Covid-19 Living Data

Trial NCT04436276
Publication Stephenson K, JAMA, 2021
Dates: 2020-07-29 to 2020-08-07
Funding: Mixed (Janssen Vaccines & Prevention BV, Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology, MassCPR, NIH, and BARDA.)
Conflict of interest: Yes

Methods
	RCT
	Location : Single center / USA Follow-up duration (months): 2.33
	5×10^10 vp Ad26.COV2.S dose 1 + placebo dose 2 (n = 5) Placebo both doses (n = 5)
Inclusion criteria	18 to 55 years old negative for SARS-CoV-2 infection by screening nasopharyngeal polymerase chain reaction and serum immunoglobulin testing body mass index of 30 or less healthy, in the investigator’s clinical judgment, as confirmed by medical history, physical examination, clinical laboratory assessments, and vital signs performed at screening participants who were of child-bearing potential were required to use highly effective contraception.
Exclusion criteria	Comorbidities related to an increased risk of severe COVID-19 pregnant or breastfeeding currently working in an occupation with a high risk of exposure to SARS-CoV-2 or considered at the investigator’s discretion to be at increased risk to acquire COVID-19 for any other reason.
Interventions
	Intervention 1 IM dose of 5×10^10 vp Ad26.COV2.S followed by 1 IM dose of placebo, 56 days later
	Control 2 IM doses of placebo, 56 days apart
Participants
	Randomized 10 participants
	Characteristics of participants Type of participants: Healthy adults N=10 2 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: NR
	Description of participants Healthy adults aged 18-55 years that were SARS-CoV-2 infection-free in a single centre in USA.
Primary outcome
	In the register 1. Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days after First Vaccination [ Time Frame: Day 8 (7 Days after first vaccination on Day 1) ] Solicited local AEs are pre-defined local (at the injection site) adverse events for which participants are specifically questioned and which are noted by participants in their diary for 7 days after first vaccination. Solicited local AEs are: injection site pain/tenderness, erythema, and swelling at the vaccination site. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. 2. Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days after Second Vaccination [ Time Frame: Day 64 (7 Days after second vaccination on Day 57) ] Solicited local AEs are pre-defined local (at the injection site) adverse events for which participants are specifically questioned and which are noted by participants in their diary for 7 days after second vaccination. Solicited local AEs are: injection site pain/tenderness, erythema, and swelling at the vaccination site. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. 3. Number of Participants with Solicited Systemic AEs for 7 Days after First Vaccination [ Time Frame: Day 8 (7 Days after first vaccination on Day 1) ] Participants will be instructed on how to record daily temperature using a thermometer and also instructed to note signs and symptoms in the diary on a daily basis for 7 days after first vaccination. Solicited systemic AEs are fatigue, headache, nausea, and myalgia. 4. Number of Participants with Solicited Systemic AEs for 7 Days after Second Vaccination [ Time Frame: Day 64 (7 Days after second vaccination on Day 57) ] Participants will be instructed on how to record daily temperature using a thermometer and also instructed to note signs and symptoms in the diary on a daily basis for 7 days after second vaccination. Solicited systemic AEs are fatigue, headache, nausea, and myalgia. 5. Number of Participants with Unsolicited AEs for 28 Days after First Vaccination [ Time Frame: Day 29 (28 Days after first vaccination on Day1) ] Number of participants with unsolicited AEs for 28 days after first vaccination will be reported. Unsolicited AEs are all AEs for which the participant is not specifically questioned. 6. Number of Participants with Unsolicited AEs for 28 Days after Second Vaccination [ Time Frame: Day 85 (28 Days after second vaccination) ] Number of participants with unsolicited AEs for 28 days after second vaccination will be reported. Unsolicited AEs are all AEs for which the participant is not specifically questioned. 7. Number of Participants with Serious Adverse Events (SAEs) from the First Vaccination until 2 Years after the Second Vaccination [ Time Frame: Day 1 (vaccination 1) up to 2 years after second vaccination (up to Day 787) ] SAE is an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. 8. Number of Participants with Adverse Events of Special Interest (AESIs) from the First Vaccination until 2 Years after the Second Vaccination [ Time Frame: Day 1 (vaccination 1) up to 2 year after second vaccination (up to Day 787) ] Number of participants with AESIs will be reported. Thrombosis with thrombocytopenia syndrome is considered to be an AESI.
	In the report 1. Solicited adverse events (AEs), collected through a diary, were recorded for each vaccination from the time of vaccination until 7 days after vaccination. 2. All other unsolicited AEs and special reporting situations, whether serious or nonserious, were reported for each vaccination from the time of vaccination until 28 days after vaccination. Unsolicited AEs with the onset date outside the timeframe defined above (>28 days after previous study vaccination), which were ongoing on the day of the subsequent vaccination, were recorded as such. 3. All serious AEs and AEs leading to participant discontinuation (regardless of the causal relationship) were reported for all participants from the moment of first vaccination until completion of the participant’s last study-related procedure, which may include contact for safety follow-up.
Documents available	Protocol Yes. In English Statistical plan Yes Data-sharing stated: Yes, With publication Data accessibility: How to access data: dbarouch@bidmc.harvard.edu
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	Low
General comment	In addition to the published article, the supplementary materials, study registry, and protocol were used in data extraction and risk of bias assessment. The article presented interim analyses for a study with ongoing follow-up. This report is part of a larger multicenter RCT. Safety results are reported in a companion report (Sadoff 2021). Only the 5×10^10 vp total dose vs placebo arms were extracted here out of the 5 randomized arms.