Tolerability, Safety, and Immunogenicity of Tetravalent Inactivated Enterovirus Vaccine (Vero Cell).

NCT06754384 | Completed Phase 1 DMC

• 1 other identifier: PRO-QEV-1001
• Study Type: interventional
• Target: 552
• Locations: 1 country
• Sites: 1

Brief Summary

The trial aims to assess the tolerability, safety, and immunogenicity of the tetravalent inactivated enterovirus vaccine in adults and children aged 6 months to 12 years. The main questions it aims to answer are:

• Phase Ⅰ: The safety of the investigational vaccine in the target population based on adverse events (AEs);
• Phase Ⅱ: The immunogenicity of the investigational vaccine in the target population. In Phase I, researchers will compare the safety of the investigational vaccine at low, medium, and high doses with the control vaccine; in Phase II, they will compare the safety and immunogenicity (including immune persistence) of the investigational vaccine at medium and high doses with the control vaccine. Procedure:
• In Phase I, will be vaccinated with the investigational vaccine (at low, medium, and high doses) or the control EV71 vaccine/placebo in a 3:1 ratio, following a vaccination schedule of 0 and 1 month. Within each age group, and under the premise of ensuring safety, a dose-escalation trial will be conducted in reverse order of age.
• In Phase II, participants in each age group will be randomly assigned to the medium-dose, high-dose investigational vaccine groups, and the control group in a 1:1:1 ratio, receiving two doses of the investigational vaccine or the EV71 vaccine (for ages 6-71 months)/placebo (for ages 6-12 years), with a one-month interval between the two doses.
• For all participants in both Phase I and Phase II, immediate reactions within 30 minutes after each dose will be observed. Diary cards/contact cards will be used to collect solicited local and systemic adverse events (AEs) for 0-7 days and unsolicited AEs for 0-30 days after vaccination. Additionally, serious adverse events (SAEs) will be monitored from the start of vaccination until 6 months post-completion of the vaccination schedule. Furthermore, for participants of reproductive age in Phase I, pregnancy events will be collected.

Conditions

Hand, Foot, and Mouth Disease (HFMD); Herpangina

Keywords

Phase Ⅰ; phase Ⅱ; tolerability; safety; immunogenicity; Hand, Foot, and Mouth Disease (HFMD); Herpangina

Outcome Measures

Primary Outcomes (3)

• Phase Ⅰ:The safety of the investigational vaccine in the target population based on AR.

  Incidence rate of AR from vaccination onset to 30 days post-full immunization in children aged 6 months to 12 years.

  60 days

• Phase Ⅱ:Evaluate the seropositive conversion rates of the investigational vaccine in the target population.

  The seropositive conversion rates of neutralizing antibodies against EV71, CA16, CA10, and CA6 on the 30th day after full vaccination in children aged 6 months to 12 years.

  60 days

• Phase Ⅱ:Evaluate the geometric mean titer (GMT) of the investigational vaccine in the target population.

  The GMT of neutralizing antibodies against EV71, CA16, CA10, and CA6 on the 30th day after full vaccination in children aged 6 months to 12 years.

  60 days

Secondary Outcomes (19)

• phase Ⅰ:Evaluate the safety of the investigational vaccine in the target population based on adverse events (AEs).

  60 days

• phase Ⅰ: Evaluate the safety of the investigational vaccine in the target population based on adverse events (AEs) in adults aged 18-59.

  7 monthes

• phase Ⅰ: Evaluate the safety of the investigational vaccine in the target population based on AEs in children aged 6 months to 12 years.

  7 monthes

• phase Ⅰ:Evaluate the safety of the investigational vaccine in adults aged 18-59 and children aged 6-12 based on laboratory abnormalities.

  3 days

• phase Ⅰ:Evaluate the safety of the investigational vaccine in children aged 24-71 months based on laboratory abnormalities.

  3 days

Study Arms (5)

Low-dose of tetravalent inactivated enterovirus vaccine (Vero cell)

EXPERIMENTAL

Low-dose of tetravalent inactivated enterovirus vaccine (Vero cell)(Only for phase Ⅰ)

Biological: Low-dose of tetravalent inactivated enterovirus vaccine (Vero cell)

Medium-dose of tetravalent inactivated enterovirus vaccine (Vero cell)

EXPERIMENTAL

Medium-dose of tetravalent inactivated enterovirus vaccine (Vero cell)

Biological: Medium-dose tetravalent inactivated enterovirus vaccine (Vero cell)

High-dose of tetravalent inactivated enterovirus vaccine (Vero cell)

EXPERIMENTAL

High-dose of tetravalent inactivated enterovirus vaccine (Vero cell)

Biological: High-dose tetravalent inactivated enterovirus vaccine (Vero cell) )

EV71 vaccine

ACTIVE COMPARATOR

EV71 vaccine (for ages 6-71 months)

Biological: EV71 inactivated enterovirus vaccine (Vero cell) )(for ages 6-71 months）

placebo

PLACEBO COMPARATOR

placebo (for ages 6-12 years)

