Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-25 @ 3:24 AM
NCT ID:
NCT05272605
Brief Summary:
This is a study of two experimental SARS-CoV-2 vaccines against the virus called SARS-CoV-2 virus. The first of the experimental vaccines is called DoCo-Pro-RBD-1 + M59® and contains a laboratory made protein which looks the same as a protein in the SARS-CoV-2 virus. As this protein is so similar to a protein in the SARS-CoV-2 virus, it allows the immune system to develop immunity against the real virus by producing specific antibodies against this protein. Antibodies are substances in the blood which could help protect against future infection. The second of the experimental vaccines that will be tested is called MIPSCo-mRNA-RBD-1. This type of vaccine uses messenger ribonucleic acid (mRNA) which is a set of instructions for a cell to make a viral protein called an antigen. Antigens are substances that can trigger the body's defences to produce antibodies that fight against the disease.
This study will test these two experimental COVID-19 vaccines in people who have previously received two doses of ComirnatyTM (Pfizer Australia Pty Ltd) or VaxzevriaTM (AstraZeneca Pty Ltd) and a third booster vaccination with either ComirnatyTM or SpikevaxTM (Moderna). This study is the first time this recombinant protein vaccine and this mRNA vaccine will be given to humans. The purpose of this study is to determine what amount, or dose, of the experimental vaccines is safe and produces the desired immune response and antibody level for future investigations. It will do this by testing 3 different dose levels for each of the two vaccines. Each participant will receive a single vaccine at one of the three dose levels, or a placebo injection. This study is the first time this recombinant protein vaccine and this mRNA vaccine will be given to humans.
Detailed Description:
This is a randomised, double-blind, placebo-controlled, dose-escalation, first-in-human study to assess the safety, reactogenicity and immunogenicity of SARS-CoV-2 beta variant DoCo-Pro-RBD-1 + MF59® and MIPSCo-mRNA-RBD-1 vaccine at three dose levels, administered intramuscularly (IM) as a single booster dose in healthy adults previously vaccinated with two doses of CominartyTM (BNT162b2 \[mRNA\]) or VaxzevriaTM (ChAdOx1-S) COVID-19 and a third booster dose of either ComirnatyTM or SpikevaxTM vaccines. The study will comprise a Dose-Escalation Phase and an Expanded Phase.
The study vaccines, DoCo-Pro-RBD-1 + MF59®, MIPSCo-mRNA-RBD-1 or placebo (normal saline) will be administered IM in the deltoid region of the upper arm.
The study will enroll healthy adults aged 18 to 64 years of age inclusive. Participants in both the Dose-Escalation Phase and Expanded Phase of the study will be stratified by prior primary course COVID-19 vaccination with CominartyTM or VaxzevriaTM.
Study:
NCT05272605
Study Brief:
Protocol Section:
NCT05272605