Epidemic Parotitis,MumpsPhase 2NCT03133923
Phase II of Live Attenuated Mumps (F-genotype) Vaccine (Human Diploid Cell, KMB-17) in Chinese Infants
A Phase 2 study testing ≥3.0 lgCCID50/mlbut <3.5lgCCID50/ml Live Attenuated Mumps Vaccine (Human Diploid Cell) in infants(8-24 months old) and ≥4.5 lgCCID50/ml Live Attenuated Mumps Vaccine (Human Diploid Cell) in infants(8-24 months old) in people with Epidemic Parotitis,Mumps, run by Institute of Medical Biology, Chinese Academy of Medical Sciences at 1 site in China.
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 to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Epidemic Parotitis,Mumps
- What is being tested?
- ≥3.0 lgCCID50/mlbut <3.5lgCCID50/ml Live Attenuated Mumps Vaccine (Human Diploid Cell) in infants(8-24 months old) and ≥4.5 lgCCID50/ml Live Attenuated Mumps Vaccine (Human Diploid Cell) in infants(8-24 months old)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,080 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2017to 1 Jul 2024
- Phase
- Phase 2
- 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 to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy males and females (from 8 months to 24 months old) as determined by medical history, physical examination, laboratory examination and clinical judgment of the investigator.
- Provided legal identification for the sake of recruitment.
- Without the routine corticosteroids of vaccination .
- Never has gone down with mumps or taken a vaccine contain mumps.
- parent(s)/legal guardian(s) are able to understand and sign informed consents and be able to read a thermometer and dividing ruler .At the same time,the parent(s)/legal guardian(s)should have the ability and objective to comply with the requirements of the protocol.
- Participants or guardians are able to attend all planned clinical appointment and obey and follow all study instructions; can persist for a 1-month visit and receive blood sample and throat swab collection according to program requirements.
- Axillary temperature ≤37℃.
Who cannot join
- Subject who has a medical history of Mumps or taken a vaccine contain mumps.
- Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine
- Convulsant,encephalopathy,psychosis or family histoty of epileptics.
- Clinical diagnosis of coagulopathy (such as clotting factor deficiency, coagulation disorders, platelet abnormalities), significant bruising or blood clotting disorder,it will couse the contraindication of subcutaneous injection
- Any prior administration of attenuated live vaccine in last 15 days;Any prior administration of subunit or inactivated vaccines in last 7 days
- Any prior administration of other research medicines in last 30 days.
Show all 12Show fewer
- Any prior administration of blood products(immunoglobulin etc.) in last 1 month;Any prior administration of immunodepressant ，cytotoxic drugs or corticosteroids in last 6 months(except the corticosteroids spray can treat irritability rhinitis orcorticosteroids to cure noncomplication acute dermatitis ).
- Any confirmed or suspected autoimmune disease or immune deficiency diseases(like favism or other diseases etc. ), including human immunodeficiency virus (HIV) infection.
- Suffering from congenital deformity or serious chronic disease(congenital heart disease，Down's syndrome,diabetes,sickle cell anemia,nervous illness,cardiocardiopathy,hypertension,bronchitis,pneumonia,asthma,infectious skin diseases)
- Acute or chronic infectious disease,active infectious;Laboratory test show Routine blood abnormal or hepatorenal dysfunction.
- Malignant disease(like cancer)，heredopathia or other disease that will cuase eccyliosis.The spleen or other important organ has been removed for any reason.
- 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
Hubei Provincial Center for Disease Control and Prevention
Wuhan, Hubei, 430079
About this study
Official title: Safety and Efficacy of Attenuated Mumps Vaccine (Human Diploid Cell)
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.
Read the detailed description
In order to evaluation the safety and immunogenicity of different doses Live Attenuated Mumps Vaccine (Human diploid cell).The study will Determine the optimal dose of vaccine and provide the clinical trail basis for the phase Ⅲ trail design.
Primary objective:
After single dose immunization of low dose(≥3.0but<3.5lgCCID50)、high dose （≥4.5lgCCID50）Live Attenuated Mumps Vaccine (Human Diploid Cell) in Chinese healthy Infants volunteer aged from 8 to 24 months old.the study will evaluate the standardized positive rate of neutralizing antibody and the GMT of the hemagglutination inhibition antibody and neutralizing antibody,proposing the immune reference dose for phase III clinical trials.
