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Report for Clinical Trial NCT00565461

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 2, Randomized, Open-Label Study to Compare the Immunogenicity and Safety of a Self-Administered LT Vaccine Patch With an LT Vaccine Patch Administered by a Clinician

To evaluate the immune responses achieved following self-administered heat-labile enterotoxin of E. coli (LT) vaccination by transcutaneous immunization compared to the immune responses achieved by clinician-administered vaccination.

NCT00565461 Prevention of Travelers' Diarrhea
MeSH: Diarrhea
HPO: Diarrhea

1 Interventions

Name: heat-labile enterotoxin of E. coli (LT)

Description: 37.5ug patch applied on either the deltoid or the thigh

Type: Biological

Group 1 Group 2 Group 3 Group 4


Primary Outcomes

Description: The primary endpoint of this trial was to compare the immunogenicity (i.e., GMTs, GMFRs and seroconversion rates for LT IgG and IgA) of subject self-administered [second] vaccination with clinician-administered [second] vaccination, using the deltoid/thigh (Vaccination 1/Vaccination 2) treatment regimen. GMT: geometric mean titer

Measure: GMTs After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.

Time: Day 0, Day 14, Day 21, Day 28, Day 35, Day 194

Description: The primary endpoint of this trial was to compare the immunogenicity (i.e., GMTs, GMFRs and seroconversion rates for LT IgG and IgA) of subject self-administered [second] vaccination with clinician-administered [second] vaccination, using the deltoid/thigh (Vaccination 1/Vaccination 2) treatment regimen. GMFR: geometric mean fold ratio GMFRs relative to the baseline titer were determined for LT IgG and LT IgA at each post-baseline time point. All GMFRs were based on log10-transformed data.

Measure: GMFR After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.

Time: Day 14, Day 21, Day 28, Day 35, Day 194

Description: The primary endpoint of this trial was to compare the immunogenicity (i.e., GMTs, GMFRs and seroconversion rates (SCR) for LT IgG and IgA) of subject self-administered [second] vaccination with clinician-administered [second] vaccination, using the deltoid/thigh (Vaccination 1/Vaccination 2) treatment regimen. seroconversion (SC): two-fold or greater rise in titer relative to Day 0 for LT IgG and a four-fold or greater rise in titer relative to Day 0 for LT IgA

Measure: Seroconversion After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.

Time: Day 14, Day 21, Day 28, Day 35, Day 194

Secondary Outcomes

Measure: Safety of Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch

Time: 6 months

Measure: Evaluation of Immunogenicity for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine.

Time: 6 months

Measure: Safety and Evaluation of Immunogenicity for Self-administration In-clinic Compared to Self-administration Away From the Clinic.

Time: 6 months

Purpose: Prevention

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 R192G

Exclusion Criteria: Subjects meeting any of the following criteria are not eligible for participation in the study: - Laboratory abnormalities [as determined by the Toxicity Grading Scale (grade 1-4)] at laboratory screening - Abnormalities at physical examination [as determined by the Toxicity Grading Scale (grade 1-4)] - Known allergies to any component of the vaccine - Known allergies to adhesives - Participated in research involving investigational product within 30 days before planned date of first vaccination - Donated blood or blood products such as plasma within the past 30 days - Ever received investigational enterotoxigenic E. coli, LT, or LT (R192G) or NasalFlu, Berna Biotech, Ltd - Ever received cholera toxin or vaccine (e.g. --- R192G ---



