Safety and Preliminary Immunogenicity Study of Inactivated Vaccine for Prevention of Rotavirus Infection

NCT04626856 | Unknown Phase 1 DMC

• 1 other identifier: AF/SC-08/03.0
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized, double-blinded, placebo-controlled, Phase 1, dose-escalation study to evaluate the safety, reactogenicity and immunogenicity of Inactivated Rotavirus Vaccine (IRV) performed in healthy adult (aged 18-49 years), adolescent (aged 6-17 years) and infant subjects (aged 2-71 months). Primary objectives of the clinical trial include assessing the safety and tolerability of IRV given at two and three dose levels and comparing the safety and tolerability of IRV after each vaccination, between dosage groups, and by pre-vaccination rotavirus immune status. Secondary objective of the clinical trial is immunogenicity evaluation after each vaccination, between dosage groups, and by pre-vaccination rotavirus immune status.

Conditions

Rotavirus Infection

Outcome Measures

Primary Outcomes (19)

• Safety index-incidence of adverse reactions/events

  Incidence of adverse reactions/events after the first dose vaccination.

  0-30 minutes after the first dose vaccination

• Safety index-incidence of adverse reactions/events

  Incidence of adverse reactions/events after the second dose vaccination.

  0-30 minutes after the second dose vaccination

• Safety index-incidence of adverse reactions/events

  Incidence of adverse reactions/events after the third dose vaccination.

  0-30 minutes after the third dose vaccination

• Safety index-incidence of abnormal blood biochemistry assessment

  Incidence of abnormal blood biochemistry assessment at Day 4 after the first dose vaccination, except children aged Month 2-71

  Day 4 after the first dose vaccination

• Safety index-incidence of abnormal blood routine assessment

  Incidence of abnormal blood routine assessment at Day 4 after the first dose vaccination, except children aged Month 2-71

  Day 4 after the first dose vaccination

• Safety index-incidence of abnormal urine routine assessment

  Incidence of abnormal urine routine assessment at Day 4 after the first dose vaccination, except children aged Month 2-71

  Day 4 after the first dose vaccination

• Safety index-incidence of abnormal blood biochemistry assessment

  Incidence of abnormal blood biochemistry assessment at Day 4 after the second dose vaccination, except children aged Month 2-71

  Day 4 after the second dose vaccination

• Safety index-incidence of abnormal blood routine assessment

  Incidence of abnormal blood routine assessment at Day 4 after the second dose vaccination, except children aged Month 2-71

  Day 4 after the second dose vaccination

• Safety index-incidence of abnormal urine routine assessment

  Incidence of abnormal urine routine assessment at Day 4 after the second dose vaccination, except children aged Month 2-71

  Day 4 after the second dose vaccination

• Safety index-incidence of abnormal blood biochemistry assessment

  Incidence of abnormal blood biochemistry assessment at Day 4 after the third dose vaccination, except children aged Month 2-71

  Day 4 after the third dose vaccination

• Safety index-incidence of abnormal blood routine assessment

  Incidence of abnormal blood routine assessment at Day 4 after the third dose vaccination, except children aged Month 2-71

  Day 4 after the third dose vaccination

• Safety index-incidence of abnormal urine routine assessment

  Incidence of abnormal urine routine assessment at Day 4 after the third dose vaccination, except children aged Month 2-71

  Day 4 after the third dose vaccination

• Safety index-incidence of adverse reactions/events

  Incidence of adverse reactions/events after the first dose vaccination.

  Day 0 to7 after the first dose vaccination

• Safety index-incidence of adverse reactions/events

  Incidence of adverse reactions/events after the first dose vaccination.

  Day 8 to30 after the first dose vaccination

• Safety index-incidence of adverse reactions/events

  Incidence of adverse reactions/events after the second dose vaccination.

  Day 0 to7 after the second dose vaccination

• Safety index-incidence of adverse reactions/events

  Incidence of adverse reactions/events after the second dose vaccination.

  Day 8 to30 after the second dose vaccination

• Safety index-incidence of adverse reactions/events

  Incidence of adverse reactions/events after the third dose vaccination.

  Day 0 to7 after the third dose vaccination

• Safety index-incidence of adverse reactions/events

  Incidence of adverse reactions/events after the third dose vaccination.

  Day 8 to30 after the third dose vaccination

• Safety index-incidence of serious adverse events

  Occurrence of serious adverse reactions/events after vaccination.