Secondary objective： Evaluate the safety of low dose(≥3.0but<3.5lgCCID50)、high dose （≥4.5lgCCID50）Live Attenuated Mumps Vaccine (Human Diploid Cell) in Chinese healthy Infants volunteer aged from 8 to 24 months old.
- Conditions
- Epidemic Parotitis,Mumps
- Being tested
- ≥3.0 lgCCID50/mlbut <3.5lgCCID50/ml Live Attenuated Mumps Vaccine (Human Diploid Cell) in infants(8-24 months old), ≥4.5 lgCCID50/ml Live Attenuated Mumps Vaccine (Human Diploid Cell) in infants(8-24 months old), Measles and Mumps Combined Vaccine，Live(SIBP)( positive control)
- Keywords
- Attenuated Mumps Vaccine(F-genotype，Human Diploid Cell, KMB-17), safety, immunogenecity
- Medical subject headings
- Mumps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
≥3.0 lgCCID50/mlbut <3.5lgCCID50/ml Live Attenuated Mumps Vaccine (Human Diploid Cell) in infants(8-24 months old)Biological
≥3.0 lgCCID50/ml but <3.5lgCCID50/ml;Live Attenuated Mumps (F-genotype) Vaccine (Human Diploid Cell, KMB-17) in 360 infants(aged 8-24 months ) on 0 day
≥4.5 lgCCID50/ml Live Attenuated Mumps Vaccine (Human Diploid Cell) in infants(8-24 months old)Biological
≥4.5CCID50/ml;Live Attenuated Mumps (F-genotype) Vaccine (Human Diploid Cell, KMB-17) in 360 infants(aged 8-24 months ) on 0 day
Measles and Mumps Combined Vaccine，Live(SIBP)( positive control)Biological
Measles and Mumps Combined Vaccine，Live(SIBP) in 360 infants(aged 8-24 months ) on 0 day
| Study group | Role | What they receive |
|---|---|---|
| Attenuated Mumps vaccine (KMB-17), low | Experimental | Biological/Vaccine: ≥3.0logCCID50/ml but <3.5 logCCID50/ml Attenuated Mumps vaccine (KMB-17)[ ≥3.0logCCID50/ml but <3.5 logCCID50/ml] in 360 infants (8-24 months old) on 0 day Receives: Biological: ≥3.0 lgCCID50/mlbut <3.5lgCCID50/ml Live Attenuated Mumps Vaccine (Human Diploid Cell) in infants(8-24 months old) |
| Attenuated Mumps vaccine (KMB-17), high | Experimental | Biological/Vaccine: ≥4.5logCCID50/ml Attenuated Mumps vaccine (KMB-17)[≥4.5 logCCID50/ml] in 360 infants (8-24 months old) on 0 day Receives: Biological: ≥4.5 lgCCID50/ml Live Attenuated Mumps Vaccine (Human Diploid Cell) in infants(8-24 months old) |
| Measles and Mumps Combined Vaccine，Live | Active comparator | manufacturer：Shanghai Institute of Biological Products Co., Ltd. (SIBP ) Measles and Mumps Combined Vaccine，Live in 360 infants in 360 infants (8-24 months old) on 0 day Receives: Biological: Measles and Mumps Combined Vaccine，Live(SIBP)( positive control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive conversion rate of Muv hemagglutination inhibition antibody of different single dose of Muv Vaccine
To compared the positive conversion rate of Muv hemagglutination inhibition antibody after vaccinate 3 diffirent group (low dose:≥3.0logCCID50/ml but <3.5logCCID50/ml,high dose：≥4.5logCCID50/ml,active comparator :shanghai institute of Biological Products Co,Ltd's measles and Mumps Combined Vaccine.live)
Measured: the 0 days（before vaccination） and 28 day after the vaccination
Positive conversion rate of Muv neutralization antibody of different single dose of Muv Vaccine
To compared the positive conversion rate of Muv neutralization antibody after vaccinate 3 diffirent group (low dose:≥3.0logCCID50/ml but <3.5logCCID50/ml,high dose：≥4.5logCCID50/ml,active comparator :shanghai institute of Biological Products Co,Ltd's measles and Mumps Combined Vaccine.live)
Measured: the 0 days（before vaccination） and 28 day after the vaccination
Secondary outcomes (4)
The GMT of the hemagglutination inhibition antibody and neutralizing antibody
evaluate the GMT of the hemagglutination inhibition antibody and neutralizing antibody in serum after the subjects get injected different dose of vaccine
Measured: the 0 days（before vaccination） and the 28 day after the vaccination
The GMT of the neutralizing antibody
evaluate the GMT of the neutralizing antibody in serum after the subjects get injected different dose of vaccine
Measured: the 0 days（before vaccination） and the 28 day after the vaccination
The incidence rate of ADR after vaccination
Study the incidence rate of ADR after vaccination
Measured: within the first 28 days after the vaccination
viral shedding after the vaccination
Using the method of PCR to detection the viral shedding of Muv after the vaccination.