HPO Nodes


HPO:
Diarrhea
Genes 352
PCSK1 MPV17 SON AK2 CYP27A1 HNF1A ERCC2 BTK LIG4 STX3 PALLD TCIRG1 RNF168 TYMP GREM1 ANTXR2 IGKC GINS1 RFX5 TERT PTEN PKP1 WIPF1 SLC25A13 RFXANK TYMP HYOU1 HLA-B CPT1A ENG FBP1 SERPING1 BMPR1A TGFB1 MAOA SDHD ACTG2 HMGCL CD55 TREH IDS STAT4 CDKN2B TLK2 PMM2 WAS BMPR1A DNAJC6 C5 AP1S1 SCNN1B CD247 CDKN2C TSHR BMPR1A GFI1 NBN ITGA2 ENG HSD3B7 NAXD RFXANK IFNGR1 NOD2 SUGCT NOD2 HEXB IL21R RFXAP TTC7A SLC39A4 IL2RB DDC CYP7B1 STAT1 ABCC8 ANTXR2 RIPK1 OPLAH RECQL4 SLC9A3 SMAD4 PHKB RAG2 LCT ALG8 MLYCD SLC7A7 ALDOB SLC19A2 MYD88 CCDC47 GLA IDUA GP1BA SI BRCA2 BTD SERPING1 CPOX NEUROG3 IL10RA CIITA SEMA3C ABCB4 ADA PLVAP UCHL1 SAMD9 SCNN1G ALAD WNT2B CIITA TNFRSF1A IL7R LCK ICOS MEN1 RET MEFV PARK7 NAGLU PIGT RAG2 COG4 SCNN1A IGHM SLC46A1 PLEC ETHE1 PTPRC LIG4 TP53 BLM ACAT1 SLC10A2 MC2R RFX5 RAG2 ITCH DNASE1L3 CFH EGFR IL2RG COG6 CYP11B2 TTR PODXL SLC39A4 ELP1 HTRA2 RNF113A ACSF3 HGSNAT CD3E ADA ATP7A TCF3 MEN1 MYO5B ACADM SLC26A3 AVP SEMA3D ZAP70 TSHR SAR1B IGHM AGA TCN2 CDKN2A NBN POLG MCM6 ADAM17 DGAT1 DES ECE1 TTC37 CD247 NAGS CFHR1 SLC7A7 NRTN BLNK TXNRD2 BLNK CR2 ATP8B1 ITGB4 RAG1 SNCA TTC37 ARX GNS SERPING1 CD79B RAG1 GP1BB VPS13C CD79A TFRC EFL1 NNT UCP2 SRP54 NLRC4 FOXP3 RET LRBA KIF1B CD3D MYO5B CYP27A1 KRAS TNFRSF13B C1R LIPA DCLRE1C DBH DCLRE1C SKIV2L PRKN LRRC8A ICOS NSUN2 CTLA4 CARMIL2 ITGB3 IL7R LIPA GATA6 HMBS SMAD4 EDNRB TTC7A SKIV2L JAK3 G6PC IL2RG CASP8 RFX6 RAG1 PINK1 CLMP IGLL1 HPS1 ITGA2B IL21 SPP1 TNFRSF13C JAK3 ABCB11 CD79A IL7R IL6 CDKN1A GALT BRCA1 EPCAM POLA1 CD19 CFHR3 CR2 STAT1 CD3D FOXP3 SPINT2 GDNF AIRE GUCY2C NHLRC2 AKR1D1 WAS MPI DCLRE1C IL2RA IKBKB KCNJ1 SGSH SP110 SAR1B MVK IKZF1 ATRX SAA1 SMAD4 STAR DAXX MRAP SLC12A3 BTK POLG MVK EDN3 CD109 OTULIN HNF4A SLC5A1 NCF4 COG4 RAG1 PIK3R1 SLC46A1 CDKN1B CHD7 SLC12A1 MGME1 HADH SMARCD2 B2M C1QA CD40LG BTK TMPRSS15 LRRK2 ZAP70 APC CD79B TTR ALG3 NR3C2 RECQL4 ITGA6 RAG2 SMAD4 IRAK1 RFXAP ACSF3 ELANE BMPR1A KCNJ11 IL2RG PALB2 SCN11A ACVRL1 ADA PIK3R1 MGME1 SCN9A MVK HMGCS2 CLCNKB CDKN1B SLC25A13 NEUROG3 RMRP RRM2B KIF23 ETHE1 DNMT3B PPP2R5D