This Phase IIb clinical study aims to compare the immunogenicity and safety of a booster dose of recombinant protein RBD fusion dimer vaccine as a heterologous booster (to subjects who have received the second dose of the Pfizer-BioNTech (Comirnaty) COVID-19 vaccine at least 182 days prior to the booster dose in this study) versus a homologous booster (subjects who received the second dose of the Comirnaty COVID-19 vaccine at least 182 days prior to the booster dose in this study) will receive a third dose of the Comirnaty vaccine). The extension part of the study aims to compare the immunogenicity and safety of a fourth dose of PHH-1V in subjects with a primovaccination with Pfizer-BioNTech (Comirnaty) COVID-19 vaccine plus either a booster dose of Comirnaty or PHH-1V versus those with three vaccinations of Comirnaty.
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Part A: Changes of the immunogenicity against Wuhan
Timeframe: 14 days
Safety and tolerability of PHH-1V as third or fourth dose
Timeframe: 7 days
Safety and tolerability of PHH-1V as third or fourth dose
Timeframe: 28 days
Safety and tolerability of PHH-1V as third or fourth dose
Timeframe: 364 days
Safety and tolerability of PHH-1V as third or fourth dose
Timeframe: Days 14, 28, 182, and 364
Part B: Changes of the immunogenicity against Omicron BA.1
Timeframe: Day 14