  From the beginning of the vaccination to 6 months after the last vaccination completed

Secondary Outcomes (4)

• Immunogenicity index-seroconversion rates of neutralizing antibody

  Day 28 after the second dose vaccination

• Immunogenicity index-seroconversion rates of neutralizing antibody

  Day 28 after the third dose vaccination

• Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody

  Day 28, 90, 180 after the second dose vaccination

• Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody

  Day 28, 90, 180 after the third dose vaccination

Other Outcomes (10)

• Immunogenicity index-seroconversion rates of IgA antibody

  Day 28 after the second vaccination

• Immunogenicity index-seroconversion rates of IgA antibody

  Day 28 after the third dose vaccination

• Immunogenicity index-geometric mean titer (GMT) of IgA antibody

  Day 28, 90, 180 after the second dose vaccination

Study Arms (17)

Low dosage in adults

EXPERIMENTAL

Low dosage Inactivated Rotavirus vaccine (Vero cell) in adults aged 18-49 years old on day 0, 28

Biological: Low dosage IRV on a 0- and 28-day schedule

Medium dosage in adults

EXPERIMENTAL

Medium dosage Inactivated Rotavirus vaccine (Vero cell) in adults aged 18-49 years old on day 0, 28

Biological: Medium dosage IRV on a 0- and 28-day schedule

High dosage in adults

EXPERIMENTAL

High dosage Inactivated Rotavirus vaccine (Vero cell) in adults aged 18-49 years old on day 0, 28

Biological: High dosage IRV on a 0- and 28-day schedule

Low dosage in adolescents

EXPERIMENTAL

Low dosage Inactivated Rotavirus vaccine (Vero cell) in adolescents aged 6-17 years old on day 0, 28

Biological: Low dosage IRV on a 0- and 28-day schedule

Medium dosage in adolescents

EXPERIMENTAL

Medium dosage Inactivated Rotavirus vaccine (Vero cell) in adolescents aged 6-17 years old on day 0, 28

Biological: Medium dosage IRV on a 0- and 28-day schedule

High dosage in adolescents

EXPERIMENTAL

High dosage Inactivated Rotavirus vaccine (Vero cell) in adolescents aged 6-17 years old on day 0, 28

Biological: High dosage IRV on a 0- and 28-day schedule

Low dosage in infants (7-71 months old)

EXPERIMENTAL

Low dosage Inactivated Rotavirus vaccine (Vero cell) in infants aged 7-71 months old on day 0, 28

Biological: Low dosage IRV on a 0- and 28-day schedule

Medium dosage in infants (7-71 months old)

EXPERIMENTAL

Medium dosage Inactivated Rotavirus vaccine (Vero cell) in infants aged 7-71 months old on day 0, 28

Biological: Medium dosage IRV on a 0- and 28-day schedule

High dosage in infants (7-71 months old)

EXPERIMENTAL

High dosage Inactivated Rotavirus vaccine (Vero cell) in infants aged 7-71 months old on day 0, 28

Biological: High dosage IRV on a 0- and 28-day schedule

Low dosage in infants (2-6 months old, two-dose)

EXPERIMENTAL

Low dosage Inactivated Rotavirus vaccine (Vero cell) in infants aged 2-6 months old on day 0, 28

Biological: Low dosage IRV on a 0- and 28-day schedule

Medium dosage in infants (2-6 months old, two-dose)

EXPERIMENTAL

Medium dosage Inactivated Rotavirus vaccine (Vero cell) in infants aged 2-6 months old on day 0, 28

Biological: Medium dosage IRV on a 0- and 28-day schedule

High dosage in infants (2-6 months old, two-dose)

EXPERIMENTAL

High dosage Inactivated Rotavirus vaccine (Vero cell) in infants aged 2-6 months old on day 0, 28

Biological: High dosage IRV on a 0- and 28-day schedule

Low dosage in infants (2-6 months old, three-dose)

EXPERIMENTAL

Low dosage Inactivated Rotavirus vaccine (Vero cell) in infants aged 2-6 months old on day 0, 28, 56

Biological: Low dosage IRV on a 0- , 28- and 56-day schedule

Medium dosage in infants (2-6 months old, three-dose)

EXPERIMENTAL

Medium dosage Inactivated Rotavirus vaccine (Vero cell) in infants aged 2-6 months old on day 0, 28, 56

