NCT04847102

A Phase III Clinical Study of a SARS-CoV-2 Messenger Ribonucleic Acid (mRNA) Vaccine Candidate Against COVID-19 in Population Aged 18 Years and Above

A Global, Multi-center, Randomized, Double-Blind, Placebo-controlled, Phase III Clinical Study to Evaluate the Protective Efficacy, Safety and Immunogenicity of SARS-CoV-2 Messenger Ribonucleic Acid (mRNA) Vaccine in Population Aged 18 Years and Older

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 28,000 (estimated)
• Sponsor: Walvax Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Approximately 28,000 subjects will be enrolled in this trial. Eligible subjects will be stratified by age (\<60 years of age and ≥60 years of age, the proportion of elderly people ≥60 years old is planned to be ≥25%) and randomly assigned into the study group and the control group at a ratio of 1:1 (14,000 in each group) to be intramuscularly administered with the investigational vaccine or placebo in a 2-dose regimen at an interval of 28 days. The experimental vaccines will be cross-vaccinated after available data of the investigational vaccine show that expected efficacy and good safety have been achieved (i.e., subjects in the study group will be vaccinated with placebo and those in the control group will be vaccinated with the investigational vaccine in the same schedule as stated above ). After the completion of the second dose for crossover vaccination, subjects will be followed up for 12 months for safety observation. An immunogenicity subgroup (n≥3000) and a reactogenicity subgroup (n≥6000) will also be included in this trial to evaluate the humoral immunity induced by the investigational vaccine and the solicited adverse events observed within 7 days post immunization. All enrolled subjects will be followed up for the evaluation of protective efficacy as well, which will be primarily characterized by the incidence rate (person-year) of COVID-19 cases collected from 14 days after complete series. Adverse events will be collected over 0-28 days after each vaccination and serious adverse events will be collected from Dose 1 through 12 months post complete series.

Conditions

• COVID-19
• SARS-CoV-2

Interventions

Type	Name	Description
BIOLOGICAL	SARS-CoV-2 mRNA Vaccine	The SARS-CoV-2 mRNA Vaccine is formulated by encapsulating the mRNA, which encodes the receptor-binding domain (RBD) of spike glycoprotein (S protein) of SARS-CoV-2 and is transcribed in-vitro by the corresponding DNA template, in lipid nanoparticles (LNPs). This vaccine is presented as a white to off-white dispersion for injection. Active substances: mRNA encoding the RBD of the S protein of SARS-CoV-2. The vaccine is supplied in single-dose pre-filled syringe with 0.5 mL dispersion for intramuscular injection. Each dose (0.5 mL) of the vaccine contains: 15 μg of mRNA encoding the RBD of the spike glycoprotein (S protein) of SARS-CoV-2, 0.339 mg of total lipids (including lipid 9001, cholesterol, DSPC, DMG-PEG2000).
BIOLOGICAL	Placebo	0.9% sodium chloride solution, 0.5 mL/vial

Timeline

• Start date: 2021-07-22
• Primary completion: 2021-11-30
• Completion: 2023-05-30
• First posted: 2021-04-15
• Last updated: 2021-11-18

Locations

12 sites across 2 countries: Indonesia, Mexico