This will be a randomized single-blind controlled trial to determine the immunogenicity, efficacy and safety of IH Convidecia (CanSino), as a second booster vaccination against Omicron and other emerging VOCs to prevent breakthrough infections among people with a sub-optimal immune response to the first booster dose. These subjects will be randomized in a ratio of 1:1 to receive a second booster dose of IH Convidecia vaccine (treatment arm), or a second booster dose of mRNA vaccine BNT162b2 (Pfizer).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
540
Subjects will be randomized to receive a second booster dose of IH Convidecia vaccine (treatment arm)
Subjects will be randomized to receive a second booster dose of BNT162b2.
Hospital Ampang
Ampang, Selangor, Malaysia
Level of saliva IgA antibodies by ELISA.
Time frame: 28 days post booster vaccination
Level of serum functional neutralizing antibodies by cPass Genscript
Time frame: 28 days post booster vaccination
Level of serum Anti-Spike IgG by ELISA.
Time frame: 28 days post booster vaccination
Level of anti S-RBD IgG by ELISA.
Time frame: 28 days post booster vaccination
Level of serum Anti-Nucleocapsid IgG by ELISA.
Time frame: 28 days post booster vaccination
Baseline level of Anti-Ad5 antibodies by ChemiLuminescence.
Time frame: Day 0
Level of pseudo neutralising antibodies against the wild-type original strain and Beta, Delta, Omicron and emerging VOCs by ELISA.
Time frame: 28 days post booster vaccination
Incidence of solicited adverse events
Incidence of solicited adverse events post booster vaccination in all subjects.
Time frame: 14 days
Incidence of serious adverse events
Incidence of serious adverse events post booster vaccination in all subjects.
Time frame: Up to 24 weeks
Incidence of adverse events of special interest (AESI)
Incidence of AESI post booster vaccination in all subjects.
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Time frame: Up to 24 weeks
Efficacy against COVID-19 infection and transmission
RT-PCR-confirmed Covid-19 breakthrough infection, whether symptomatic or not.
Time frame: At least 14 days post booster dose.
Efficacy against COVID-19 infection and transmission
RT-PCR-confirmed Covid-19 secondary attack rate among household members after an index case is detected.
Time frame: Within 7 days after the sample date of the index case.
Level of saliva IgA antibodies by ELISA.
Time frame: 14 days post booster vaccination
Level of serum functional neutralizing antibodies by cPass Genscript
Time frame: 14 days post booster vaccination
Level of serum Anti-Spike IgG by ELISA.
Time frame: 14 days post booster vaccination
Level of anti S-RBD IgG by ELISA.
Time frame: 14 days post booster vaccination
Level of T cell responses by Intracellular Cytokine Staining (Th1/Th2) in subgroup subjects.
Time frame: Up to 24 weeks
Level of T cell response by Enzyme-linked Immunospot (Elispot) in subgroup subjects.
Time frame: Up to 24 weeks