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Report for Clinical Trial NCT00751777

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Immunogenicity and Safety of a Two Vaccination Regimen With an LT Vaccine Patch in Healthy Adults

To evaluate and compare the immune responses and safety following a two vaccination regimen by transcutaneous immunization with heat-labile enterotoxin of E. coli (LT) patches or placebo patches.

NCT00751777 Prevention of Travelers' Diarrhea
MeSH:Dysentery Diarrhea
HPO:Diarrhea

2 Interventions

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

Description: Travelers' Diarrhea Vaccine System
Type: Biological
Group Labels: 1

Group 1: 37.5 µg LT patch

Name: Placebo

Description: Travelers' Diarrhea Vaccine System
Type: Biological
Group Labels: 1

Group 2: 0 µg LT patch (placebo)


Primary Outcomes

Measure: Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo

Time: Day 0, Day 14, Day 21, Day 28, Day 35, Day 90, Day 194

Description: GMFRs relative to the baseline titer were determined at each post-baseline time point. All GMFRs were based on log10-transformed data.

Measure: Geometric Mean Fold Ratio (GMFR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo

Time: Day 14, Day 21, Day 28, Day 35, Day 90, Day 194

Description: Definition of SCR: Seroconversion IgG: ≥ 2-fold rise of LT IgG titer relative to baseline Seroconversion IgA: ≥ 4-fold rise of LT IgA titer relative to baseline

Measure: Seroconversion (SCR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo

Time: Day 14, Day 21, Day 28, Day 35, Day 90, Day 194

Secondary Outcomes

Description: LT subjects (Group 1) were followed for six months longer (until Day 380) than Placebo subjects (Group 2) (until Day 194)

Measure: Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch

Time: 13 months

Measure: Evaluation of Residual LT in the Patch and on the Skin at the Patch Site Post-wear

Time: 1 month

Description: GMT

Measure: Evaluation of LT-specific Immune Responses One-year After Original Treatment Regimen in LT Patch Group

Time: 13 months

Description: GMFR

Measure: Evaluation of LT-specific Immune Responses One Year After Original Treatment Regimen in LT Patch Group

Time: 13 months

Description: SCR

Measure: Evaluation of LT-specific Immune Responses One Year After Original Treatment Regimen in LT Patch Group

Time: 13 months

Purpose: Prevention

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 R192G

Exclusion Criteria: - 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 or within 90 days after first vaccination - Donated blood or blood products such as plasma within 30 days prior to planned date of first vaccination or within 90 days after first vaccination - 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:
HP:0002014: Diarrhea
Genes 355
MEFV JAK3 IL2RG CD247 NCF4 PIGT IL2RG MYO5B PMM2 GALT JAK3 MYO5B ITGA2 PTEN ABCB4 USP7 CD40LG IGHM HEXB MLYCD SKIV2L TTC37 TMPRSS15 DCLRE1C MC2R ZAP70 KIF1B NOD2 IL6 ABCC8 HSD3B7 PRKN EFL1 SLC12A3 CARMIL2 POLG LRRC8A ANTXR2 ATP8B1 OTULIN SNCA WNT2B MRAP SLC46A1 CHD7 SERPING1 FOXP3 UCP2 IGKC CPOX ABCB11 IRAK1 CD3D DAXX UCHL1 VPS13C SLC9A3 SMAD4 TSHR SCNN1G CD79B DDC DGAT1 SRP54 ANTXR2 SLC12A1 IL7R BMPR1A BMPR1A AKR1D1 SMAD4 SLC39A4 ICOS ADA DNASE1L3 IL7R GATA6 GREM1 ITGB4 EPCAM B2M ALG3 RFX5 ARX LCK ELP1 DCLRE1C CLCNKB SERPING1 EDN3 MVK LIG4 GINS1 TYMP KRAS PALB2 ELANE CASP8 SCNN1A MCM6 CYP11B2 CD79A PODXL CFH SMAD4 SERPING1 HTRA2 LRBA ACADM SLC5A1 NEUROG3 NBN FBP1 BLNK ITGA2B RET RFXAP DCLRE1C ALG8 SLC26A3 RMRP TCF3 C5 TSHR MEN1 PLVAP RECQL4 ACTG2 EDNRB CDKN2B RET GNS SLC10A2 LCT SCNN1B RAG2 DBH ADA EGFR STAT1 TTC37 STAR WAS RFXANK ALDOB IL21R RFXANK SGSH CDKN1A RFX6 POLG KIF23 PARK7 ACSF3 TTR ATP7A ACSF3 RAG1 TTR CIITA IDUA RFXAP ADA DNMT3B RAG2 NLRC4 CR2 BTK C1R GFI1 LIPA IL2RG TNFRSF13C ATRX SON ACVRL1 SKIV2L PIK3R1 SAR1B KCNJ11 SLC46A1 CD55 TERT SLC7A7 MEN1 COG4 SAA1 GDNF ACAT1 NEUROG3 NAXD SCN11A ITCH CD79A CDKN1B GLA RNF113A RAG1 MGME1 SAR1B ETHE1 RAG1 NNT TLK2 GUCY2C BTK TFRC SMAD4 NHLRC2 CD19 KCNJ1 MVK ETHE1 CLMP STAT4 MVK PHKB IL10RA BRCA2 STAT1 CD79B HLA-B MGME1 SLC39A4 WAS IL21 SMARCD2 SEMA3D AK2 ZAP70 TREH GP1BB IL2RA HMGCL TCN2 BLM TNFRSF1A AGA SUGCT TYMP SLC25A13 MYD88 SAMD9 TNFRSF13B LIPA HPS1 COG6 IKZF1 SLC7A7 NOD2 BTK MPI LRRK2 HMBS RFX5 PPP2R5D ITGA6 CFHR1 ICOS BMPR1A LIG4 TXNRD2 ITGB3 CR2 RAG1 PCSK1 SDHD NAGLU RIPK1 OPLAH AIRE CDKN1B DNAJC6 ERCC2 ALAD HYOU1 HGSNAT C1QA TP53 PPP2R5D AP1S1 CYP27A1 RAG2 SEMA3C RECQL4 CFHR3 SCN9A BMPR1A AVP CCDC47 TCIRG1 RAG2 MAOA RRM2B IKBKB CTLA4 DES PINK1 PKP1 NR3C2 CYP7B1 CIITA SI HADH ADAM17 FOXP3 CPT1A G6PC CD3E PALLD COG4 SPP1 CD247 PIK3R1 STX3 HNF1A NAGS TTC7A TTC7A RNF168 ECE1 PLEC APC HNF4A SLC19A2 IFNGR1 CD3D WIPF1 SLC25A13 SPINT2 NRTN NSUN2 TGFB1 POLA1 NBN IGHM CDKN2A MPV17 BLNK IDS IL7R SP110 F5 PTPRC CDKN2C IGLL1 IL2RB BTD HMGCS2 ENG BRCA1 ENG CD109 CYP27A1 GP1BA
Protein Mutations 1
R192G
SNP 0