Detail

Basic Information Clinical Results Relationship Graph

Basic Information

Gene symbol	S	Synonyms	E2	Type of gene	protein-coding
Chromosome	-	Map location	NC_004718.3 (21492..25259)	dbXrefs
Gene perturbation-related omics dataset	PerturbAtlas
Description	spike glycoprotein

GTO ID	GTC0545
Trial ID	NCT04785144
Disease	COVID-19
Altered gene	S
Therapeutic/Target gene	Therapeutic gene
Therapy	mRNA vaccine
Treatment	mRNA-1273.351
Phase	Phase1
Recruitment status	Completed
Title	Phase 1, Open-Label, Randomized Study of the Safety and Immunogenicity of a SARS-CoV-2 Variant Vaccine (mRNA-1273.351) in Naïve and Previously Vaccinated Adults
Year	2021
Country	United States
Company sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Other ID(s)	21-0002\|5UM1AI148373-03

Vector information

Vector	lipid nanoparticle

Clinical Result

Cohort1: mRNA-1273.351_dose level 2

Administration route	intramuscular injection
Dosage	mRNA-1273.351, 0.5 mL, 50 mcg
Pts	25
Age	Adult, Older_Adult
Outcome	Number of Participants With Any Medically-attended Adverse Events (MAAEs):1(4.0%)\|Frequency of Any New-onset Chronic Medical Conditions (NOCMCs):0(0.0%)\|Frequency of Any Protocol Specified Adverse Events of Special Interest (AESIs):1(4.0%)\|Frequency of Any Serious Adverse Events (SAEs):0(0.0%)\|Frequency of Solicited Reactogenicity Adverse Events (AEs):Local Events:24(96.0%); Systemic Events:22(88.0%)\|Grade of Solicited Reactogenicity Adverse Events (AEs):None:1(4.0%); Mild:4(16.0%); Moderate:18(72.0%); Severe:2(8.0%)\|Frequency of Unsolicited Adverse Events (AEs) by Relationship to Study Product:Not Related:10; Related:12\|Grade of Any Unsolicited Adverse Events (AEs):Mild:14; Moderate:6; Severe:2
Adverse reactions	No serious clinical adverse events
References	PMID: 35547849

Cohort2: mRNA-1273.351_dose level 1_mRNA-1273_dose level 1

Administration route	intramuscular injection
Dosage	mRNA-1273.351, 0.5 mL, 25 mcg; mRNA-1273, 0.5 mL, 25 mcg
Pts	23
Age	Adult, Older_Adult
Outcome	Number of Participants With Any Medically-attended Adverse Events (MAAEs):1(4.3%)\|Frequency of Any New-onset Chronic Medical Conditions (NOCMCs):1(4.3%)\|Frequency of Any Protocol Specified Adverse Events of Special Interest (AESIs):1(4.3%)\|Frequency of Any Serious Adverse Events (SAEs):1(4.3%)\|Frequency of Solicited Reactogenicity Adverse Events (AEs):Local Events:20(87.0%); Systemic Events:20(87.0%)\|Grade of Solicited Reactogenicity Adverse Events (AEs):None:1(4.3%); Mild:6(26.1%); Moderate:13(56.5%); Severe:3(13.0%)\|Frequency of Unsolicited Adverse Events (AEs) by Relationship to Study Product:Not Related:11; Related:3\|Grade of Any Unsolicited Adverse Events (AEs):Mild:7; Moderate:6; Severe:1
Adverse reactions	0/23(All-cause mortality); 1/23(Nervous system disorders)
References	PMID: 35547849

Cohort3: mRNA-1273.351_dose level 2_Day 57_mRNA-1273_dose level 3_Days 1 and 29

Administration route	intramuscular injection
Dosage	mRNA-1273, 0.5 mL, 100 mcg, on Days 1 and 29; mRNA-1273.351, 0.5 mL, 50 mcg, on Day 57
Pts	5
Age	Adult, Older_Adult
Outcome	Number of Participants With Any Medically-attended Adverse Events (MAAEs):0(0.0%)\|Frequency of Any New-onset Chronic Medical Conditions (NOCMCs):1(20.0%)\|Frequency of Any Protocol Specified Adverse Events of Special Interest (AESIs):1(20.0%)\|Frequency of Any Serious Adverse Events (SAEs):0(0.0%)\|Frequency of Solicited Reactogenicity Adverse Events (AEs):Local Events:5(100.0%); Systemic Events:5(100.0%)\|Grade of Solicited Reactogenicity Adverse Events (AEs):None:0(0.0%); Mild:0(0.0%); Moderate:2(40.0%); Severe:3(60.0%)\|Frequency of Unsolicited Adverse Events (AEs) by Relationship to Study Product:Not Related:4; Related:3\|Grade of Any Unsolicited Adverse Events (AEs):Mild:4; Moderate:3; Severe:0
Adverse reactions	No serious clinical adverse events
References	PMID: 35547849

