NCT04626856

Safety and Preliminary Immunogenicity Study of Inactivated Vaccine for Prevention of Rotavirus Infection

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 2 Months – 49 Years
• Healthy volunteers: Accepted

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.

Conditions

• Rotavirus Infection

Interventions

Type	Name	Description
BIOLOGICAL	Low dosage IRV on a 0- and 28-day schedule	Inactivated Rotavirus vaccine (Vero cell) of 80EU/0.5ml on day 0, 28
BIOLOGICAL	Medium dosage IRV on a 0- and 28-day schedule	Inactivated Rotavirus vaccine (Vero cell) of 160EU/0.5ml on day 0, 28
BIOLOGICAL	High dosage IRV on a 0- and 28-day schedule	Inactivated Rotavirus vaccine (Vero cell) of 320EU/0.5ml on day 0,28
BIOLOGICAL	Low dosage IRV on a 0- and 28-day schedule	Inactivated Rotavirus vaccine (Vero cell) of 80EU/0.5ml on day 0,28
BIOLOGICAL	Medium dosage IRV on a 0- and 28-day schedule	Inactivated Rotavirus vaccine (Vero cell) of 160EU/0.5ml on day 0,28
BIOLOGICAL	High dosage IRV on a 0- and 28-day schedule	Inactivated Rotavirus vaccine (Vero cell) of 320EU/0.5ml on day 0,28
BIOLOGICAL	Low dosage IRV on a 0- and 28-day schedule	Inactivated Rotavirus vaccine (Vero cell) of 80EU/0.5ml on day 0,28
BIOLOGICAL	Medium dosage IRV on a 0- and 28-day schedule	Inactivated Rotavirus vaccine (Vero cell) of 160EU/0.5ml on day 0,28
BIOLOGICAL	High dosage IRV on a 0- and 28-day schedule	Inactivated Rotavirus vaccine (Vero cell) of 320EU/0.5ml on day 0,28
BIOLOGICAL	Low dosage IRV on a 0- and 28-day schedule	Inactivated Rotavirus vaccine (Vero cell) of 80EU/0.5ml on day 0,28
BIOLOGICAL	Medium dosage IRV on a 0- and 28-day schedule	Inactivated Rotavirus vaccine (Vero cell) of 160EU/0.5ml on day 0,28
BIOLOGICAL	High dosage IRV on a 0- and 28-day schedule	Inactivated Rotavirus vaccine (Vero cell) of 320EU/0.5ml on day 0,28
BIOLOGICAL	Low dosage IRV on a 0- , 28- and 56-day schedule	Inactivated Rotavirus vaccine (Vero cell) of 80EU/0.5ml on day 0,28,56
BIOLOGICAL	Medium dosage IRV on a 0- , 28- and 56-day schedule	Inactivated Rotavirus vaccine (Vero cell) of 160EU/0.5ml on day 0,28,56
BIOLOGICAL	High dosage IRV on a 0- , 28- and 56-day schedule	Inactivated Rotavirus vaccine (Vero cell) of 320EU/0.5ml on day 0,28,56
BIOLOGICAL	Placebo on day 0, 28	Two doses of placebo at the vaccination schedule of day 0,28
BIOLOGICAL	Placebo on day 0, 28, 56	Three doses of placebo at the vaccination schedule of day 0, 28,56

Timeline

• Start date: 2020-12-03
• Primary completion: 2021-06-01
• Completion: 2021-08-01
• First posted: 2020-11-13
• Last updated: 2020-12-10

Locations

1 site across 1 country: China