A Phase II Clinical Trial for Live Attenuated Mumps (F-genotype) Vaccine (Human Diploid Cell, KMB-17) in Chinese Children
A Phase I, Safety Study of Live Attenuated Mumps (F-genotype) Vaccine (Human Diploid Cell, KMB-17) in Chinese Children
Sponsors
Source
Chinese Academy of Medical Sciences
Oversight Info
Has Dmc
Yes
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 preliminary test results showed that the vaccine possessed good
immunogenicity and good antigenic cross-reactivity. The application of this vaccine will
provide more effective means to prevent and control of mumps epidemic.
Overall Status
Completed
Start Date
2012-10-01
Completion Date
2013-04-01
Primary Completion Date
2013-04-01
Phase
Phase 1
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Evaluate the Safety of Attenuated Mumps Vaccine (Human Diploid Cell, KMB-17) in Chinese Adults. |
within the first 28 days after the vaccination |
|
Evaluate the Safety of Attenuated Mumps Vaccine (Human Diploid Cell, KMB-17) in Chinese Children. |
within the first 28 days after the vaccination |
|
Evaluate the safety of Attenuated Mumps Vaccine (Human Diploid Cell, KMB-17) in Chinese Children. |
within the first 28 days after the vaccination |
|
Evaluate the safety of Attenuated Mumps Vaccine (Human Diploid Cell, KMB-17) in Chinese Infants. |
within the first 28 days after the vaccination |
Secondary Outcome
Measure |
Time Frame |
|
Evaluate the seroconversion rate of anti-Mumps antibodies in serum of adults, children and infants, after vaccination. |
within the first 28 days after the vaccination |
|
Evaluate the abnormity change of live and kidney function indexes in serum of adults, children and infants, after vaccination |
within the first 4 days after the vaccination |
Enrollment
300
Condition
Intervention
Intervention Type
Biological
Intervention Name
Description
Attenuated Mumps vaccine (KMB-17) of 3.50±0.25logCCID50/ml in adults (16-59 years old)，children (5-15 years old or 2-4 years old) and infants (8-23 months old) on day 0.
Arm Group Label
3.50±0.25logCCID50/ml in adults
3.50±0.25logCCID50/ml in children (5-15 years old)
3.50±0.25logCCID50/ml in children (2-4 years old)
3.50±0.25logCCID50/ml in infants
Intervention Type
Biological
Intervention Name
Description
Attenuated Mumps vaccine (KMB-17) of 4.25±0.25 logCCID50/ml in adults (16-59 years old)，children (5-15 years old or 2-4 years old) and infants (8-23 months old) on day 0.
Arm Group Label
4.25±0.25 logCCID50/ml in adults
4.25±0.25 logCCID50/ml in children (5-15 years old)
4.25±0.25 logCCID50/ml in children (2-4 years old)
4.25±0.25 logCCID50/ml in infants
Intervention Type
Biological
Intervention Name
Description
Attenuated Mumps vaccine (KMB-17) of 5.00±0.25 logCCID50/ml in adults (16-59 years old)，children (5-15 years old or 2-4 years old) and infants (8-23 months old) on day 0.
Arm Group Label
5.00±0.25 logCCID50/ml in adults
5.00±0.25 logCCID50/ml in children (5-15 years old)
5.00±0.25 logCCID50/ml in children (2-4 years old)
5.00±0.25 logCCID50/ml in infants
Intervention Type
Biological
Intervention Name
Description
0 logCCID50/ml in adults (16-59 years old)，children (5-15 years old or 2-4 years old) and infants (8-23 months old) on day 0.
Arm Group Label
0 logCCID50/ml in adults
0 logCCID50/ml in children (5-15 years old)
0 logCCID50/ml in children (2-4 years old)
0 logCCID50/ml in infants
Intervention Type
Biological
Intervention Name
Description
Attenuated Mumps vaccine (Zhe Jiang Vacn Bio-pharmaceutical Co., LTD.; NO.20110528-1) in children (2-4 years old) and infants (8-23 months old) on day 0.
