A Booster Dose of Inactivated Vaccine (Vero Cell) Against EV71 in Chinese Children

NCT01734408 | Completed Phase 2

• 1 other identifier: JSVCT005b
• Study Type: interventional
• Target: 773
• 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 II study of inactivated vaccine (vero cell) against EV71 has completed last month in Jiangsu Province in China. The data from the phase II study suggested that the inactivated EV71 vaccine had a clinically acceptable safety and good immunogenicity for healthy Chinese children and infants. But the antibody titer against EV71 was found decreased significantly at month 8 compared to that at day 56. Considering the similar dynamic trend had also been found in the antibody against poliovirus induced by polio vaccines, and whose immunization schedule contains a booster dose administrated at 1 to 1.5 year after the first 3 doses of fundamental immunity. In order to find a better immunization schedule for children, the investigators decided to perform this booster immunity trial among these children who had received two doses of EV71 vaccines (around one year after the fundamental immunity). The investigators do the recruitment among these children who had participated in the previous phase II trial and received EV71 vaccines, and randomize them in a ratio of 2:1 to receive either a booster dose of EV71 vaccines or placebo.

Conditions

EV71-associated Disease

Keywords

immunogenicity; safety; inactivated EV71 vaccine

Outcome Measures

Primary Outcomes (1)

• Geometric mean titer (GMT) of anti-EV71 antibodies

  GMT of anti-EV71 antibodies in serum 28 days after booster dose injection

  28 days after vaccination

Secondary Outcomes (3)

• Safety of EV71 vaccine in healthy children

  28 days after vaccination

• Geometric mean fold increase (GMFI) of anti-EV71 antibodies

  28 days after vaccination

• Seroconversion of anti-EV71 antibodies

  28 days after vaccination

Study Arms (8)

alum-adjuvant 160U /0.5ml EV71 vaccine

EXPERIMENTAL

A booster dose of alum-adjuvant 160U /0.5ml EV71 vaccine in 160 children whom had received two doses of alum-adjuvant 160U/0.5ml EV71 vaccines one year before.

Biological: alum-adjuvant 160U /0.5ml

placebo A

PLACEBO COMPARATOR

A 0/0.5ml placebo in 80 children whom had received two doses of alum-adjuvant 160U/0.5ml EV71 vaccines one year before.

Biological: 0/0.5ml placebo

alum-adjuvant 320U /0.5ml EV71 vaccine

EXPERIMENTAL

A booster dose of alum-adjuvant 320U /0.5ml EV71 vaccine in 160 children whom had received two doses of alum-adjuvant 320U/0.5ml EV71 vaccines one year before.

Biological: alum-adjuvant 320U /0.5ml

placebo B

PLACEBO COMPARATOR

A 0/0.5ml placebo in 80 children whom had received two doses of alum-adjuvant 320U/0.5ml EV71 vaccines one year before.

Biological: 0/0.5ml placebo

alum-adjuvant 640U /0.5ml EV71 vaccine

EXPERIMENTAL

A booster dose of alum-adjuvant 640U /0.5ml EV71 vaccine in 160 children whom had received two doses of alum-adjuvant 640U/0.5ml EV71 vaccines one year before.

Biological: alum-adjuvant 640U /0.5ml

placebo C

PLACEBO COMPARATOR

A 0/0.5ml placebo in 80 children whom had received two doses of alum-adjuvant 640U/0.5ml EV71 vaccines one year before.

Biological: 0/0.5ml placebo

adjuvant-free 640U /0.5ml EV71 vaccine

EXPERIMENTAL

A booster dose of adjuvant-free 640U /0.5ml EV71 vaccine in 160 children whom had received two doses of adjuvant-free 640U/0.5ml EV71 vaccines one year before.

Biological: adjuvant-free 640U /0.5ml

placebo D

PLACEBO COMPARATOR

A 0/0.5ml placebo in 80 children whom had received two doses of adjuvant-free 640U/0.5ml EV71 vaccines one year before.

Biological: 0/0.5ml placebo

Interventions

alum-adjuvant 160U /0.5ml BIOLOGICAL

inactivated vaccine (vero cell) alum-adjuvant 160U /0.5ml EV71 vaccine

alum-adjuvant 160U /0.5ml EV71 vaccine

alum-adjuvant 320U /0.5ml BIOLOGICAL

inactivated vaccine (vero cell) alum-adjuvant 320U /0.5ml EV71 vaccine

alum-adjuvant 320U /0.5ml EV71 vaccine

alum-adjuvant 640U /0.5ml BIOLOGICAL

inactivated vaccine (vero cell) alum-adjuvant 640U /0.5ml EV71 vaccine

alum-adjuvant 640U /0.5ml EV71 vaccine

adjuvant-free 640U /0.5ml BIOLOGICAL

inactivated vaccine (vero cell) adjuvant-free 640U /0.5ml EV71 vaccine

adjuvant-free 640U /0.5ml EV71 vaccine

0/0.5ml placebo BIOLOGICAL

0/0.5ml placebo

placebo A; placebo B; placebo C; placebo D

Eligibility Criteria

• Age: 21 Months - 51 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Had participated in the previous phase II trial and received at least 1 dose of EV71 vaccine.
• Healthy children as established by medical history and clinical examination
• The subjects' guardians are able to understand and sign the informed consent
• 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:

• Had participated in the previous phase II trial and received placebo.
• Subject who has a medical history of EV71-associated disease with specific laboratory evidence
• \<= 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)

• Shenyu W, Jingxin L, Zhenglun L, Xiuling L, Qunying M, Fanyue M, Hua W, Yuntao Z, Fan G, Qinghua C, Yuemei H, Xin Y, Huijie G, Fengcai Z. A booster dose of an inactivated enterovirus 71 vaccine in chinese young children: a randomized, double-blind, placebo-controlled clinical trial. J Infect Dis. 2014 Oct 1;210(7):1073-82. doi: 10.1093/infdis/jiu113. Epub 2014 Mar 12.

  PMID: 24625805 DERIVED

MeSH Terms

Interventions

Aluminum Hydroxide

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Aluminum Compounds; Anions; Ions; Electrolytes

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: PRINCIPAL INVESTIGATOR
• PI Title: vice director

Study Record Dates

• First Submitted: November 22, 2012
• First Posted: November 27, 2012
• Study Start: November 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: February 1, 2013
• Last Updated: October 23, 2013

Record last verified: 2013-10

Locations

CN (1)