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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:
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