Covid 19 Research using Clinical Trials (Home Page)
BNT162a1Wiki
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (5)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug154 | BNT162b1 Wiki | 1.00 |
| drug156 | BNT162c2 Wiki | 1.00 |
| drug155 | BNT162b2 Wiki | 1.00 |
| drug592 | Hydroxychloroquine (HCQ) Wiki | 0.41 |
| drug1016 | Placebo Wiki | 0.05 |
Correlated MeSH Terms (8)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D012327 | RNA Virus Infections NIH | 0.35 |
| D012141 | Respiratory Tract Infections NIH | 0.16 |
| D014777 | Virus Diseases NIH | 0.09 |
| D055371 | Acute Lung Injury NIH | 0.08 |
| D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.08 |
| D012128 | Respiratory Distress Syndrome, Adult NIH | 0.07 |
| D003141 | Communicable Diseases NIH | 0.07 |
| D007239 | Infection NIH | 0.05 |
Correlated HPO Terms (1)
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0011947 | Respiratory tract infection HPO | 0.16 |
There are 2 clinical trials
Clinical Trials
1 A PHASE 1/2, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO DESCRIBE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND POTENTIAL EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY ADULTS
This is a Phase 1/2, randomized, placebo-controlled, observer-blind, dose-finding, and vaccine candidate-selection study in healthy adults. The study will evaluate the safety, tolerability, immunogenicity, and potential efficacy of up to 4 different SARS-CoV-2 RNA vaccine candidates against COVID-19: - As a 2-dose or single-dose schedule - At up to 3 different dose levels - In 3 age groups (18 to 55 years of age, 65 to 85 years of age, and 18 to 85 years of age The study consists of 3 stages. Stage 1: to identify preferred vaccine candidate(s), dose level(s), number of doses, and schedule of administration (with the first 15 participants at each dose level of each vaccine candidate comprising a sentinel cohort); Stage 2: an expanded-cohort stage; and Stage 3; a final candidate/dose large-scale stage.
NCT04368728 SARS-CoV-2 Infection COVID-19 Biological: BNT162a1 Biological: BNT162b1 Biological: BNT162b2 Biological: BNT162c2 Other: Placebo
Primary Outcomes
Description: Pain at the injection site, redness, and swelling as self-reported on electronic diaries.
Measure: Percentage of participants reporting local reactions Time: For 7 days after dose 1 and dose 2Description: Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.
Measure: Percentage of participants reporting systemic events Time: For 7 days after dose 1 and dose 2Description: As elicited by investigational site staff
Measure: Percentage of participants reporting adverse events Time: From dose 1 through 1 month after the last doseDescription: As elicited by investigational site staff
Measure: Percentage of participants reporting serious adverse events Time: From dose 1 through 6 months after the last doseDescription: As measured at the central laboratory
Measure: Percentage of sentinel cohort participants with abnormal hematology and chemistry laboratory values Time: 1 day after dose 1Description: As measured at the central laboratory
Measure: Percentage of sentinel cohort participants with abnormal hematology and chemistry laboratory values Time: 7 days after dose 1Description: As measured at the central laboratory
Measure: Percentage of sentinel cohort participants with abnormal hematology and chemistry laboratory values Time: 7 days after dose 2Description: As measured at the central laboratory
Measure: Percentage of sentinel cohort participants with grading shifts in hematology and chemistry laboratory assessments Time: Between baseline and 1 day after dose 1Description: As measured at the central laboratory
Measure: Percentage of sentinel cohort participants with grading shifts in hematology and chemistry laboratory assessments Time: Between baseline and 7 days after dose 1Description: As measured at the central laboratory
Measure: Percentage of sentinel cohort participants with grading shifts in hematology and chemistry laboratory assessments Time: Between before dose 2 and 7 days after dose 2Secondary Outcomes
Description: As measured at the central laboratory
Measure: SARS-CoV-2-specific WT serum neutralizing antibody levels, expressed as GMTs Time: Through 2 years after the final doseDescription: As measured at the central laboratory
Measure: GMFR in SARS-CoV-2-specific WT serum neutralizing titers from before vaccination to each subsequent time point Time: Through 2 years after the final doseDescription: As measured at the central laboratory
