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MumpsPhase 1NCT01712906

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

A Phase 1 study testing 3.50±0.25logCCID50/ml, 4.25±0.25 logCCID50/ml and 5.00±0.25 logCCID50/ml in people with Mumps, run by Institute of Medical Biology, Chinese Academy of Medical Sciences at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 8 months to 59 yearsHealthy volunteers can take part
Conditions the study is for
Mumps
What is being tested?
3.50±0.25logCCID50/ml, 4.25±0.25 logCCID50/ml and 5.00±0.25 logCCID50/ml
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
300 participants
Where
1 siteChina
Study dates
Oct 2012to Apr 2013
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 months to 59 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 23Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Hebei Provincial Center for Diseases Control and Prevention

    Shijiazhuang, Hebei, 050021

Other trials in China

About this study

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

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.

Conditions
Mumps
Being tested
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)
Keywords
Live Attenuated Mumps (F-genotype) Vaccine
Medical subject headings
Mumps

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3.50±0.25logCCID50/mlBiological

    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.

  • 4.25±0.25 logCCID50/mlBiological

    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/mlBiological

    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/mlBiological

    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.

Study groups in NCT01712906
Study groupRoleWhat they receive
3.50±0.25logCCID50/ml in adultsExperimentalAttenuated Mumps vaccine (KMB-17) of 3.50±0.25logCCID50/ml in 16 adults aged 16-59 years old on day 0.
Receives: Biological: 3.50±0.25logCCID50/ml
4.25±0.25 logCCID50/ml in adultsExperimentalAttenuated Mumps vaccine (KMB-17) of 4.25±0.25 logCCID50/ml in 16 adults aged 16-59 years old on day 0.
Receives: Biological: 4.25±0.25 logCCID50/ml
5.00±0.25 logCCID50/ml in adultsExperimentalAttenuated Mumps vaccine (KMB-17) of 4.25±0.25 logCCID50/ml in 16 adults aged 16-59 years old on day 0.
Receives: Biological: 5.00±0.25 logCCID50/ml
0 logCCID50/ml in adultsPlacebo comparator0 logCCID50/ml in 18 adults aged 16-59 years old on day 0.
Receives: Biological: 0 logCCID50/ml
3.50±0.25logCCID50/ml in children (5-15 years old)ExperimentalAttenuated Mumps vaccine (KMB-17) of 3.50±0.25logCCID50/ml in 16 children aged 5-15 years old on day 0.
Receives: Biological: 3.50±0.25logCCID50/ml
4.25±0.25 logCCID50/ml in children (5-15 years old)ExperimentalAttenuated Mumps vaccine (KMB-17) of 4.25±0.25 logCCID50/ml in 16 children aged 5-15 years old on day 0.
Receives: Biological: 4.25±0.25 logCCID50/ml
5.00±0.25 logCCID50/ml in children (5-15 years old)ExperimentalAttenuated Mumps vaccine (KMB-17) of 5.00±0.25 logCCID50/ml in 16 children aged 5-15 years old on day 0.
Receives: Biological: 5.00±0.25 logCCID50/ml
0 logCCID50/ml in children (5-15 years old)Placebo comparator0 logCCID50/ml in 18 children aged 5-15 years old on day 0.
Receives: Biological: 0 logCCID50/ml
3.50±0.25logCCID50/ml in children (2-4 years old)ExperimentalAttenuated Mumps vaccine (KMB-17) of 3.50±0.25logCCID50/ml in 16 children aged 2-4 years old on day 0.
Receives: Biological: 3.50±0.25logCCID50/ml
4.25±0.25 logCCID50/ml in children (2-4 years old)ExperimentalAttenuated Mumps vaccine (KMB-17) of 4.25±0.25 logCCID50/ml in 16 children aged 2-4 years old on day 0.
Receives: Biological: 4.25±0.25 logCCID50/ml
5.00±0.25 logCCID50/ml in children (2-4 years old)ExperimentalAttenuated Mumps vaccine (KMB-17) of 5.00±0.25 logCCID50/ml in 16 children aged 2-4 years old on day 0.
Receives: Biological: 5.00±0.25 logCCID50/ml
0 logCCID50/ml in children (2-4 years old)Placebo comparator0 logCCID50/ml in 18 children aged 2-4 years old on day 0.
Receives: Biological: 0 logCCID50/ml
Attenuated Mumps vaccine in children (2-4 years old)Active comparatorAttenuated Mumps vaccine (Zhe Jiang Vacn Bio-pharmaceutical Co., LTD.; NO.20110528-1) in 18 children aged 2-4 years old on day 0.
Receives: Biological: Attenuated Mumps vaccine (Zhe Jiang Vacn Bio-pharmaceutical Co., LTD.; NO.20110528-1)
3.50±0.25logCCID50/ml in infantsExperimentalAttenuated Mumps vaccine (KMB-17) of 3.50±0.25logCCID50/ml in 16 infants aged 8-23 months old on day 0.
Receives: Biological: 3.50±0.25logCCID50/ml
4.25±0.25 logCCID50/ml in infantsExperimentalAttenuated Mumps vaccine (KMB-17) of 4.25±0.25 logCCID50/ml in 16 infants aged 8-23 months old on day 0.
Receives: Biological: 4.25±0.25 logCCID50/ml
5.00±0.25 logCCID50/ml in infantsExperimentalAttenuated Mumps vaccine (KMB-17) of 5.00±0.25 logCCID50/ml in 16 infants aged 8-23 months old on day 0.
Receives: Biological: 5.00±0.25 logCCID50/ml
0 logCCID50/ml in infantsPlacebo comparator0 logCCID50/ml in 18 infants aged 8-23 months old on day 0.
Receives: Biological: 0 logCCID50/ml
Attenuated Mumps vaccine in infantsActive comparatorAttenuated Mumps vaccine (Zhe Jiang Vacn Bio-pharmaceutical Co., LTD.; NO.20110528-1) in 18 infants aged 8-23 months old on day 0.
Receives: Biological: Attenuated Mumps vaccine (Zhe Jiang Vacn Bio-pharmaceutical Co., LTD.; NO.20110528-1)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: within the first 28 days after the vaccination

  2. 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.

    Measured: within the first 28 days after the vaccination

  3. 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.

    Measured: within the first 28 days after the vaccination

  4. 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.

    Measured: within the first 28 days after the vaccination

Secondary outcomes (2)

  1. 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.

    Measured: within the first 28 days after the vaccination

  2. 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.

    Measured: within the first 4 days after the vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionApr 2013
  4. Study completionApr 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01712906
Sponsor's protocol ID
FMumps-KMB17-I-IMB-CAMS
Status last verified
Oct 2023
First submitted
22 Oct 2012
Last updated
10 Oct 2023
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 24614759

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 3.50±0.25logCCID50/ml, 4.25±0.25 logCCID50/ml and 5.00±0.25 logCCID50/ml in people with Mumps, run by Institute of Medical Biology, Chinese Academy of Medical Sciences at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01712906, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.

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