RBDCOV aims to generate robust data to demonstrate the safety and immunogenicity of this vaccine given as a booster vaccination to induce a higher and more durable immune response, for potential new variants. It should be effective in the prevention of COVID-19.
To achieve the project objectives, it is crucial involve as many European stakeholders as possible. That is why the RBDCOV consortium rely on the expertise and the experience of the 12 project partners. The RBDCOV benefits from the perspective of specific populations, i.e. People with immunocompromising conditions, that have been largely excluded from Phase III trials with already authorised SARS-CoV2 vaccines, as vaccine-related immune responsiveness is unclear in this population, who are at higher risk of severe COVID-19.
Phase I trials are usually conducted in a small number of volunteers with no specific conditions. The aim of Phase I trials is to find out the safe dose range, and to look for any side effects. The initial dose given will be very small, and gradually increased if no or only mild side effects are observed. A new medicine must meet certain pre-set requirements before it can continue to Phase II trials. Phase I, II, and III trials are commonly known together as “clinical development”.
Phase II trials are generally the first studies with a new medicine in patients. They are usually conducted in a small number of patients who are monitored closely. These trials are often larger than Phase I trials.
Phase II studies are designed to find out if the medicine has a beneficial effect on the disease in question: They might compare the new medicine to an existing treatment or to a placebo. They also set out to determine the best dose range and how often the medicine should be given and investigate the best way to manage any side effects.
Phase III trials are generally large (comprising thousands of patients) and involve several study sites, sometimes in different countries. They compare the new medicine to existing treatments, in order to show the safety and efficacy of the new medicine. Most Phase III trials are randomised. Phase I, II, and III trials are commonly known as ‘clinical development’. Phase III studies are critical to applications for marketing authorisation.
Phase IV trials are usually conducted after marketing authorisation is granted and the medicine is in general use.
Phase IV studies are also known as post-authorisation safety studies (PASS) and may be voluntary or imposed by the regulatory authorities. The possibility also exists of requesting the marketing authorisation holder to conduct post-authorisation efficacy studies (PAESs) in order to complement efficacy data that are available at the time of the initial authorisation. Phase IV studies collect additional information about side-effects and safety, long-term risks, and benefits, and/or how well the medicine works when used widely.
