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NCT Number: NCT01712906

A Phase I, Safety Study of 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.

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Key information

Conditions

Mumps Infections Mononegavirales Infections Mouth Diseases Paramyxoviridae Infections Parotid Diseases Parotitis RNA Virus Infections Rubulavirus Infections Salivary Gland Diseases Stomatognathic Diseases Virus Diseases

Age range

8 month–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hebei Provincial Center for Diseases Control and Prevention

Shijiazhuang, Hebei, 050021, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3.50±0.25logCCID50/ml

Biological

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/ml

Biological

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/ml

Biological

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/ml

Biological

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.

Primary outcomes

  1. 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

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

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

    Time frame: within the first 28 days after the vaccination

    Adverse reactions associated with vaccine were observed in Chinese Children (from 5 to 15 years old) after the vaccination.

  3. Evaluate the safety of Attenuated Mumps Vaccine (Human Diploid Cell, KMB-17) in Chinese Children.

    Time frame: within the first 28 days after the vaccination

    Adverse reactions associated with vaccine were observed in Chinese Children (from 2 to 4 years old) after the vaccination.

  4. Evaluate the safety of Attenuated Mumps Vaccine (Human Diploid Cell, KMB-17) in Chinese Infants.

    Time frame: within the first 28 days after the vaccination

    Adverse reactions associated with vaccine were observed in Chinese Infants (from 8 to 23 months old) after the vaccination.

Secondary outcomes

  1. Evaluate the seroconversion rate of anti-Mumps antibodies in serum of adults, children and infants, after vaccination.

    Time frame: within the first 28 days after the 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.

  2. Evaluate the abnormity change of live and kidney function indexes in serum of adults, children and infants, after vaccination

    Time frame: within the first 4 days after the 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.

Sponsors and collaborators

Lead sponsor

Institute of Medical Biology, Chinese Academy of Medical Sciences

Other

Collaborators

  • Hebei Provincial Center for Diseases Control and Prevention

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 24, 2012
Registry last updated
Oct 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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