A Phase I Study to Evaluate Safety, Tolerability, and Immunogenicity of a PIKA COVID-19 Vaccine in Healthy Individuals

Summary

This is a Phase I, open label, dose-escalation study of three dose levels of the SARS-CoV-2 spike antigen administered intramuscularly (IM) in combination with a fixed dosage of PIKA adjuvant vaccine to evaluate the safety, tolerability, and immunogenicity of PIKA COVID-19 vaccine candidate in healthy individuals aged 18 years and above. The study will comprise of two arms. Arm A will include subjects who never been infected with COVID-19 or with a history of COVID-19 infection for not less than 6 months prior to study participation and Arm B will include subjects who will be receiving PIKA vaccine as a booster vaccination dose to COVID-19 primary vaccination of inactivated or mRNA Covid 19 vaccines.

Timeline

Start

2021-10-18

Primary completion

2022-05-15

Completion

2022-09-15

Publications

• Lim RJ, Qiu X, Leong RN, Gutierrez JL, Halima A, Mostafa M, Ghoneim Y, Abdrabo M, Rashad M, Hannawi S, Liu Y, Mojares Z. Safety, tolerability, and immunogenicity of PIKA-adjuvanted recombinant SARS-CoV-2 spike protein subunit vaccine in healthy adults: an open-label randomized phase I clinical trial. Clin Exp Vaccine Res. 2024 Oct;13(4):315-328. doi: 10.7774/cevr.2024.13.4.315. Epub 2024 Oct 31.

Drugs

Indications