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.
The Phase I clinical trial is an open-label observation involving healthy adults and children, as well as a randomized, double-blind, placebo-controlled study in healthy infants to evaluate the safety, tolerability, and immunogenicity of the investigaional vaccine. The investigational vaccine is available in both high-dose and low-dose formulations. The placebo is identical to the trial vaccine in all components except for the rotavirus. This study will enroll 100 participants, consisting of 20 adults aged 18-59 years, 20 children aged 2-6 years, and 60 infants aged 6-12 weeks. Participants will be enrolled sequentially, starting with adults, followed by children, and then infants. Enrollment for the subsequent group will begin after a 14-day safety observation period and confirmation of acceptable safety in the preceding group. Adult and child participants will receive the investigational vaccine in an open-label manner. The infants will be enrolled into two cohorts of 30 participants each: a low-dose cohort and a high-dose cohort. Within each cohort, the infants will be randomly assigned to two groups at a ratio of 2:1 and will receive either the investigational vaccine or a placebo in a double-blind manner. The immunization schedule for both the vaccine and placebo consists of three doses administered at 28-day intervals. Adverse events (AE) will be collected for all participants until 42 days after the last dose vaccination. Stool samples will be collected after each vaccination to detect vaccine strain shedding among infant participants. Serious adverse events (SAE) will be observed for 6 months from the last dose for adults and children or 12 months for infants. Blood samples from the infants will be collected at predetermined times to evaluate the immunogenicity of the investigational vaccine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
100
Oral hexavalent reassortant rotavirus attenuated live vaccine (high-dose) three doses administered orally
Oral hexavalent reassortant rotavirus attenuated live vaccine (high-dose) three doses administered orally
Oral hexavalent reassortant rotavirus attenuated live vaccine (low-dose) three doses administered orally
Placebo of experimental vaccine for infants three doses administered orally
Oral hexavalent reassortant rotavirus attenuated live vaccine (high-dose) three doses administered orally
Placebo of experimental vaccine for infants three doses administered orally
Hebei Provincial Center for Disease Control and Prevention
Shijiazhuang, Hebei, China
Evaluate the safety of the investigational vaccine
Incidence of adverse events/reactions
Time frame: 0 day after the first dose till 42 days after the last dose
Evaluate the safety of the investigational vaccine
Incidence of adverse events/reactions
Time frame: 0-14 days after each dose
Evaluate the safety of the investigational vaccine
Incidence of adverse events/reactions
Time frame: 0-30 minutes after each dose
Evaluate the safety of the investigational vaccine in the healthy adults and children groups
Incidence of clinically significant abnormal laboratory parameters on day 3 after each dose in adult and children groups
Time frame: day 3 after each dose
Evaluate the safety of the investigational vaccine
Incidence of serious adverse events (SAEs)
Time frame: Within 6 months after the last dose
Evaluate the safety of the investigational vaccine in the healthy infant group
Incidence of serious adverse events (SAEs) and adverse events of special interest (AESIs)
Time frame: Within 12 months after the last dose in the infant group
Evaluate the immunogenicity and immune persistence of the investigated vaccine in healthy infants.
Seroconversion rate of serum IgA antibodies against vaccine serotype rotavirus.
Time frame: 28 days after the full vaccination course
Evaluate the immunogenicity and immune persistence of the investigated vaccine in healthy infants.
Seropositivity rate of serum IgA antibodies against vaccine serotype rotavirus.
Time frame: 28 days after the full vaccination course
Evaluate the immunogenicity and immune persistence of the investigated vaccine in healthy infants.
Geometric mean concentration (GMC) of serum IgA antibodies against vaccine serotype rotavirus.
Time frame: 28 days after the full vaccination course
Evaluate the immunogenicity and immune persistence of the investigated vaccine in healthy infants.
Geometric mean increase (GMI) of serum IgA antibodies against vaccine serotype rotavirus.
Time frame: 28 days after the full vaccination course
Evaluate the immunogenicity and immune persistence of the investigated vaccine in healthy infants.
Seropositivity rate of serum IgA antibodies against vaccine serotype rotavirus
Time frame: 6 months and 12 months after the full vaccination course
Evaluate the immunogenicity and immune persistence of the investigated vaccine in healthy infants.
Geometric mean concentration (GMC) of serum IgA antibodies against vaccine serotype rotavirus
Time frame: 6 months and 12 months after the full vaccination course
Evaluate the fecal shedding of investigated vaccine strain in healthy infants after vaccination.
The shedding rate of the rotavirus vaccine strain in the stool.
Time frame: 0-14 days after each dose
Evaluate the fecal shedding of investigated vaccine strain in healthy infants after vaccination.
The shedding duration of the rotavirus vaccine strain in the stool.
Time frame: 0-14 days after each dose
Evaluate the reassortment and reversion of the rotavirus vaccine strain in stool samples of healthy infants after vaccination
The incidence of reassortment and reversion of the rotavirus vaccine strain in stool samples.
Time frame: 0-14 days after each dose,
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