The purpose of this research study is to evaluate the safety of and the body's immune response to single and multiple vaccinations in healthy men and women. We want to find out what effects GBP511 has on you and your health. We are doing this study to find out:
If the study drug has any side effects when given as single and multiple vaccinations.
If reactogenicity, an indication that the immune systems is working and is preparing to protect the body against future infection, occurs. This is a normal physical inflammatory response that occurs after vaccination, manifesting as localised reactions that may include pain or redness at the injection site, or systemic symptoms such as headache or fever.
If immunogenicity which is when GBP511 causes your body to make antibodies against the non-harmful viral proteins contained within GBP511, called 'neutralising antibodies (Nab),' occurs. And if GBP511 will cause the specialised cells of the body's immune system to mount a defence against the non-harmful viral proteins contained within GBP511, called 'cell-mediated immunity (CMI)'.
In this study, GBP511 will be administered with and without adjuvant, CAS-1. An adjuvant is an ingredient used in some vaccines that help produce a stronger immune response in the people receiving the vaccine and thus helps the vaccine work better.
This study will recruit approximately 368 participants in total and will be conducted in two stages:
Stage 1 will look at two vaccinations with GBP511 when given with and without the CAS-1 adjuvant; and Stage 2 will look at either one or two vaccinations with two candidate GBP511 vaccines chosen from Stage 1 of the study.
Participants will be required to attend Linear's clinical unit on two separate occasions to receive their two vaccinations. On the first day of dosing (Visit 2/Day 1) and second day of dosing (Visit 5/Day 29), we will be testing a single dose of the study drug in up to 168 healthy volunteers who will be divided into 3 groups. Group 1, Groups 2 and 3 will have 56 people each. These 3 groups will be divided into treatment subgroups, with a total of 6 test subgroups and 3 control subgroups. In all groups, neither you or the study doctor will know what subgroup you are part of, and therefore what treatment (GBP511 or Comirnaty+ placebo) you will receive.
For Stage 1, participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
Participants who are healthy as determined by medical evaluation including medical history, vital signs, physical examination, clinical laboratory tests, and medical judgement of the investigator.
Participants who are willing and able to attend all scheduled visits and comply with all study procedures.
Body mass index (BMI) within the range of 18.5-32.0 kg/m2 (revised) at screening
Any clinically significant respiratory symptoms (e.g., cough, sore throat), febrile illness (tympanic temperature >38°C), or acute illness within 24 hours prior to the 1st study vaccination. Prospective participants with these conditions cannot be included until 24 hours after resolution.
Concurrent or a history of virologically or serologically confirmed SARS-CoV-2 infection, or suspected SARS-CoV-2 infection as determined by the investigator, within 24 weeks prior to the 1st study vaccination.
History of virologically or serologically confirmed SARS-CoV-1, or MERS disease.
History of congenital, hereditary, acquired immunodeficiency, or autoimmune disease.
Sequential
Test Drug 1-1 (GBP511 low dose)
Biological/Vaccineinjection volume of 0.5mililiter (mL) with 2-doses at 4 weeks interval in stage 1 and 1-dose or 2-doses at 4 weeks interval in stage 2. Low dose: 2μg/strain, Mid dose: 6μg/strain, High dose: 18μg/strain
Test Drug 1-2 (GBP511 mid dose)
Biological/Vaccineinjection volume of 0.5mililiter (mL) with 2-doses at 4 weeks interval in stage 1 and 1-dose or 2-doses at 4 weeks interval in stage 2. Low dose: 2μg/strain, Mid dose: 6μg/strain, High dose: 18μg/strain
Test Drug 1-3 (GBP511 high dose)
Biological/Vaccineinjection volume of 0.5mililiter (mL) with 2-doses at 4 weeks interval in stage 1 and 1-dose or 2-doses at 4 weeks interval in stage 2. Low dose: 2μg/strain, Mid dose: 6μg/strain, High dose: 18μg/strain
Test Drug 2-1 (GBP511 low dose + CAS-1)
Biological/Vaccineinjection volume of 0.5mililiter (mL) with 2-doses at 4 weeks interval in stage 1 and 1-dose or 2-doses at 4 weeks interval in stage 2. GBP511 - Low dose: 2μg/strain, Mid dose: 6μg/strain, High dose: 18μg/strain CAS-1 standard adjuvant dose
Test Drug 2-2 (GBP511 mid dose + CAS-1)
Biological/Vaccineinjection volume of 0.5mililiter (mL) with 2-doses at 4 weeks interval in stage 1 and 1-dose or 2-doses at 4 weeks interval in stage 2. GBP511 - Low dose: 2μg/strain, Mid dose: 6μg/strain, High dose: 18μg/strain CAS-1 standard adjuvant dose
Test Drug 2-3 (GBP511 high dose + CAS-1)
Biological/Vaccineinjection volume of 0.5mililiter (mL) with 2-doses at 4 weeks interval in stage 1 and 1-dose or 2-doses at 4 weeks interval in stage 2. GBP511 - Low dose: 2μg/strain, Mid dose: 6μg/strain, High dose: 18μg/strain CAS-1 standard adjuvant dose
Comparator (Comirnaty)
Biological/Vaccineinjection volume of 0.3mililiter (mL) with single-dose at visit 2. 30 mcg of SARS-CoV-2 LP.8.1 spike protein mRNA per 0.3mL
Placebo (Normal Saline)
Biological/Vaccineinjection volume of 0.5mililiter (mL) with single-dose at visit 5.
Test Drug 13 (Stage 2, GBP511-A or B)
Biological/VaccineParticipants will receive 2 intramuscular injections of the test vaccine in stage 2. Injections on Day 1, 29 (Visit 2, 5), in line with the selected dose regimen in stage 1.
Test Drug 14 (Stage 2, GBP511-A or B)
Biological/VaccineParticipants will receive 2 intramuscular injections of the test vaccine in stage 2. Injections on Day 1, 29 (Visit 2, 5), in line with the selected dose regimen in stage 1.
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Treatment groupsSee each treatment group below.
Percentage of participants experiencing any immediate reactions
For stage 1
Percentage of participants reporting any solicited local AEs
For stage 1
Percentage of participants reporting any solicited systemic AEs
For stage 1
Percentage of participants experiencing any unsolicited AEs
For stage 1
Geometric mean titer (GMT) of neutralizing antibody against each matched strain measured by a pseudo-virus neutralization assay
For stage 1
Geometric mean ratio (GMR) of neutralizing antibody against each matched strain measured by a pseudo-virus neutralization assay
For stage 1
Percentage of participants with ≥ 2-fold and 4-fold rises against each matched strain in pseudo-virus neutralizing antibody titer
For stage 1
GMT of RBD-binding IgG antibody against each matched strain measured by ECL assay at each time point.
For stage 1,2
GMT of neutralizing antibody against each strain measured by a pseudo-virus neutralization assay at each time point.
For Stage 1\&2, some of the following endpoints may be evaluated in a subset of participants at all or partial time points.
GMR of neutralizing antibody against each strain measured by a pseudo-virus neutralization assay, from each pre-vaccination to subsequent time point.
For Stage 1\&2, some of the following endpoints may be evaluated in a subset of participants at all or partial time points.
Percentage of participants with ≥ 2-fold and 4-fold rises against each strain in pseudo-virus neutralizing antibody titer, from baseline to each subsequent time point.
For stage 1\& 2, Some of the following endpoints may be evaluated in a subset of participants at all or partial time points.
GMT ratios of neutralizing antibody against each matched and mismatched strain measured by a pseudo-virus neutralization assay
For Stage 2
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