Phase II/III of Live Attenuated Mumps (F-genotype) Vaccine (Human Diploid Cell, KMB-17) in Healthy Children Aged 5-11

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 results of phase I and II clinical trials showed that the vaccine possessed good immunogenicity and good antigenic cross-reactivity in infants (8-24 months old).

Study Overview

• Status: Active, not recruiting
• Conditions: Epidemic Parotitis, Mumps
• Intervention / Treatment: Biological: Attenuated Mumps vaccine (KMB-17) in phase II and III; Biological: Placebo in phase II; Biological: Attenuated Mumps vaccine (KMB-17) in phase III; Biological: Placebo in phase III

Detailed Description

This study will recruit 12,000 subjects and be divided into two stages. The first stage will evaluate the immunogenicity and safety of F-genotype mumps live attenuated vaccine (human diploid cells) after vaccination in 720 healthy children aged 5-11 years, and explore the detoxification in 144 subjects, who randomly selected from these 720 subjects. The second stage will evaluate the clinical protective efficacy, immunogenicity and safety of F-genotype mumps live attenuated vaccine (human diploid cells) after vaccination in 11280 healthy children aged 5-11 years.

• Study Type: Interventional
• Enrollment (Actual): 11999
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Qihan Li, PhD; Phone Number: +8687168335905; Email: cherryzhang629@126.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430079
      • Hubei Provincial Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 11 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy people aged 5-11 years (including boundary values), both men and women.
• Proven legal identity.
• Participants and parent(s)/legal guardian(s) should understand the contents of the informed consent form, the vaccine in this trial, voluntarily sign the informed consent form, and be capable of using thermometers, scales, and filling in diary cards and contact cards as required.
• Participants and parent(s)/legal guardian(s) should be able to communicate well with investigators, understand and comply with the requirements of this trial.
• Axillary temperature ≤37.0 ℃.

Exclusion Criteria:

