Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03268083
Recruitment Status : Unknown
Verified August 2017 by Enimmune Corporation.
Recruitment status was:  Active, not recruiting
First Posted : August 31, 2017
Last Update Posted : August 31, 2017
Sponsor:
Information provided by (Responsible Party):
Enimmune Corporation

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

Layout table for study information
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

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




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03268083


Locations
Layout table for location information
Taiwan
Sherry Chen
Taipei, Da-an Dist, Taiwan, 10683
Sponsors and Collaborators
Enimmune Corporation
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Enimmune Corporation
ClinicalTrials.gov Identifier: NCT03268083    
Other Study ID Numbers: EV-BR1501
First Posted: August 31, 2017    Key Record Dates
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:
Layout table for MeSH terms
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs