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

Primary Purpose

Mumps

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

3.50±0.25logCCID50/ml

4.25±0.25 logCCID50/ml

5.00±0.25 logCCID50/ml

0 logCCID50/ml

Attenuated Mumps vaccine (Zhe Jiang Vacn Bio-pharmaceutical Co., LTD.; NO.20110528-1)

About this trial

This is an interventional prevention trial for Mumps focused on measuring Live Attenuated Mumps (F-genotype) Vaccine

Eligibility Criteria

8 Months - 59 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Hebei Provincial Center for Diseases Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm 17

Arm 18

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Active Comparator

Experimental

Placebo Comparator

Active Comparator

Arm Label

3.50±0.25logCCID50/ml in adults

4.25±0.25 logCCID50/ml in adults

5.00±0.25 logCCID50/ml in adults

0 logCCID50/ml in adults

3.50±0.25logCCID50/ml in children (5-15 years old)

4.25±0.25 logCCID50/ml in children (5-15 years old)

5.00±0.25 logCCID50/ml in children (5-15 years old)

0 logCCID50/ml in children (5-15 years old)

3.50±0.25logCCID50/ml in children (2-4 years old)

4.25±0.25 logCCID50/ml in children (2-4 years old)

5.00±0.25 logCCID50/ml in children (2-4 years old)

0 logCCID50/ml in children (2-4 years old)

Attenuated Mumps vaccine in children (2-4 years old)

3.50±0.25logCCID50/ml in infants

4.25±0.25 logCCID50/ml in infants

5.00±0.25 logCCID50/ml in infants

0 logCCID50/ml in infants

Attenuated Mumps vaccine in infants

Arm Description

Attenuated Mumps vaccine (KMB-17) of 3.50±0.25logCCID50/ml in 16 adults aged 16-59 years old on day 0.

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 18 adults aged 16-59 years old on day 0.

Attenuated Mumps vaccine (KMB-17) of 3.50±0.25logCCID50/ml in 16 children aged 5-15 years old on day 0.

Attenuated Mumps vaccine (KMB-17) of 4.25±0.25 logCCID50/ml in 16 children aged 5-15 years old on day 0.

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 18 children aged 5-15 years old on day 0.

Attenuated Mumps vaccine (KMB-17) of 3.50±0.25logCCID50/ml in 16 children aged 2-4 years old on day 0.

Attenuated Mumps vaccine (KMB-17) of 4.25±0.25 logCCID50/ml in 16 children aged 2-4 years old on day 0.

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 18 children aged 2-4 years old on day 0.

Attenuated Mumps vaccine (Zhe Jiang Vacn Bio-pharmaceutical Co., LTD.; NO.20110528-1) in 18 children aged 2-4 years old on day 0.

Attenuated Mumps vaccine (KMB-17) of 3.50±0.25logCCID50/ml in 16 infants aged 8-23 months old on day 0.

Attenuated Mumps vaccine (KMB-17) of 4.25±0.25 logCCID50/ml in 16 infants aged 8-23 months old on day 0.

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 18 infants aged 8-23 months old on day 0.

Attenuated Mumps vaccine (Zhe Jiang Vacn Bio-pharmaceutical Co., LTD.; NO.20110528-1) in 18 infants aged 8-23 months old on day 0.

Outcomes

Primary Outcome Measures

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

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.

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.

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT01712906

First Posted

October 22, 2012

Last Updated

October 7, 2023

Sponsor

Institute of Medical Biology, Chinese Academy of Medical Sciences

Collaborators

Hebei Provincial Center for Diseases Control and Prevention

1. Study Identification

Unique Protocol Identification Number

NCT01712906

Brief Title

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

Official Title

A Phase II Clinical Trial for Live Attenuated Mumps (F-genotype) Vaccine (Human Diploid Cell, KMB-17) in Chinese Children

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

October 2012 (undefined)

Primary Completion Date

April 2013 (Actual)

Study Completion Date

April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institute of Medical Biology, Chinese Academy of Medical Sciences

Collaborators

Hebei Provincial Center for Diseases Control and Prevention

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mumps

Keywords

Live Attenuated Mumps (F-genotype) Vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

300 (Actual)

8. Arms, Groups, and Interventions

Arm Title

3.50±0.25logCCID50/ml in adults

Arm Type

Experimental

Arm Description

Attenuated Mumps vaccine (KMB-17) of 3.50±0.25logCCID50/ml in 16 adults aged 16-59 years old on day 0.

