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Phase II/III of Live Attenuated Mumps (F-genotype) Vaccine (Human Diploid Cell, KMB-17) in Healthy Children Aged 5-11

Primary Purpose

Epidemic Parotitis, Mumps

Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Attenuated Mumps vaccine (KMB-17) in phase II and III
Placebo in phase II
Attenuated Mumps vaccine (KMB-17) in phase III
Placebo in phase III
Sponsored by
Institute of Medical Biology, Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Epidemic Parotitis, Mumps focused on measuring Mumps, F-genotype, Live Attenuated Vaccine, Human Diploid Cell

Eligibility Criteria

5 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy people aged 5-11 years (including boundary values), both men and women.
  • Proven legal identity.
  • Participants and parent(s)/legal guardian(s) should understand the contents of the informed consent form, the vaccine in this trial, voluntarily sign the informed consent form, and be capable of using thermometers, scales, and filling in diary cards and contact cards as required.
  • Participants and parent(s)/legal guardian(s) should be able to communicate well with investigators, understand and comply with the requirements of this trial.
  • Axillary temperature ≤37.0 ℃.

Exclusion Criteria:

  • Contraindications for vaccination.
  • History of allergy to vaccines or drugs
  • Have a history of mumps disease
  • Except for one dose of vaccine containing mumps at the age of 18~24 months before enrollment, any vaccine containing mumps has been vaccinated.
  • Any prior administration of attenuated live vaccine in last 15 days;Any prior administration of subunit or inactivated vaccines in last 7 days
  • Convulsant,encephalopathy,psychosis or family history of epileptics.
  • Those who developed acute disease within 2 weeks, or had symptoms of fever or upper respiratory tract infection within 7 days.
  • For any reason, the spleen was removed partially or completely
  • Clinical diagnosis of coagulopathy (such as clotting factor deficiency, coagulation disorders, platelet abnormalities), significant bruising or blood clotting disorder,it will cause the contraindication of subcutaneous injection
  • Suffering from congenital deformity or serious chronic disease(congenital heart disease,Down's syndrome,diabetes,sickle cell anemia,nervous illness,angiocardiopathy,hypertension,bronchitis,pneumonia,asthma,infectious skin diseases)
  • Any prior administration of blood products(immunoglobulin etc.) in last 1 month;Any prior administration of immunodepressant, cytotoxic drugs or corticosteroids in last 6 months(except the corticosteroids spray can treat irritability rhinitis or corticosteroids to cure noncomplication acute dermatitis ).
  • Receipt of immunosuppressive therapy within 6 months before signing the informed consent form, such as long-term systemic glucocorticoid therapy (with systemic glucocorticoid therapy for more than 2 weeks within 6 months, such as prednisone or similar drugs) ), but local administration (such as ointment, eye drops, inhalation, or nasal spray) is allowed. The local administration should not exceed the dosage recommended in the instructions or have any signs of systemic exposure.
  • Any prior administration of other research medicines during the same period.
  • Any other situations judged by investigators as not suitable for participating in this study

Sites / Locations

  • Hubei Provincial Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Attenuated Mumps vaccine (KMB-17) in phase II and III

Placebo in phase II

Attenuated Mumps vaccine (KMB-17) in phase III

Placebo in phase III

Arm Description

≥4.3logCCID50/ml Attenuated Mumps vaccine (KMB-17)[≥4.3 logCCID50/ml] in 360 children (5-11 years old) on 0 day

Freeze-dried stabilizer and diluent without mumps virus antigen in 360 children (5-11 years old) on 0 day

≥4.3logCCID50/ml Attenuated Mumps vaccine (KMB-17)[≥4.3 logCCID50/ml] in 5640 children (5-11 years old) on 0 day

Freeze-dried stabilizer and diluent without mumps virus antigen in 5640 children (5-11 years old) on 0 day

Outcomes

Primary Outcome Measures

Phase II: Positive conversion rate of MuV hemagglutination inhibition antibody of Muv Vaccine
To compared the positive conversion rate of MuV hemagglutination inhibition antibody at 28 days after vaccination.
Phase II: Positive conversion rate of MuV neutralization antibody of MuV Vaccine
To compared the positive conversion rate of Muv hemagglutination inhibition antibody at 28 days after vaccination.
Phase III: The protective effect of the MuV vaccine group compared with the placebo group in preventing mumps according with the protocol
To compared the the number of cases of mumps in the vaccine group and the placebo group after 29-day-post injection within 12 months after vaccination

