Safety and Immune Response of Adjuvanted SARS-CoV-2 (COVID-19) Beta Variant RBD Recombinant Protein (DoCo-Pro-RBD-1 + MF59®) and mRNA (MIPSCo-mRNA-RBD-1) Vaccines in Healthy Adults
Condition: SARS-CoV-2
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): Adjuvanted SARS-CoV-2 beta variant RBD recombinant protein vaccine (DoCo-Pro-RBD-1 + MF59); SARS-CoV-2 beta variant RBD mRNA vaccine; Normal Saline
Intervention type(s): Biological; Biological; Other
Intervention description(s): 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.; 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.; Placebo comparator
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: COVID-19