Phase I Clinical Trial of Inactivated Rotavirus Vaccine in a Population Aged 6 Weeks-49 Years Old

A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Dose Escalation Study to Evalution the Safety, Tolerability of Inactivated Rotavirus Vaccine in a Population Aged 6 Weeks-49 Years Old

The research objective is to evaluate the safety and tolerability of the inactivated rotavirus vaccine and explore its preliminary immunogenicity.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Biological: Inactivated rotavirus vaccine (low dose); Biological: Inactivated rotavirus vaccine (high dose); Biological: Placebo

Detailed Description

This is a Phase I, single center, randomized, double-blind, placebo-controlled, dose escalation clinical trial conducted in Hebei Province, China. The purpose of this study is to evaluate the safety and tolerability of the inactivated rotavirus vaccine and explore its preliminary immunogenicity.

• Study Type: Interventional
• Enrollment (Actual): 375
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Hebei
    • Shijiangzhuang, Hebei, China, 050021
      • Hebei Provincial Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Subjects aged 6-12 weeks, 1-5 years old, 18-49 years old, able to provide legal identification;
• The subjects or the legal guardians of the subject have the ability to understand the research procedure, agree to participate in the study (or the legal guardian of the subject agrees to the child's participation in the study), and signs an informed consent form;
• The subjects or their legals guardian are able to participate in all planned follow-up visits;
• On the day of enrollment, the axillary body temperature was ≤ 37.0 ℃;
• Standards for certain groups of people:

Subjects aged ≥ 1 year: Laboratory test indicators (as specified in the protocol) within the normal range, or those with abnormalities but no clinical significance (evaluated by clinical doctors); Female participants of childbearing age: non pregnant, non lactating, and agreed to take effective contraceptive measures within 8 months after participating in the study.

Exclusion Criteria:

• Previously received any rotavirus vaccine;
• Previous history of acute gastroenteritis caused by rotavirus;
• Have a history of intussusception, congenital abnormalities in the digestive system, chronic diarrhea, and other diseases in the past;
• Have any history of severe allergies to vaccines or drugs in the past, such as allergic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, and local allergic necrosis reaction (Arthurs reaction);
• Suffering from serious congenital malformations, developmental disorders, and genetic defects that may interfere with the progress or completion of the study (including but not limited to: Down syndrome, thalassemia, etc.);
• Diagnosed with congenital or acquired immunodeficiency, or suspected of having systemic diseases that may interfere with the conduct or completion of the study, such as tuberculosis, hepatitis B, hepatitis C, human immunodeficiency virus (HIV), syphilis infection, etc;
• Having a history or family history of convulsions, epilepsy, encephalopathy, and mental illness;
• Suffering from contraindications for intramuscular injection such as thrombocytopenia, any coagulation disorders, or receiving anticoagulant therapy;
• Recently receiving immunosuppressive therapy, such as systemic glucocorticoid therapy for more than 2 weeks continuously after birth or 6 months before vaccination, such as prednisone or similar drugs using >5mg/day (note: local and inhaled/nebulized steroids can be used);
• Any absence of spleen or splenectomy, functional absence of spleen caused by any circumstances;
• Hypertensive subjects (systolic blood pressure ≥ 140mmHg and/or diastolic blood pressure ≥ 90mmHg, suitable for adults);
• Three days prior to the first dose of the vaccine, there was an acute illness or a period of acute exacerbation of a chronic disease;
• Received inactivated vaccine within 7 days before enrollment and attenuated live vaccine within 14 days;
• Have received blood or blood related products or immunoglobulin (acceptable for hepatitis B immunoglobulin) within 3 months prior to enrollment;
• Plan to move before the end of the study or leave the local area for a long time during the scheduled study visit;
• The researchers believe that there are any conditions in the subjects that may interfere with the evaluation of the research objectives;
• Standards for certain groups of people:

Subjects aged 6-12 weeks: single fetus gestational age<37 weeks or>42 weeks, birth weight<2.5kg or>4.0kg; multiple fetuses; abnormal birth process (difficult labor, instrumental midwifery) or a history of asphyxia and neurological damage; children with pathological jaundice.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Age group of 18-49 years old; Using a dose escalation trial, divided into 2 dose groups with 25 participants in each group.	Biological: Inactivated rotavirus vaccine (low dose); The protein content of each dose is 2.5 μg. The antigen content shall not be less than 2000U, and each person shall receive one dose of 0.5ml.; Biological: Inactivated rotavirus vaccine (high dose); The protein content of each dose is 5 μg. The antigen content shall not be less than 4000U, and each person shall receive one dose of 0.5ml.; Biological: Placebo; Aluminum hydroxide adjuvant.
Experimental: Age group of 1-5 years old; Using a dose escalation trial, divided into 2 dose groups with 25 participants in each group.	Biological: Inactivated rotavirus vaccine (low dose); The protein content of each dose is 2.5 μg. The antigen content shall not be less than 2000U, and each person shall receive one dose of 0.5ml.; Biological: Inactivated rotavirus vaccine (high dose); The protein content of each dose is 5 μg. The antigen content shall not be less than 4000U, and each person shall receive one dose of 0.5ml.; Biological: Placebo; Aluminum hydroxide adjuvant.
Experimental: Age group of 6-12 months old; Using a dose escalation trial, divided into 2 dose groups with 25 participants in each group. In addition, a dose exploration trial was conducted, with a total of 225 subjects aged 6-12 weeks enrolled, with 100 participants in both high-dose and low-dose groups, and 25 participants in the placebo control group	Biological: Inactivated rotavirus vaccine (low dose); The protein content of each dose is 2.5 μg. The antigen content shall not be less than 2000U, and each person shall receive one dose of 0.5ml.; Biological: Inactivated rotavirus vaccine (high dose); The protein content of each dose is 5 μg. The antigen content shall not be less than 4000U, and each person shall receive one dose of 0.5ml.; Biological: Placebo; Aluminum hydroxide adjuvant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence rate of AE	The incidence of all adverse events within 0-30 days after each dose of vaccination	0~30 day after vaccination
Incidence rate of SAE	The incidence of all SAE from the start of the first dose of vaccination to the 6 months after achieving the entire immunization process	From the first dose of vaccination to the 6 months after achieving the entire immunization process

Collaborators and Investigators

• Sponsor: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
• Investigators: Study Chair: Lin Du, Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2021
• Primary Completion (Actual): November 30, 2023
• Study Completion (Estimated): October 31, 2024

Study Registration Dates

• First Submitted: April 1, 2024
• First Submitted That Met QC Criteria: April 1, 2024
• First Posted (Actual): April 5, 2024

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Inactivated Rotavirus Vaccine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: 202012005

Drug and device information, study documents

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