Secondary Outcome Measures

Phase II/III: Adverse reactions/events rate
Occurence of adverse reactions/events within 0-14 days after vaccination
Phase II/III: Adverse reactions/events rate
Occurence of adverse reactions/events within 0-28 days after vaccination
Phase II/III: Serious adverse events rate
Occurence of serious adverse events within 12 months after vaccination
Phase II/III: Positive rate of the hemagglutination inhibition antibody and neutralizing antibody
To compared positive rate of the hemagglutination inhibition antibody and neutralizing antibodies against MuV at 28 days after the vaccination
Phase II/III: The GMT of the hemagglutination inhibition antibody and neutralizing antibody
To compared the GMT of the hemagglutination inhibition antibody and neutralizing antibodies against MuV at 28 days after the vaccination
Phase III: The protective effect of the MuV vaccine group compared with the placebo group in preventing mumps
To compared the the number of cases of mumps in the vaccine group and the placebo group after injection within 12 months after vaccination
Phase III: Positive conversion rate of MuV hemagglutination inhibition antibody of Muv Vaccine
To compared the positive conversion rate of MuV hemagglutination inhibition antibody at 28 days after vaccination.
Phase III: Positive conversion rate of MuV neutralization antibody of MuV Vaccine
To compared the positive conversion rate of Muv hemagglutination inhibition antibody at 28 days after vaccination.
Phase II/III: Positive rate of the hemagglutination inhibition antibody and neutralizing antibody
To compared positive rate of the hemagglutination inhibition antibody and neutralizing antibodies against MuV at 12 months after the vaccination
Phase II/III: The GMT of the hemagglutination inhibition antibody and neutralizing antibody
To compared the GMT of the hemagglutination inhibition antibody and neutralizing antibodies against MuV at 12 months after the vaccination
Phase II/III: Detoxification
Viral copies in pharyngeal swabs or gargles at 3, 7, 14, 28 days after vaccination were tested by PCR.

Full Information

First Posted
September 27, 2020
Last Updated
October 8, 2023
Sponsor
Institute of Medical Biology, Chinese Academy of Medical Sciences
Collaborators
Hubei Provincial Center for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT04591405
Brief Title
Phase II/III of Live Attenuated Mumps (F-genotype) Vaccine (Human Diploid Cell, KMB-17) in Healthy Children Aged 5-11
Official Title
Phase II/III of Live Attenuated Mumps (F-genotype) Vaccine (Human Diploid Cell, KMB-17) in Healthy Children Aged 5-11
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 12, 2020 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Medical Biology, Chinese Academy of Medical Sciences
Collaborators
Hubei Provincial Center for Disease Control and Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Mumps is an acute infectious respiratory disease caused by the mumps virus (MuV), which occurs mainly in children and adolescents. Its main clinical symptoms were parotid gland suppurative swelling and pain with fever. The pathological changes and harm caused by mumps was not only confined to the parotid gland, on the contrary, the social harm caused by serious complications cannot be ignored. As mumps is a vaccine-preventable infectious disease, vaccination is a fundamental strategy for controlling mumps. So far, there are 13 genotypes of MuV. Based on the analysis of molecular epidemiology, the main epidemic strain of MuV in China was the F genotype. The commonly used vaccine strains represented only a small number of known genotypes, e.g. Jeryl-Lynn (JL) and Rubini strains, which belong to type A, Urabe strain belongs to type B, and L-Zagreb strains belongs to type D. Virus seed of Live Attenuated Mumps Vaccine (Human diploid cell) developed by the institute was SP-A strain, which was the first separation and preparation of the attenuated mumps viruses in China. SP-A belongs to F genotype, which was the domestic epidemic genotype. In addition, the cell substrate prepared for vaccine was human diploid cell (KMB-17 strain), which is much safer to use. The results of phase I and II clinical trials showed that the vaccine possessed good immunogenicity and good antigenic cross-reactivity in infants (8-24 months old).
Detailed Description
This study will recruit 12,000 subjects and be divided into two stages. The first stage will evaluate the immunogenicity and safety of F-genotype mumps live attenuated vaccine (human diploid cells) after vaccination in 720 healthy children aged 5-11 years, and explore the detoxification in 144 subjects, who randomly selected from these 720 subjects. The second stage will evaluate the clinical protective efficacy, immunogenicity and safety of F-genotype mumps live attenuated vaccine (human diploid cells) after vaccination in 11280 healthy children aged 5-11 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epidemic Parotitis, Mumps
Keywords
Mumps, F-genotype, Live Attenuated Vaccine, Human Diploid Cell

