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

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.

Overall Status Completed
Start Date October 2012
Completion Date April 2013
Primary Completion Date April 2013
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: 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.

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
Location Countries

China

Verification Date

October 2012

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
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.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Triple (Participant, Care Provider, Investigator)

Source: ClinicalTrials.gov