SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT00565461

Developed by Shray Alag, 2019.
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 251
CDKN1A HEXB PCSK1 CDKN1B IL10RA CDKN2A CDKN2B CDKN2C MYD88 SCN11A TMPRSS15 ERCC2 SAMD9 ATP7A PLVAP RNF168 GALT MAOA RIPK1 ATRX HLA-B MYO5B ACAT1 AVP B2M CYP27A1 RNF113A NAGLU CD109 MC2R AKR1D1 BLNK GATA6 CD55 ITGA6 ACTG2 TCIRG1 HMBS SRP54 NBN MCM6 DAXX IKZF1 NCF4 SLC46A1 HMGCL DBH ATP8B1 TSHR HMGCS2 NHLRC2 ITGA2 ITGA2B ACVRL1 PTEN ADA HNF4A NSUN2 ITGB3 ITGB4 DDC GDNF TTR GINS1 GFI1 MEFV STAR NAGS NLRC4 STAT1 ABCB4 MEN1 BLM JAK3 PHKB DES SAA1 BMPR1A AP1S1 STX3 FBP1 ICOS ANTXR2 PTPRC OTULIN GLA BRCA1 BRCA2 CLCNKB CIITA COG6 CCDC47 BTD KCNJ1 AGA PIK3R1 ABCC8 BTK KCNJ11 UCP2 RECQL4 HPS1 IL21 SCN9A SCNN1A SCNN1B SCNN1G PKP1 SERPING1 ACSF3 AK2 CYP7B1 ALG8 ALAD NR3C2 ADAM17 C5 PLEC NME1 ALDOB COG4 GNS DNASE1L3 SDHD OPLAH GP1BA GP1BB DNMT3B PMM2 FOXP3 MPI TLK2 KRAS MPV17 RAG1 RAG2 EFL1 HNF1A SEMA3C TCF3 SLC26A3 KIF23 ITCH CARMIL2 HYOU1 WAS WIPF1 TCN2 NRTN POLA1 SGSH RRM2B POLG ARX SLC19A2 HGSNAT APC ELP1 AIRE CASP8 SI SLC39A4 RFX6 CHD7 CPOX TXNRD2 RET LCK CPT1A IDS SLC7A7 ECE1 IDUA TYMP LCT SKIV2L CR2 SP110 RFX5 RFXAP ZAP70 PALB2 EDN3 EDNRB MLYCD SLC5A1 TFRC TTC7A IFNGR1 RMRP LIG4 SEMA3D HSD3B7 CD3D PIGT LIPA SLC9A3 CD247 PPP2R5D SLC10A2 SPINT2 SLC12A1 SLC12A3 CD19 EGFR DCLRE1C SUGCT GUCY2C TREH RFXANK ETHE1 IGHM TTC37 MRAP IL21R SAR1B IGKC NAXD CD40LG TNFRSF13C LRRC8A ABCB11 ELANE TNFRSF13B SMARCD2 CD79A CD79B CLMP ALG3 CTLA4 IGLL1 GREM1 HADH LRBA TNFRSF1A IKBKB ENG IL2RA EPCAM IL2RG G6PC NNT PALLD NEUROG3 TP53 DGAT1 MVK IL7R SMAD4 MGME1 SON