vaccine

Outcome Measures

Primary Outcomes (4)

• The GMT of anti-EV71 antibodies in serum after first vaccination

  to evaluate the GMT of anti-EV71 antibodies in serum 28 days after first vaccination

  28 days after first vaccination

• The GMT of anti-EV71 antibodies in serum after second vaccination

  to evaluate the GMT of anti-EV71 antibodies in serum 28 days after second vaccination

  28 days after second vaccination

• Frequency of systemic and local adverse reactions after the first vaccination

  Frequency of systemic and local adverse reactions in healthy Children and infants following first doses of EV71 vaccine

  28 days after the first vaccination

• Frequency of systemic and local adverse reactions after the second vaccination

  Frequency of systemic and local adverse reactions in healthy Children and infants following second doses of EV71 vaccine

  28 days after the second vaccination

Secondary Outcomes (7)

• The seroconversion rate of anti-EV71 antibodies in serum after first vaccination

  28 days after first vaccination

• The seroconversion rate of anti-EV71 antibodies in serum after second vaccination

  28 days after second vaccination

• Frequency of adverse events and any SAE after the first vaccination

  28 days after the first vaccination

• Frequency of adverse events and any SAE after the second vaccination

  28 days after the second vaccination

• The clinical abnormality of hematological examination, blood biochemical test and urinalysis after first vaccination in children

  3 days after first vaccination

Study Arms (10)

160U /0.5ml in children (from 12 to 36 months old)

EXPERIMENTAL

inactivated vaccine(vero cell) against EV71 of 160U /0.5ml in 120 children aged 12-36 months old on day0,28

Biological: 160U /0.5ml EV71 Vaccine

320U /0.5ml in children (from 12 to 36 months old)

EXPERIMENTAL

inactivated vaccine(vero cell) against EV71 of 320U /0.5ml in 120 children aged 12-36 months old on day0,28

Biological: 320U /0.5ml EV71 vaccine

640U /0.5ml in children (from 12 to 36 months old)

EXPERIMENTAL

inactivated vaccine(vero cell) against EV71 of 640U /0.5ml in 120 children aged 12-36 months old on day0,28

Biological: 640U /0.5ml EV71 vaccine

(without adjuvant) 640U /0.5ml in children (12-36months)

EXPERIMENTAL

inactivated vaccine(vero cell) against EV71 of (without adjuvant) 640U /0.5ml in 120 children aged 12-36 months old on day0,28

Biological: (without adjuvant) 640U /0.5ml

160U /0.5ml in infants (from 6 to 11 months old)

EXPERIMENTAL

inactivated vaccine(vero cell) against EV71 of 160U /0.5ml in 120 infants aged 6-11 months old on day0,28

Biological: 160U /0.5ml EV71 Vaccine

320U /0.5ml in infants (from 6 to 11 months old)

EXPERIMENTAL

inactivated vaccine(vero cell) against EV71 of 320U /0.5ml in 120 infants aged 6-11 months old on day0,28

Biological: 320U /0.5ml EV71 vaccine

640U /0.5ml in infants (from 6 to 11 months old)

EXPERIMENTAL

inactivated vaccine(vero cell) against EV71 of 640U /0.5ml in 120 infants aged 6-11 months old on day0,28

Biological: 640U /0.5ml EV71 vaccine

(without adjuvant) 640U /0.5ml in infants (from 6 to 11 months

EXPERIMENTAL

inactivated vaccine(vero cell) against EV71 of (without adjuvant) 640U /0.5ml in 120 infants aged 6-11 months old on day0,28

Biological: (without adjuvant) 640U /0.5ml

0/0.5ml placebo in children (from 12 to 36 months old)

PLACEBO COMPARATOR

0/0.5ml placebo in 120 children aged 12-36 months old on day0,28

Biological: 0/0.5ml placebo

0/0.5ml placebo in infants (from 6 to 11 months old)

