Covid-19 Living Data

Trial NCT04368728
Publication Mulligan MJ, Nature, 2020
Dates: 04/05/2020 to 19/06/2020
Funding: Private (BioNTech SE, Pfizer)
Conflict of interest: Yes

Methods
	RCT
	Location : / United States Follow-up duration (months): 45
	*
Inclusion criteria	healthy men and nonpregnant women 18 to 55 years of age
Exclusion criteria	Key exclusion criteria included individuals with known infection with human immunodeficiency virus, hepatitis C virus, or hepatitis B virus immunocompromised individuals and those with a history of autoimmune disease and those with increased risk for severe COVID-19, previous clinical or microbiological diagnosis of COVID-19, receipt of medications intended to prevent COVID-19, previous vaccination with any coronavirus vaccine, a positive serological test for SARS-CoV-2 IgM and/or IgG at the screening visit, and a SARS-CoV-2 nucleic acid amplification test (NAAT)-positive nasal swab within 24 hours before study vaccination.
Interventions
	Intervention
	Control
Participants
	Randomized * participants
	Characteristics of participants Type of participants: Healthy volunteers N=* 23 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: 24-42
	Description of participants Healthy adult volunteers with HIV-negative and SARS-CoV-2 infection-free in multiple centres in the USA.
Primary outcome
	In the register 1. Percentage of participants in Phase 1 reporting local reactions, 2. Percentage of participants in Phase 1 reporting systemic events, 3. Percentage of participants in Phase 1 reporting adverse events, 4. Percentage of participants in Phase 1 reporting serious adverse events, 5. Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values [day 1 anfer dose 1], 6. Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values [day 7 after dose 1], 7. Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values [day 7 after dose 2], 8. Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments [from baseline to 1 day after dose 1], 9. Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments [from baseline to 7 days after dose 1], 10, Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments [from before dose 2 to 7 days after dose 2], 11. In the first 360 participants randomized into Phase 2/3, percentage of participants reporting local reactions, 12. In the first 360 participants randomized into Phase 2/3, percentage of participants reporting systemic events, 13. In the first 360 participants randomized into Phase 2/3, percentage of participants reporting adverse events, 14. In the first 360 participants randomized into Phase 2/3, percentage of participants reporting serious adverse events, 15. In a subset of at least 6000 participants randomized in Phase 2/3, percentage of participants reporting local reactions, 16. In a subset of at least 6000 participants randomized in Phase 2/3, percentage of participants reporting systemic events, 17. Percentage of participants in Phase 2/3 reporting adverse events, 18. Percentage of participants in Phase 2/3 reporting serious adverse events, 19. Confirmed COVID-19 in Phase 2/3 participants without evidence of infection before vaccination, 20. Confirmed COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination
	In the report the proportion of participants reporting solicited local reactions, systemic events, and use of antipyretic and/or pain medication within 7 days after vaccination, AEs and SAEs (available through up to ~45 days after Dose 1), and the proportion of participants with clinical laboratory abnormalities 1 and 7 days after vaccination and grading shifts in laboratory assessments between baseline and 1 and 7 days after Dose 1 and between Dose 2 and 7 days after Dose 2.
Documents available	Protocol Yes. In Statistical plan Data-sharing stated: , Data accessibility:
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review	High
General comment	In addition to the pre-print, the online trial registry (methods only, no resutls data available) were used for extraction and assessment of bias. As this is an ongoing trial, some outcomes with long time point measurements (e.g;, 2 years) are not present in the report; GMTs were not fully reported; Sample size was small; Not all trial arms were included in the report.