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| Name | Class |
|---|---|
| Göteborg University | OTHER |
| United Medix Laboratories Ltd. | UNKNOWN |
| Oy Medfiles Ltd | INDUSTRY |
| University of Helsinki |
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This is a Phase II b, double-blind, randomized, placebo-controlled study in healthy adults (age 18-65 years) to evaluate the safety, immunogenicity, different diagnostic tools and efficacy of ETVAX. Participants will travel to Grand Popo, Africa for 12 days. Prior travelling participants will be vaccinated with two doses of vaccine or placebo. Vaccine Preventable Outcome will be identified and then characterized as to incidence, duration, severity and frequency of Moderate or Severe Travellers diarrhea. Health related information and assessments will be recorded during the travel.
This is a Phase II b, double-blind, randomized, placebo-controlled study in healthy adults (age 18-65 years) to evaluate the safety, immunogenicity, different diagnostic tools and efficacy of two doses of ETVAX. Study participants will be recruited among students, and personnel at the University of Helsinki and Helsinki University Hospital and among those responding to recruitment advertisements. To be eligible, the participants have to commit themselves to comply with the study protocol which involves in addition to vaccination, study visits and sampling, and commitment to travel to Grand Popo, Benin and stay there for 12 days. After providing written informed consent, eligible participants will be randomized (ratio 1:1, and block randomization in groups of 6) and immunized with two doses of vaccine or placebo, given 14±7 days apart while in Finland. The last dose of vaccine will be administered at least one week before departure (and no more than 30 days prior to travel) to Benin. Eligible participants will pay four pre-travel visits (V0 + V 1-3) to Aava Travel Clinic / University of Helsinki prior to travel. They will be asked to fill in pre-travel questionnaire latest at visit 1 (Q1) and fill in an Adverse Event Form (AEF1 and AEF2) after each dose, and give blood and fecal samples and saliva before travel. The participants will go together to Benin in groups of 25-35 individuals at a time.
In Benin, the participants will be seen within 48 hours of arrival to the study site in Grand Popo. Once the participants arrive at the study site in Grand Popo, they will be provided with practical information and contact details of the study personnel. They will receive the health card (HC1) and a stool collection kit with instructions.
Diarrhea reporting, stool collection, and stool submission procedures will be reviewed with the study participants. One routine visit at day 4 is planned for review of the participant's health status and collection of a routine stool sample. Other visits will take place when and if the participant gets Travelers Diarrhea (TD) episodes for collection of study specific stool samples and health related information and assessments. If more than one diarrhea episode occurs, 48 diarrhea and symptom (TD defined symptoms) free hours must have passed between the episodes for the new episode to be counted as a separate one. One or two days prior to departure from the Grand Popo site, all participants will have a final review of their HC1s. Health Card ( HC2) will be given. After 1-6 days back in Finland the participant has to give blood and a routine stool sample and they fill in Questionnaire 2 (Q2), HC2 will be reviewed. Approx. 30 days after return to Finland the last stool and blood sample will be collected and the post-travel questionnaire (Q3) filled and HC2 reviewed. Participants who get urinary tract infection will fill in Urinary questionnaire 4 (QU4) form at the time of infection. This follow-up is valid until V5.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ETVAX | Experimental | Contains inactivated Tetravalent ETEC vaccine, 10 ug Double-mutant heat-labile toxin (dmLT) and effervescent power for oral solution administered twice 14 (plus minus 7) days intervals. |
|
| Placebo | Placebo Comparator | Effervescent power for oral solution administered wice 14 (plus-minus 7) days intervals |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E. coli ETVAX | Biological | Oral suspension Sterile water is added to dmLT . Vaccine is poured to the effervescent solution and needed amount of dmLT is added. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Number of vaccine attributable adverse events | Number of vaccine attributable adverse events | From first vaccination until leave for Benin, approximately 13-50 days |
