A phase III trial of two SARS-CoV-2 Adjuvanted Recombinant Protein Vaccines for prevention against COVID-19 in adults 18 years of age

January 9, 2019 | Ongoing Projects | Reading time: 6 min

Investigators
Dr. Kwaku Poku Asante, Dr. Seyram Kaali, Dr. Samuel Harrison, Dr. Prince Agyapong Darko, Dr. Cynthia Yaa Bema, Dr. Felicia Serwah, Mr. Elvis Ato Wilson, Dr. Afia Korkor Opare Yeboah, Mr. Peter Anlaaku, Mr. Owusu Boahen, Mr. Zakariah Buwah, Mr. Francis Kornu Mensah, Dr. David Dosoo, Dr. Dennis Adu-Gyasi, Mr. Kingsley Kayan, Mr. Elisha Adeniji, Mr. Richard Boakye

Background
The outbreak of COVID-19 in late 2019 has caused significant morbidity and mortality and disruption of socioeconomic activities all over the world. To date, there have been approximately 1,700 cases and close to 1,500 deaths in Ghana. The pandemic exacerbated exiting inequities in access to healthcare between and within countries with minimal access to COVID-19 vaccines in Low and Middle Income Countries including Ghana. Against this backdrop, Sanofi Pasteur is developing two candidate vaccines for active immunization and prevention of SARS-CoV-2 infection and COVID-19 disease.

Objectives
This Phase III study will assess how well the study vaccines protect against infection and illness caused by the SARS-CoV-2 virus. It will also assess how safe the vaccines are and how well the body's immune system is activated by the vaccines to fight SARS-CoV-2 infection.

Methodology
The study is recruiting adults aged 18 years and above and randomly assigning them in a random manner to receive the study vaccine or the placebo. Following informed consent and after an initial assessment for eligibility, participants receive two doses of the vaccine or placebo three weeks apart and are followed up over a period of about 13 months to assess the occurrence of COVID-19-like illness. The study team also assess participants for any illnesses or injuries they may experience in the course of the study. Nasopharyngeal and blood samples are collected at planned visits to help make these assessments.

Key Findings
Interim analysis showed that the vaccine was highly protective against severe COVID-19 and moderately protective against moderate disease. At the same time the vaccine was found to have an acceptable safety profile.

Expected Outcomes
The outcomes include efficacy, safety and immunogenicity of the candidate vaccines administered as a two dose primary vaccination series with or without a booster.

Funders
Sanofi Pasteur Inc.

Collaborators
Kumasi Centre for Collaborative Research and Navrongo Health Research Centre