Project Summary

The study is a Phase III, Placebo-controlled, Randomized, Observer-blinded, Multi-national, Multi-center Study to Assess the Safety, Reactogenicity, and Immunogenicity of Heterologous Booster Vaccination of a SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine (GBP510) adjuvanted with AS03 in Adults Aged 18 Years and Older.

The purpose of this study is to assess the safety, reactogenicity, and immunogenicity of heterologous booster vaccination of a SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine (GBP510) adjuvanted with AS03 in adults aged 18 years and older. For the country Nepal, Dhulikhel Hospital, Kathmandu University Hospital, and Teaching Hospital are the 2 sites to recruit 420 participants and 18 years and older individuals who have received primary vaccination of WHO EUA qualified COVID-19 vaccine at least 12 weeks prior to study vaccination will be enrolled in each of 6 cohorts which is determined based on the type of COVID-19 vaccine previously administered, and block-randomized in 6:1 ratio to receive either one dose of GBP510 adjuvanted with AS03 (Test Vaccine) or placebo. Approximately 10% of participants or more in each cohort will be elderly population aged 65 years and older. The study is planned to be for 12 months after the booster dose to monitor safety, reactogenicity, and immunogenicity. All participants will be unblinded at 4 weeks post-study vaccination (Visit 5).

Over the study period, participants in the test groups will attend 8 planned visits including 1 telephone call made 7 days after the heterologous booster vaccination (Day 7+3 after Visit 2), and will be followed for up to 12 months after the booster dose. Participants in the placebo groups will attend 5 planned visits including 1 telephone call made 7 days after a single dose of placebo, and will be followed for approximately 4 weeks after the placebo vaccination.

Study Duration

From December 2022

Objectives

To compare the immune responses against the original strain prior to and post heterologous dose of GBP510 25μg adjuvanted with AS03 and demonstrate superiority of post booster versus pre-booster in adults aged 18 years and older.

Team Members

Principal Investigator(s): Dr. Dipesh Tamrakar, Prof. Dr. Rajeev Shrestha

Co-Investigator(s): Dr. Sony Shakya, Dr. Anmol Purna Shrestha, Dr. Nikesh Mani Shrestha, Mr. Surendra K Madhup, Dr. Samita Adhikary, Dr. Shrisiti Jonchhe, Dr.Pranodan Poudel, Dr. Prabin Poudel, Dr. Kshitij Chapagain, Dr. Mukul Upadhyay Nepal

Project Coordinator: Dr. Shristi Jonchhe

Research Assistants: Ms. Reena Kharbuja, Ms. Sunita Shrestha, Ms. Shishir Ranjitkar, Ms. Melina Thapa, Ms. Laxmi Shova Hakuduwal, Ms. Rasmi Koirala, Ms. Sampada G.c, Ms. Menuka Dawadi, Ms. Anusha KC, Ms. Arati Kuikel, Ms.Pooja Tamang, Mr. Suman Shrestha, Ms. Suprina Shrestha.

Supported by: SK bio science Co. Ltd.

Collaborating Partners: International Vaccine Institute (IVI)