There are 11 clinical trials

Clinical Trials

1 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 Biological: meCS6 + LT(R192G)

MeSH:Diarrhea

HPO:Diarrhea

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 ---

2 A Randomized, Observer-Blind, Placebo-Controlled Study to Assess the Safety and Immunogenicity of Intramuscular Inactivated Influenza A/H5N1 Vaccine Administered With and Without an Adjuvant Patch in Healthy Adults

This is a Phase 1/2, randomized, observer-blind, placebo-controlled clinical trial. A maximum of 500 eligible subjects in 10 groups will be enrolled, randomized and vaccinated in this study. Subjects will receive an intramuscular injection of either the influenza A/H5N1 (low, medium or high dose) or placebo on Day 0 and Day 21 with or without a patch. This study will be performed in two parts. In Part 1, an initial safety evaluation will be performed in 100 randomized subjects. A Safety Review Committee (SRC)will review all safety data, including laboratory values, through the Day 7 visit, and compare those data against Stopping Criteria. If the treatments are considered safe, Part 2 of the study will be initiated and a second vaccination will be administered to subjects in Part 1 on Day 21. In Part 2, the remaining 400 subjects will be randomized, treated, and will follow the same visit structure and protocol-defined requirements as subjects in Part 1, without the additional laboratory safety measurements. An SRC review will also be performed of all safety data through the Day 28 visit for subjects participating in Part 1.

NCT00532792 Pandemic Influenza Biological: A/H5N1 Biological: A/H5N1 Biological: A/H5N1 Biological: A/H5N1 Biological: A/H5N1 Biological: A/H5N1 Biological: A/H5N1 Biological: A/H5N1 Biological: A/H5N1 Biological: Placebo

MeSH:Influenza, Human Influenza in Birds

Acceptable forms of birth control are: abstinence, hormonal contraceptives (oral, injectable, implant, patch, ring), double-barrier contraceptives (condom or diaphragm, with spermicide), and IUD 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 egg protein allergy - Known allergies to adhesives - Known disturbance of coagulation - Participated in research involving investigational product within 45 days before planned date of first vaccination - Donated or received blood or blood products such as plasma within the past 45 days - Received any licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to planned date of 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 ---

3 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' Diar Prevention of Travelers' Diarrhea Biological: heat-labile enterotoxin of E. coli (LT)

MeSH:Diarrhea

HPO:Diarrhea

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 ---

4 Randomized, Double-Blinded, Placebo-Controlled, Dose Ranging Study to Assess the Immunogenicity and Safety of LT Application in Healthy Adults

The main purpose of this study is to evaluate the body's immune response to the LT patch at different doses. The secondary purpose of this study is to evaluate the safety of the LT patches at different doses and the safety of the skin preparation system. Another secondary purpose is to compare the safety and the body's immune response to LT patches placed on the upper arm versus the lower back.

NCT00672035 Traveler's Diarrhea Biological: Biological: heat-labile enterotoxin of E. coli (LT)

MeSH:Diarrhea

HPO:Diarrhea

- Ever received investigational enterotoxigenic E. coli, LT, or LT(R192G) or NasalFlu, Berna Biotech, Ltd. - Ever received cholera toxin or vaccine (e.g. --- R192G ---

5 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 Biological: heat-labile enterotoxin of E. coli (LT) Biological: Placebo

MeSH:Dysentery Diarrhea

HPO:Diarrhea

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 ---

6 A Randomized Blinded, LT Dose-ranging Study to Assess the Immunogenicity and Safety of Different Doses of LT Adjuvant Patch Administered in Conjunction With Different Doses of Inactivated Influenza A/H5N1 Vaccine in Healthy Adults

This is a Phase 2, randomized, blinded, clinical trial. Up to 500 eligible subjects will be enrolled and randomized in a 1:2:2:1:2:2 ratio into one of six groups, and vaccinated in this study. Subjects will receive an intramuscular injection of the influenza A/H5N1 (low or high dose) on Day 0 with or without a patch (low or high dose).

NCT00908687 Pandemic Influenza Biological: A/H5N1 Biological: A/H5N1 Biological: LT Adjuvant Patch Biological: LT Adjuvant Patch

MeSH:Influenza, Human

Acceptable forms of birth control are: abstinence, hormonal contraceptives (oral, injectable, implant, patch, ring), double-barrier contraceptives (condom or diaphragm, with spermicide) and IUD Exclusion Criteria: - Clinically significant laboratory abnormalities at screening - Abnormalities at physical examination [as determined by the Toxicity Grading Scale (grade 1-4)] - Known allergies to any component of the vaccine - Known egg protein allergy - Known allergies to adhesives - Known disturbance of coagulation - Participated in research involving investigational product within 45 days before planned date of vaccination - Donated or received blood or blood products such as plasma within the past 45 days - Received any licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to planned date of vaccination - Ever received investigational enterotoxigenic E. coli, or LT (R192G) or NasalFlu, Berna Biotech Ltd - Ever received cholera toxin or vaccine (e.g. --- R192G ---