PLACEBO COMPARATOR

0/0.5ml placebo in 120 infants aged 6-11 months old on day0,28

Biological: 0/0.5ml placebo

Interventions

160U /0.5ml EV71 Vaccine BIOLOGICAL

inactivated vaccine (vero cell) against EV71 of 160U /0.5ml, two doses, 28 days interval

160U /0.5ml in children (from 12 to 36 months old); 160U /0.5ml in infants (from 6 to 11 months old)

320U /0.5ml EV71 vaccine BIOLOGICAL

inactivated vaccine(vero cell) against EV71 of 320U /0.5ml, two doses, 28 days interval

320U /0.5ml in children (from 12 to 36 months old); 320U /0.5ml in infants (from 6 to 11 months old)

640U /0.5ml EV71 vaccine BIOLOGICAL

inactivated vaccine (vero cell) against EV71 of 640U /0.5ml, two doses, 28 days interval

640U /0.5ml in children (from 12 to 36 months old); 640U /0.5ml in infants (from 6 to 11 months old)

(without adjuvant) 640U /0.5ml BIOLOGICAL

inactivated vaccine (vero cell) against EV71 of (without adjuvant) 640U /0.5ml, two doses, 28 days interval

(without adjuvant) 640U /0.5ml in children (12-36months); (without adjuvant) 640U /0.5ml in infants (from 6 to 11 months

0/0.5ml placebo BIOLOGICAL

0/0.5ml placebo, two doses, 28 days interval

0/0.5ml placebo in children (from 12 to 36 months old); 0/0.5ml placebo in infants (from 6 to 11 months old)

Eligibility Criteria

• Age: 6 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• For children group (aged from 12-36 months):
• Healthy children aged from 12 to 36 months old as established by medical history and clinical examination
• The subjects' 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
• Subjects with temperature \<=37.0°C on axillary setting
• For infants group (aged from 6-11 months):
• Healthy infants aged from 6 to 11 months old as established by medical history and clinical examination
• The subjects' 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
• Subjects with temperature \<=37.0°C on axillary setting

You may not qualify if:

• For children group (aged from 12-36 months):
• Subject who has a medical history of HFMD
• \<= 37 weeks gestation
• Subjects with a birth weight \<2.5 kg
• 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
• Severe malnutrition or dysgenopathy
• Major congenital defects or serious chronic illness, including perinatal brain damage
• Autoimmune disease
• Bleeding disorder diagnosed by a doctor or significant bruising or bleeding difficulties with IM injections or blood draws
• Any acute infections in last 7 days
• Any prior administration of immunodepressant or corticosteroids in last 6month
• Any prior administration of blood products in last 3 month
• Any prior administration of other research medicines in last 1 month

Sponsors & Collaborators

• Jiangsu Province Centers for Disease Control and Prevention: lead
• Bejing Vigoo Biological Co., LTD: collaborator

Study Sites (1)

Jiangsu Provincial Center for Diseases Control and Prevention

Nanjing, Jiangsu, 210009, China

Location

Related Publications (1)

• Zhu FC, Liang ZL, Li XL, Ge HM, Meng FY, Mao QY, Zhang YT, Hu YM, Zhang ZY, Li JX, Gao F, Chen QH, Zhu QY, Chu K, Wu X, Yao X, Guo HJ, Chen XQ, Liu P, Dong YY, Li FX, Shen XL, Wang JZ. Immunogenicity and safety of an enterovirus 71 vaccine in healthy Chinese children and infants: a randomised, double-blind, placebo-controlled phase 2 clinical trial. Lancet. 2013 Mar 23;381(9871):1037-45. doi: 10.1016/S0140-6736(12)61764-4.

  PMID: 23352749 DERIVED

MeSH Terms

Interventions

Adjuvants, Pharmaceutic

Intervention Hierarchy (Ancestors)

Pharmaceutic Aids; Pharmaceutical Preparations; Specialty Uses of Chemicals; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2011
• First Posted: July 22, 2011
• Study Start: July 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: May 1, 2012
• Last Updated: May 31, 2012

Record last verified: 2012-05

Locations

CN (1)