Measured: the 0（before vaccination）,4,10 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.
- First posted28 Apr 2017
- Study start20 May 2017
- Primary completion10 Nov 2017
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidemic Parotitis,MumpsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,080 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Medical Biology, Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Hubei Provincial Center for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Beifang Yang, PhD, Principal investigator, Hubei Provincial Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03133923
- Sponsor's protocol ID
- 2015L00195
- Status last verified
- Oct 2023
- First submitted
- 17 Apr 2017
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Attenuated Mumps Vaccine (Human Diploid Cell)
- ClinicalTrials.gov ID
- NCT03133923
- Acronym / sponsor ID
- 2015L00195
- Conditions
- Epidemic Parotitis,Mumps
- Keywords
- Attenuated Mumps Vaccine(F-genotype，Human Diploid Cell, KMB-17), safety, immunogenecity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,080 participants (estimated)
- Lead sponsor
- Institute of Medical Biology, Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Hubei Provincial Center for Disease Control and Prevention
- Study start
- 20 May 2017 (actual)
- Primary completion
- 10 Nov 2017 (actual)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 28 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In order to evaluation the safety and immunogenicity of different doses Live Attenuated Mumps Vaccine (Human diploid cell).The study will Determine the optimal dose of vaccine and provide the clinical trail basis for the phase Ⅲ trail design.
Primary objective:
After single dose immunization of low dose(≥3.0but<3.5lgCCID50)、high dose （≥4.5lgCCID50）Live Attenuated Mumps Vaccine (Human Diploid Cell) in Chinese healthy Infants volunteer aged from 8 to 24 months old.the study will evaluate the standardized positive rate of neutralizing antibody and the GMT of the hemagglutination inhibition antibody and neutralizing antibody,proposing the immune reference dose for phase III clinical trials.
Secondary objective： Evaluate the safety of low dose(≥3.0but<3.5lgCCID50)、high dose （≥4.5lgCCID50）Live Attenuated Mumps Vaccine (Human Diploid Cell) in Chinese healthy Infants volunteer aged from 8 to 24 months old.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Attenuated Mumps vaccine (KMB-17), low | Experimental | Biological: ≥3.0 lgCCID50/mlbut <3.5lgCCID50/ml Live Attenuated Mumps Vaccine (Human Diploid Cell) in infants(8-24 months old)Biological/Vaccine: ≥3.0logCCID50/ml but <3.5 logCCID50/ml Attenuated Mumps vaccine (KMB-17)[ ≥3.0logCCID50/ml but <3.5 logCCID50/ml] in 360 infants (8-24 months old) on 0 day |
| Attenuated Mumps vaccine (KMB-17), high | Experimental | Biological: ≥4.5 lgCCID50/ml Live Attenuated Mumps Vaccine (Human Diploid Cell) in infants(8-24 months old)Biological/Vaccine: ≥4.5logCCID50/ml Attenuated Mumps vaccine (KMB-17)[≥4.5 logCCID50/ml] in 360 infants (8-24 months old) on 0 day |
| Measles and Mumps Combined Vaccine，Live | Active comparator | Biological: Measles and Mumps Combined Vaccine，Live(SIBP)( positive control)manufacturer：Shanghai Institute of Biological Products Co., Ltd. (SIBP ) Measles and Mumps Combined Vaccine，Live in 360 infants in 360 infants (8-24 months old) on 0 day |
Who may qualify
- Ages
- 8 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Healthy males and females (from 8 months to 24 months old) as determined by medical history, physical examination, laboratory examination and clinical judgment of the investigator.
