Publications by authors named "Jose Limuel Gutierrez"
Purpose: This phase I study aimed to assess the safety, tolerability, and immunogenicity of the PIKA-adjuvanted recombinant severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike (S) protein subunit vaccine in healthy adults aged 18 years and older.
Materials And Methods: This is a phase I, open-label, dose-escalation study at three dose levels (5 µg, 10 µg, and 20 µg) of the PIKA coronavirus disease 2019 (COVID-19) vaccine administered intramuscularly. The three vaccine arms are (A) subjects who have never received any COVID-19 vaccination or have had COVID-19 infection for >6 months prior to enrolment; (B1) subjects whose COVID-19 primary vaccination series was completed with an inactivated COVID-19 vaccine; and (B2) subjects whose primary series was completed with messenger RNA COVID-19 vaccine.
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
October 2024
Article Synopsis
- The study assessed the safety and effectiveness of a new COVID-19 booster vaccine (PIKA-adjuvanted recombinant) for adults who have already received two doses of an inactivated vaccine.
- Participants were divided into two groups: one received the PIKA vaccine, while the other got an inactivated vaccine, with their safety monitored and immune response measured through antibody levels over time.
- Results showed that the PIKA vaccine significantly increased neutralizing antibodies against both the Omicron variant and the original SARS-CoV-2 virus shortly after vaccination, although there was no long-term difference in antibody levels between the two vaccines after 90 days.