Measure: Proportion of participants achieving a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2-specific WT serum neutralizing antibody levels Time: Through 2 years after the final doseDescription: As measured at the central laboratory
Measure: SARS-CoV-2--spike protein-specific binding antibody levels and RBD-specific binding antibody levels, expressed as GMCs Time: Through 2 years after the final doseDescription: As measured at the central laboratory
Measure: Proportion of participants achieving a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2--spike protein-specific binding antibody levels and RBD-specific binding antibody levels Time: Through 2 years after the final doseDescription: As measured at the central laboratory
Measure: GMFR in SARS-CoV-2-spike protein-specific binding antibody levels and RBD-specific binding antibody levels from before vaccination to each subsequent time point Time: Through 2 years after the final doseDescription: As measured at the central laboratory
Measure: GMR of the geometric mean of SARS-CoV-2-specific WT serum neutralizing titers to the geometric mean of SARS CoV 2 (spike protein and RBD) specific binding antibody levels Time: Through 2 years after the final doseDescription: Per 1000 person-years of follow-up
Measure: Confirmed COVID-19 incidence Time: From the last dose of study intervention to the end of the study, up to 2 years2 A Multi-site, Phase I/II, 2-Part, Dose-Escalation Trial Investigating the Safety and Immunogenicity of Four Prophylactic SARS-CoV-2 RNA Vaccines Against COVID-2019 Using Different Dosing Regimens in Healthy Adults
The trial has two parts: a dose-finding part (Part A) with four dose cohorts (treatment groups) for each vaccine and one pre-defined and one optional dose level for a de-escalation approach and, a second part (Part B) dedicated to recruit expansion cohorts with dose levels which are selected from data generated in Part A. The vaccines BNT162a1, BNT162b1, and BNT162b2 will be administered using a Prime/Boost (P/B) regimen. The vaccine BNT162c2 will be administered using a Single dose (SD) regimen.
NCT04380701 Infections, Respiratory Virus Diseases Infection Viral Vaccine Adverse Reaction RNA Virus Infections Biological: BNT162a1 Biological: BNT162b1 Biological: BNT162b2 Biological: BNT162c2 MeSH:Infection Communicable Diseases Respiratory Tract Infections RNA Virus Infections Virus Diseases
HPO:Respiratory tract infection
Primary Outcomes
Measure: Solicited local reactions at the injection site (pain, tenderness, erythema/redness, induration/swelling) recorded up to 7±1 days after each immunization. Time: up to 7 days following each dose administration
Measure: Solicited systemic reactions (nausea, vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, loss of appetite, malaise, and fever) recorded up to 7±1 days after each immunization. Time: up to 7 days following each dose administration
Description: For BNT162a1, BNT162b1, BNT162b2 (P/B): occurring up to 21±2 days after the prime immunization.
Measure: The proportion of subjects with at least 1 unsolicited treatment emergent adverse event (TEAE): Time: 21 days following dose administration
Description: For BNT162a1, BNT162b1, BNT162b2 (P/B): occurring up to 28±4 days after the boost immunization.
For BNT162c2 (SD): The proportion of subjects with at least 1 unsolicited TEAE occurring up to 28±4 days after the immunization.
Measure: The proportion of subjects with at least 1 unsolicited treatment emergent adverse event (TEAE): Time: 28 days following dose administration
Secondary Outcomes
Description: Functional antibody responses at 7±1 days and 21±2 days after primary immunization and at 21±2 days, 63±5 days, and 162±7 days after the boost immunization.
Measure: For BNT162a1, BNT162b1, BNT162b2 (P/B): Time: up to 162 days following dose administration
Description: Fold increase in functional antibody titers 7±1 days and 21±2 days after primary immunization and at 21±2 days, 63±5 days, and 162±7 days after the boost immunization.
Measure: For BNT162a1, BNT162b1, BNT162b2 (P/B): Time: up to 162 days following dose administration
Description: Number of subjects with seroconversion defined as a minimum of 4-fold increase of functional antibody titers as compared to baseline at 7±1 days and 21±2 days after primary immunization and at 21±2 days, 63±5 days, and 162±7 days after the boost immunization.