7 A Phase 2, Gender-Stratified, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of a Two Vaccination Regimen With the Travelers' Diarrhea Vaccine System in Healthy Adults

The purpose of this study is to evaluate and compare the safety and immune responses following a two vaccination regimen by transcutaneous immunization with heat-labile enterotoxin of E. coli (LT) patches or Placebo, with or without alcohol swabbing

NCT01067781 Diarrhea Biological: Heat-Labile Enterotoxin of E. coli (LT) Biological: Placebo

MeSH:Diarrhea

HPO:Diarrhea

Exclusion Criteria: 1. Abnormalities at physical exam [as determined by the Toxicity Grading Scale (Grade 1-4)]; 2. Laboratory abnormalities [as determined by the Toxicity Grading Scale (Grade 1 4)] at screening; 3. Participated in research involving investigational product within 30 days before planned date of first vaccination; 4. Ever received investigational enterotoxigenic E. coli, LT, or LT (R192G) or NasalFlu, Berna Biotech, Ltd; 5. Women who are pregnant or breastfeeding; 6. Clinically significant underlying enteric, pulmonary, cardiac or renal disease; 7. Current seizure disorder; 8. Current use of immunosuppressive therapy (inhaled steroids are allowed); 9. Known or suspected alcohol abuse or illicit drug use within the last year; 10. --- R192G ---

8 Phase I Study to Determine the Safety and Immunogenicity of an Oral ETEC Candidate Vaccine, Attenuated, Recombinant Double Mutant Heat-Labile Toxin (dmLT) From Enterotoxigenic Escherichia Coli

The purpose of this study is to learn if a new candidate vaccine (dmLT) against ETEC (E. coli infection) is safe. This vaccine will be tested to see what effects it has on the body and the ability of the vaccine to help the body resist disease. Researchers want to find the highest dose of dmLT vaccine that can be given without causing severe side effects. Most E. coli bacteria are harmless to humans and can even be beneficial. However, some are harmful, and can cause diarrhea. About 32 healthy adults, ages 18-45, will participate in this study. This study will require volunteers to stay in the research facility for several nights. Participants will be assigned to receive 1 of 4 vaccine doses by mouth. Study procedures include: stool samples, blood samples, and documenting side effects. Participants will be involved in study related procedures for about 8 months.

NCT01147445 Gastroenteritis Escherichia Coli Biological: Double Mutant Heat- Labile Toxin (dmLT)

MeSH:Gastroenteritis

The rationale for using an E. coli heat labile enterotoxin (LT) (R192G/L211A) vaccine, also called double-mutant LT (dmLT), is that it is expected to be especially well tolerated by subjects. --- R192G ---

9 A Phase 1/2, Randomized, Open-Label, Study to Assess the Immunogenicity and Safety of a Vaccine Enhancement Patch (VEP) When Administered With Two Doses of Intramuscular Inactivated Influenza H5N1 Vaccine in Healthy Adults

Groups 1 to 3 will receive two vaccinations on Day 0 and Day 21. Group 1 will receive 3.8µg A/H5N1 antigen formulated with AS03 adjuvant, administered by IM injection. Group 2 will receive 15µg A/H5N1 by IM alone. Group 3 will also receive 15µg A/H5N1 antigen administered IM but followed by the topical application of a VEP at the vaccination site. Group 4 will receive a single vaccination on Day 0 of 30µg A/H5N1antigen by IM, followed by application of a VEP at the vaccination site. The VEP (Vaccine Enhancement Patch) contains 50 mcg LT (heat-labile enterotoxin of E. coli)

NCT01353534 Healthy Biological: A/H5N1 Antigen Drug: Vaccine Enhancement Patch

MeSH:Influenza in Birds

Exclusion Criteria: - Clinically significant laboratory abnormalities at screening - abnormalities at physical examination - known allergies to any component of the A/H5N1 antigen - known egg protein allergy - known allergies to adhesives - known coagulation disorders - use of any anticoagulant medication within 30 days prior to vaccination or planned usage during the study period - participated in research involving investigational product within 30 days before planned date of vaccination or planned participation during study period - donated or received blood or blood products such as plasma within the three months before planned date of vaccination or planned donation or use during the study period - received or planned receipt of seasonal influenza vaccine during the study period - received any licensed vaccines within 2 weeks (inactivated vaccines) or 4 weeks (live vaccines) prior to planned date of vaccination - planned receipt of any licensed vaccine during the first 42 days on study - previous or planned vaccination with any vaccine containing an oil in water emulsion adjuvant - previous or planned vaccination with pandemic vaccine against A/H5N1 or previous proven contact with A/H5N1 wild type virus - ever received investigational enterotoxigenic E. coli LT, or LT (R192G) or NasalFlu, Berna Biotech, Ltd. --- R192G ---

