This is a phase 2, randomized, controlled, observer-blind study to evaluate the immunogenicity and safety of different formulations of the investigational adjuvanted recombinant SARS-CoV-2 trimeric S-protein (from B.1.351 variant) subunit vaccine (SCB-2020S), when administered as 2-dose vaccination series 21 days apart to adults ≥ 18 years of age.
Clover has developed a second candidate vaccine, SCB-2020S, that contains S protein from the dominant B.1.351 variant. The purpose of clinical study CLO-SCB-2020-001 is to assess the immunogenicity and safety of different formulations of the SCB-2020S compared to the prototype SCB-2019 vaccine, and to select a formulation of SCB-2020S for further clinical development. The protocol plans to enroll 150 participants. There will be 5 study arms and participants will receive two intramuscular (i.m.) injections, one at Day 1 and one at Day 22.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
a recombinant SARS-Co-2 trimeric S-protein (from B.1.351 variant) subunit vaccine for COVID-19
Geometric mean titer (GMT) of SARS-CoV-2 neutralising antibodies to B.1.351 variant
Time frame: Days 36
Proportion of subjects achieving seroconversion of SARS-CoV-2 neutralising antibodies to B.1.351 variant
Seroconversion rate (percentage of participants with a ≥4-fold increase in titer from that at Day 1 (or from LLoQ if Day 1 titer \<LLoQ).
Time frame: Day 36
Geometric mean fold rise (GMFR) of SARS-Cov-2 neutralising antibodies to B.1.351 variant
Time frame: Day 36/Day 1
Geometric mean titer (GMT) of SARS-CoV-2 neutralising antibodies to Wuhan strain
Time frame: Day 36
Proportion of subjects achieving seroconversion of SARS-CoV-2 neutralising antibodies to Wuhan strain
Seroconversion rate (percentage of participants with a ≥4-fold increase in titer from that at Day 1 (or from LLoQ if Day 1 titer \<LLoQ).
Time frame: Day 36
Geometric mean fold rise (GMFR) of SARS-Cov-2 neutralising antibodies to Wuhan strain
Time frame: Day 36/Day 1
Geometric mean titer (GMT) of antibody titers specific to SCB-2019 antigen
Time frame: Day 36
Proportion of subjects achieving seroconversion of antibodies specific to SCB-2019
Seroconversion rate (percentage of participants with a ≥4-fold increase in titer from that at Day 1 (or from LLoQ if Day 1 titer \<LLoQ).
Time frame: Day 36
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Geometric mean fold rise (GMFR) of antibodies specific to SCB-2019
Time frame: Day 36/Day 1
Geometric mean titer (GMT) of SARS-CoV-2 neutralising antibodies to B.1.351 variant
Time frame: Day 205
Proportion of subjects achieving seroconversion of SARS-CoV-2 neutralising antibodies to B.1.351 variant
Seroconversion rate (percentage of participants with a ≥4-fold increase in titer from that at Day 1 (or from LLoQ if Day 1 titer \<LLoQ).
Time frame: Day 205
Geometric mean fold rise (GMFR) of SARS-Cov-2 neutralising antibodies to B.1.351 variant
Time frame: Day 205/Day 1
Geometric mean titer (GMT) of SARS-CoV-2 neutralising antibodies to Wuhan strain
Time frame: Day 205
Proportion of subjects achieving seroconversion of SARS-CoV-2 neutralising antibodies to Wuhan strain
Seroconversion rate (percentage of participants with a ≥4-fold increase in titer from that at Day 1 (or from LLoQ if Day 1 titer \<LLoQ).
Time frame: Day 205
Geometric mean fold rise (GMFR) of SARS-Cov-2 neutralising antibodies to Wuhan strain
Time frame: Day 205/Day 1
Geometric mean titer (GMT) of antibody titers specific to SCB-2019 antigen
Time frame: Day 205
Proportion of subjects achieving seroconversion of antibodies specific to SCB-2019
Seroconversion rate (percentage of participants with a ≥4-fold increase in titer from that at Day 1 (or from LLoQ if Day 1 titer \<LLoQ).
Time frame: Day 205
Geometric mean fold rise (GMFR) of antibodies specific to SCB-2019
Time frame: Day 205/Day 1
Reactogenicity of the vaccines as indicated by the occurrence of solicited local reactions and solicited systemic adverse events.
Percentage of participants with local injection site reactions (pain, redness, swelling) and systemic adverse events (fatigue, headache, myalgia, arthralgia, loss of appetite, nausea, chills, and fever)
Time frame: 7 days after each dose
Safety of the vaccines in terms of the occurrence of unsolicited adverse events
Percentage of participants with any adverse event other that those listed above as solicited adverse events
Time frame: Up to 21 days after second dose (Day 43)
Safety of the vaccines in terms of the occurrence of medically attended adverse events (MAAEs), serious adverse events (SAEs), adverse events leading to discontinuation from study, and adverse events of special interest (AESI).
Percentage of participants with any adverse events in this category
Time frame: through study completion, an average of 7 months
Proportion of subjects with abnormal markers of hematology, biochemistry and coagulation parameters
Time frame: Day 29