Safety and Preliminary Immunogenicity Study of Inactivated Vaccine for Prevention of Rotavirus Infection
NCT ID: NCT04626856
Last Updated: 2020-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
32 participants
INTERVENTIONAL
2020-12-03
2021-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Low dosage in adults
Low dosage Inactivated Rotavirus vaccine (Vero cell) in adults aged 18-49 years old on day 0, 28
Low dosage IRV on a 0- and 28-day schedule
Inactivated Rotavirus vaccine (Vero cell) of 80EU/0.5ml on day 0, 28
Medium dosage in adults
Medium dosage Inactivated Rotavirus vaccine (Vero cell) in adults aged 18-49 years old on day 0, 28
Medium dosage IRV on a 0- and 28-day schedule
Inactivated Rotavirus vaccine (Vero cell) of 160EU/0.5ml on day 0, 28
High dosage in adults
High dosage Inactivated Rotavirus vaccine (Vero cell) in adults aged 18-49 years old on day 0, 28
High dosage IRV on a 0- and 28-day schedule
Inactivated Rotavirus vaccine (Vero cell) of 320EU/0.5ml on day 0,28
Low dosage in adolescents
Low dosage Inactivated Rotavirus vaccine (Vero cell) in adolescents aged 6-17 years old on day 0, 28
Low dosage IRV on a 0- and 28-day schedule
Inactivated Rotavirus vaccine (Vero cell) of 80EU/0.5ml on day 0,28
Medium dosage in adolescents
Medium dosage Inactivated Rotavirus vaccine (Vero cell) in adolescents aged 6-17 years old on day 0, 28
Medium dosage IRV on a 0- and 28-day schedule
Inactivated Rotavirus vaccine (Vero cell) of 160EU/0.5ml on day 0,28
High dosage in adolescents
High dosage Inactivated Rotavirus vaccine (Vero cell) in adolescents aged 6-17 years old on day 0, 28
High dosage IRV on a 0- and 28-day schedule
Inactivated Rotavirus vaccine (Vero cell) of 320EU/0.5ml on day 0,28
Low dosage in infants (7-71 months old)
Low dosage Inactivated Rotavirus vaccine (Vero cell) in infants aged 7-71 months old on day 0, 28
Low dosage IRV on a 0- and 28-day schedule
Inactivated Rotavirus vaccine (Vero cell) of 80EU/0.5ml on day 0,28
Medium dosage in infants (7-71 months old)
Medium dosage Inactivated Rotavirus vaccine (Vero cell) in infants aged 7-71 months old on day 0, 28
Medium dosage IRV on a 0- and 28-day schedule
Inactivated Rotavirus vaccine (Vero cell) of 160EU/0.5ml on day 0,28
High dosage in infants (7-71 months old)
High dosage Inactivated Rotavirus vaccine (Vero cell) in infants aged 7-71 months old on day 0, 28
High dosage IRV on a 0- and 28-day schedule
Inactivated Rotavirus vaccine (Vero cell) of 320EU/0.5ml on day 0,28
Low dosage in infants (2-6 months old, two-dose)
Low dosage Inactivated Rotavirus vaccine (Vero cell) in infants aged 2-6 months old on day 0, 28
Low dosage IRV on a 0- and 28-day schedule
Inactivated Rotavirus vaccine (Vero cell) of 80EU/0.5ml on day 0,28
Medium dosage in infants (2-6 months old, two-dose)
Medium dosage Inactivated Rotavirus vaccine (Vero cell) in infants aged 2-6 months old on day 0, 28
Medium dosage IRV on a 0- and 28-day schedule
Inactivated Rotavirus vaccine (Vero cell) of 160EU/0.5ml on day 0,28
High dosage in infants (2-6 months old, two-dose)
High dosage Inactivated Rotavirus vaccine (Vero cell) in infants aged 2-6 months old on day 0, 28
High dosage IRV on a 0- and 28-day schedule
Inactivated Rotavirus vaccine (Vero cell) of 320EU/0.5ml on day 0,28
Low dosage in infants (2-6 months old, three-dose)
Low dosage Inactivated Rotavirus vaccine (Vero cell) in infants aged 2-6 months old on day 0, 28, 56
