Phase IV Study of Concomitant Administration of the sIPV and HepA

NCT06460545 | Not Yet Recruiting Phase 4

• 1 other identifier: sIPV-402
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 3

Brief Summary

This study is a randomized, open-labeled phase IV clinical trial to evaluate the immunogenicity and safety of concomitant administration of sIPV and HepA-L or HepA-I in children aged 18 months. The primary immunogenicity endpoints in all groups are the seroconversion rates of type I, II, and III anti-poliovirus neutralizing antibodies and the seroconversion rate of anti-hepatitis A virus antibodies 30 days after the final administration. The secondary immunogenicity endpoints are (1) the GMT/GMC of type I, II, and III anti-poliovirus neutralizing antibodies as well as the anti-hepatitis A virus antibodies 30 days after the final administration; (2) the seropositive rates of the anti-hepatitis A virus antibodies 30 days after the final administration; (3) the GMFI of type I, II, and III anti-poliovirus neutralizing antibodies as well as the anti-hepatitis A virus antibodies 30 days after the final administration. The secondary safety endpoints are the incidence of adverse events (AEs) within 30 minutes after each injection, the incidence of solicited local and systematic AEs in the period of solicitation after each injection, the incidence of unsolicited AEs in 30 days after each injection, the incidence of AEs in 30 days after each injection, and the incidence of serious adverse events in 6 months after administrations.

Conditions

Polio; Hepatitis A

Outcome Measures

Primary Outcomes (7)

• Immunogenicity index-seroconversion rate of type I anti-poliovirus neutrilizing antibody

  Neutralizing antibody assay will be performed using the neutralization 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 30 after vaccination

• Immunogenicity index-seroconversion rate of type II anti-poliovirus neutrilizing antibody

  Neutralizing antibody assay will be performed using the neutralization 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 30 after vaccination

• Immunogenicity index-seroconversion rate of type III anti-poliovirus neutrilizing antibody

  Neutralizing antibody assay will be performed using the neutralization 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 30 after vaccination

• Immunogenicity index-seropositive rate of type I anti-poliovirus neutrilizing antibody

  Neutralizing antibody assay will be performed using the neutralization method. Seroconversion will be defined as the level (≥1:8).

  Day 30 after vaccination

• Immunogenicity index-seropositive rate of type II anti-poliovirus neutrilizing antibody

  Neutralizing antibody assay will be performed using the neutralization method. Seroconversion will be defined as the level (≥1:8).

  Day 30 after vaccination

• Immunogenicity index-seropositive rate of type III anti-poliovirus neutrilizing antibody

  Neutralizing antibody assay will be performed using the neutralization method. Seroconversion will be defined as the level (≥1:8).

  Day 30 after vaccination

• Immunogenicity index-seroconversion rate of anti-hepatitis A virus antibody

  Antibody assay will be performed using the ELISA method. Seroconversion will be defined as a change from seronegative (\<20mIU/ml) to seropositive (≥20mIU/ml), or a ≥4-fold increase from baseline

  Between baseline and day 30 after vaccination

Secondary Outcomes (14)

• Immunogenicity index-geometric mean titer (GMT) of type I anti-poliovirus neutrilizing antibody

  Day 30 after vaccination

• Immunogenicity index-geometric mean titer (GMT) of type II anti-poliovirus neutrilizing antibody

  Day 30 after vaccination

• Immunogenicity index-geometric mean titer (GMT) of type III anti-poliovirus neutrilizing antibody

  Day 30 after vaccination

• Immunogenicity index-geometric mean concentration (GMC) of anti-hepatitis A virus antibody

  Day 30 after vaccination

• Immunogenicity index-seropositive rate of anti-hepatitis A virus antibody

  Day 30 after vaccination

Study Arms (5)

sIPV + HepA-L (coconmitant vaccination cohort)

EXPERIMENTAL

Concomitant administration of sIPV and HepA-L at 18 months of age

Biological: sIPV (booster dose at 18 months of age); Biological: HepA-L

sIPV + HepA-I (coconmitant vaccination cohort)

EXPERIMENTAL

Concomitant administration of sIPV and HepA-I at 18 months of age, and another dose administration of HepA-I at 24 months of age

Biological: sIPV (booster dose at 18 months of age); Biological: HepA-I

sIPV (individual vaccination cohort)

EXPERIMENTAL

One booster dose of sIPV at 18 months of age

Biological: sIPV (booster dose at 18 months of age)

HepA-L (individual vaccination cohort)