Arm Title

4.25±0.25 logCCID50/ml in adults

Arm Type

Experimental

Arm Description

Attenuated Mumps vaccine (KMB-17) of 4.25±0.25 logCCID50/ml in 16 adults aged 16-59 years old on day 0.

Arm Title

5.00±0.25 logCCID50/ml in adults

Arm Type

Experimental

Arm Description

Attenuated Mumps vaccine (KMB-17) of 4.25±0.25 logCCID50/ml in 16 adults aged 16-59 years old on day 0.

Arm Title

0 logCCID50/ml in adults

Arm Type

Placebo Comparator

Arm Description

0 logCCID50/ml in 18 adults aged 16-59 years old on day 0.

Arm Title

3.50±0.25logCCID50/ml in children (5-15 years old)

Arm Type

Experimental

Arm Description

Attenuated Mumps vaccine (KMB-17) of 3.50±0.25logCCID50/ml in 16 children aged 5-15 years old on day 0.

Arm Title

4.25±0.25 logCCID50/ml in children (5-15 years old)

Arm Type

Experimental

Arm Description

Attenuated Mumps vaccine (KMB-17) of 4.25±0.25 logCCID50/ml in 16 children aged 5-15 years old on day 0.

Arm Title

5.00±0.25 logCCID50/ml in children (5-15 years old)

Arm Type

Experimental

Arm Description

Attenuated Mumps vaccine (KMB-17) of 5.00±0.25 logCCID50/ml in 16 children aged 5-15 years old on day 0.

Arm Title

0 logCCID50/ml in children (5-15 years old)

Arm Type

Placebo Comparator

Arm Description

0 logCCID50/ml in 18 children aged 5-15 years old on day 0.

Arm Title

3.50±0.25logCCID50/ml in children (2-4 years old)

Arm Type

Experimental

Arm Description

Attenuated Mumps vaccine (KMB-17) of 3.50±0.25logCCID50/ml in 16 children aged 2-4 years old on day 0.

Arm Title

4.25±0.25 logCCID50/ml in children (2-4 years old)

Arm Type

Experimental

Arm Description

Attenuated Mumps vaccine (KMB-17) of 4.25±0.25 logCCID50/ml in 16 children aged 2-4 years old on day 0.

Arm Title

5.00±0.25 logCCID50/ml in children (2-4 years old)

Arm Type

Experimental

Arm Description

Attenuated Mumps vaccine (KMB-17) of 5.00±0.25 logCCID50/ml in 16 children aged 2-4 years old on day 0.

Arm Title

0 logCCID50/ml in children (2-4 years old)

Arm Type

Placebo Comparator

Arm Description

0 logCCID50/ml in 18 children aged 2-4 years old on day 0.

Arm Title

Attenuated Mumps vaccine in children (2-4 years old)

Arm Type

Active Comparator

Arm 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.

Arm Title

3.50±0.25logCCID50/ml in infants

Arm Type

Experimental

Arm Description

Attenuated Mumps vaccine (KMB-17) of 3.50±0.25logCCID50/ml in 16 infants aged 8-23 months old on day 0.

Arm Title

4.25±0.25 logCCID50/ml in infants

Arm Type

Experimental

Arm Description

Attenuated Mumps vaccine (KMB-17) of 4.25±0.25 logCCID50/ml in 16 infants aged 8-23 months old on day 0.

Arm Title

5.00±0.25 logCCID50/ml in infants

Arm Type

Experimental

Arm Description

Attenuated Mumps vaccine (KMB-17) of 5.00±0.25 logCCID50/ml in 16 infants aged 8-23 months old on day 0.

Arm Title

0 logCCID50/ml in infants

Arm Type

Placebo Comparator

Arm Description

0 logCCID50/ml in 18 infants aged 8-23 months old on day 0.

Arm Title

Attenuated Mumps vaccine in infants

Arm Type

Active Comparator

Arm 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.

Intervention Type

Biological

Intervention Name(s)

3.50±0.25logCCID50/ml

Intervention 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(s)

4.25±0.25 logCCID50/ml

Intervention 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(s)

5.00±0.25 logCCID50/ml

Intervention 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(s)

0 logCCID50/ml

Intervention 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(s)

Attenuated Mumps vaccine (Zhe Jiang Vacn Bio-pharmaceutical Co., LTD.; NO.20110528-1)

Intervention 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.

Primary Outcome Measure Information:

Title

Evaluate the Safety of Attenuated Mumps Vaccine (Human Diploid Cell, KMB-17) in Chinese Adults.

Description

Adverse reactions associated with vaccine were observed in Chinese Adults (from 16 to 59 years old) after the vaccination

Time Frame