Phase II Clinical Trial of the Inactivated Rotavirus Vaccine

NCT06080906 | Unknown Phase 2

• 1 other identifier: RV-201
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized, double-blinded, placebo-controlled phase 2 clinical trial to evaluate the immunogenicity and safety of Inactivated Rotavirus Vaccine (IRV) in children (aged 2-71 months). Primary immunogenicity endpoints in two age groups are the anti-RV neutralizing antibody geometric mean titers (GMTs) 28 days after the final dose, anti-RV neutralizing antibody geometric mean increase (GMI), and seroconversion rates between baseline and 28 days after the final dose. The secondary safety endpoints are the number of adverse events/reactions within 30 minutes after each dose, the number of solicited adverse events/reactions within 7 days after each dose, the number of unsolicited adverse events/reactions within 28/30 days after each dose, and the number of serious adverse events (SAE) between the first dose up to 6 months after the final dose. The exploratory endpoints are the anti-RV IgG and IgA antibody GMT 28 days after the final dose, GMI and seroconversion rates of anti-RV IgG and IgA antibody between baseline and 28 days after the final dose, GMT and seropositive rates of anti-RV neutralizing antibody, IgG antibody and IgA antibody 90, 180, and 360 days after the final dose. Besides, as the exploratory endpoint, the GMT, GMI, and seroconversion rates of cross-neutralizing antibodies against G3 and G9 type of RV, gene transcription differences in peripheral blood mononuclear cells on Day 0 and 28 after the final dose will be assessed.

Conditions

Rotavirus Infections; Diarrhea

Keywords

Rotavirus Infections; Inactivated Rotavirus Vaccine; Diarrhea

Outcome Measures

Primary Outcomes (6)

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

  Neutralizing antibody assay will be performed using the neutralization and ELISA method.

  Day 28 after the second vaccination

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

  Neutralizing antibody assay will be performed using the neutralization and ELISA method.

  Day 28 after the third vaccination

• Immunogenicity index-geometric mean increase (GMI) of neutralizing antibody

  Neutralizing antibody assay will be performed using the neutralization and ELISA method.

  Between baseline and day 28 after the second vaccination

• Immunogenicity index-geometric mean increase (GMI) of neutralizing antibody

  Neutralizing antibody assay will be performed using the neutralization and ELISA method.

  Between baseline and day 28 after the third vaccination

• Immunogenicity index-seroconversion rates of neutralizing antibody

  Neutralizing antibody assay will be performed using the neutralization and ELISA method. Seroconversion will be defined as a change from seronegative (\<1:8) to seropositive (≥1:8), or a ≥4-fold increase from baseline.

  Between baseline and day 28 after the second vaccination

• Immunogenicity index-seroconversion rates of neutralizing antibody

  Neutralizing antibody assay will be performed using the neutralization and ELISA method. Seroconversion will be defined as a change from seronegative (\<1:8) to seropositive (≥1:8), or a ≥4-fold increase from baseline.

  Between baseline and day 28 after the third vaccination

Secondary Outcomes (10)

• Safety index-incidence of adverse reactions/events

  0-30 minutes after the first dose vaccination

• Safety index-incidence of adverse reactions/events

  0-30 minutes after the second dose vaccination

• Safety index-incidence of adverse reactions/events

  0-30 minutes after the third dose vaccination

• Safety index-incidence of solicited adverse reactions/events

  Day 0 to 7 after the first dose vaccination

• Safety index-incidence of solicited adverse reactions/events

  Day 0 to 7 after the second dose vaccination

Other Outcomes (31)

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

  Day 28 after the second vaccination

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

  Day 28 after the third vaccination

• Immunogenicity index-geometric mean increase (GMI) of IgG antibody

  Between baseline and day 28 after the second vaccination

Study Arms (4)

Tolldlers (7-71 months old, two-dose)

EXPERIMENTAL

Inactivated Rotavirus vaccine (Vero cell) in toddlers aged 7-71 months old on Day 0, 28

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

Infants (2-6 months old, three-dose)

EXPERIMENTAL

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

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

Placebo in Tolldlers (7-71 months old, two-dose)