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
A randomized, double-blind, placebo-controlled design
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
11999 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Attenuated Mumps vaccine (KMB-17) in phase II and III
Arm Type
Experimental
Arm Description
≥4.3logCCID50/ml Attenuated Mumps vaccine (KMB-17)[≥4.3 logCCID50/ml] in 360 children (5-11 years old) on 0 day
Arm Title
Placebo in phase II
Arm Type
Placebo Comparator
Arm Description
Freeze-dried stabilizer and diluent without mumps virus antigen in 360 children (5-11 years old) on 0 day
Arm Title
Attenuated Mumps vaccine (KMB-17) in phase III
Arm Type
Experimental
Arm Description
≥4.3logCCID50/ml Attenuated Mumps vaccine (KMB-17)[≥4.3 logCCID50/ml] in 5640 children (5-11 years old) on 0 day
Arm Title
Placebo in phase III
Arm Type
Placebo Comparator
Arm Description
Freeze-dried stabilizer and diluent without mumps virus antigen in 5640 children (5-11 years old) on 0 day
Intervention Type
Biological
Intervention Name(s)
Attenuated Mumps vaccine (KMB-17) in phase II and III
Intervention Description
≥4.3logCCID50/ml Attenuated Mumps vaccine (KMB-17)[≥4.3 logCCID50/ml] in 360 children (5-11 years old) on 0 day
Intervention Type
Biological
Intervention Name(s)
Placebo in phase II
Intervention Description
Freeze-dried stabilizer and diluent without mumps virus antigen in 360 children (5-11 years old) on 0 day
Intervention Type
Biological
Intervention Name(s)
Attenuated Mumps vaccine (KMB-17) in phase III
Intervention Description
≥4.3logCCID50/ml Attenuated Mumps vaccine (KMB-17)[≥4.3 logCCID50/ml] in 5640 children (5-11 years old) on 0 day
Intervention Type
Biological
Intervention Name(s)
Placebo in phase III
Intervention Description
Freeze-dried stabilizer and diluent without mumps virus antigen in 5640 children (5-11 years old) on 0 day
Primary Outcome Measure Information:
Title
Phase II: Positive conversion rate of MuV hemagglutination inhibition antibody of Muv Vaccine
Description
To compared the positive conversion rate of MuV hemagglutination inhibition antibody at 28 days after vaccination.
Time Frame
28 day after the vaccination
Title
Phase II: Positive conversion rate of MuV neutralization antibody of MuV Vaccine
Description
To compared the positive conversion rate of Muv hemagglutination inhibition antibody at 28 days after vaccination.
Time Frame
28 day after the vaccination
Title
Phase III: The protective effect of the MuV vaccine group compared with the placebo group in preventing mumps according with the protocol
Description
To compared the the number of cases of mumps in the vaccine group and the placebo group after 29-day-post injection within 12 months after vaccination
Time Frame
within 12 months after vaccination
Secondary Outcome Measure Information:
Title
Phase II/III: Adverse reactions/events rate
Description
Occurence of adverse reactions/events within 0-14 days after vaccination
Time Frame
within 14 days after vaccination
Title
Phase II/III: Adverse reactions/events rate
Description
Occurence of adverse reactions/events within 0-28 days after vaccination
Time Frame
within 28 days after vaccination
Title
Phase II/III: Serious adverse events rate
Description
Occurence of serious adverse events within 12 months after vaccination
Time Frame
within 12 months after vaccination
Title
Phase II/III: Positive rate of the hemagglutination inhibition antibody and neutralizing antibody
Description
To compared positive rate of the hemagglutination inhibition antibody and neutralizing antibodies against MuV at 28 days after the vaccination
Time Frame
28 day after the vaccination
Title
Phase II/III: The GMT of the hemagglutination inhibition antibody and neutralizing antibody
Description
To compared the GMT of the hemagglutination inhibition antibody and neutralizing antibodies against MuV at 28 days after the vaccination
Time Frame
28 day after the vaccination
Title
Phase III: The protective effect of the MuV vaccine group compared with the placebo group in preventing mumps
Description
To compared the the number of cases of mumps in the vaccine group and the placebo group after injection within 12 months after vaccination
Time Frame
within 12 months after vaccination
Title
Phase III: Positive conversion rate of MuV hemagglutination inhibition antibody of Muv Vaccine
Description