EXPERIMENTAL

One dose of Hep-L at 18 months of age

Biological: HepA-L

HepA-I (individual vaccination cohort)

EXPERIMENTAL

Two doses of Hep-I at 18 and 24 months of age, respectively

Biological: HepA-I

Interventions

sIPV (booster dose at 18 months of age) BIOLOGICAL

Sabin-strain-based inactivated vaccine (Vero cells), 0.5mL for each dose at 18 months of age for the booster one

sIPV (individual vaccination cohort); sIPV + HepA-I (coconmitant vaccination cohort); sIPV + HepA-L (coconmitant vaccination cohort)

HepA-L BIOLOGICAL

Freeze-dried/lyophilized live-attenuated hepatitis A virus vaccine, 1.0mL for each dose at 18 months of age

HepA-L (individual vaccination cohort); sIPV + HepA-L (coconmitant vaccination cohort)

HepA-I BIOLOGICAL

Inactivated hepatitis A virus vaccine, 0.5mL for each dose, two doses at 18 and 24 months of age, respectively

HepA-I (individual vaccination cohort); sIPV + HepA-I (coconmitant vaccination cohort)

Eligibility Criteria

• Age: 4 Months - 4 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age Requirement: Children aged 4 months at the time of enrollment
• Vaccination Requirement: volunteers have already taken administration 2 doses of sabin-strain-based inactivated poliovirus vaccine (produced by IMBCAMS), and have not yet been injected with the third dose containing poliovirus antigen.
• 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, and sign the informed consent form.
• Adherence: Legal guardians or appointed representatives of volunteers must be able to comply with the requirements in the study as well as complete relevant visits on time.
• Birth condition: Full-term birth (37\~42 gestational weeks) and normal birth weight (no less than 2500g).
• Temperature Requirement: Axillary body temperature prior to vaccination is less than 37.3°C.

You may not qualify if:

• Health Requirement: Volunteers cannot meet health requirements through physical examinations.
• History of Related Illness: Volunteers have a history of developing Hepatitis A, poliomyelitis, or immunodeficiency.
• Birth Condition: Volunteers have a history of abnormal labor stage, asphyxia, nervous system damage, or clinically confirmed pathologic jaundice。
• Allergic History: Volunteers 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: Volunteers 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 within 14 days (including the 14th day) prior to vaccination.
• Acute Illness: Volunteers have experienced acute illnesses (e.g., fever) within 3 days prior to vaccination with the investigational vaccine.
• Neurological and Mental Health: Volunteers have a history of seizures, convulsions, cerebral palsy, epilepsy, mental illness, or a family history of such conditions.
• Health Conditions: Volunteers have known congenital abnormalities, developmental disorders, genetic defects, or severe malnutrition, among other conditions.
• Coagulation Abnormalities: Volunteers have a history of coagulation disorders (e.g., coagulation factor deficiency, coagulation disorders).
• Infectious Diseases: Volunteers have infectious diseases that may affect the study, such as human immunodeficiency virus (HIV) infection, hepatitis, and tuberculosis.
• Special Condition: Volunteers who could not tolerate venipuncture, or had a history of needle and blood sickness.
• Organ Removal History: Volunteers have a history of organ removal (e.g., thyroid, pancreas, liver, spleen).
• History of Blood Products: Volunteers have a history of loss of blood, blood transfusion, the use of adjuvant therapies, or immunoglobulin within 3 months prior to vaccination.
• Immune Therapy: Volunteers 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.
• Participation in Other Clinical Studies: Volunteers are currently or have plans to participate in other clinical studies before enrollment.

Sponsors & Collaborators

• Institute of Medical Biology, Chinese Academy of Medical Sciences: lead

Study Sites (3)

Jiu Longpo District Center for Disease Control and Disease

Chongqing, Chongqing Municipality, China

Location

Wanzhou District Center for DIsease Control and Prevention

Chongqing, Chongqing Municipality, China

Location

Jiangjin District Center for Disease Control and Prevention

Chongqing, Chonqing, China

Location

MeSH Terms

Conditions

Poliomyelitis; Hepatitis A

Interventions

Aging

Condition Hierarchy (Ancestors)

Myelitis; Central Nervous System Infections; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Growth and Development; Physiological Phenomena

Study Officials

• Jiawei Xu

  Chongqing Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jingsi Yang

CONTACT

0871-68334551; yjs@imbcams.com.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 14, 2024
• Study Start: June 15, 2024
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): December 15, 2027
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)