The Oral Hexavalent Reassortant Rotavirus Attenuated Live Vaccine (Vero Cells)

NCT06950645 | Completed Phase 1 DMC

• 1 other identifier: PRO-RV-1001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The Phase I clinical trial of the oral hexavalent reassortant rotavirus attenuated live vaccine (Vero Cells) will be conducted in a population ranging from 6 weeks to 59 years of age. The objective of this study is to evaluate the safety of investigational vaccine in healthy adults and children, as well as its safety tolerability, and immunogenicity in healthy infants. The study will be an open-label observation in adults and children, and a randomized, double-blind, placebo-controlled clinical trial in infants.

Conditions

Rotavirus Gastroenteritis

Keywords

Phase I; sequential design; safety; tolerability; immunogenicity; Rotavirus gastroenteritis; vaccine

Outcome Measures

Primary Outcomes (1)

• Evaluate the safety of the investigational vaccine

  Incidence of adverse events/reactions

  0 day after the first dose till 42 days after the last dose

Secondary Outcomes (14)

• Evaluate the safety of the investigational vaccine

  0-14 days after each dose

• Evaluate the safety of the investigational vaccine

  0-30 minutes after each dose

• Evaluate the safety of the investigational vaccine in the healthy adults and children groups

  day 3 after each dose

• Evaluate the safety of the investigational vaccine

  Within 6 months after the last dose

• Evaluate the safety of the investigational vaccine in the healthy infant group

  Within 12 months after the last dose in the infant group

Study Arms (6)

Adult

EXPERIMENTAL

The experimental vaccine will be administered in three doses, with a 28-day interval between each dose.

Biological: Oral hexavalent reassortant rotavirus attenuated live vaccine

Children

EXPERIMENTAL

The experimental vaccine will be administered in three doses, with a 28-day interval between each dose

Biological: Oral hexavalent reassortant rotavirus attenuated live vaccine

Infants low-dose 1

EXPERIMENTAL

They will receive three low-dose experimental vaccine in a double-blind setting, with a 28-day interval between each dose.

Biological: Oral hexavalent reassortant rotavirus attenuated live vaccine

Infants low-dose 2

PLACEBO COMPARATOR

They will receive three doses of the placebo in a double-blind setting, with a 28-day interval between each dose

Biological: Placebo

Infants high-dose 1

EXPERIMENTAL

They will receive three high-dose experimental vaccine in a double-blind setting, with a 28-day interval between each dose

Biological: Oral hexavalent reassortant rotavirus attenuated live vaccine

Infants high-dose 2

PLACEBO COMPARATOR

They will receive three doses of the placebo in a double-blind setting,with a 28-day interval between each dose

Biological: Placebo

Interventions

Placebo BIOLOGICAL

Placebo of experimental vaccine for infants three doses administered orally

Infants low-dose 2

Oral hexavalent reassortant rotavirus attenuated live vaccine BIOLOGICAL

Oral hexavalent reassortant rotavirus attenuated live vaccine (high-dose) three doses administered orally

Adult

Eligibility Criteria

• Age: 6 Weeks - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• The participant and/or their guardian is willing and able to comply with all study procedures, sign the informed consent form, and remain contactable throughout the study period.
• Provide legal identification.
• Male or female, aged 6 to 12 weeks, or 2 to 6 years, or 18 to 59 years, and in good health.
• Fertile participants have no plans for pregnancy from the time of signing the informed consent form until 3 months after the last dose of the study vaccine and agree to use effective contraception, and have no plans for sperm or egg donation.

You may not qualify if:

• Known allergy to the vaccine or its components, such as urticaria, dyspnea, angioedema, etc.
• Current diarrhea or vomiting, or other gastrointestinal diseases, or having experienced gastroenteritis or any acute illness or acute exacerbation of chronic disease within the past 7 days, or those currently using antibiotics or antiviral therapy.
• History of intussusception or chronic gastrointestinal disease, including gastrointestinal congenital anomalies that can easily cause intussusception (e.g., Meckel's diverticulum).
• For infant and pediatric participants: congenital malformations or developmental disabilities, genetic defect diseases, severe malnutrition, or severe chronic diseases (such as Down syndrome, diabetes, sickle cell anemia, neurological disorders, Guillain-Barré syndrome); For adult participants: uncontrolled chronic diseases or severe disease history, including but not limited to cardiovascular diseases (such as drug-uncontrolled hypertension, i.e., systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg), hematologic diseases, hepatic and renal diseases, gastrointestinal diseases, respiratory diseases, malignant tumors, history of major organ transplantation, or any other disease or medical condition that the investigator believes may interfere with the trial results.
• Presence of autoimmune diseases or immunodeficiency diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid disease, asplenia, functional asplenia, HIV infection).
• Household members living with the participant are in an immunodeficient or immunosuppressed state or are currently/soon to be receiving immunosuppressive therapy, cytotoxic therapy, etc.
• Presence of coagulation dysfunction (such as deficiency of coagulation factors, abnormal platelets).
• Received \>14 days of immunosuppressive therapy or other immunomodulatory therapy, cytotoxic therapy within the past 6 months (for adult and pediatric participants) or since birth (for infant participants), or planned to receive such treatment during the study period.
• Chronic alcoholism \[weekly alcohol consumption \>14 drinking units (1 drinking unit = 14 grams of 100% alcohol = 360 mL beer, or 150 mL wine, or 45 mL distilled spirits/liquor)\] or history of drug abuse (repeated, excessive use of narcotic drugs, psychotropic substances, volatile organic solvents, etc.) (for adult participants).
• Suffering from/having suffered from severe neurological diseases (epilepsy, convulsions or seizures) or mental illness, or having a family history of the same.
• Received immunoglobulin or other blood products within 6 months before receiving the trial vaccine (for adult and pediatric groups) or in the past (for infant group), or planned to receive such treatment during the study period.
• Received other investigational drugs or vaccines within the past 30 days, or planned to receive such drugs or vaccines during the study period.
• Received live attenuated vaccines or COVID-19 vaccines within the past 14 days, or subunit or inactivated vaccines and other process vaccines within the past 7 days.
• Had axillary temperature ≥38.0℃ within the past 3 days.
• On the day planned for vaccination with the trial vaccine, having a fever with axillary temperature \>37.0℃.

Sponsors & Collaborators

• Sinovac Life Sciences Co., Ltd.: lead

Study Sites (1)

Hebei Provincial Center for Disease Control and Prevention

Shijiazhuang, Hebei, 050021, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The masking is only conducted for the infant group, while the adult and children group is open-label.
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study features a single-arm, open-label design for the adult and children groups, and a randomized, double-blind, placebo-controlled design for the infant group.

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: April 30, 2025
• Study Start: March 27, 2024
• Primary Completion: December 21, 2024
• Study Completion: December 18, 2025
• Last Updated: March 20, 2026

Record last verified: 2025-05

Locations

CN (1)