Low dosage IRV on a 0- , 28- and 56-day schedule
Inactivated Rotavirus vaccine (Vero cell) of 80EU/0.5ml on day 0,28,56
Medium dosage in infants (2-6 months old, three-dose)
Medium dosage Inactivated Rotavirus vaccine (Vero cell) in infants aged 2-6 months old on day 0, 28, 56
Medium dosage IRV on a 0- , 28- and 56-day schedule
Inactivated Rotavirus vaccine (Vero cell) of 160EU/0.5ml on day 0,28,56
High dosage in infants (2-6 months old, three-dose)
High dosage Inactivated Rotavirus vaccine (Vero cell) in infants aged 2-6 months old on day 0, 28, 56
High dosage IRV on a 0- , 28- and 56-day schedule
Inactivated Rotavirus vaccine (Vero cell) of 320EU/0.5ml on day 0,28,56
Placebo on day 0, 28
Two doses of placebo at the vaccination schedule of day 0,28
Placebo on day 0, 28
Two doses of placebo at the vaccination schedule of day 0,28
Placebo on day 0, 28, 56
Three doses of placebo at the vaccination schedule of day 0, 28,56
Placebo on day 0, 28, 56
Three doses of placebo at the vaccination schedule of day 0, 28,56
Interventions
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Low dosage IRV on a 0- and 28-day schedule
Inactivated Rotavirus vaccine (Vero cell) of 80EU/0.5ml on day 0, 28
Medium dosage IRV on a 0- and 28-day schedule
Inactivated Rotavirus vaccine (Vero cell) of 160EU/0.5ml on day 0, 28
High dosage IRV on a 0- and 28-day schedule
Inactivated Rotavirus vaccine (Vero cell) of 320EU/0.5ml on day 0,28
Low dosage IRV on a 0- and 28-day schedule
Inactivated Rotavirus vaccine (Vero cell) of 80EU/0.5ml on day 0,28
Medium dosage IRV on a 0- and 28-day schedule
Inactivated Rotavirus vaccine (Vero cell) of 160EU/0.5ml on day 0,28
High dosage IRV on a 0- and 28-day schedule
Inactivated Rotavirus vaccine (Vero cell) of 320EU/0.5ml on day 0,28
Low dosage IRV on a 0- and 28-day schedule
Inactivated Rotavirus vaccine (Vero cell) of 80EU/0.5ml on day 0,28
Medium dosage IRV on a 0- and 28-day schedule
Inactivated Rotavirus vaccine (Vero cell) of 160EU/0.5ml on day 0,28
High dosage IRV on a 0- and 28-day schedule
Inactivated Rotavirus vaccine (Vero cell) of 320EU/0.5ml on day 0,28
Low dosage IRV on a 0- and 28-day schedule
Inactivated Rotavirus vaccine (Vero cell) of 80EU/0.5ml on day 0,28
Medium dosage IRV on a 0- and 28-day schedule
Inactivated Rotavirus vaccine (Vero cell) of 160EU/0.5ml on day 0,28
High dosage IRV on a 0- and 28-day schedule
Inactivated Rotavirus vaccine (Vero cell) of 320EU/0.5ml on day 0,28
Low dosage IRV on a 0- , 28- and 56-day schedule
Inactivated Rotavirus vaccine (Vero cell) of 80EU/0.5ml on day 0,28,56
Medium dosage IRV on a 0- , 28- and 56-day schedule
Inactivated Rotavirus vaccine (Vero cell) of 160EU/0.5ml on day 0,28,56
High dosage IRV on a 0- , 28- and 56-day schedule
Inactivated Rotavirus vaccine (Vero cell) of 320EU/0.5ml on day 0,28,56
Placebo on day 0, 28
Two doses of placebo at the vaccination schedule of day 0,28
Placebo on day 0, 28, 56
Three doses of placebo at the vaccination schedule of day 0, 28,56
Eligibility Criteria
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Inclusion Criteria
* Congenital malformations, developmental disorders, genetic defects, severe malnutrition and other conditions；
* Have Congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus Erythematosus (SLE) , juvenile Rheumatoid Arthritis, or other autoimmune diseases；
* History of Cerebral Palsy, seizures, mental illness.
