A Phase II/III, Randomized, Double-blinded Study to Evaluate the Efficacy, Safety and Immunogenicity of a Booster Dose of PIKA Recombinant SARS-CoV-2 Vaccine in Adults Who Received 2 or More Doses of Inactivated Covid-19 Vaccine.

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.

开始日期2022-10-03

申办/合作机构

Yisheng Biopharma (Singapore) Pte Ltd.

NCT05305300 / Completed临床1期

A Phase I Study to Evaluate the Safety, Tolerability, and Immunogenicity of a PIKA COVID-19 Vaccine in Healthy Adults Who is COVID-19 naïve or Had Previous COVID-19 Infection or Completed Inactivated or mRNA COVID-19 Vaccination.

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.

开始日期2021-10-18

申办/合作机构

Yisheng Biopharma (Singapore) Pte Ltd.

100 项与 PIKA COVID-19 vaccine(Yisheng Biopharma (Singapore) Pte. Ltd.) 相关的临床结果

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100 项与 PIKA COVID-19 vaccine(Yisheng Biopharma (Singapore) Pte. Ltd.) 相关的转化医学

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100 项与 PIKA COVID-19 vaccine(Yisheng Biopharma (Singapore) Pte. Ltd.) 相关的专利（医药）

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项与 PIKA COVID-19 vaccine(Yisheng Biopharma (Singapore) Pte. Ltd.) 相关的文献（医药）

2024-01-01·Clinical and Experimental Vaccine Research

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

Article

作者: Alberto, Edison ; Trillana, Maricris ; Capeding, Maria Rosario ; Liu, Yuan ; Leong, Robert Neil ; Carlos, Josefina ; Mojares, Zenaida ; Qiu, Xiangyan ; Lim, Renan James ; Gutierrez, Jose Limuel

PurposeThis study evaluated the safety and immunogenicity of the PIKA-adjuvanted recombinant severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein subunit vaccine as a booster dose for healthy adults who had previously received two or more doses of an inactivated coronavirus disease 2019 (COVID-19) vaccine.Materials and MethodsThe study was a phase II multicenter, double-blinded, comparator-controlled, randomized trial. Participants were randomly assigned to receive either the PIKA COVID-19 vaccine booster dose or an inactivated COVID-19 vaccine (Sinovac, China). Safety was assessed based on adverse events, while immunogenicity was measured by neutralizing antibodies against SARS-CoV-2 and serum immunoglobulin G (IgG) levels. Data on safety and immunogenicity were collected in the short-term (within 14 days after the booster dose) and long-term (from 90 to 365 days after the booster dose).ResultsThe PIKA-adjuvanted vaccine demonstrated a significant increase in neutralizing antibodies against the Omicron variant (geometric mean ratio [GMR]=2.0 on day 7, p-value <0.001; GMR=2.7 on day 14, p-value <0.001) and the wild type SARS-CoV-2 virus (GMR=2.3 on day 7, p-value <0.001; GMR=2.8 on day 14, p-value<0.001) in the early post-vaccination period when compared to the inactivated vaccine. Additionally, the PIKA COVID-19 vaccine showed higher seroconversion rates for neutralizing antibodies against both variants during the first 14 days post-vaccination. However, there were no significant differences in neutralizing antibody levels between the two vaccines from day 90 to day 360 post-vaccination. Serum IgG antibody levels for the PIKA COVID-19 vaccine were also higher throughout the study period. The incidence of adverse events was slightly higher in the PIKA COVID-19 group, with the most common events being pain at the injection site and headache. All adverse events were mild or moderate, with no reports of severe or life-threatening adverse events in either group.ConclusionThe PIKA COVID-19 vaccine, when administered as a booster dose, showed promising short- and long-term immunogenicity with no emergent safety issues identified. The booster dose of the PIKA COVID-19 vaccine elicited a robust immune response against various SARS-CoV-2 variants and provided some seroprotection for up to 360 days (ClinicalTrials.gov registration number: NCT05463419).

100 项与 PIKA COVID-19 vaccine(Yisheng Biopharma (Singapore) Pte. Ltd.) 相关的药物交易

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