A Study to Evaluate the Immunogenicity and Safety of EV71 Vaccine in Pediatric Subjects Aged 3 to 6 Years and 2 to 35 Months Old

• ClinicalTrials.gov Identifier: NCT03268083
• Recruitment Status: Unknown
• First Posted: August 31, 2017
• Last Update Posted: August 31, 2017
• Sponsor: Enimmune Corporation
• Information provided by (Responsible Party): Enimmune Corporation

Study Description

Brief Summary:

The objectives of this study are to evaluate the immune response and safety profiles of two injections of EV71 vaccine administrated with or without adjuvant Al(OH)3 at 0.5-μg and 1-μg dose in children aged 3 to 6 years old and 2 to 35 months old infants/toddlers.

Condition or disease	Intervention/treatment	Phase
Enterovirus Infections	Biological: EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AI(OH)3] per dose); Biological: EV71 vaccine ([1 μg total protein + adjuvant 150 μg AI(OH)3] per dose); Biological: EV71 vaccine ([1 μg total protein ] per dose)	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 140 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: An Open-Label, Dose-Finding, Phase II Study to Evaluate the Immunogenicity and Safety of the Bioreactor-generated EV71 Vaccine in Pediatric Subjects Aged 3 to 6 Years and 2 to 35 Months Old
• Actual Study Start Date: July 2016
• Actual Primary Completion Date: August 2017
• Estimated Study Completion Date: December 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: Group A1; 3 to 6 years	Biological: EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AI(OH)3] per dose); Two vaccinations at 28 days apart
Experimental: Group A2; 3 to 6 years	Biological: EV71 vaccine ([1 μg total protein + adjuvant 150 μg AI(OH)3] per dose); Two vaccinations at 28 days apart
Experimental: Group A3; 3 to 6 years	Biological: EV71 vaccine ([1 μg total protein ] per dose); Two vaccinations at 28 days apart
Experimental: Group B1; 2 to 35 months	Biological: EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AI(OH)3] per dose); Two vaccinations at 28 days apart
Experimental: Group B2; 2 to 35 months	Biological: EV71 vaccine ([1 μg total protein + adjuvant 150 μg AI(OH)3] per dose); Two vaccinations at 28 days apart
Experimental: Group B3; 2 to 35 months	Biological: EV71 vaccine ([1 μg total protein ] per dose); Two vaccinations at 28 days apart

Outcome Measures

Primary Outcome Measures :

1. Serum neutralizing antibody titers (NT) induced by the EV71 vaccine [ Time Frame: Day 56 ]
   Evaluate the immunogenicity change of serum neutralizing antibody titers induced by the EV71 vaccine from baseline on Day 56
2. Seroconversion rate (SCR) based on neutralizing antibody titers [ Time Frame: Day 56 ]
   Evaluate the immunogenicity change of SCR from baseline on Day 56
3. Serum neutralizing antibody titers (NT) induced by the EV71 vaccine [ Time Frame: Day 28 ]
   Evaluate the immunogenicity change of serum neutralizing antibody titers induced by the EV71 vaccine from baseline on Day 28
4. Serum neutralizing antibody titers (NT) induced by the EV71 vaccine [ Time Frame: Day 196 ]
   Evaluate the immunogenicity change of serum neutralizing antibody titers induced by the EV71 vaccine from baseline on Day 196
5. Seroconversion rate (SCR) based on neutralizing antibody titers [ Time Frame: Day 28 ]
   Evaluate the immunogenicity change of SCR from baseline on Day 28
6. Seroconversion rate (SCR) based on neutralizing antibody titers [ Time Frame: Day 196 ]
   Evaluate the immunogenicity change of SCR from baseline on Day 196

Secondary Outcome Measures :

1. Solicited adverse events [ Time Frame: 7 days after each vaccination ]
2. Unsolicited adverse events [ Time Frame: 28 days after each vaccination ]
3. The occurrence of overall adverse events (AEs) and serious adverse event (SAEs) [ Time Frame: Day 0 to Day 196 ]
4. The occurrence of EV 71 breakthrough infection after Visit 3 [ Time Frame: Day 57 to Day 364 ]
5. Serum neutralizing antibody titers (NT) induced by the EV71 vaccine [ Time Frame: Day 364 ]
   Evaluate the immunogenicity of serum neutralization antibody titer induced by the EV 71 vaccine on Day 364

Eligibility Criteria

• Ages Eligible for Study: 2 Months to 6 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

1. Healthy children aged from 3 to 6 years old (i.e. ≥ 3 years old and < 7 years old) for Part A,and from 2 to 35 months old (i.e. ≥ 2 months old and < 36 months old) for Part B at the time of first vaccination.
2. Subject's guardians are able and willing to comply with study procedures and provide the signed informed consent.
3. Subject is able and can comply with the requirements of the protocol.
4. Subject with body temperature ≤38°C.

Exclusion Criteria:

1. Subject with previous known exposure to Enterovirus 71 (EV71).
2. Subject with a history of herpangina, hand-foot-mouth disease,and acute hemorrhagic conjunctivitis associated with enterovirus infection in the past 3 months.
3. Subject with gestation < 37 weeks.
4. Subject with birth weight <2.5 kg.
5. Subject with a history of hypersensitivity to vaccines, or a history of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
6. Family history of seizures or progressive neurological disease.
7. Family history of congenital or hereditary immunodeficiency.
8. Severe malnutrition or dysgenopathy.
9. Major congenital defects or serious chronic illness, including perinatal brain damage.
10. Subject diagnosed of having autoimmune disease (e.g., celiac disease, type I diabetes, lupus (SLE), juvenile dermatomyositis, scleroderma, juvenile idiopathic arthritis (JIA), immune (or idiopathic) thrombocytopenia purpura).
11. Bleeding disorder diagnosed by a doctor or significant bruising or hemostatic difficulties with IM injections or blood draws.
12. Any acute infections 7 days prior to administrating the first vaccination.
13. Use of any investigational product (including drug, vaccine) within 30 days prior to vaccination or planned use during the study period.
14. Administration of any vaccines within 14 days prior to randomization.
15. Use of immunoglobulins or any blood products within 3 months prior to vaccination or planned use during the study period.
16. Chronic administration (defined as > 14 days) of immunosuppressants or other immunomodulators or systemic corticosteroids within 6 months prior to vaccination or planned use during the study period.
17. Subjects who had ever received investigational EV-71 vaccine prior to randomization.
18. Under anti-tuberculosis prevention or therapy.
19. Any condition that in the opinion of the investigator may interfere with the evaluation of study objectives.

Contacts and Locations

Locations

Taiwan

Sherry Chen

Taipei, Da-an Dist, Taiwan, 10683

Sponsors and Collaborators

Enimmune Corporation

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hung MC, Cho CY, Chen CJ, Lai CC, Wu KG. Immunogenicity and safety of an inactivated enterovirus A71 vaccine in children 3-6 years and 2-35 months of age- an open-label, randomized phase IIb clinical trial. Vaccine. 2019 Sep 3;37(37):5559-5566. doi: 10.1016/j.vaccine.2019.07.096. Epub 2019 Aug 6.

• Responsible Party: Enimmune Corporation
• ClinicalTrials.gov Identifier: NCT03268083
• Other Study ID Numbers: EV-BR1501
• First Posted: August 31, 2017
• Last Update Posted: August 31, 2017
• Last Verified: August 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Enimmune Corporation:

Foot-and-Mouth Disease; Vaccines; Hand, Foot and Mouth Disease; EV71 vaccine

Additional relevant MeSH terms:

Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Vaccines; Immunologic Factors; Physiological Effects of Drugs