Covid-19 Living Data

Trial NCT04712110
Publication Masuda T, Vaccine, 2022
Dates: 2021-02-12 to 2021-03-17
Funding: Mixed (Takeda Pharmaceutical Company Limited ; the Japan Agency for Medical Research and Development (AMED))
Conflict of interest: Yes

Methods
	RCT
	Location : Multicenter / Japan Follow-up duration (months): 1.6
	NVX-CoV2373 (n = 150) placebo (n = 50)
Inclusion criteria	Healthy Japanese male and female adult participants aged >= 20 years of age at the time of signing of informed consent Participants who understand and are willing to comply with trial procedures and are available for the duration of follow-up.
Exclusion criteria	Received any other SARS-CoV-2 or other experimental novel coronavirus vaccine prior to the trial close contact of anyone known to have COVID-19 within 30 days prior to the trial vaccination tested positive for SARS-CoV-2 prior to the trial or before the trial vaccination on current treatment with other investigational agents for prophylaxis of COVID-19 traveled outside of Japan in the 30 days prior to the trial participation clinically significant active infection (as assessed by the Investigator) or oral temperature >= 38 degree Celsius within 3 days of the intended date of vaccination known hypersensitivity or allergy to any of the investigational vaccine components history or any illness that, in the opinion of the Investigator, might interfere with the results of the trial or pose additional risk to the participants due to participation in the trial known or suspected impairment/alteration of immune function, including history of any autoimmune disease or neuro-inflammatory disease: abnormalities of splenic or thymic function known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time any serious chronic or progressive disease (eg, neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease) body mass index (BMI) greater than or equal to 30 kg/m^2 (BMI= weight in kg/ height in meters^2) participating in any clinical trial with another investigational product within 30 days prior to the trial vaccination or intend to participate in another clinical trial at any time during the conduct of this trial received or plan to receive any other licensed vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to trial dose administration acute or chronic clinically significant disease including pulmonary, cardiovascular, hepatic or renal abnormality evaluated by physical examination involved in the trial conduct or their first degree relatives history or infection of hepatitis B, hepatitis C, and human immunodeficiency virus infection pregnant or breastfeeding.
Interventions
	Intervention 2 IM doses of 5mcg NVX-CoV2373, 21 days apart
	Control 2 IM doses of saline placebo, 21 days apart
Participants
	Randomized 200 participants
	Characteristics of participants Type of participants: Healthy adults N=200 114 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: 20-77
	Description of participants Healthy Japanese adults aged ≥ 20 years with no history/risk of SARS-CoV-2 infection and no prior exposure to other approved/investigational SARS-CoV-2 vaccines or treatments at 2 centers in Japan.
Primary outcome
	In the register 1. Percentage of Participants with Reported Solicited Local Adverse Events (AEs) for 7 Days Following Each Vaccination [ Time Frame: 7 days after each vaccination ] 2. Percentage of Participants with Solicited Systemic AEs for 7 Days Following Each Vaccination [ Time Frame: 7 days after each vaccination ] 3. Percentage of Participants with Unsolicited AEs for 49 Days Following First Vaccination (Day 1) [ Time Frame: 49 days after first vaccination (Day 1) ] 4. Percentage of Participants with Serious Adverse Events (SAE) until Day 50 [ Time Frame: Up to Day 50 ] 5. Percentage of Participants with Adverse Event of Special Interest (AESI) until Day 50 [ Time Frame: Up to Day 50 ] 6. Percentage of Participants with Medically-Attended Adverse Events (MAAEs) until Day 50 [ Time Frame: Up to Day 50 ] 7. Percentage of Participants with Any AE Leading to Discontinuation of Vaccination [ Time Frame: Up to Day 50 (up to discontinuation of vaccination) ] 8. Percentage of Participants with Any AE Leading to Participant's Withdrawal from the Trial until Day 50 [ Time Frame: Up to Day 50 ] 9. Percentage of Participants with SARS-CoV-2 Infection until Day 50 [ Time Frame: Up to Day 50 ] 10. Geometric Mean Titers (GMT) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 36 [ Time Frame: Day 36 ] 11. Geometric Mean Fold Rise (GMFR) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 36 [ Time Frame: Day 36 ] 12. Seroconversion Rate (SCR) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 36 [ Time Frame: Day 36 13. Seroresponce Rate (SRR) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 36 [ Time Frame: Day 36 ]
	In the report 1) solicited AEs for 7 days after each injection; 2) unsolicited AEs for 49 days after the first injection (i.e., 21 days following first injection [day of injection + 20 subsequent days] and 28 days following second injection [day of second injection + 27 subsequent days]); 3) MAAEs, SAEs, AEs leading to injection discontinuation and 4) AEs leading to withdrawal from the trial up to and including day 50; and 5) the proportion of participants with SARS-CoV-2 infection through day 50. 6) Serum IgG Ab levels against SARS-CoV-2 rS protein on day 36.
Documents available	Protocol NR Statistical plan * Data-sharing stated: Yes, After the publication of the final study results within three months from initial request Data accessibility: https://vivli.org/ourmember/takeda/ Taisei Masuda. Corresponding author at Takeda Pharmaceutical Company Limited. taisei.masuda@takeda.com
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	Some concerns
General comment	In addition to the published article, the trial registry and supplementary appendix were used in data extraction and assessment of risk of bias. The primary outcomes reported reflect the primary outcomes in the registry. The trial (n = 200) achieved its target sample size (n = 200). The article presented preliminary analyses for a study with ongoing follow-up. Some outcomes listed in the registry (Adverse Event of Special Interest) were not reported in the paper.