10 Safety, Reactogenicity, Tolerability, Immunogenicity and Efficacy of Live Attenuated ETEC ACE527 Vaccine Administered Alone or With a Double Mutant E. Coli Heat Labile Toxin (dmLT) in Healthy Adult Volunteers

This is a research study about an experimental (investigational) oral ETEC vaccine (ACE527). ACE527 is a live attenuated vaccine that is being made to prevent disease from enterotoxigenic Escherichia coli (ETEC), which causes watery diarrhea, largely in children living in developing countries and in travelers to those countries. This research study is also testing an investigational adjuvant called dmLT. An adjuvant is something that is added to a vaccine to make it work better. The purpose of this study is two-fold. First, Part A aims to find out if the vaccine by itself or the vaccine combined with the adjuvant is safe, tolerable, and initiates an immune response. Second, Part B aims to find out if the vaccine by itself or the vaccine combined with the adjuvant prevents diarrheal disease when challenged with ETEC H10407. About 60 healthy adults, ages 18-50, will participate in Part A, and they will be required to stay in the research facility for several nights for the first dose, but will not be required to stay overnight for the second and third doses. Participants will be assigned to receive either the vaccine alone, the vaccine with adjuvant, or placebo by mouth. Study procedures include: stool samples, blood samples, and documentation of side effects. Participants will be involved in study related procedures for about 8 months. Interested volunteers from Part A will along with volunteers who were never vaccinated in Part A will return to participate in Part B. These volunteers will be required to stay overnight in the research facility for several nights after challenge, after which they will be treated with antibiotics and sent home. Study procedures include stool samples, blood samples, and documentation of infection with ETEC H10407. If the vaccine with/without adjuvant is effective, the volunteers should not development diarrhea, but if the vaccine with/without adjuvant is not effective, the volunteers will have diarrhea for a few days.

NCT01739231 Diarrhea Biological: ACE527 Biological: dmLT Biological: CeraVacx placebo Biological: H10407 challenge strain

MeSH:Diarrhea

HPO:Diarrhea

LT(R192G/L211A), or dmLT, is a derivative of wild-type enterotoxigenic Escherichia coli heat-labile enterotoxin that has been genetically modified by replacing the arginine at amino acid position 192 with glycine and the leucine at amino acid position 211 with alanine. --- R192G ---

11 Phase I Evaluation of the Safety, Reactogenicity and Immunogenicity of Fractional-dose Inactivated Polio Vaccine (fIPV) Given Intradermally With Double Mutant [LT(R192G/L211A)] Enterotoxigenic Escherichia Coli Heat Labile Toxin (dmLT) Adjuvant

Polio is a serious disease that can cause paralysis and death. It is caused by a virus and can be prevented by vaccine. The World Health Organization's (WHO) Global Polio Eradication Initiative is trying to get rid of all polio disease around the world. Researchers want to help by testing a new vaccine. In many countries, people are vaccinated with oral polio vaccine (OPV) given by mouth during childhood. OPV is good at giving immunity (protection from polio) in the body and the gastrointestinal (GI) tract. Immunity in the GI tract is called mucosal immunity. The downsides of using OPV are that it can be shed into the environment in people's feces after vaccination where it can infect people who are not vaccinated, and it can cause paralysis in 2-4 of every one million children vaccinated with OPV. The United States (U.S.) stopped giving any OPV to people for vaccinations in the 1990's. Since then, a polio vaccine called inactivated polio vaccine (IPV) is given as an injection for routine childhood immunizations in the U.S. You cannot get polio infection from IPV and it will not be shed into the environment. In 2016, the WHO started a plan to help other countries gradually get rid of OPV. The downside of using IPV by itself is that, unlike OPV, it doesn't give enough mucosal immunity to protect people living in places where there is still polio. There are also supply shortages of IPV, which is a problem if there are outbreaks of polio. For the supply of IPV to help more people, it is safe and effective to use a tiny dose of IPV injected under the top layer of skin (intradermal or ID injection) rather than getting the full dose in the muscle. This is called a fractional dose of IPV, or fIPV. To help stop using OPV globally, a better fIPV vaccine is needed. fIPV vaccine needs a substance to help stimulate a mucosal immune response. dmLT is a substance that has been shown to stimulate a mucosal immune response. It has been shown to be safe and effective in both humans and animals, both by itself and when given with other vaccines. This study will test a mixture of fIPV-dmLT given intradermally (under the outer layer of the skin). This is the first study done in humans to give this combination intradermally. The IPV vaccine has already been approved by the FDA. The fIPV-dmLT vaccine has not been approved by the FDA.

NCT03922061 Polio Biological: dmLT Biological: fIPV

MeSH:Poliomyelitis

Phase I Evaluation of the Safety, Reactogenicity and Immunogenicity of Fractional-dose Inactivated Polio Vaccine (fIPV) Given Intradermally With Double Mutant [LT(R192G/L211A)] Enterotoxigenic Escherichia Coli Heat Labile Toxin (dmLT) Adjuvant. --- R192G ---

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