2. I and/or my guardian voluntarily participate and sign an informed consent form, and can follow the requirements of the clinical trial protocol;
3. Have never received oral rotavirus live attenuated vaccine.
Exclusion Criteria
2. Subjects with history of intussusception or suffering from intussusception；
3. Subjects with history of convulsions and convulsions; history of epilepsy, mental illness and their family history；
4. Subjects with history of allergy to vaccination；
5. Acute attacks of various acute diseases (fever) or chronic diseases within 3 days before receiving the study vaccine；
6. Subjects receiving immune enhancement or immunosuppressive therapy within 3 months (continuous oral or infusion for more than 14 days)；
7. Subjects vaccinated with live attenuated vaccine within 14 days and other vaccines within 7 days before vaccination；
8. Subjects with history of coagulation dysfunction (e.g. Coagulation factor deficiency, coagulation disease);
9. Subjects with primary and secondary immunocompromised (history of thyroid, pancreas, liver, spleen resection, or need for treatment for thyroid disease in the past 12 months)；
10. Subjects with abnormal blood biochemistry, blood routine, and urine routine related indicators that have clinical significance\* before vaccination；
11. Subjects who are currently or plan to participate in other clinical studies;
12. According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
Note\*: The criterion of no clinical significance is "the laboratory test value between the upper limit (ULN) or lower limit (LLN) of the reference value range and the grade 1 adverse event" as judged by the doctor to have no clinical significance.
（1）18-49-year-old women who have plans to become pregnant within the past 2 months or are pregnant or are breastfeeding； （2）Positive pregnancy test of female subjects of childbearing age； （3）18-49-year-old adults with hypertension that cannot be controlled by drugs (on site measurement: systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg)； （4）24-month-old infant subjects with a history of dystocia, suffocation rescue, neurological damage； （5）24-month-old baby subjects are born prematurely (delivered after the 37th week of pregnancy), low weight (birth weight for girls \<2300g, boys \<2500g).
1. Subjects with serious adverse reaction after the previous vaccination;
3. Subjects vaccinated with other rotavirus vaccines other than the research vaccine during the study period;
4. Other exclusion reasons considered by the researcher.
2 Months
49 Years
ALL
Yes
Sponsors
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Henan Provincal Center for Disease Control and Prevention
UNKNOWN
Chinese Academy of Medical Sciences
OTHER
Responsible Party
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Li Hongjun
PI
Principal Investigators
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Hongjun Li, Ph.D
Role: STUDY_CHAIR
Chinese Academy of Medical Sciences
Locations
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Henan Provincial Center for Disease Control and Prevention
Zhenzhou, Henan, China
Countries
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References
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Wu JY, Zhang W, Pu J, Liu Y, Huang LL, Zhou Y, Gao JM, Tan JB, Liu XL, Yang J, Lin XC, Feng GW, Yin N, Chen R, Hu XQ, Yi S, Ye J, Kuang XJ, Wang Y, Zhang GM, Sun MS, Wang YX, Hu ZY, Yang JS, Li HJ. A randomized, double-blind, placebo-controlled phase I clinical trial of rotavirus inactivated vaccine (Vero cell) in a healthy adult population aged 18-49 years to assess safety and preliminary observation of immunogenicity. Vaccine. 2024 Jul 25;42(19):4030-4039. doi: 10.1016/j.vaccine.2024.05.014. Epub 2024 May 24.
Other Identifiers
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AF/SC-08/03.0
Identifier Type: -
Identifier Source: org_study_id