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| Name | Class |
|---|---|
| Hebei Provincial Center for Diseases Control and Prevention | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3.50±0.25logCCID50/ml in adults | Experimental | Attenuated 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 | Experimental | Attenuated 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 | Experimental | Attenuated 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 Comparator | 0 logCCID50/ml in 18 adults aged 16-59 years old on day 0. |
|
| 3.50±0.25logCCID50/ml in children (5-15 years old) | Experimental | Attenuated Mumps vaccine (KMB-17) of 3.50±0.25logCCID50/ml in 16 children aged 5-15 years old on day 0. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3.50±0.25logCCID50/ml | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the seroconversion rate of anti-Mumps antibodies in serum of adults, children and infants, after vaccination. | The seroconversion rate of anti-MuV antibodies was evaluated in serum of adults at the 0 and 28 days after vaccination. The seroconversion rate of anti-MuV antibodies was evaluated in serum of children at the 0 and 28 days after vaccination. The seroconversion rate of anti-MuV antibodies was evaluated in serum of infants at the 0 and 28 days after vaccination. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yuliang Zhao, Master | Hebei Provincial Center for Diseases Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hebei Provincial Center for Diseases Control and Prevention | Shijiazhuang | Hebei | 050021 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24614759 | Derived | 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. |
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| 4.25±0.25 logCCID50/ml in children (5-15 years old) |
| Experimental |
Attenuated 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) | Experimental | Attenuated 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 Comparator | 0 logCCID50/ml in 18 children aged 5-15 years old on day 0. |
|
| 3.50±0.25logCCID50/ml in children (2-4 years old) | Experimental | Attenuated 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) | Experimental | Attenuated 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) | Experimental | Attenuated 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 Comparator | 0 logCCID50/ml in 18 children aged 2-4 years old on day 0. |
|
| Attenuated Mumps vaccine in children (2-4 years old) | Active Comparator | Attenuated 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 | Experimental | Attenuated 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 | Experimental | Attenuated 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 | Experimental | Attenuated 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 Comparator | 0 logCCID50/ml in 18 infants aged 8-23 months old on day 0. |
|
| Attenuated Mumps vaccine in infants | Active Comparator | Attenuated Mumps vaccine (Zhe Jiang Vacn Bio-pharmaceutical Co., LTD.; NO.20110528-1) in 18 infants aged 8-23 months old on day 0. |
|
| 4.25±0.25 logCCID50/ml | Biological | 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. |
|
| 5.00±0.25 logCCID50/ml | Biological | 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 | Biological | 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) | Biological | 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. |
|
| 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 | The abnormity change of live and kidney function indexes were evaluated in serum of adults at 0, 4 days after vaccination. The abnormity change of live and kidney function indexes were evaluated in serum of children at 0, 4 days after vaccination. The abnormity change of live and kidney function indexes were evaluated in serum of infants at 0, 4 days after vaccination. | within the first 4 days after the vaccination |
| ID | Term |
|---|---|
| D009107 | Mumps |
| ID | Term |
|---|---|
| D019351 | Rubulavirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D010309 | Parotitis |
| D010305 | Parotid Diseases |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D036881 | Long-Term Synaptic Depression |
| ID | Term |
|---|---|
| D009473 | Neuronal Plasticity |
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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