Biological: Medium dosage IRV on a 0- , 28- and 56-day schedule

High dosage in infants (2-6 months old, three-dose)

EXPERIMENTAL

High dosage Inactivated Rotavirus vaccine (Vero cell) in infants aged 2-6 months old on day 0, 28, 56

Biological: High dosage IRV on a 0- , 28- and 56-day schedule

Placebo on day 0, 28

PLACEBO COMPARATOR

Two doses of placebo at the vaccination schedule of day 0,28

Biological: Placebo on day 0, 28

Placebo on day 0, 28, 56

PLACEBO COMPARATOR

Three doses of placebo at the vaccination schedule of day 0, 28,56

Biological: Placebo on day 0, 28, 56

Interventions

Low dosage IRV on a 0- and 28-day schedule BIOLOGICAL

Inactivated Rotavirus vaccine (Vero cell) of 80EU/0.5ml on day 0, 28

Low dosage in adults

Medium dosage IRV on a 0- and 28-day schedule BIOLOGICAL

Inactivated Rotavirus vaccine (Vero cell) of 160EU/0.5ml on day 0, 28

Medium dosage in adults

High dosage IRV on a 0- and 28-day schedule BIOLOGICAL

Inactivated Rotavirus vaccine (Vero cell) of 320EU/0.5ml on day 0,28

High dosage in adults

Low dosage IRV on a 0- , 28- and 56-day schedule BIOLOGICAL

Inactivated Rotavirus vaccine (Vero cell) of 80EU/0.5ml on day 0,28,56

Low dosage in infants (2-6 months old, three-dose)

Medium dosage IRV on a 0- , 28- and 56-day schedule BIOLOGICAL

Inactivated Rotavirus vaccine (Vero cell) of 160EU/0.5ml on day 0,28,56

Medium dosage in infants (2-6 months old, three-dose)

High dosage IRV on a 0- , 28- and 56-day schedule BIOLOGICAL

Inactivated Rotavirus vaccine (Vero cell) of 320EU/0.5ml on day 0,28,56

High dosage in infants (2-6 months old, three-dose)

Placebo on day 0, 28 BIOLOGICAL

Two doses of placebo at the vaccination schedule of day 0,28

Placebo on day 0, 28

Placebo on day 0, 28, 56 BIOLOGICAL

Three doses of placebo at the vaccination schedule of day 0, 28,56

Placebo on day 0, 28, 56

Eligibility Criteria

• Age: 2 Months - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• months old to 49 years old, healthy resident, excluding the following:
• 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.
• I and/or my guardian voluntarily participate and sign an informed consent form, and can follow the requirements of the clinical trial protocol;
• Have never received oral rotavirus live attenuated vaccine.

You may not qualify if:

• Armpit temperature \>37.0℃ before vaccination；
• Subjects with history of intussusception or suffering from intussusception；
• Subjects with history of convulsions and convulsions; history of epilepsy, mental illness and their family history；
• Subjects with history of allergy to vaccination；
• Acute attacks of various acute diseases (fever) or chronic diseases within 3 days before receiving the study vaccine；
• Subjects receiving immune enhancement or immunosuppressive therapy within 3 months (continuous oral or infusion for more than 14 days)；
• Subjects vaccinated with live attenuated vaccine within 14 days and other vaccines within 7 days before vaccination；
• Subjects with history of coagulation dysfunction (e.g. Coagulation factor deficiency, coagulation disease);
• 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)；
• Subjects with abnormal blood biochemistry, blood routine, and urine routine related indicators that have clinical significance\* before vaccination；
• Subjects who are currently or plan to participate in other clinical studies;
• 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).
• Subjects with serious adverse reaction after the previous vaccination;

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead
• Henan Provincal Center for Disease Control and Prevention: collaborator

Study Sites (1)

Henan Provincial Center for Disease Control and Prevention

Zhenzhou, Henan, 450016, China

Location

Related Publications (1)

• 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.

  PMID: 38796326 DERIVED

MeSH Terms

Conditions

Rotavirus Infections

Interventions

Appointments and Schedules

Condition Hierarchy (Ancestors)

Reoviridae Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Organization and Administration; Health Services Administration

Study Officials

• Hongjun Li, Ph.D

  Chinese Academy of Medical Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 13, 2020
• Study Start: December 3, 2020
• Primary Completion: June 1, 2021
• Study Completion: August 1, 2021
• Last Updated: December 10, 2020

Record last verified: 2020-12

Locations

CN (1)