Biological: placebo (for ages 6-12 years)

Interventions

placebo (for ages 6-12 years) BIOLOGICAL

placebo (for ages 6-12 years)

placebo

Low-dose of tetravalent inactivated enterovirus vaccine (Vero cell) BIOLOGICAL

Low-dose tetravalent inactivated enterovirus vaccine (Vero cell) )(only for phase Ⅰ）

Low-dose of tetravalent inactivated enterovirus vaccine (Vero cell)

Medium-dose tetravalent inactivated enterovirus vaccine (Vero cell) BIOLOGICAL

Medium-dose tetravalent inactivated enterovirus vaccine (Vero cell)

Medium-dose of tetravalent inactivated enterovirus vaccine (Vero cell)

High-dose tetravalent inactivated enterovirus vaccine (Vero cell) ) BIOLOGICAL

High-dose tetravalent inactivated enterovirus vaccine (Vero cell) )

High-dose of tetravalent inactivated enterovirus vaccine (Vero cell)

EV71 inactivated enterovirus vaccine (Vero cell) )(for ages 6-71 months） BIOLOGICAL

EV71 inactivated enterovirus vaccine (Vero cell) )(for ages 6-71 months）

EV71 vaccine

Eligibility Criteria

• Age: 6 Months - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy participants aged 18-59 years (only applicable for Phase I) or 6 months to 12 years.
• Participants and/or their legal guardians are able to understand and voluntarily sign the informed consent form (for participants aged 8-12, both the participant and their guardian must sign).
• Willing and able to comply with all visit schedules, sample collection, vaccinations, and other trial procedures, and maintain contact during the trial period.
• Provide identification for the participant and/or their guardian.
• Participants of childbearing participants and their sexual partners must voluntarily use effective contraceptive measures from the time of signing the informed consent form until three months after the completion of the two-dose vaccination series with the investigational vaccine, and have no plans to donate sperm or ova (only applicable for Phase I participants aged 18-59 years).

You may not qualify if:

• History of HFMD or HA (only applicable to Phase II clinical trial participants).
• Presence of uncontrolled chronic diseases or history of serious illnesses, including but not limited to cardiovascular diseases, hematological diseases, liver and kidney diseases, digestive system diseases, respiratory diseases, malignant tumors, and history of major organ transplantation.
• Severe congenital malformations, genetic defects, or malnutrition.
• Presence of autoimmune diseases or immunodeficiency diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid diseases, asplenia, functional asplenia, HIV infection).
• Abnormal coagulation function (such as coagulation factor deficiency, platelet abnormalities).
• Suffering from/having suffered from severe neurological diseases (epilepsy, convulsions, or seizures \[excluding febrile convulsions\]), mental illness, or having a family history of mental illness.
• Acute illnesses or acute exacerbations of chronic illnesses within the past 3 days.
• Having been vaccinated with a vaccine containing any of the components EV71, CA16, CA10, CA6 (including marketed vaccines or investigational vaccines).
• Having received ≥14 days of immunosuppressive or other immunomodulatory treatment (adults: prednisone ≥20mg/day, or children: ≥2mg/kg/day, or equivalent doses; excluding topical or inhaled corticosteroids) within the past 6 months, or cytotoxic treatment, or planning to receive such treatment during the trial.
• Having received immunoglobulins or other blood products within the past 6 months, or planning to receive such treatment during the trial.
• Having received other investigational drugs or vaccines within the past 30 days, or planning to receive such drugs or vaccines during the trial.
• Having received live attenuated vaccines or nucleic acid vaccines within the past 14 days, or subunit or inactivated vaccines within the past 7 days.
• Known allergy to any component of the investigational vaccine (inactivated EV71, CA16, CA10, and CA6 viruses, aluminum hydroxide adjuvant, disodium phosphate, sodium dihydrogen phosphate, sodium chloride, water for injection).
• Participants who are breastfeeding, pregnant, or planning to become pregnant within 3 months after the two doses of vaccination in this trial (only applicable to Phase I).
• On the day of planned vaccination with the investigational vaccine, having an axillary temperature \>37.0°C before vaccination, or other vital sign measurements outside the normal range.

Sponsors & Collaborators

• Sinovac Biotech Co., Ltd: lead

Study Sites (1)

Zhejiang Provincial Center for Disease Control and Prevention

Hangzhou, Hangzhou, China

Location

MeSH Terms

Conditions

Hand, Foot and Mouth Disease; Herpangina

Condition Hierarchy (Ancestors)

Coxsackievirus Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Infections; Echovirus Infections

Study Officials

• Wang Shenyu, Dr.

  Zhejiang Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2024
• First Posted: December 31, 2024
• Study Start: January 15, 2025
• Primary Completion: December 30, 2025
• Study Completion: February 10, 2026
• Last Updated: March 4, 2026

Record last verified: 2024-12

Locations

CN (1)