A Phase II/III Study of PIKA Recombinant SARS-CoV-2 Vaccine as a Booster Dose.

Phase 2/3 Completed 5860 enrolled Yisheng Biopharma (Singapore) Pte. Ltd.

RandomizedSequentialTriple-blindPrevention

Summary

This is a Phase II/III, randomized, double-blinded study in adults ≥ 18 years old who received 2 or more doses of inactivated COVID-19 vaccine to evaluate the efficacy, safety and immunogenicity of a booster dose of PIKA COVID-19 vaccine compared to the comparator inactivated COVID-19 vaccine. Phase II/III will be a competitive enrollment process in all participating countries. Once the target number of subjects is reached, the enrollment in all participating countries in the particular phase will be stopped.

Timeline

Start: 2022-10-03
Primary completion: 2023-12-28
Completion: 2024-04-11

Publications

Lim RJ, Qiu X, Alberto E, Capeding MR, Carlos J, Leong RN, Gutierrez JL, Trillana M, Liu Y, Mojares Z. Safety and immunogenicity of PIKA-adjuvanted recombinant SARS-CoV-2 spike protein subunit vaccine as a booster against SARS-CoV-2: a phase II, open-label, randomized, double-blinded study. Clin Exp Vaccine Res. 2024 Oct;13(4):329-337. doi: 10.7774/cevr.2024.13.4.329. Epub 2024 Oct 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	CoronaVac	Vaccine	—	Intramuscular
Subject	PIKA COVID-19 Vaccine	Vaccine	—	Intramuscular

Indications

No indication recorded.