- Provided legal identification for the sake of recruitment.
- Without the routine corticosteroids of vaccination .
- Never has gone down with mumps or taken a vaccine contain mumps.
- parent(s)/legal guardian(s) are able to understand and sign informed consents and be able to read a thermometer and dividing ruler .At the same time,the parent(s)/legal guardian(s)should have the ability and objective to comply with the requirements of the protocol.
Key exclusion criteria (12 listed)
- Subject who has a medical history of Mumps or taken a vaccine contain mumps.
- Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine
- Convulsant,encephalopathy,psychosis or family histoty of epileptics.
- Clinical diagnosis of coagulopathy (such as clotting factor deficiency, coagulation disorders, platelet abnormalities), significant bruising or blood clotting disorder,it will couse the contraindication of subcutaneous injection
- Any prior administration of attenuated live vaccine in last 15 days;Any prior administration of subunit or inactivated vaccines in last 7 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ≥3.0 lgCCID50/mlbut <3.5lgCCID50/ml Live Attenuated Mumps Vaccine (Human Diploid Cell) in infants(8-24 months old)≥3.0 lgCCID50/ml but <3.5lgCCID50/ml;Live Attenuated Mumps (F-genotype) Vaccine (Human Diploid Cell, KMB-17) in 360 infants(aged 8-24 months ) on 0 day | Biological | Attenuated Mumps vaccine (KMB-17), low |
| ≥4.5 lgCCID50/ml Live Attenuated Mumps Vaccine (Human Diploid Cell) in infants(8-24 months old)≥4.5CCID50/ml;Live Attenuated Mumps (F-genotype) Vaccine (Human Diploid Cell, KMB-17) in 360 infants(aged 8-24 months ) on 0 day | Biological | Attenuated Mumps vaccine (KMB-17), high |
| Measles and Mumps Combined Vaccine，Live(SIBP)( positive control)Measles and Mumps Combined Vaccine，Live(SIBP) in 360 infants(aged 8-24 months ) on 0 day | Biological | Measles and Mumps Combined Vaccine，Live |
Primary outcome
Positive conversion rate of Muv hemagglutination inhibition antibody of different single dose of Muv Vaccine
Time frame: the 0 days（before vaccination） and 28 day after the vaccination
To compared the positive conversion rate of Muv hemagglutination inhibition antibody after vaccinate 3 diffirent group (low dose:≥3.0logCCID50/ml but <3.5logCCID50/ml,high dose：≥4.5logCCID50/ml,active comparator :shanghai institute of Biological Products Co,Ltd's measles and Mumps Combined Vaccine.live)
Positive conversion rate of Muv neutralization antibody of different single dose of Muv Vaccine
Time frame: the 0 days（before vaccination） and 28 day after the vaccination
To compared the positive conversion rate of Muv neutralization antibody after vaccinate 3 diffirent group (low dose:≥3.0logCCID50/ml but <3.5logCCID50/ml,high dose：≥4.5logCCID50/ml,active comparator :shanghai institute of Biological Products Co,Ltd's measles and Mumps Combined Vaccine.live)
4 secondary outcomes
The GMT of the hemagglutination inhibition antibody and neutralizing antibody
Time frame: the 0 days（before vaccination） and the 28 day after the vaccination
The GMT of the neutralizing antibody
Time frame: the 0 days（before vaccination） and the 28 day after the vaccination
The incidence rate of ADR after vaccination
Time frame: within the first 28 days after the vaccination
viral shedding after the vaccination
Time frame: the 0（before vaccination）,4,10 days after the vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beifang Yang, PhD principal investigator
Hubei Provincial Center for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ≥3.0 lgCCID50/mlbut <3.5lgCCID50/ml Live Attenuated Mumps Vaccine (Human Diploid Cell) in infants(8-24 months old) and ≥4.5 lgCCID50/ml Live Attenuated Mumps Vaccine (Human Diploid Cell) in infants(8-24 months old) in people with Epidemic Parotitis,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 7 inclusion and 12 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: status not confirmed, 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Positive conversion rate of Muv hemagglutination inhibition antibody of different single dose of Muv Vaccine (time frame: the 0 days（before vaccination） and 28 day after the vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.