| Immunogenicity: Fold change of serum titers of IgA and IgG against LTB | Fold change of serum titers of Immunoglobulin A (IgA) and Immunoglobulin G (IgG) against heat-labile toxin (LTB) | Change from baseline (just before first vaccination) to Visit 3 (5-6 days after second vaccination), an average of 20 days |
| Immunogenicity: Number of subjects responding to heat-labile toxin (LTB) | Number of subjects responding to heat-labile toxin (LTB) based on serum Immunoglobulin A (IgA) and Immunoglobulin G (IgG) (i.e. fold change at least 2) | Change from baseline (just before first vaccination) to Visit 3 (5-6 days after second vaccination), an average of 20 days |
| Immunogenicity: Fold change of serum titers of Immunoglobulin A (IgA) and Immunoglobulin G (IgG) against O78 lipopolysaccharide (LPS) | Fold change of serum titers of Immunoglobulin A (IgA) and Immunoglobulin G (IgG) against O78 lipopolysaccharide (LPS) | Change from baseline (just before first vaccination) to Visit 3 (5-6 days after second vaccination), an average of 20 days |
| Immunogenicity: Number of subjects responding to O78 lipopolysaccharide (LPS) | Number of subjects responding to O78 lipopolysaccharide (LPS) based on serum Immunoglobulin A (IgA) and Immunoglobulin G (IgG) (i.e. fold change at least 2) | Change from baseline (just before first vaccination) to Visit 3 (5-6 days after second vaccination), an average of 20 days |
| Diagnostic Tools:To set the optimal threshold limits of the two quantitativePolymerase chain reaction (PCR ) procedures |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: The incidence of Vaccine Preventable Outcomes (VPO) | The incidence of cases with moderate or severe ETEC VPO diarrhea in the vaccinated and placebo groups of travelers. | 12 days in Benin and 30 days post-travel in Finland, approximately 42 days |
| Diagnostic Tools:Extent to which the non-culture based PCR assays can help resolve mixed ETEC infections |
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Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anu Kantele | University of Helsinki, Dept. of Infectious Diseases | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lääkärikeskus Aava, matkailuklinikka | Helsinki | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40409390 | Derived | Mlangeni T, Jian C, Hakkinen HK, de Vos WM, Salonen A, Kantele A. Travel to the tropics: Impact on gut microbiota. Travel Med Infect Dis. 2025 Jul-Aug;66:102869. doi: 10.1016/j.tmaid.2025.102869. Epub 2025 May 21. | |
| 39932427 | Derived | Liu J, Jokiranta TS, Carlin N, Stroup S, Zhang J, Sjostrand B, Svennerholm A-M, Houpt ER, Kantele A. Use of a TaqMan Array Card for identification of enterotoxins and colonization factors directly from stool samples in an enterotoxigenic E. coli vaccine study. Microbiol Spectr. 2025 Mar 4;13(3):e0187024. doi: 10.1128/spectrum.01870-24. Epub 2025 Feb 11. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 6, 2025 | |
| Reset | May 21, 2025 | |
| Release | Jun 28, 2025 | |
| Reset | Jul 17, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 6, 2025 | May 21, 2025 | |||
| Jun 28, 2025 |
| ID | Term |
|---|---|
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| OTHER |
| University of Virginia | OTHER |
A randomized, placebo-controlled phase IIb
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Other parts will be blinded except unblinded person who prepares the doses.
| Placebo | Other | Oral suspension |
|
To set the optimal threshold limits of the two quantitative Polymerase chain reaction (PCR ) procedures by setting limits for the number of amplification cycles (Cq values) which best allows (in terms of sensitivity, specificity, and positive predictive value) for identification of clinically significant ETEC TD cases, as well as cases associated with other enteric pathogens using the culture based bacterial detection method as the "Gold standard" for comparison. |
| 12 days in Benin and 30 days post-travel in Finland, approximately 42 days |
Percentage of clinically significant Traveller's Diarrhea cases with mixed infection where decision about what is the primary causative agent is concordant between Amphidial qPCR method and culture-based antigen detection method |
| 12 days in Benin and 30 days post-travel in Finland, approximately 42 days |
| Diagnostic Tools:The extent to which the TaqMan array yields results for ETEC colonization factor that are comparable to those obtained by culture based methods. | Percentage of clinically significant Traveller's Diarrhea cases with mixed infection where decision about what is the primary causative agent is concordant between TaqMan arrays qPCR method and culture-based antigen detection method | 12 days in Benin and 30 days post-travel in Finland, approximately 42 days |
| Jul 17, 2025 |