| Protocol No: | ECCT/21/06/06 | Date of Protocol: | 18-05-2021 |
| Study Title: |
A parallel-group, Phase III, multi-stage, modified double-blind, multi-armed study to assess the efficacy, safety, and immunogenicity of two SARS-CoV-2 Adjuvanted |
| Study Objectives: |
Key Primary objectives |
| Laymans Summary: |
This is a Phase 3 study (efficacy study) of two experimental vaccines against SARS-CoV-2. The full names are: This study is also known as “VAT00008” or “CoVPN 3005.”
The study vaccine is developed by Sanofi Pasteur, a company that produces vaccines against other diseases such as diphtheria, tetanus, pertussis, meningitis and
The vaccine will be manufactured using the same technology as is used to make an influenza vaccine that is licensed in the US for the prevention of influenza in The study will enroll about 37,500 participants globally. The purpose of the study is to learn if: The study vaccines can prevent symptomatic COVID-19 illness The vaccines are safe The vaccines make people too uncomfortable The study vaccines can prevent infection with SARS-CoV-2 The sudy vaccines can prevent severe COVID-19 illness and hospitalization An outbreak of severe respiratory illness by this virus began in Wuhan city, China in December 2019. It was described as Coronavirus disease 2019 (COVID-19) which is a respiratory disease caused by the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The outbreak rapidly escalated leading to WHO declaring it a Pandemic in March 2020. Since then, public health measures of isolation, quarantine, social distancing to contain the spread of the virus have been used to stop the spread of the virus. Despite these measures, by 11 May 2020 the virus had been detected in 192 countries. The burden has been catastrophic: As at 2 may 2021, there were more than 3.1 million deaths and over 151 million confirmed cases worldwide. In the same time, more than 3.3 million cases, and 82 thousand deaths were reported in Africa. In Kenya, as of 10 May 2021, more than 163,620 cases and 2,907 deaths were reported. The clinical profile of the illness caused by SARS-CoV-2, is variable. The majority of cases are mild or individuals may have no symptoms. Among those with symptoms, typical presentation includes fever, cough, and shortness of breath. The severe manifestations include acute respiratory failure requiring intensive care unit (ICU) admission and some cases result in death. While mostly self-limited, symptoms such as fatigue and dyspnea appear to persist in many individuals for up to 2 months after illness onset despite viral clearance. Adults over 50 years of age and individuals with chronic medical conditions like diabetes and hypertension are at a higher risk of severe disease and death. In response to the disease, vaccines have been developed and rollout began. However, new variants of the virus have emerged. They were originally named after the country in which they were first detected but have now been renamed thus:(the alpha (B.1.1.7) variant, Beta (B.1.351) variant, the Gamma (P.1) variant, the Delta (B.1.617) variant). These variants have now spread from their countries of origin, been detected in other countries around the world and early study data has shown that vaccines are not equally effective against the emerging variants. Sanofi Pasteur initiated development of vaccine using a coronavirus protein (SARS-CoV-2 Spike (S) protein). After reviewing phase 1 and II study data, this phase III study-VAT00008, is designed to investigate how well two Recombinant vaccines (monovalent vaccine-containing one variant & bivalent vaccine-containing two variants) protect people from developing symptoms when infected by the corona virus and how safe they are when administered by intramuscular injectionin adults who are at least 18 years of aged by comparing their action to that of a placebo (this is a substance that looks like the vaccine but has no action on the body). The study will be conducted in two stages among about 21 046 people. Stage one will enroll about 10160 people (5080 will receive vaccine and 5080 will receive placebo) and stage two will enroll about 10886 people (half will receive vaccine and half will receive placebo). Based on decisions of the Study Oversight Group (OG), participants will be invited upon consent to continue participation as part of an unblinded crossover / booster study design. The participant unblinding and consent will trigger the end of the initial double-blind primary series design and the start of the Crossover / Booster design, which includes a primary series vaccination for initial placebo recipients (i.e., crossover vaccination) and a booster for both initial placebo and vaccine recipients (i.e., booster vaccination). Butere site expects to enroll approximately 420 out of the 429 participants who remain active in the study protocol version 5.0 dated 08 Sep 2021. |
| Abstract of Study: |
Background |