Diarrheal Disease, InfectiousPhase 1NCT05409196
Phase 1 Trial for Safety, Tolerability, and Immunogenicity of a Live, Attenuated, Oral Shigella/ETEC Combination Vaccine to Healthy Adults
A Phase 1 study testing ShigETEC live, attenuated, oral vaccine in people with Diarrheal Disease, Infectious and Gastrointestinal Disease, run by Eveliqure Biotechnologies GmbH at 1 site in Hungary.
Trial summary
This is a Phase 1 dose escalating study to assess the safety, tolerability, and immunogenicity of ShigETEC, a live, attenuated Shigella/ETEC combination vaccine given orally to healthy European adults 18 to 45 years of age. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Diarrheal Disease, Infectious, Gastrointestinal Disease, Reactive Arthritis
- What is being tested?
- ShigETEC live, attenuated, oral vaccine
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteHungary
- Study dates
- 16 Sep 2020to 21 Jun 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Generally healthy male and non-pregnant, non-nursing female adults aged 18 to 45 years
- Who are determined by medical history, physical examination and clinical judgment to be eligible for this study;
- Who provide written informed consent after the nature of the study had been explained;
- Who are available for the two to three months duration of follow-up (from enrolment to study completion);
- Who are available to be interviewed by study staff for the 2-month post-immunization follow-up;
Who cannot join
- Subjects who are perceived to be unavailable or difficult to contact for evaluation or study visits during the study period;
- Who have a known or suspected disease of cancer (excluding healed skin lesions), the immune system, or those who are receiving immunosuppressive therapy, including systemic corticosteroids or cytotoxic agents;
- Who have received any blood products, including immunoglobulin, in the period from six months prior to vaccination or are anticipated to receive such products through to the conclusion of the study;
- Who have ever received a cholera vaccine;
- Who are receiving antibiotics or completed antibiotic therapy in previous 7 days;
- Who have or are participating in or have concluded participation in a clinical research study in the last 30 days or have not cleared the experimental product or the biological effects of such experimental products prior to vaccination or received a licensed vaccine in the 30 days prior to vaccination;
Show all 20Show fewer
- Who have a chronic non-gastrointestinal medical condition (e.g. hypertension, hyperlipidemia) that is not well controlled with medication;
- Who have a significant history of or current diagnosis of diseases of the gastrointestinal tract (i.e. liver, gallbladder, bowel, or stomach), are on medication for such disease, or have had significant bowel surgery (with the exclusion of hernia repair or appendectomy);
- Who have significant abnormality of blood chemistry, hematology, or screening tests (including tests for hepatitis B, HIV, HCV);
- Who have a history of reactive arthritis following GI infection;
- Who expect to work in the subsequent 2 weeks as a food handler or in direct patient, child day care, or elder care;
- Who have immunocompromised household member;
- Who have ever had a diagnosed Shigella or ETEC infection;
- Who have developed symptoms of Shigella or ETEC infections after having travelled to Shigella or ETEC endemic areas in the past 12 months;
- Who have any condition which in the opinion of the investigator puts the subject at risk of non-compliance with the protocol;
- Who have known allergy to quinolone or azithromycin that will be used in the study;
- Who are HLA-B27 positive (a possible risk factor for reactive arthritis following naturally acquired bacterial gastrointestinal infection).
- Who are dependent of the Sponsor, of the investigational team or his/her immediate family, or are medical students at the Clinical Trial Study Site in Debrecen.
- Who are living in community (i.e. students living in a dormitory).
- Who are positive for CoVID19 infection by PCR testing prior to randomization.
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Debreceni Egyetem, Klinikai Központ, Belgyógyászati Klinika, Klinikai Farmakológiai Részleg
Debrecen
About this study
Official title: Phase 1 Two Stage Randomized, Double-blind, Placebo Controlled Dose- and Schedule Ranging Trial to Assess the Acute Safety, Tolerability, and Immunogenicity of a Live, Attenuated Shigella/ETEC Combination Vaccine Delivered Orally to Healthy Adults Age 18 to 45 Years Old
This is a Phase 1 dose escalating study to assess the safety, tolerability, and immunogenicity of ShigETEC, a live, attenuated Shigella/ETEC combination vaccine given orally to healthy European adults 18 to 45 years of age.
The major aim is the development of an efficacious and safe vaccine that prevents diarrhea caused by Shigella and ETEC in travelers, military personal visiting endemic countries and children of the developing world.
This Phase 1 safety and immunogenicity study used a double-blind, placebo-control design and was conducted in two stages, a single ascending and a multiple ascending stage.
Read the detailed description
ShigETEC vaccine is intended to stimulate an immune response in which protective antibodies are generated that prevent infection if a vaccinee is subsequently exposed to Shigella and ETEC.
Main objective of the study:
In Stage 1 is to determine Maximum Tolerated Single Dose of ShigETEC vaccine. Determine optimal immunogenicity of single dose in dose escalation.
In Stage 2 is to determine safety of multiple dose regimens of ShigETEC Determine number of doses for maximum immune response to Shigella and ETEC.
In both stages to determine the duration of shedding.
