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Report for Clinical Trial NCT00090688

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Safety and Immunogenicity of Oral Microencapsulated CS6 Vaccine and LT(R192G) Adjuvant in Volunteers

The study will enroll approximately 60 volunteers. The vaccine is given as a drink in flavored soda water. Volunteers will either receive a 3-dose vaccination with doses spaced two weeks apart or a 4-dose vaccination with doses spaced 2 days apart depending upon their availability for follow-up. Once assigned to a vaccination schedule, volunteers will be randomly assigned to receive the meCS6 vaccine with or without the mLT adjuvant for all vaccine doses. Neither the study investigators nor the volunteers will know which group they are assigned. Volunteers will be asked to be available for clinic visits and telephone follow-ups during the study period and provide blood and stool specimens for testing.

NCT00090688 Diarrhea
MeSH:Diarrhea
HPO:Diarrhea

1 Interventions

Name: meCS6 + LT(R192G)

Type: Biological


Primary Outcomes

Measure: Safety

Measure: Mucosal Immunogenicity

Measure: Systemic Immunogenicity

Purpose: Prevention

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 R192G

Safety and Immunogenicity of Oral Microencapsulated CS6 Vaccine and LT(R192G) Adjuvant in Volunteers. --- R192G ---

Phase 1 meCS6 + LT(R192G) Vaccine Study The study will enroll approximately 60 volunteers. --- R192G ---

Inclusion Criteria: - Available for required follow-up period - Women must have a negative pregnancy test - Women must not to try to become pregnant while on study and for 2 months after study is completed Exclusion Criteria: - History of travellers' diarrhea - Occupation that involves handling of E. coli or cholera bacteria, or E. coli vaccine - Regular use of anti-diarrheal, anti-constipation, or antacid therapy - Abnormal bowel habits - Pregnant or nursing women - History of chronic gastrointestinal illness or major gastrointestinal surgery - Allergies to vaccines - Positive HIV, Hepatitis B or Hepatitis C tests - Regular use of oral steroid medication - Clinically significant abnormalities on physical examination Inclusion Criteria: - Available for required follow-up period - Women must have a negative pregnancy test - Women must not to try to become pregnant while on study and for 2 months after study is completed Exclusion Criteria: - History of travellers' diarrhea - Occupation that involves handling of E. coli or cholera bacteria, or E. coli vaccine - Regular use of anti-diarrheal, anti-constipation, or antacid therapy - Abnormal bowel habits - Pregnant or nursing women - History of chronic gastrointestinal illness or major gastrointestinal surgery - Allergies to vaccines - Positive HIV, Hepatitis B or Hepatitis C tests - Regular use of oral steroid medication - Clinically significant abnormalities on physical examination Diarrhea Diarrhea The Phase 1 section of this study is a randomized double blind trial in which a total of 60 subjects (minimum of 52 allowable) will receive on of two oral vaccine doses according to the following chart: Group Subset N CS6(Encapsulated) LT(R192G) I A 15 0.95mg 2 micrograms II B 15 0.95mg -- III A 15 0.95mg 2 micrograms IV B 15 0.95mg -- *minimum of 13 volunteers/group Volunteers in Group I will receive three immunizations (study days 0, 14, and 28) during the vaccine series. --- 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