Cohort4: mRNA-1273.351_dose level 2_Day 57_mRNA-1273_dose level 2_Days 1 and 29

Administration route	intramuscular injection
Dosage	mRNA-1273, 0.5 mL, 50 mcg, on Days 1 and 29; mRNA-1273.351, 0.5 mL, 50 mcg, on Day 57
Pts	6
Age	Adult, Older_Adult
Outcome	Number of Participants With Any Medically-attended Adverse Events (MAAEs):0(0.0%)\|Frequency of Any New-onset Chronic Medical Conditions (NOCMCs):0(0.0%)\|Frequency of Any Protocol Specified Adverse Events of Special Interest (AESIs):0(0.0%)\|Frequency of Any Serious Adverse Events (SAEs):0(0.0%)\|Frequency of Solicited Reactogenicity Adverse Events (AEs):Local Events:6(100.0%); Systemic Events:6(100.0%)\|Grade of Solicited Reactogenicity Adverse Events (AEs):None:0(0.0%); Mild:2(33.3%); Moderate:4(66.7%); Severe:0(0.0%)\|Frequency of Unsolicited Adverse Events (AEs) by Relationship to Study Product:Not Related:5; Related:1\|Grade of Any Unsolicited Adverse Events (AEs):Mild:4; Moderate:2; Severe:0
Adverse reactions	No serious clinical adverse events
References	PMID: 35547849

Cohort5: mRNA-1273_dose level 3_Days 1 and 29

Administration route	intramuscular injection
Dosage	mRNA-1273.351, 0.5 mL, 100 mcg, on Days 1 and 29
Pts	12
Age	Adult, Older_Adult
Outcome	Number of Participants With Any Medically-attended Adverse Events (MAAEs):0(0.0%)\|Frequency of Any New-onset Chronic Medical Conditions (NOCMCs):0(0.0%)\|Frequency of Any Protocol Specified Adverse Events of Special Interest (AESIs):0(0.0%)\|Frequency of Any Serious Adverse Events (SAEs):0(0.0%)\|Frequency of Solicited Reactogenicity Adverse Events (AEs):Local Events:10(83.3%); Systemic Events:12(100.0%)\|Grade of Solicited Reactogenicity Adverse Events (AEs):None:0(0.0%); Mild:2(16.7%); Moderate:6(50.0%); Severe:4(33.3%)\|Frequency of Unsolicited Adverse Events (AEs) by Relationship to Study Product:Not Related:6; Related:5\|Grade of Any Unsolicited Adverse Events (AEs):Mild:9; Moderate:1; Severe:1
Adverse reactions	No serious clinical adverse events
References	PMID: 35547849

Cohort6: mRNA-1273_dose level 2_Days 1 and 29

Administration route	intramuscular injection
Dosage	mRNA-1273.351, 0.5 mL, 50 mcg, , on Days 1 and 29
Pts	13
Age	Adult, Older_Adult
Outcome	Number of Participants With Any Medically-attended Adverse Events (MAAEs):0(0.0%)\|Frequency of Any New-onset Chronic Medical Conditions (NOCMCs):0(0.0%)\|Frequency of Any Protocol Specified Adverse Events of Special Interest (AESIs):0(0.0%)\|Frequency of Any Serious Adverse Events (SAEs):0(0.0%)\|Frequency of Solicited Reactogenicity Adverse Events (AEs):Local Events:12(92.3%); Systemic Events:11(84.6%)\|Grade of Solicited Reactogenicity Adverse Events (AEs):None:1(7.7%); Mild:3(23.1%); Moderate:7(53.8%); Severe:2(15.4%)\|Frequency of Unsolicited Adverse Events (AEs) by Relationship to Study Product:Not Related:0; Related:16\|Grade of Any Unsolicited Adverse Events (AEs):Mild:11; Moderate:5; Severe:0
Adverse reactions	No serious clinical adverse events
References	PMID: 35547849

Cohort7: mRNA-1273.351_dose level 3_Day 29_mRNA-1273_dose level 3_Day 1

Administration route	intramuscular injection
Dosage	mRNA-1273, 0.5 mL, 100 mcg, on Day 1; mRNA-1273.351, 0.5 mL, 100 mcg, on Day 29
Pts	13
Age	Adult, Older_Adult
Outcome	Number of Participants With Any Medically-attended Adverse Events (MAAEs):0(0.0%)\|Frequency of Any New-onset Chronic Medical Conditions (NOCMCs):0(0.0%)\|Frequency of Any Protocol Specified Adverse Events of Special Interest (AESIs):0(0.0%)\|Frequency of Any Serious Adverse Events (SAEs):0(0.0%)\|Frequency of Solicited Reactogenicity Adverse Events (AEs):Local Events:13(100.0%); Systemic Events:12(92.3%)\|Grade of Solicited Reactogenicity Adverse Events (AEs):None:0(0.0%); Mild:1(7.7%); Moderate:8(61.5%); Severe:4(30.8%)\|Frequency of Unsolicited Adverse Events (AEs) by Relationship to Study Product:Not Related:3; Related:4\|Grade of Any Unsolicited Adverse Events (AEs):Mild:4; Moderate:3; Severe:0
Adverse reactions	No serious clinical adverse events
References	PMID: 35547849