Measure: For BNT162a1, BNT162b1, BNT162b2 (P/B): Time: up to 162 days following dose administration
Description: Functional antibody responses at 7±1 days, 21±2 days, 42±3 days, 84±5 days, and 183±7 days after the primary immunization.
Measure: For BNT162c2 (SD): Time: up to 183 days following dose administration
Description: Fold increase in functional antibody titers at 7±1 days, 21±2 days, 42±3 days, 84±5 days, and 183±7 days after the primary immunization.
Measure: For BNT162c2 (SD): Time: up to 183 days following dose administration
Description: Number of subjects with seroconversion defined as a minimum of 4-fold increase of functional antibody titers as compared to baseline at 7±1 days, 21±2 days, 42±3 days, 84±5 days, and 183±7 days after the primary immunization.
Measure: For BNT162c2 (SD): Time: up to 183 days following dose administration
Related HPO nodes (Using clinical trials)
HP:0011947: Respiratory tract infection
Genes 645
CCDC103 GATA6 IL2RG COL13A1 NCF4 DNAI1 EPG5 CSPP1 RYR1 ABCA12 CACNA1B IL2RG POLR3A DNAAF2 TRAIP CLCA4 JAK3 SOX11 OFD1 IL17RC SLC12A6 IGHM TCTN3 NECTIN1 INSR IER3IP1 GAS8 DCLRE1C BCR NOTCH3 CLEC7A PSAP VPS33A LRRC56 PWRN1 ATM TGFB1 BCL10 RAG2 CCDC39 CD8A NKX2-1 OCRL DNAH11 CHD7 TINF2 FOXP3 RANBP2 CR2 RNU4ATAC SETBP1 CD3D MALT1 PLP1 HYDIN SPAG1 TAP2 AGA IRAK4 DNAH9 NELFA IL7R TNFSF12 RUNX2 DNAAF4 IL17RA ADA DNAI2 DNAH5 GRHL3 FOXP1 ATP6V0A2 DNAH1 LCK DNAI1 SMARCA4 ORC6 ELP1 MASP2 DCLRE1C SLC5A7 RSPH3 MTHFD1 NIPAL4 G6PC3 CCNO IRF8 CHAMP1 SLC52A3 CCDC39 PIK3CD SDCCAG8 NHP2 EPM2A SCNN1A MYSM1 CD81 TNFSF12 UNC119 CCDC65 ARMC4 RAG1 ARID2 LRBA NCF2 SMN1 CDCA7 FLNA DCLRE1C RMRP TBC1D23 TPM3 NFKB2 DSG1 NKX2-1 SFTPA2 SMPD1 UBE2A RAG2 FAT4 SNORD116-1 IPW MYO5A WAS CFTR KDM6A ICOS RYR1 SLC25A22 NFKB1 DNAH11 RPGR RAG1 SOX4 NCF1 ARSB NME8 ALMS1 ARMC4 DCLRE1C TSC1 STAT3 STAT3 CR2 TSC1 RAB3GAP2 GFI1 ARID1A TAF1 HACD1 ALB RNF125 ADAMTS3 UMPS LAMTOR2 LEPR SMARCB1 IDUA CARD11 LAMB2 CFTR CCDC151 USP9X LEP TECPR2 DNMT3B RSPH4A COL6A1 TNFSF11 BIRC3 RYR1 PRKDC GLB1 TYK2 PEPD HLA-DPA1 TCIRG1 LRRC56 CFTR FBLN5 SNORD115-1 TNFRSF13B SCNN1G GNPTAB CORO1A CXCR4 DNAAF6 IDUA SNX10 MED25 CFAP410 FCGR3A BTK GMNN ABCA12 RAC1 ACP5 EDARADD CD19 POLE GBA LAMA2 STAT1 LIPN NFKB2 DRC1 VPS13A WAS NFKB1 NFKB2 STK36 AK2 MGP GBA CCDC22 SLC1A4 RNF113A DNAJB13 SULT2B1 BLM TAP1 INPPL1 TNFRSF1A CFAP298 ZBTB24 PIK3R1 RPGR DNAH5 DNAL1 CFAP298 GATA2 BTK SMPD1 ICOS DCTN4 DKC1 FUCA1 DNAAF1 LIG4 CSF2RB ACADVL PRPS1 RAG1 GAS2L2 AGRN RIPK1 FMO3 SNAP25 CSF2RA PTPN22 INPPL1 ALPL MGP MAGEL2 HGSNAT DNAAF5 ELN TTC25 SLC25A1 DNAAF3 RAG2 TGFB1 FCN3 PMM2 RSPH9 