A Phase I, Safety Study of Live Attenuated Mumps (F-genotype) Vaccine (Human Diploid Cell, KMB-17) in Chinese Children

This study has been completed.
Sponsor:
Collaborator:
Institute of Medical Biology CAMS
Information provided by (Responsible Party):
Longding Liu, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01712906
First received: October 22, 2012
Last updated: April 26, 2013
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
The Study Focused on the Safety of Attenuated Mumps Vaccine (Human Diploid Cell) Against Mumps in Chinese Adults, Children and Infants.
Biological: 3.50±0.25logCCID50/ml
Biological: 4.25±0.25 logCCID50/ml
Biological: 5.00±0.25 logCCID50/ml
Biological: 0 logCCID50/ml
Biological: Attenuated Mumps vaccine (Zhe Jiang Vacn Bio-pharmaceutical Co., LTD.; NO.20110528-1)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: A Phase II Clinical Trial for Live Attenuated Mumps (F-genotype) Vaccine (Human Diploid Cell, KMB-17) in Chinese Children

Resource links provided by NLM:


Further study details as provided by Chinese Academy of Medical Sciences:

Primary Outcome Measures:
  • Evaluate the Safety of Attenuated Mumps Vaccine (Human Diploid Cell, KMB-17) in Chinese Adults. [ Time Frame: within the first 28 days after the vaccination ] [ Designated as safety issue: Yes ]
    Adverse reactions associated with vaccine were observed in Chinese Adults (from 16 to 59 years old) after the vaccination

  • Evaluate the Safety of Attenuated Mumps Vaccine (Human Diploid Cell, KMB-17) in Chinese Children. [ Time Frame: within the first 28 days after the vaccination ] [ Designated as safety issue: Yes ]
    Adverse reactions associated with vaccine were observed in Chinese Children (from 5 to 15 years old) after the vaccination.

  • Evaluate the safety of Attenuated Mumps Vaccine (Human Diploid Cell, KMB-17) in Chinese Children. [ Time Frame: within the first 28 days after the vaccination ] [ Designated as safety issue: Yes ]
    Adverse reactions associated with vaccine were observed in Chinese Children (from 2 to 4 years old) after the vaccination.

  • Evaluate the safety of Attenuated Mumps Vaccine (Human Diploid Cell, KMB-17) in Chinese Infants. [ Time Frame: within the first 28 days after the vaccination ] [ Designated as safety issue: Yes ]
    Adverse reactions associated with vaccine were observed in Chinese Infants (from 8 to 23 months old) after the vaccination.


Secondary Outcome Measures:
  • Evaluate the seroconversion rate of anti-Mumps antibodies in serum of adults, children and infants, after vaccination. [ Time Frame: within the first 28 days after the vaccination ] [ Designated as safety issue: Yes ]

    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.


  • Evaluate the abnormity change of live and kidney function indexes in serum of adults, children and infants, after vaccination [ Time Frame: within the first 4 days after the vaccination ] [ Designated as safety issue: Yes ]

    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.