PLACEBO COMPARATOR

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

Biological: Placebo on Day 0, 28

Placebo in Infants (2-6 months old, three-dose)

PLACEBO COMPARATOR

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

Biological: Placebo on Day 0, 28, 56

Interventions

IRV on a 0- and 28-day schedule BIOLOGICAL

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

Tolldlers (7-71 months old, two-dose)

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

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

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 in Tolldlers (7-71 months old, two-dose)

Placebo on Day 0, 28, 56 BIOLOGICAL

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

Placebo in Infants (2-6 months old, three-dose)

Eligibility Criteria

• Age: 2 Months - 71 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age Requirement: Infants and toddlers aged 2 to 71 months at the time of enrollment.
• Provision of Legal Identification: Volunteers and their legal guardians or appointed representatives must provide valid legal identification documents.
• Informed Consent: Legal guardians or appointed representatives of volunteers must have the capacity to understand the informed consent document and the research process, voluntarily participate, sign the informed consent form, and be able to comply with the requirements in the study as well as complete relevant visits on time.
• No Previous Rotavirus Vaccination: Infants and toddlers enrolled in the study should not have received any rotavirus vaccines before enrollment.

You may not qualify if:

• Temperature Requirement: Axillary body temperature prior to vaccination is up to 37.3°C or more.
• Allergic History: Subjects have a history of allergies to any component of the investigational vaccine (e.g., aluminum hydroxide), any history of vaccine allergies, suspected allergies, or any other severe adverse reactions.
• Vaccine History: Subjects received any inactivated vaccines or subunit vaccines within 7 days (including the 7th day) prior to vaccination with the investigational vaccine, or any other live attenuated vaccines or COVID-19 vaccines within 14 days (including the 14th day) prior to vaccination.
• Health Conditions: Subjects have known congenital abnormalities, developmental disorders, genetic defects, or severe malnutrition, among other conditions.
• Immune-Related Diseases: Subjects have compromised primary or secondary immune function, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), juvenile rheumatoid arthritis (JRA), inflammatory bowel disease, or other autoimmune diseases.
• Gastrointestinal Conditions: Subjects have a history of intussusception or chronic gastrointestinal diseases.
• Neurological and Mental Health: Subjects have a history of seizures, convulsions, cerebral palsy, epilepsy, mental illness, or a family history of such conditions.
• Acute Illness: Subjects have experienced acute illnesses (e.g., fever) within 3 days prior to vaccination with the investigational vaccine.
• Immune Therapy: Subjects have received immune-enhancing or immune-suppressing therapy within the last 3 months (continuous oral or intravenous administration for more than 14 days) prior to vaccination.
• Coagulation Abnormalities: Subjects have a history of coagulation disorders (e.g., coagulation factor deficiency, coagulation disorders).
• Organ Removal History: Subjects have a history of organ removal (e.g., thyroid, pancreas, liver, spleen) or have asplenia syndrome.
• Participation in Other Clinical Studies: Subjects are currently or have plans to participate in other clinical studies before enrollment.
• Contraindication of the second and third doses of vaccine
• Severe Adverse Reactions: Subjects experienced severe adverse reactions after receiving the previous vaccine dose.
• Vaccination with Other Rotavirus Vaccines During the Study: Subjects received other rotavirus vaccines during the study period.

Sponsors & Collaborators

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

Study Sites (1)

Tongxu Center for Disease Prevention and Control

Kaifeng, Henan, China

RECRUITING

MeSH Terms

Conditions

Rotavirus Infections; Diarrhea

Interventions

Appointments and Schedules

Condition Hierarchy (Ancestors)

Reoviridae Infections; RNA Virus Infections; Virus Diseases; Infections; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Organization and Administration; Health Services Administration

Study Officials

• Yanxia Wang

  Henan Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongjun Li

CONTACT

13888918945; lihj6912@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 300 toddlers (aged 7-71 months) and 300 infants (aged 2-6 months) will be eligible for parallel enrollment

Study Record Dates

• First Submitted: October 8, 2023
• First Posted: October 12, 2023
• Study Start: October 20, 2023
• Primary Completion: February 17, 2025
• Study Completion: June 17, 2025
• Last Updated: January 3, 2024

Record last verified: 2024-01

Locations

CN (1)