Arm Group Label
Attenuated Mumps vaccine in children (2-4 years old)
Attenuated Mumps vaccine in infants
Eligibility
Criteria
Inclusion Criteria:
- Healthy subjects (8 months-59 years old) as established by medical history and
clinical examination
- The subjects oneself or their legal guardian must be aware of this vaccines
- Voluntarily participate in the study and signed Informed Consent Form
- Subjects with temperature ≤ 37.0℃
- With the ability and objective to comply with the requirements of the protocol
- Persist for a 1-month visit and receive blood tests according to program requirements
Exclusion Criteria:
- Subject who has a clinical diagnosis Mumps
- Subject who vaccinated Mumps vaccine in last 6 months
- ≤37 weeks gestation
- weight ≤ 2500 g when it was born
- Allergy or serious side-effects to a vaccine or any ingredient of vaccine
- Epilepsy, seizures, convulsions, neurological illness
- Congenital or hereditary immunodeficiency
- Autoimmune disease
- Severe malnutrition or dysgenopathy
- Asthma, thyroidectomy, angioneurotic edema, diabetes or cancer
- Asplenia, functional asplenia, and any circumstances leading to the asplenia or
splenectomy
- Clinical diagnosis of coagulopathy (such as clotting factor deficiency, coagulation
disorders, platelet abnormalities), significant bruising or blood clotting disorder
- Acute illness or acute exacerbation of chronic disease in last 7 days
- Any prior administration of immunodepressant or corticosteroids in last 6 months
- Any prior administration of blood products in last 3 months
- Any prior administration of live-attenuated vaccine in last 28 days or 1 months
- Any prior administration of subunit or inactivated vaccines in last 14 days
- Under the anti-TB prevention or therapy
- Fever before vaccination, axillary temperature ﹥37.0℃
- The laboratory test abnormalities before vaccination, including blood tests
(hemoglobin, total white blood cells, WBC, platelets), blood biochemistry tests (ALT,
total bilirubin, direct bilirubin, Cr, BUN) and urine tests (urine protein, urine
sugar, blood cells), etc.
- Hypertension or hypotension. Systolic blood pressure ﹥140mmHg and/or diastolic blood
pressure ﹥90mmHg; systolic blood pressure ﹤90mmHg and/or diastolic blood pressure
﹤60mmHg
- Breast-feeding, pregnant, planning a pregnancy within 60 days or positive pregnancy
test women
- Any condition that in the opinion of the investigator, may interfere with the
evaluation of study objectives
Gender
All
Minimum Age
8 Months
Maximum Age
59 Years
Healthy Volunteers
Accepts Healthy Volunteers
Overall Official
Last Name |
Role |
Affiliation |
|
Yuliang Zhao, Master |
Principal Investigator |
Hebei Provincial Center for Diseases Control and Prevention |
Location
Facility |
|
Hebei Provincial Center for Diseases Control and Prevention Shijiazhuang Hebei 050021 China |
Location Countries
Country
China
Verification Date
2012-10-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
Chinese Academy of Medical Sciences
Investigator Full Name
Longding Liu
Investigator Title
Professor
Has Expanded Access
No
Condition Browse
Number Of Arms
18
Intervention Browse
Mesh Term
Vaccines
Arm Group
Arm Group Label
3.50±0.25logCCID50/ml in adults
Arm Group Type
Experimental
Description
Attenuated Mumps vaccine (KMB-17) of 3.50±0.25logCCID50/ml in 16 adults aged 16-59 years old on day 0.
Arm Group Label
4.25±0.25 logCCID50/ml in adults
Arm Group Type
Experimental
Description
Attenuated Mumps vaccine (KMB-17) of 4.25±0.25 logCCID50/ml in 16 adults aged 16-59 years old on day 0.
Arm Group Label
5.00±0.25 logCCID50/ml in adults
Arm Group Type
Experimental
Description
Attenuated Mumps vaccine (KMB-17) of 4.25±0.25 logCCID50/ml in 16 adults aged 16-59 years old on day 0.
Arm Group Label
0 logCCID50/ml in adults
Arm Group Type
Placebo Comparator
Description
0 logCCID50/ml in 18 adults aged 16-59 years old on day 0.
