SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT00090688

Developed by Shray Alag, 2019.
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 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