Healthy volunteers (prevention of diarrheal disease due to infection with enterotoxigenic E. coli [ETEC]) MedDRA version: 21.1 Level: LLT Classification code 10054983 Term: Prophylaxis against traveller's diarrhea System Organ Class: 100000004865 MedDRA version: 20.1 Level: LLT Classification code 10022665 Term: Intestinal infection due to enterotoxigenic E. coli System Organ Class: 100000004862
Conditions
Interventions
Product Name: ETVAX
Product Code: Wet formulation
Pharmaceutical Form: Oral suspension
INN or Proposed INN: Not known
Other descriptive name: ESCHERICHIA COLI (INACTIVATED)
Concentration unit: billion
Sponsors
Scandinavian Biopharma Holding AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female aged 18-50 years, inclusive at the time of signing the informed consent. • Healthy constitution as established by medical history and physical examination. • Willing and able to give written informed consent for participation in the study • Able to comply with study activities, as judged by the Investigator. • Female Participants: Women of child-bearing potential (for definition see Section 9.3.6): - Have to agree to use an acceptable birth control method during participation in the investigation (see Section 9.3.6). - A negative pregnancy test (beta human chorionic gonadotropin dipstick test in urine) at Visit 2/Day 1 will be required. • Male Participants: - Have to agree to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 280 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • An acute or chronic medical condition that, in the opinion of the investigator/physician, would render ingestion of the investigational products unsafe or would interfere with the evaluation of responses. This includes, but is not limited to gastrointestinal diseases, and autoimmune diseases. • Current malignancy or history of malignancy during the last five years, based on anamnesis. • Gastroenteritis within two weeks prior to vaccination. • Regular use of laxatives, antacids or other agents that lower stomach acidity. • Any planned major surgery during the duration of the study. • After 10 minutes supine rest, any vital signs outside the following ranges: -Systolic BP > 160 mm Hg -Diastolic BP > 100 mm Hg -Heart rate 85 beats per minute • Antibiotic therapy within two weeks prior to the vaccination. • Known Hepatitis A, B, C, and/or HIV infection. • Concomitant intake of immunomodulating drugs during the study period or less than three months prior to the first immunization. Local anti-histamine treatment is however allowed. • Any other significant medical conditions (e.g. poorly controlled psychiatric condition) judged by the Investigator to preclude entry. • Intends to receive any other vaccine during the study period, or within two weeks prior to trial vaccination. • Has previously received Dukoral or any type of enterotoxigenic Escherichia coli (ETEC) or cholera vaccines. • Brought up in ETEC-endemic areas (e.g., urban and rural areas of Central and South America, Caribbean, most countries in Asia, Africa, etc.). • Has travelled to ETEC-endemic areas within the last 3 years OR spent > two months in ETEC endemic areas during the last 10 years. • Intends to travel to ETEC endemic countries during the study period. • Known or suspected history of drug, chemical or alcohol abuse, as deemed by the investigator/physician. • History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to ETVAX®. • Participation in any other clinical study that included drug treatment with the last administration within the past 3 months prior to administration of treatment in this study. Patients consented and screened but not dosed in previous clinical studies are not excluded • Concomitant participation in any other clinical study. • Females who are pregnant as determined by urine test at inclusion and prior to each vaccination. • Females who are nursing. • Unable to participate in all study visits. • Any condition or circumstance which would make the subject unsuitable for participation in the study in the opinion of the investigator/physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate non-inferiority, in terms of immunogenicity, between the wet formulation and the newly developed partially dried formulation of selected components of ETVAX®. ;Secondary Objective: To evaluate the safety and tolerability of the new formulation of the vaccine.;Primary end point(s): The primary endpoint to be measured for each patient in the study is response (yes/no) to a vaccine. A vaccine responder will be defined by a =2-fold increase in IgA and/or IgG antibody levels against LTB in serum between post- compared to pre-immunization samples. The response rates (seroconversion rates) of IgA and/or IgG anti-LTB antibodies in serum will be derived and compared between the two treatment groups. ;Timepoint(s) of evaluation of this end point: Serum collected prior first vaccination and 6-10 days post second vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Occurrence of solicited symptoms for six days after each vaccination (day of vaccination and five subsequent days). ;Timepoint(s) of evaluation of this end point: Adverse events will be collected at each dosing visit (Day 1 and Day 15) and the following 5 days after each vaccination (i.e. day of vaccination and five subsequent days) | — |
Countries
Sweden
Contacts
Public ContactChief Medical Officer
Scandinavian Biopharma Holding AB
Outcome results
None listed