• Contraindications for vaccination.
• History of allergy to vaccines or drugs
• Have a history of mumps disease
• Except for one dose of vaccine containing mumps at the age of 18~24 months before enrollment, any vaccine containing mumps has been vaccinated.
• Any prior administration of attenuated live vaccine in last 15 days;Any prior administration of subunit or inactivated vaccines in last 7 days
• Convulsant,encephalopathy,psychosis or family history of epileptics.
• Those who developed acute disease within 2 weeks, or had symptoms of fever or upper respiratory tract infection within 7 days.
• For any reason, the spleen was removed partially or completely
• Clinical diagnosis of coagulopathy (such as clotting factor deficiency, coagulation disorders, platelet abnormalities), significant bruising or blood clotting disorder,it will cause the contraindication of subcutaneous injection
• Suffering from congenital deformity or serious chronic disease(congenital heart disease，Down's syndrome,diabetes,sickle cell anemia,nervous illness,angiocardiopathy,hypertension,bronchitis,pneumonia,asthma,infectious skin diseases)
• 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 or corticosteroids to cure noncomplication acute dermatitis ).
• Receipt of immunosuppressive therapy within 6 months before signing the informed consent form, such as long-term systemic glucocorticoid therapy (with systemic glucocorticoid therapy for more than 2 weeks within 6 months, such as prednisone or similar drugs) ), but local administration (such as ointment, eye drops, inhalation, or nasal spray) is allowed. The local administration should not exceed the dosage recommended in the instructions or have any signs of systemic exposure.
• Any prior administration of other research medicines during the same period.
• Any other situations judged by investigators as not suitable for participating in this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Attenuated Mumps vaccine (KMB-17) in phase II and III; ≥4.3logCCID50/ml Attenuated Mumps vaccine (KMB-17)[≥4.3 logCCID50/ml] in 360 children (5-11 years old) on 0 day	Biological: Attenuated Mumps vaccine (KMB-17) in phase II and III; ≥4.3logCCID50/ml Attenuated Mumps vaccine (KMB-17)[≥4.3 logCCID50/ml] in 360 children (5-11 years old) on 0 day
Placebo Comparator: Placebo in phase II; Freeze-dried stabilizer and diluent without mumps virus antigen in 360 children (5-11 years old) on 0 day	Biological: Placebo in phase II; Freeze-dried stabilizer and diluent without mumps virus antigen in 360 children (5-11 years old) on 0 day
Experimental: Attenuated Mumps vaccine (KMB-17) in phase III; ≥4.3logCCID50/ml Attenuated Mumps vaccine (KMB-17)[≥4.3 logCCID50/ml] in 5640 children (5-11 years old) on 0 day	Biological: Attenuated Mumps vaccine (KMB-17) in phase III; ≥4.3logCCID50/ml Attenuated Mumps vaccine (KMB-17)[≥4.3 logCCID50/ml] in 5640 children (5-11 years old) on 0 day
Placebo Comparator: Placebo in phase III; Freeze-dried stabilizer and diluent without mumps virus antigen in 5640 children (5-11 years old) on 0 day	Biological: Placebo in phase III; Freeze-dried stabilizer and diluent without mumps virus antigen in 5640 children (5-11 years old) on 0 day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase II: Positive conversion rate of MuV hemagglutination inhibition antibody of Muv Vaccine	To compared the positive conversion rate of MuV hemagglutination inhibition antibody at 28 days after vaccination.	28 day after the vaccination
Phase II: Positive conversion rate of MuV neutralization antibody of MuV Vaccine	To compared the positive conversion rate of Muv hemagglutination inhibition antibody at 28 days after vaccination.	28 day after the vaccination
Phase III: The protective effect of the MuV vaccine group compared with the placebo group in preventing mumps according with the protocol	To compared the the number of cases of mumps in the vaccine group and the placebo group after 29-day-post injection within 12 months after vaccination	within 12 months after vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase II/III: Adverse reactions/events rate	Occurence of adverse reactions/events within 0-14 days after vaccination	within 14 days after vaccination
Phase II/III: Adverse reactions/events rate	Occurence of adverse reactions/events within 0-28 days after vaccination	within 28 days after vaccination
Phase II/III: Serious adverse events rate	Occurence of serious adverse events within 12 months after vaccination	within 12 months after vaccination
Phase II/III: Positive rate of the hemagglutination inhibition antibody and neutralizing antibody	To compared positive rate of the hemagglutination inhibition antibody and neutralizing antibodies against MuV at 28 days after the vaccination	28 day after the vaccination
Phase II/III: The GMT of the hemagglutination inhibition antibody and neutralizing antibody	To compared the GMT of the hemagglutination inhibition antibody and neutralizing antibodies against MuV at 28 days after the vaccination	28 day after the vaccination
Phase III: The protective effect of the MuV vaccine group compared with the placebo group in preventing mumps	To compared the the number of cases of mumps in the vaccine group and the placebo group after injection within 12 months after vaccination	within 12 months after vaccination
Phase III: Positive conversion rate of MuV hemagglutination inhibition antibody of Muv Vaccine	To compared the positive conversion rate of MuV hemagglutination inhibition antibody at 28 days after vaccination.	28 day after the vaccination
Phase III: Positive conversion rate of MuV neutralization antibody of MuV Vaccine	To compared the positive conversion rate of Muv hemagglutination inhibition antibody at 28 days after vaccination.	28 day after the vaccination
Phase II/III: Positive rate of the hemagglutination inhibition antibody and neutralizing antibody	To compared positive rate of the hemagglutination inhibition antibody and neutralizing antibodies against MuV at 12 months after the vaccination	12 months after vaccination
Phase II/III: The GMT of the hemagglutination inhibition antibody and neutralizing antibody	To compared the GMT of the hemagglutination inhibition antibody and neutralizing antibodies against MuV at 12 months after the vaccination	12 months after vaccination
Phase II/III: Detoxification	Viral copies in pharyngeal swabs or gargles at 3, 7, 14, 28 days after vaccination were tested by PCR.	at 3, 7, 14, 28 days after vaccination

Collaborators and Investigators

• Sponsor: Institute of Medical Biology, Chinese Academy of Medical Sciences
• Collaborators: Hubei Provincial Center for Disease Control and Prevention
• Investigators: Study Chair: Qihan Li, Institute of Medical Biology, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2020
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: September 27, 2020
• First Submitted That Met QC Criteria: October 12, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 8, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Mumps; F-genotype; Live Attenuated Vaccine; Human Diploid Cell
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Stomatognathic Diseases; Mouth Diseases; Paramyxoviridae Infections; Mononegavirales Infections; Salivary Gland Diseases; Rubulavirus Infections; Parotid Diseases; Sialadenitis; Mumps; Parotitis; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: 20190710

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No