A Phase I, Safety Study of Live Attenuated Mumps (F-genotype) Vaccine (Human Diploid Cell, KMB-17) in Chinese Children
A Phase II Clinical Trial for Live Attenuated Mumps (F-genotype) Vaccine (Human Diploid Cell, KMB-17) in Chinese Children
1 other identifier
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2012
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 22, 2012
CompletedFirst Posted
Study publicly available on registry
October 24, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedOctober 10, 2023
October 1, 2023
6 months
October 22, 2012
October 7, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Evaluate the Safety of Attenuated Mumps Vaccine (Human Diploid Cell, KMB-17) in Chinese Adults.
Adverse reactions associated with vaccine were observed in Chinese Adults (from 16 to 59 years old) after the vaccination
within the first 28 days after the vaccination
Evaluate the Safety of Attenuated Mumps Vaccine (Human Diploid Cell, KMB-17) in Chinese Children.
Adverse reactions associated with vaccine were observed in Chinese Children (from 5 to 15 years old) after the vaccination.
within the first 28 days after the vaccination
Evaluate the safety of Attenuated Mumps Vaccine (Human Diploid Cell, KMB-17) in Chinese Children.
Adverse reactions associated with vaccine were observed in Chinese Children (from 2 to 4 years old) after the vaccination.
within the first 28 days after the vaccination
Evaluate the safety of Attenuated Mumps Vaccine (Human Diploid Cell, KMB-17) in Chinese Infants.
Adverse reactions associated with vaccine were observed in Chinese Infants (from 8 to 23 months old) after the vaccination.
within the first 28 days after the vaccination
Secondary Outcomes (2)
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
Study Arms (18)
3.50±0.25logCCID50/ml in adults
EXPERIMENTALAttenuated Mumps vaccine (KMB-17) of 3.50±0.25logCCID50/ml in 16 adults aged 16-59 years old on day 0.
4.25±0.25 logCCID50/ml in adults
EXPERIMENTALAttenuated Mumps vaccine (KMB-17) of 4.25±0.25 logCCID50/ml in 16 adults aged 16-59 years old on day 0.
5.00±0.25 logCCID50/ml in adults
EXPERIMENTALAttenuated Mumps vaccine (KMB-17) of 4.25±0.25 logCCID50/ml in 16 adults aged 16-59 years old on day 0.
0 logCCID50/ml in adults
PLACEBO COMPARATOR0 logCCID50/ml in 18 adults aged 16-59 years old on day 0.
3.50±0.25logCCID50/ml in children (5-15 years old)
EXPERIMENTALAttenuated Mumps vaccine (KMB-17) of 3.50±0.25logCCID50/ml in 16 children aged 5-15 years old on day 0.
4.25±0.25 logCCID50/ml in children (5-15 years old)
EXPERIMENTALAttenuated Mumps vaccine (KMB-17) of 4.25±0.25 logCCID50/ml in 16 children aged 5-15 years old on day 0.
5.00±0.25 logCCID50/ml in children (5-15 years old)
EXPERIMENTALAttenuated Mumps vaccine (KMB-17) of 5.00±0.25 logCCID50/ml in 16 children aged 5-15 years old on day 0.
0 logCCID50/ml in children (5-15 years old)
PLACEBO COMPARATOR0 logCCID50/ml in 18 children aged 5-15 years old on day 0.
3.50±0.25logCCID50/ml in children (2-4 years old)
EXPERIMENTALAttenuated Mumps vaccine (KMB-17) of 3.50±0.25logCCID50/ml in 16 children aged 2-4 years old on day 0.
4.25±0.25 logCCID50/ml in children (2-4 years old)
EXPERIMENTALAttenuated Mumps vaccine (KMB-17) of 4.25±0.25 logCCID50/ml in 16 children aged 2-4 years old on day 0.
5.00±0.25 logCCID50/ml in children (2-4 years old)
EXPERIMENTALAttenuated Mumps vaccine (KMB-17) of 5.00±0.25 logCCID50/ml in 16 children aged 2-4 years old on day 0.
0 logCCID50/ml in children (2-4 years old)
PLACEBO COMPARATOR0 logCCID50/ml in 18 children aged 2-4 years old on day 0.
Attenuated Mumps vaccine in children (2-4 years old)
ACTIVE COMPARATORAttenuated Mumps vaccine (Zhe Jiang Vacn Bio-pharmaceutical Co., LTD.; NO.20110528-1) in 18 children aged 2-4 years old on day 0.
3.50±0.25logCCID50/ml in infants
EXPERIMENTALAttenuated Mumps vaccine (KMB-17) of 3.50±0.25logCCID50/ml in 16 infants aged 8-23 months old on day 0.
4.25±0.25 logCCID50/ml in infants
EXPERIMENTALAttenuated Mumps vaccine (KMB-17) of 4.25±0.25 logCCID50/ml in 16 infants aged 8-23 months old on day 0.
5.00±0.25 logCCID50/ml in infants
EXPERIMENTALAttenuated Mumps vaccine (KMB-17) of 5.00±0.25 logCCID50/ml in 16 infants aged 8-23 months old on day 0.
0 logCCID50/ml in infants
PLACEBO COMPARATOR0 logCCID50/ml in 18 infants aged 8-23 months old on day 0.
Attenuated Mumps vaccine in infants
ACTIVE COMPARATORAttenuated Mumps vaccine (Zhe Jiang Vacn Bio-pharmaceutical Co., LTD.; NO.20110528-1) in 18 infants aged 8-23 months old on day 0.
Interventions
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.
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hebei Provincial Center for Diseases Control and Prevention
Shijiazhuang, Hebei, 050021, China
Related Publications (1)
Liang Y, Ma J, Li C, Chen Y, Liu L, Liao Y, Zhang Y, Jiang L, Wang XY, Che Y, Deng W, Li H, Cui X, Ma N, Ding D, Xie Z, Cui P, Ji Q, Wang J, Zhao Y, Wang J, Li Q. Safety and immunogenicity of a live attenuated mumps vaccine: a phase I clinical trial. Hum Vaccin Immunother. 2014;10(5):1382-90. doi: 10.4161/hv.28334. Epub 2014 Mar 10.
PMID: 24614759DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yuliang Zhao, Master
Hebei Provincial Center for Diseases Control and Prevention
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2012
First Posted
October 24, 2012
Study Start
October 1, 2012
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
October 10, 2023
Record last verified: 2023-10