To compared the positive conversion rate of MuV hemagglutination inhibition antibody at 28 days after vaccination.
Time Frame
28 day after the vaccination
Title
Phase III: Positive conversion rate of MuV neutralization antibody of MuV Vaccine
Description
To compared the positive conversion rate of Muv hemagglutination inhibition antibody at 28 days after vaccination.
Time Frame
28 day after the vaccination
Title
Phase II/III: Positive rate of the hemagglutination inhibition antibody and neutralizing antibody
Description
To compared positive rate of the hemagglutination inhibition antibody and neutralizing antibodies against MuV at 12 months after the vaccination
Time Frame
12 months after vaccination
Title
Phase II/III: The GMT of the hemagglutination inhibition antibody and neutralizing antibody
Description
To compared the GMT of the hemagglutination inhibition antibody and neutralizing antibodies against MuV at 12 months after the vaccination
Time Frame
12 months after vaccination
Title
Phase II/III: Detoxification
Description
Viral copies in pharyngeal swabs or gargles at 3, 7, 14, 28 days after vaccination were tested by PCR.
Time Frame
at 3, 7, 14, 28 days after vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy people aged 5-11 years (including boundary values), both men and women. Proven legal identity. Participants and parent(s)/legal guardian(s) should understand the contents of the informed consent form, the vaccine in this trial, voluntarily sign the informed consent form, and be capable of using thermometers, scales, and filling in diary cards and contact cards as required. Participants and parent(s)/legal guardian(s) should be able to communicate well with investigators, understand and comply with the requirements of this trial. Axillary temperature ≤37.0 ℃. Exclusion Criteria: Contraindications for vaccination. History of allergy to vaccines or drugs Have a history of mumps disease Except for one dose of vaccine containing mumps at the age of 18~24 months before enrollment, any vaccine containing mumps has been vaccinated. Any prior administration of attenuated live vaccine in last 15 days;Any prior administration of subunit or inactivated vaccines in last 7 days Convulsant,encephalopathy,psychosis or family history of epileptics. Those who developed acute disease within 2 weeks, or had symptoms of fever or upper respiratory tract infection within 7 days. For any reason, the spleen was removed partially or completely Clinical diagnosis of coagulopathy (such as clotting factor deficiency, coagulation disorders, platelet abnormalities), significant bruising or blood clotting disorder,it will cause the contraindication of subcutaneous injection Suffering from congenital deformity or serious chronic disease(congenital heart disease,Down's syndrome,diabetes,sickle cell anemia,nervous illness,angiocardiopathy,hypertension,bronchitis,pneumonia,asthma,infectious skin diseases) Any prior administration of blood products(immunoglobulin etc.) in last 1 month;Any prior administration of immunodepressant, cytotoxic drugs or corticosteroids in last 6 months(except the corticosteroids spray can treat irritability rhinitis or corticosteroids to cure noncomplication acute dermatitis ). Receipt of immunosuppressive therapy within 6 months before signing the informed consent form, such as long-term systemic glucocorticoid therapy (with systemic glucocorticoid therapy for more than 2 weeks within 6 months, such as prednisone or similar drugs) ), but local administration (such as ointment, eye drops, inhalation, or nasal spray) is allowed. The local administration should not exceed the dosage recommended in the instructions or have any signs of systemic exposure. Any prior administration of other research medicines during the same period. Any other situations judged by investigators as not suitable for participating in this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qihan Li
Organizational Affiliation
Institute of Medical Biology, Chinese Academy of Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Hubei Provincial Center for Disease Control and Prevention
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430079
Country
China

12. IPD Sharing Statement

Learn more about this trial

Phase II/III of Live Attenuated Mumps (F-genotype) Vaccine (Human Diploid Cell, KMB-17) in Healthy Children Aged 5-11

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