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
| Sponsors |
Lead Sponsor: Chinese Academy of Medical Sciences |
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| Source | Chinese Academy of Medical Sciences | ||||||||||
| 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. |
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| Overall Status | Completed | ||||||||||
| Start Date | October 2012 | ||||||||||
| Completion Date | April 2013 | ||||||||||
| Primary Completion Date | April 2013 | ||||||||||
| Phase | Phase 1 | ||||||||||
| Study Type | Interventional | ||||||||||
| Primary Outcome |
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| Secondary Outcome |
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| Enrollment | 300 | ||||||||||
| Condition | |||||||||||
| Intervention |
Intervention Type: Biological Intervention Name: 3.50±0.25logCCID50/ml 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. Intervention Type: Biological Intervention Name: 4.25±0.25 logCCID50/ml 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. Intervention Type: Biological Intervention Name: 5.00±0.25 logCCID50/ml 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. Intervention Type: Biological Intervention Name: 0 logCCID50/ml 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. Intervention Type: Biological Intervention Name: Attenuated Mumps vaccine (Zhe Jiang Vacn Bio-pharmaceutical Co., LTD.; NO.20110528-1) 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. |
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| 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 |
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| Overall Official |
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| Location |
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| Location Countries |
China |
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| Verification Date |
October 2012 |
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| Responsible Party |
Type: Principal Investigator Investigator Affiliation: Chinese Academy of Medical Sciences Investigator Full Name: Longding Liu Investigator Title: Professor |
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| Has Expanded Access | No | ||||||||||
| Condition Browse | |||||||||||
| Number Of Arms | 18 | ||||||||||
| Arm Group |
Label: 3.50±0.25logCCID50/ml in adults 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. Label: 4.25±0.25 logCCID50/ml in adults 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. Label: 5.00±0.25 logCCID50/ml in adults 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. Label: 0 logCCID50/ml in adults Type: Placebo Comparator Description: 0 logCCID50/ml in 18 adults aged 16-59 years old on day 0. Label: 3.50±0.25logCCID50/ml in children (5-15 years old) 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. Label: 4.25±0.25 logCCID50/ml in children (5-15 years old) 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. Label: 5.00±0.25 logCCID50/ml in children (5-15 years old) 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. Label: 0 logCCID50/ml in children (5-15 years old) Type: Placebo Comparator Description: 0 logCCID50/ml in 18 children aged 5-15 years old on day 0. Label: 3.50±0.25logCCID50/ml in children (2-4 years old) 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. Label: 4.25±0.25 logCCID50/ml in children (2-4 years old) 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. Label: 5.00±0.25 logCCID50/ml in children (2-4 years old) 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. Label: 0 logCCID50/ml in children (2-4 years old) Type: Placebo Comparator Description: 0 logCCID50/ml in 18 children aged 2-4 years old on day 0. Label: Attenuated Mumps vaccine in children (2-4 years old) 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. Label: 3.50±0.25logCCID50/ml in infants 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. Label: 4.25±0.25 logCCID50/ml in infants 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. Label: 5.00±0.25 logCCID50/ml in infants 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. Label: 0 logCCID50/ml in infants Type: Placebo Comparator Description: 0 logCCID50/ml in 18 infants aged 8-23 months old on day 0. Label: Attenuated Mumps vaccine in infants 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. |
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| Study Design Info |
Allocation: Randomized Intervention Model: Parallel Assignment Primary Purpose: Prevention Masking: Triple (Participant, Care Provider, Investigator) |
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