Detail

Basic Information Clinical Results Relationship Graph

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	GTC0566
Trial ID	NCT05375838
Disease	COVID-19 \| Influenza
Altered gene	HA\|S
Therapeutic/Target gene	Therapeutic gene
Therapy	mRNA vaccine
Treatment	mRNA-1073;mRNA-1010;mRNA-1273\|Elasomeran\|Spikevax
Location approved	NULL;NULL;UK, Canada, Taiwan, Switzerland, Japan, EU, Australia, South Korea, Singapore, US
Phase	Phase1\|Phase2
Recruitment status	Completed
Title	Phase 1/2, Randomized, Stratified, Observer-blind Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1073 (SARS-CoV-2 and Influenza Vaccine) Compared to Co-administered mRNA-1010 (Influenza) and mRNA-1273 (SARS-CoV-2) Vaccines and to mRNA- 1010 Vaccine and mRNA-1273 Vaccine Alone in Healthy Adults 18-75 Years of Age
Year	2022
Country	United States
Company sponsor	ModernaTX, Inc.
Other ID(s)	mRNA-1073-P101

Vector information

Vector	lipid nanoparticle

Cohort1: mRNA-1273_Placebo

Administration route	intramuscular injection
Dosage	mRNA-1273 plus placebo, 2 injections, on Day 1
Pts	49
Age	Adult, Older_Adult
Outcome	Number of Participants With Solicited Local and Systemic Adverse Reaction (ARs):Solicited Local ARs Measure Type: Count of Participants:38 77.6%; Solicited Systemic ARs:31 63.3%\|Number of Participants With Unsolicited Adverse Events (AEs):Measure Type: Count of Participants:7 14.3%\|Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically-Attended AEs (MAAEs) and AEs Leading to Discontinuation:SAEs:Measure Type: Count of Participants:2 4.1%; AESIs:0 0.0%; MAAEs:13 26.5%; AEs leading to discontinuation:0 0.0%
Adverse reactions	0/49(All-cause mortality); 2/49(Cardiac disorders; Infections and infestations)

Cohort2: mRNA-1010_Placebo

Administration route	intramuscular injection
Dosage	mRNA-1010 plus placebo, 2 injections, on Day 1
Pts	99
Age	Adult, Older_Adult
Outcome	Number of Participants With Solicited Local and Systemic Adverse Reaction (ARs):Solicited Local ARs Measure Type: Count of Participants:80 81.6%; Solicited Systemic ARs:70 71.4%\|Number of Participants With Unsolicited Adverse Events (AEs):Measure Type: Count of Participants:21 21.2%\|Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically-Attended AEs (MAAEs) and AEs Leading to Discontinuation:SAEs:Measure Type: Count of Participants:1 1.0%; AESIs:2 2.0%; MAAEs:38 38.4%; AEs leading to discontinuation:0 0.0%
Adverse reactions	0/99(All-cause mortality); 1/99(Injury, poisoning and procedural complications)

Cohort3: mRNA-1010_mRNA-1273

Administration route	intramuscular injection
Dosage	mRNA-1010 plus mRNA-1273, 2 injections, on Day 1
Pts	101
Age	Adult, Older_Adult
Outcome	Number of Participants With Solicited Local and Systemic Adverse Reaction (ARs):Solicited Local ARs Measure Type: Count of Participants:90 89.1%; Solicited Systemic ARs:87 86.1%\|Number of Participants With Unsolicited Adverse Events (AEs):Measure Type: Count of Participants:14 13.9%\|Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically-Attended AEs (MAAEs) and AEs Leading to Discontinuation:SAEs:Measure Type: Count of Participants:0 0.0%; AESIs:0 0.0%; MAAEs:32 31.7%; AEs leading to discontinuation:0 0.0%
Adverse reactions	No serious clinical adverse events

Cohort4: mRNA-1073_dose level 1

Administration route	intramuscular injection
Dosage	mRNA-1273 Low Dose, plus placebo, 2 injections, on Day 1
Pts	100
Age	Adult, Older_Adult
Outcome	Number of Participants With Solicited Local and Systemic Adverse Reaction (ARs):Solicited Local ARs Measure Type: Count of Participants:92 92.0%; Solicited Systemic ARs:80 80.0%\|Number of Participants With Unsolicited Adverse Events (AEs):Measure Type: Count of Participants:19 19.0%\|Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically-Attended AEs (MAAEs) and AEs Leading to Discontinuation:SAEs:Measure Type: Count of Participants:0 0.0%; AESIs:1 1.0%; MAAEs:34 34.0%; AEs leading to discontinuation:0 0.0%
Adverse reactions	No serious clinical adverse events

Cohort5: mRNA-1073_dose level 2

Administration route	intramuscular injection
Dosage	mRNA-1273 Medium Dose, plus placebo, 2 injections, on Day 1
Pts	98
Age	Adult, Older_Adult
Outcome	Number of Participants With Solicited Local and Systemic Adverse Reaction (ARs):Solicited Local ARs Measure Type: Count of Participants:76 77.6%; Solicited Systemic ARs:63 64.3%\|Number of Participants With Unsolicited Adverse Events (AEs):Measure Type: Count of Participants:11 11.2%\|Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically-Attended AEs (MAAEs) and AEs Leading to Discontinuation:SAEs:Measure Type: Count of Participants:1 1.0%; AESIs:0 0.0%; MAAEs:34 34.7%; AEs leading to discontinuation:0 0.0%
Adverse reactions	0/98(All-cause mortality); 1/98(Infections and infestations; Neoplasms benign, malignant and unspecified(incl cysts and polyps))

Cohort6: mRNA-1073_dose level 3

Administration route	intramuscular injection
Dosage	mRNA-1273 High Dose, plus placebo, 2 injections, on Day 1
Pts	100
Age	Adult, Older_Adult
Outcome	Number of Participants With Solicited Local and Systemic Adverse Reaction (ARs):Solicited Local ARs Measure Type: Count of Participants:78 78.0%; Solicited Systemic ARs:67 67.0%\|Number of Participants With Unsolicited Adverse Events (AEs):Measure Type: Count of Participants:22 22.0%\|Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically-Attended AEs (MAAEs) and AEs Leading to Discontinuation:SAEs:Measure Type: Count of Participants:0 0.0%; AESIs:1 1.0%; MAAEs:44 44.0%; AEs leading to discontinuation:0 0.0%
Adverse reactions	No serious clinical adverse events

Overview of Knowledge Graph