Cohort8: mRNA-1273.351_dose level 2_Day 29_mRNA-1273_dose level 2_Day 1

Administration route	intramuscular injection
Dosage	mRNA-1273, 0.5 mL, 50 mcg, on Day 1; mRNA-1273.351, 0.5 mL, 50 mcg, on Day 29
Pts	12
Age	Adult, Older_Adult
Outcome	Number of Participants With Any Medically-attended Adverse Events (MAAEs):0(0.0%)\|Frequency of Any New-onset Chronic Medical Conditions (NOCMCs):0(0.0%)\|Frequency of Any Protocol Specified Adverse Events of Special Interest (AESIs):0(0.0%)\|Frequency of Any Serious Adverse Events (SAEs):0(0.0%)\|Frequency of Solicited Reactogenicity Adverse Events (AEs):Local Events:11(91.7%); Systemic Events:11(91.7%)\|Grade of Solicited Reactogenicity Adverse Events (AEs):None:1(8.3%); Mild:2(16.7%); Moderate:7(58.3%); Severe:2(16.7%)\|Frequency of Unsolicited Adverse Events (AEs) by Relationship to Study Product:Not Related:6; Related:2\|Grade of Any Unsolicited Adverse Events (AEs):Mild:4; Moderate:3; Severe:1
Adverse reactions	No serious clinical adverse events
References	PMID: 35547849

Cohort9: mRNA-1273.351_dose level 2_Days 1 and 29_mRNA-1273_dose level 2_Days 1 and 29

Administration route	intramuscular injection
Dosage	mRNA-1273, 0.5 mL, 50 mcg, on Days 1 and 29; mRNA-1273.351, 0.5 mL, 50 mcg, on Days 1 and 29
Pts	13
Age	Adult, Older_Adult
Outcome	Number of Participants With Any Medically-attended Adverse Events (MAAEs):0(0.0%)\|Frequency of Any New-onset Chronic Medical Conditions (NOCMCs):1(7.7%)\|Frequency of Any Protocol Specified Adverse Events of Special Interest (AESIs):1(7.7%)\|Frequency of Any Serious Adverse Events (SAEs):0(0.0%)\|Frequency of Solicited Reactogenicity Adverse Events (AEs):Local Events:12(92.3%); Systemic Events:12(92.3%)\|Grade of Solicited Reactogenicity Adverse Events (AEs):None:0(0.0%); Mild:1(7.7%); Moderate:9(69.2%); Severe:3(23.1%)\|Frequency of Unsolicited Adverse Events (AEs) by Relationship to Study Product:Not Related:7; Related:13\|Grade of Any Unsolicited Adverse Events (AEs):Mild:15; Moderate:5; Severe:0
Adverse reactions	No serious clinical adverse events
References	PMID: 35547849

Cohort10: mRNA-1273.351_dose level 1_Days 1 and 29_mRNA-1273_dose level 1_Days 1 and 29

Administration route	intramuscular injection
Dosage	mRNA-1273, 0.5 mL, 25 mcg, on Days 1 and 29; mRNA-1273.351, 0.5 mL, 25 mcg, on Days 1 and 29
Pts	13
Age	Adult, Older_Adult
Outcome	Number of Participants With Any Medically-attended Adverse Events (MAAEs):0(0.0%)\|Frequency of Any New-onset Chronic Medical Conditions (NOCMCs):0(0.0%)\|Frequency of Any Protocol Specified Adverse Events of Special Interest (AESIs):0(0.0%)\|Frequency of Any Serious Adverse Events (SAEs):0(0.0%)\|Frequency of Solicited Reactogenicity Adverse Events (AEs):Local Events:13(100.0%); Systemic Events:12(92.3%)\|Grade of Solicited Reactogenicity Adverse Events (AEs):None:0(0.0%); Mild:4(30.8%); Moderate:6(46.2%); Severe:3(23.1%)\|Frequency of Unsolicited Adverse Events (AEs) by Relationship to Study Product:Not Related:8; Related:10\|Grade of Any Unsolicited Adverse Events (AEs):Mild:5; Moderate:10; Severe:3
Adverse reactions	No serious clinical adverse events
References	PMID: 35547849

Relationship Graph

Overview of Knowledge Graph