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The Sanofi study VAT00008 at AMBSO

Background

The outbreak of a severe respiratory illness in Wuhan city-Hubei Province, China in December 2019 heralded the appearance of a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) within the human population.

The rapid escalation of the outbreak led to a 20th January 2020 declaration of a Public Health Emergency of International Concern by the World Health Organization. This was later followed by the 11th March 2020 declaration of a Pandemic! The virus which has been detected in so many countries/regions worldwide has led to significant morbidity, mortality, and negative economic impact.

The major objectives of the study are: -

1) To assess, in participants who are have never suffered from COVID-19, the clinical efficacy of the study vaccine (called CoV2 preS dTM-AS03) for the prevention of symptomatic COVID-19 occurring ≥ 14 days after the second injection.

2) To assess the safety of the study vaccine (CoV2 preS dTM-AS03) as compared to placebo throughout the study.

Participation of the intended categories will contribute to learning more in the search for safe and effective COVID-19 vaccines.

Need for Covid-19 Vaccines

Whereas many variants of the virus have emerged, the use of standard operating procedures and just a few locally approved vaccines will not do much to counter the global burden of SARS-CoV-2 infections and associated diseases. The need for more safe and effective vaccines is therefore paramount.

The Sanofi Covid-19 Trial

AMBSO will therefore participate in a multi-site, multi-national study titledMonovalent and Bivalent Recombinant Protein Vaccines against COVID-19 in adults 18 years of age and older”. To test a Covid-19 Vaccine which was developed by Sanofi Pasteur, a pharmaceutical company in France. AMBSO will conduct this trial among consenting residents of Kampala and Wakiso districts. There are also other 09 sites in Uganda which are going to participate in this one-year clinical trial.

Approximately 800 people in Uganda shall participate in this study including;

1) Participants who are 18 years of age and older, who do not intend to receive an authorized/approved COVID-19 vaccine and are willing to participate for the entire follow up duration of 13 months.

2) Female participants to be recruited shall also not be pregnant and lactating, while those of child bearing potential should be willing to use effective methods of contraception.