CYBB SMARCE1 ASAH1 COL6A3 AICDA SLC35A1 ELANE IKBKB PGM3 CCDC40 CCDC103 ERCC2 KAT6B PEPD KRAS MCM4 CD3E COG4 SPINK5 CD19 SMARCC2 WASHC5 SLC18A3 WRAP53 KCNJ6 GLI3 STING1 MANBA DNAAF5 RFC2 MAPK1 ERCC3 CD3D WIPF1 MS4A1 TERC TGFB1 B2M POLA1 SHROOM4 NBN BLNK CYBC1 CFB IL7R SP110 MCIDAS MYL2 CTLA4 PRTN3 IL2RB CCDC40 EP300 IFIH1 ATM CHAT SCN10A KIF1A GNPTAB CRELD1 DNAJB13 TERT SCNN1B JAK3 ZMYND10 MKRN3-AS1 TPM2 CD247 DOCK8 MBTPS2 SCNN1A TRAF3IP2 PRKCD ACTA1 RSPH4A NGLY1 FLI1 COLQ LETM1 NFE2L2 CCNO RSPH1 TBCE VAMP1 TPP2 SAMD9L ZBTB24 ZAP70 CD3G NR2F2 OSTM1 LAMTOR2 TK2 GUSB CARMIL2 NRAS LRRC8A ARID1B CTCF SELENON LIMK1 GAA SLC46A1 CHRM3 TBL2 MYSM1 DNAI2 SLC29A3 RELB SDR9C7 CD3E NADK2 SPAG1 COL11A2 TNFRSF13C SFTPC RSPH3 SCNN1G IL2RG SH3KBP1 CD79B SRP54 EPG5 ICOS FCGR2A BACH2 UBB AFF4 MAP3K20 KIAA0586 IL7R HPS6 HERC2 TERT GSN RFX5 ERF IKBKB IL17RA SCNN1G LEPR CLCN7 SCN11A DPM2 NCF2 AFF4 EXOSC9 TRPS1 CCBE1 MYH3 ELANE NME8 COG6 CASP8 CARD11 DNAAF4 SLC35C1 DNAAF1 DPF2 KMT2D CD79A CLIP2 USB1 PYROXD1 LYST CCDC114 NBN BLNK TIRAP RFXAP PCGF2 TCF3 MECP2 CTSC TAPBP DNAAF2 NOTCH2 RSPH1 HLA-DPB1 GNS CD81 PGM3 SCNN1B ADA EGFR NCF4 GTF2E2 STAT1 PARN CCDC114 CFI RFXANK TNFRSF13C IL21R MSN TNFRSF13B RFXANK TBC1D24 SLC25A24 SGSH PTPN22 GATA4 PNP NFIX USB1 TSC2 CIITA IDUA GALNS RFXAP ADA DNMT3B RAG2 ITGA3 CFAP300 STX1A EHMT1 ITGA7 ADNP NGLY1 BTK MYO9A TTC25 SPEF2 IL2RG NCF1 ROR2 SCN9A SCNN1A TNFRSF13C MKRN3 NSD2 GTF2H5 ZNHIT3 TARS1 CXCR4 PIK3R1 RTEL1 TRIP11 CD55 OFD1 FOXJ1 HELLS ZMYND10 CYP4F22 NDN ALOXE3 COG4 NFKBIA AP3D1 CD79A PLEC SFTPC GAS2L2 MPLKIP RAG1 ALOX12B IGH RAG1 USP9X PIGN ALMS1 XIAP GBA NXN TFRC TSC2 ACTA1 PNP TNFRSF11A PCNT CD79B HLA-B GTF2I SH2D1A IL21 SMARCD2 ZAP70 RNU4ATAC DNAAF3 IL2RA P4HTM AGA ARID1B RSPH9 SAMD9 IGLL1 GUSB TNFRSF13B LTBP3 CYBA ASAH1 NPM1 IKZF1 CYBA KIAA0556 RFX5 MS4A1 ALG12 JAGN1 SLC26A2 CR2 NAGLU NSMCE3 PLG UNG CFAP221 SGCG COL13A1 DNAAF6 SIK1 LYST SNRPN TRIP4 PWAR1 ECM1 MESP2 TGM1 COL11A2 IRAK4 TCIRG1 TBC1D24 TIMM8A SELENON CD19 RAG2 IKBKG DLL3 MUC5B IL17F NPAP1 ELP1 BAZ1B HYDIN CTLA4 ZNF341 CIITA EXTL3 KPTN CACNA1C XIAP PEX13 PLCG2 COL6A2 CYBB PIK3R1 CTC1 LRRC6 NOP10 RNF168 IFNGR1 GAS8 CFTR PLOD1 SYT2 IGHM PANK2 WDR19 PTPRC MESP2 FOXP1 FLNA TBCD IGLL1 CRKL VPS33A SMN1 NIPBL LEP WDR34 SCNN1B NHLRC1 CCDC151 DOCK8 LRRC6 GTF2IRD1 CREBBP TBX6 DDR2 CCDC65 Protein Mutations 1
H275Y SNP 0
Primary Outcomes
