Evaluation of the Safety and Preliminary Immunogenicity of Inactivated Rotavirus Vaccine (Vero Cell) in Healthy Population: a Randomized, Double-blind, Placebo Parallel-controlled Phase I Clinical Trial
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Rotavirus Infection
- Sponsor
- Chinese Academy of Medical Sciences
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Safety index-incidence of adverse reactions/events
- Last Updated
- 5 years ago
Overview
Brief Summary
This study is a randomized, double-blinded, placebo-controlled, Phase 1, dose-escalation study to evaluate the safety, reactogenicity and immunogenicity of Inactivated Rotavirus Vaccine (IRV) performed in healthy adult (aged 18-49 years), adolescent (aged 6-17 years) and infant subjects (aged 2-71 months). Primary objectives of the clinical trial include assessing the safety and tolerability of IRV given at two and three dose levels and comparing the safety and tolerability of IRV after each vaccination, between dosage groups, and by pre-vaccination rotavirus immune status. Secondary objective of the clinical trial is immunogenicity evaluation after each vaccination, between dosage groups, and by pre-vaccination rotavirus immune status.
Detailed Description
This clinical trial aimed to evaluate safety and immunogenicity effect of IRV（Vero cell）in Chinese healthy adults, adolescents and infants. The subjects were divided into 5 groups. Two dose and three dose levels will be evaluated. Adult (aged 18-49 years), adolescents (aged 6-17 years), infant subjects (aged 7-71 months) and infant subjects (aged 2-6 months) will receive intramuscular (IM) injection on Days 0 and 28. Infant subjects (aged 2-6 months) subjects will receive intramuscular (IM) injection on Days 0 , 28 and 56. Three dose subgroups (low dose, medium dose and high dose were included in each age group. To maintain blindness in the trial, subjects were randomized in a 3:1 ratio to receive different dosages of the vaccine group or placebo group. In the analysis, the placebo subjects of the same age group were combined to ensure that the analysis ratio of the experimental vaccine group to the placebo group is 1:1. Therefore, 24 subjects in the experimental vaccine group and 8 subjects in the placebo group were chose in each dose group. Subjects were randomized to receive different dosages of the vaccine or placebo. Vaccination was performed in the adult group first, then on the adolescents, and on the infants last. Within each age group, dose-escalation with the principle from low to high dosage.
Investigators
Li Hongjun
PI
Chinese Academy of Medical Sciences
Eligibility Criteria
Inclusion Criteria
- •2 months old to 49 years old, healthy resident, excluding the following:
- •Congenital malformations, developmental disorders, genetic defects, severe malnutrition and other conditions；
- •Have Congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus Erythematosus (SLE) , juvenile Rheumatoid Arthritis, or other autoimmune diseases；
- •History of Cerebral Palsy, seizures, mental illness.
- •I and/or my guardian voluntarily participate and sign an informed consent form, and can follow the requirements of the clinical trial protocol;
- •Have never received oral rotavirus live attenuated vaccine.
Exclusion Criteria
- •First dose exclusion criteria:
- •Armpit temperature \>37.0℃ before vaccination；
- •Subjects with history of intussusception or suffering from intussusception；
- •Subjects with history of convulsions and convulsions; history of epilepsy, mental illness and their family history；
- •Subjects with history of allergy to vaccination；
- •Acute attacks of various acute diseases (fever) or chronic diseases within 3 days before receiving the study vaccine；
- •Subjects receiving immune enhancement or immunosuppressive therapy within 3 months (continuous oral or infusion for more than 14 days)；
- •Subjects vaccinated with live attenuated vaccine within 14 days and other vaccines within 7 days before vaccination；
- •Subjects with history of coagulation dysfunction (e.g. Coagulation factor deficiency, coagulation disease);
- •Subjects with primary and secondary immunocompromised (history of thyroid, pancreas, liver, spleen resection, or need for treatment for thyroid disease in the past 12 months)；
Outcomes
Primary Outcomes
Safety index-incidence of adverse reactions/events
Time Frame: Day 8 to30 after the third dose vaccination
Incidence of adverse reactions/events after the third dose vaccination.
Safety index-incidence of abnormal urine routine assessment
Time Frame: Day 4 after the third dose vaccination
Incidence of abnormal urine routine assessment at Day 4 after the third dose vaccination, except children aged Month 2-71
Safety index-incidence of abnormal blood biochemistry assessment
Time Frame: Day 4 after the third dose vaccination
Incidence of abnormal blood biochemistry assessment at Day 4 after the third dose vaccination, except children aged Month 2-71
Safety index-incidence of abnormal blood routine assessment
Time Frame: Day 4 after the third dose vaccination
Incidence of abnormal blood routine assessment at Day 4 after the third dose vaccination, except children aged Month 2-71
Safety index-incidence of serious adverse events
Time Frame: From the beginning of the vaccination to 6 months after the last vaccination completed
Occurrence of serious adverse reactions/events after vaccination.
Secondary Outcomes
- Immunogenicity index-seroconversion rates of neutralizing antibody(Day 28 after the third dose vaccination)
- Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody(Day 28, 90, 180 after the third dose vaccination)