Arm Group Label
3.50±0.25logCCID50/ml in children (5-15 years old)
Arm Group Type
Experimental
Description
Attenuated Mumps vaccine (KMB-17) of 3.50±0.25logCCID50/ml in 16 children aged 5-15 years old on day 0.
Arm Group Label
4.25±0.25 logCCID50/ml in children (5-15 years old)
Arm Group Type
Experimental
Description
Attenuated Mumps vaccine (KMB-17) of 4.25±0.25 logCCID50/ml in 16 children aged 5-15 years old on day 0.
Arm Group Label
5.00±0.25 logCCID50/ml in children (5-15 years old)
Arm Group Type
Experimental
Description
Attenuated Mumps vaccine (KMB-17) of 5.00±0.25 logCCID50/ml in 16 children aged 5-15 years old on day 0.
Arm Group Label
0 logCCID50/ml in children (5-15 years old)
Arm Group Type
Placebo Comparator
Description
0 logCCID50/ml in 18 children aged 5-15 years old on day 0.
Arm Group Label
3.50±0.25logCCID50/ml in children (2-4 years old)
Arm Group Type
Experimental
Description
Attenuated Mumps vaccine (KMB-17) of 3.50±0.25logCCID50/ml in 16 children aged 2-4 years old on day 0.
Arm Group Label
4.25±0.25 logCCID50/ml in children (2-4 years old)
Arm Group Type
Experimental
Description
Attenuated Mumps vaccine (KMB-17) of 4.25±0.25 logCCID50/ml in 16 children aged 2-4 years old on day 0.
Arm Group Label
5.00±0.25 logCCID50/ml in children (2-4 years old)
Arm Group Type
Experimental
Description
Attenuated Mumps vaccine (KMB-17) of 5.00±0.25 logCCID50/ml in 16 children aged 2-4 years old on day 0.
Arm Group Label
0 logCCID50/ml in children (2-4 years old)
Arm Group Type
Placebo Comparator
Description
0 logCCID50/ml in 18 children aged 2-4 years old on day 0.
Arm Group Label
Attenuated Mumps vaccine in children (2-4 years old)
Arm Group Type
Active Comparator
Description
Attenuated Mumps vaccine (Zhe Jiang Vacn Bio-pharmaceutical Co., LTD.; NO.20110528-1) in 18 children aged 2-4 years old on day 0.
Arm Group Label
3.50±0.25logCCID50/ml in infants
Arm Group Type
Experimental
Description
Attenuated Mumps vaccine (KMB-17) of 3.50±0.25logCCID50/ml in 16 infants aged 8-23 months old on day 0.
Arm Group Label
4.25±0.25 logCCID50/ml in infants
Arm Group Type
Experimental
Description
Attenuated Mumps vaccine (KMB-17) of 4.25±0.25 logCCID50/ml in 16 infants aged 8-23 months old on day 0.
Arm Group Label
5.00±0.25 logCCID50/ml in infants
Arm Group Type
Experimental
Description
Attenuated Mumps vaccine (KMB-17) of 5.00±0.25 logCCID50/ml in 16 infants aged 8-23 months old on day 0.
Arm Group Label
0 logCCID50/ml in infants
Arm Group Type
Placebo Comparator
Description
0 logCCID50/ml in 18 infants aged 8-23 months old on day 0.
Arm Group Label
Attenuated Mumps vaccine in infants
Arm Group Type
Active Comparator
Description
Attenuated Mumps vaccine (Zhe Jiang Vacn Bio-pharmaceutical Co., LTD.; NO.20110528-1) in 18 infants aged 8-23 months old on day 0.
Firstreceived Results Date
N/A
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Triple (Participant, Care Provider, Investigator)
Study First Submitted
October 22, 2012
Study First Submitted Qc
October 22, 2012
Study First Posted
October 24, 2012
Last Update Submitted
April 26, 2013
Last Update Submitted Qc
April 26, 2013
Last Update Posted
April 30, 2013
ClinicalTrials.gov processed this data on December 13, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.