Enrollment: 300
Study Start Date: October 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 3.50±0.25logCCID50/ml in adults
Attenuated Mumps vaccine (KMB-17) of 3.50±0.25logCCID50/ml in 16 adults aged 16-59 years old on day 0.
Biological: 3.50±0.25logCCID50/ml
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.
Experimental: 4.25±0.25 logCCID50/ml in adults
Attenuated Mumps vaccine (KMB-17) of 4.25±0.25 logCCID50/ml in 16 adults aged 16-59 years old on day 0.
Biological: 4.25±0.25 logCCID50/ml
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.
Experimental: 5.00±0.25 logCCID50/ml in adults
Attenuated Mumps vaccine (KMB-17) of 4.25±0.25 logCCID50/ml in 16 adults aged 16-59 years old on day 0.
Biological: 5.00±0.25 logCCID50/ml
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.
Placebo Comparator: 0 logCCID50/ml in adults
0 logCCID50/ml in 18 adults aged 16-59 years old on day 0.
Biological: 0 logCCID50/ml
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.
Experimental: 3.50±0.25logCCID50/ml in children (5-15 years old)
Attenuated Mumps vaccine (KMB-17) of 3.50±0.25logCCID50/ml in 16 children aged 5-15 years old on day 0.
Biological: 3.50±0.25logCCID50/ml
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.
Experimental: 4.25±0.25 logCCID50/ml in children (5-15 years old)
Attenuated Mumps vaccine (KMB-17) of 4.25±0.25 logCCID50/ml in 16 children aged 5-15 years old on day 0.
Biological: 4.25±0.25 logCCID50/ml
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.
Experimental: 5.00±0.25 logCCID50/ml in children (5-15 years old)
Attenuated Mumps vaccine (KMB-17) of 5.00±0.25 logCCID50/ml in 16 children aged 5-15 years old on day 0.
Biological: 5.00±0.25 logCCID50/ml
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.
Placebo Comparator: 0 logCCID50/ml in children (5-15 years old)
0 logCCID50/ml in 18 children aged 5-15 years old on day 0.
Biological: 0 logCCID50/ml
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.
Experimental: 3.50±0.25logCCID50/ml in children (2-4 years old)
Attenuated Mumps vaccine (KMB-17) of 3.50±0.25logCCID50/ml in 16 children aged 2-4 years old on day 0.
Biological: 3.50±0.25logCCID50/ml
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.
Experimental: 4.25±0.25 logCCID50/ml in children (2-4 years old)
Attenuated Mumps vaccine (KMB-17) of 4.25±0.25 logCCID50/ml in 16 children aged 2-4 years old on day 0.
Biological: 4.25±0.25 logCCID50/ml
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.
Experimental: 5.00±0.25 logCCID50/ml in children (2-4 years old)
Attenuated Mumps vaccine (KMB-17) of 5.00±0.25 logCCID50/ml in 16 children aged 2-4 years old on day 0.
Biological: 5.00±0.25 logCCID50/ml
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.
Placebo Comparator: 0 logCCID50/ml in children (2-4 years old)
0 logCCID50/ml in 18 children aged 2-4 years old on day 0.
Biological: 0 logCCID50/ml
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.
Active Comparator: Attenuated Mumps vaccine in children (2-4 years old)
Attenuated Mumps vaccine (Zhe Jiang Vacn Bio-pharmaceutical Co., LTD.; NO.20110528-1) in 18 children aged 2-4 years old on day 0.
Biological: Attenuated Mumps vaccine (Zhe Jiang Vacn Bio-pharmaceutical Co., LTD.; NO.20110528-1)
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.
Experimental: 3.50±0.25logCCID50/ml in infants
Attenuated Mumps vaccine (KMB-17) of 3.50±0.25logCCID50/ml in 16 infants aged 8-23 months old on day 0.
Biological: 3.50±0.25logCCID50/ml
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.
Experimental: 4.25±0.25 logCCID50/ml in infants
Attenuated Mumps vaccine (KMB-17) of 4.25±0.25 logCCID50/ml in 16 infants aged 8-23 months old on day 0.
Biological: 4.25±0.25 logCCID50/ml
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.
Experimental: 5.00±0.25 logCCID50/ml in infants
Attenuated Mumps vaccine (KMB-17) of 5.00±0.25 logCCID50/ml in 16 infants aged 8-23 months old on day 0.
Biological: 5.00±0.25 logCCID50/ml
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.
Placebo Comparator: 0 logCCID50/ml in infants
0 logCCID50/ml in 18 infants aged 8-23 months old on day 0.
Biological: 0 logCCID50/ml
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.
Active Comparator: Attenuated Mumps vaccine in infants
Attenuated Mumps vaccine (Zhe Jiang Vacn Bio-pharmaceutical Co., LTD.; NO.20110528-1) in 18 infants aged 8-23 months old on day 0.
Biological: Attenuated Mumps vaccine (Zhe Jiang Vacn Bio-pharmaceutical Co., LTD.; NO.20110528-1)
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

Ages Eligible for Study:   8 Months to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01712906

Locations
China, Hebei
Hebei Provincial Center for Diseases Control and Prevention
Shijiazhuang, Hebei, China, 050021
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Institute of Medical Biology CAMS
Investigators
Principal Investigator: Yuliang Zhao, Master Hebei Provincial Center for Diseases Control and Prevention
  More Information

No publications provided by Chinese Academy of Medical Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Longding Liu, Professor, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01712906     History of Changes
Other Study ID Numbers: FMumps-KMB17-I-IMB-CAMS
Study First Received: October 22, 2012
Last Updated: April 26, 2013
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Mumps
Rubulavirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Parotitis
Parotid Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on October 19, 2014