Clover Biopharmaceuticals has announced that its protein-based COVID-19 S-Trimer vaccine candidates, in combination with adjuvants from either GSK or
The Phase I trial was a randomised, observer-blind, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of the adjuvanted COVID-19 S-Trimer vaccine candidates formulated with different antigen levels. No serious adverse events related to the vaccine candidates were reported and the majority of adverse events were mild and transient.
According to the company, when formulated with GSK's pandemic adjuvant system, the S-Trimer induced neutralising antibody titers in 100 percent of participants at the selected 9µg S-Trimer dose in both adult and elderly groups (geometric mean titers [GMT] were >1:1,800). When adjuvanted with
Based on the positive Phase I results, Clover and its partners expect to initiate a global Phase II/III efficacy study of the S-Trimer vaccine candidate in combination with GSK's pandemic adjuvant system in
The company also stated that the preliminary results from their stability studies show that S-Trimer is stable at two to eight degrees Celsius for at least six months, or at room temperature and 40o C for at least one month. Thus, the enterprise said this ability to store it at standard refrigeration temperatures could make S-Trimer vaccines more suitable for broad global distribution.
The Phase 1 clinical trial was funded by the
COVID-19 S-Trimer vaccine
S-Trimer is a vaccine candidate which includes trimeric SARS-CoV-2 Spike (S) protein subunits. SARS-CoV-2 uses the trimeric S protein on its surface to infect human cells by binding to the human angiotensin-converting enzyme 2 (ACE2). S-Trimer resembles the native trimeric viral S protein and is produced via a rapid mammalian cell-culture based expression system.
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