Measure: Solicited local reactions at the injection site (pain, tenderness, erythema/redness, induration/swelling) recorded up to 7±1 days after each immunization. Time: up to 7 days following each dose administrationMeasure: Solicited systemic reactions (nausea, vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, loss of appetite, malaise, and fever) recorded up to 7±1 days after each immunization. Time: up to 7 days following each dose administration
Description: For BNT162a1, BNT162b1, BNT162b2 (P/B): occurring up to 21±2 days after the prime immunization.
Measure: The proportion of subjects with at least 1 unsolicited treatment emergent adverse event (TEAE): Time: 21 days following dose administrationDescription: For BNT162a1, BNT162b1, BNT162b2 (P/B): occurring up to 28±4 days after the boost immunization. For BNT162c2 (SD): The proportion of subjects with at least 1 unsolicited TEAE occurring up to 28±4 days after the immunization.
Measure: The proportion of subjects with at least 1 unsolicited treatment emergent adverse event (TEAE): Time: 28 days following dose administrationSecondary Outcomes
Description: Functional antibody responses at 7±1 days and 21±2 days after primary immunization and at 21±2 days, 63±5 days, and 162±7 days after the boost immunization.
Measure: For BNT162a1, BNT162b1, BNT162b2 (P/B): Time: up to 162 days following dose administrationDescription: Fold increase in functional antibody titers 7±1 days and 21±2 days after primary immunization and at 21±2 days, 63±5 days, and 162±7 days after the boost immunization.
Measure: For BNT162a1, BNT162b1, BNT162b2 (P/B): Time: up to 162 days following dose administrationDescription: Number of subjects with seroconversion defined as a minimum of 4-fold increase of functional antibody titers as compared to baseline at 7±1 days and 21±2 days after primary immunization and at 21±2 days, 63±5 days, and 162±7 days after the boost immunization.
Measure: For BNT162a1, BNT162b1, BNT162b2 (P/B): Time: up to 162 days following dose administrationDescription: Functional antibody responses at 7±1 days, 21±2 days, 42±3 days, 84±5 days, and 183±7 days after the primary immunization.
Measure: For BNT162c2 (SD): Time: up to 183 days following dose administrationDescription: Fold increase in functional antibody titers at 7±1 days, 21±2 days, 42±3 days, 84±5 days, and 183±7 days after the primary immunization.
Measure: For BNT162c2 (SD): Time: up to 183 days following dose administrationDescription: Number of subjects with seroconversion defined as a minimum of 4-fold increase of functional antibody titers as compared to baseline at 7±1 days, 21±2 days, 42±3 days, 84±5 days, and 183±7 days after the primary immunization.
Measure: For BNT162c2 (SD): Time: up to 183 days following dose administration