NCT04934215 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Dan JM, Mateus J, Kato Y, Hastie KM, Yu ED, Faliti CE, Grifoni A, Ramirez SI, Haupt S, Frazier A, Nakao C, Rayaprolu V, Rawlings SA, Peters B, Krammer F, Simon V, Saphire EO, Smith DM, Weiskopf D, Sette A, Crotty S
Immunological memory to SARS-CoV-2 assessed for up to 8 months after infection. Science. 2021 Feb 5;371(6529). pii: eabf4063. doi: 10.1126/science.abf4063. Epub 2021 Jan 6.
Marot S, Malet I, Leducq V, Zafilaza K, Sterlin D, Planas D, Gothland A, Jary A, Dorgham K, Bruel T; Sorbonne Université SARS-CoV-2 Neutralizing Antibodies Study Group, Burrel S, Boutolleau D, Schwartz O, Gorochov G, Calvez V, Marcelin AG
Rapid decline of neutralizing antibodies against SARS-CoV-2 among infected healthcare workers. Nat Commun. 2021 Feb 8;12(1):844. doi: 10.1038/s41467-021-21111-9. Erratum in: Nat Commun. 2021 May 10;12(1):2824.
Pean De Ponfilly G, Pilmis B, El Kaibi I, Castreau N, Laplanche S, Le Monnier A
Is the second dose of vaccination useful in previously SARS-CoV-2-infected healthcare workers? Infect Dis Now. 2021 Nov;51(8):673-675. doi: 10.1016/j.idnow.2021.07.001. Epub

Evaluation of Post-vaccination Anti-SARS-CoV-2 Serological Response in Health Care Workers With a History of COVID-19.

Clinical trial NCT04934215 - References