Stage 1 is conducted in an inpatient hospital setting at a single site through Day 6. A total of 48 subjects (2 vaccine recipients to each placebo recipient) are to be enrolled sequentially in 4 different ascending dose groups (12 subjects per group) to receive a single oral dose of the ShigETEC vaccine starting at a dose in the first group of 1 x 10^9 Colony Forming Units (CFU) of vaccine or a placebo. Each group will have baseline serum and stool samples collected at the time of admission, but in any case, before vaccination. Following 12-16 hours, they would receive oral immunization followed by evaluation of acute safety and tolerability for 6 days. Provided that no stopping rules are met through 6 days of follow-up for the entire group then the next group would be enrolled until all 4 groups were enrolled and evaluated through 6 days of assessment. Subjects in each group would be discharged to outpatient follow-up 6 days after dosing (7 days in hospital) if they were asymptomatic for shigellosis-like illness. Any subject with symptomatic illness would be treated with an appropriate course of antibiotic at the time of discharge. Daily stools will be tested for the presence of the ShigETEC vaccine until at least 2 sequential specimens are negative. If shedding persists through 14 days then the participant would be treated with antibiotics regardless of any symptomatology. All subjects would then be followed through 60 days following immunization to collect adverse events and blood samples.
Stage 2 of the study is an outpatient double-blind, placebo-controlled study. In this stage, a total of 36 subjects (2 vaccine recipients to each placebo recipient) will be enrolled in 3 different groups (12 subjects per group). The optimal dose and schedule of ShigETEC will be determined by analysis of the safety, shedding, and immunogenicity of each of the immunization schedules and interval of 3 days between doses (e.g dosing on days 1, 4, 7 and 10 for four doses.) Each group will be enrolled and followed for acute safety and tolerability from the first dose of vaccine through 6 days following the last dose of vaccine administered in their schedule and then for 60 days following the last dose of vaccine for other adverse events. Blood for serum immunogenicity studies will be obtained pre-immunization and at 6, 10, 28, and 60 days following the last immunization. Stool samples for evaluation of vaccine shedding will be collected as available (with a target of daily) through up to 14 days following the last dose of vaccine/placebo. Stool samples pre immunization and at or nearest to days 10 and 28 after the last vaccine dose for each group were evaluated for IgA titers to vaccine components. Collection of stool samples for determining vaccine shedding were terminated after two sequential negative samples after day 6 following the last dose.
- Being tested
- ShigETEC live, attenuated, oral vaccine, Placebo
- Keywords
- Shigellosis
- Medical subject headings
- Dysentery, Gastrointestinal Diseases, Arthritis, Reactive, Dysentery, Bacillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShigETEC live, attenuated, oral vaccineBiological
Vaccine or placebo will be delivered orally as a single dose in Stage 1 and between 2 and 4 doses at 3-day intervals in Stage 2 of the Study.
PlaceboDrug
Vaccine or placebo will be delivered orally as a single dose in Stage 1 and between 2 and 4 doses at 3-day intervals in Stage 2 of the Study.
| Study group | Role | What they receive |
|---|---|---|
| ShigETEC vaccine | Experimental | In Stage 1 subjects will be allocated randomly to one of four study cohorts to receive a single oral dose of one of four escalating dose levels of ShigETEC vaccine (ShigETEC 1x10^9 CFU, ShigETEC 1x10^10 CFU, ShigETEC 5x10^10 CFU, ShigETEC 2x10^11 CFU). 8 subjects per dose group will be administered.
Subjects in Stage 2 will be enrolled sequentially by group and allocated randomly to one of three study cohorts determined from Stage 1 to receive either two, three or four doses of the 5x10^10 ShigETEC vaccine at 3-day interval. 8 subjects per dose group will be administered. Receives: Biological: ShigETEC live, attenuated, oral vaccine |
| Placebo | Placebo comparator | In Stage 1: 4 subjects in each dose group will receive a single oral dose of placebo
In Stage 2: 4 subjects in each cohort will either receive 2, 3 or 4 doses of placebo at 3-day intervals. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and percentage of participants with treatment related acute adverse events post vaccination
Acute gastrointestinal and systemic illness symptoms following immunization(s)- treatment related Adverse events according to CTCAE v4.0 including nausea, vomiting, diarrhoea, abdominal pain, fever, joint ache, muscle/joint aches, fatigue/malaise, headache, loss of appetite.
Measured: Day 1-6 following each vaccination
Number and percentage of participants with any adverse event.
Number and percentage of participants with adverse event according to CTCAE v4.0 occuring during the entire study period
Measured: until 60 days after the last vaccination (max 60 days in stage 1)
Number and percentage of participants with any adverse event.
Number and percentage of participants with adverse event according to CTCAE v4.0 occuring during the entire study period
Measured: until 60 days after the last vaccination (max 110 days in stage 2)
Number and percentage of participants with serious adverse event.
Number and percentage of participants with serious adverse event occurring during the entire study period in stage 1
Measured: until 60 days after the last vaccination (max 60 days in stage 1)
Number and percentage of participants with serious adverse event.
Number and percentage of participants with serious adverse event occurring during the entire study period in stage 2
Measured: until 60 days after the last vaccination (max 110 days in stage 2)
Number and percentage of participants with Vaccine Shedding
Fecal shedding of vaccine - duration of detectable presence of ShigETEC in stool by polymerase chain reaction (PCR) and/or culture.
Measured: 14 days after last immunization
Reactogenicity
Reactogenicity events accumulated through day 6 for acute safety and tolerability in acute changes in reactogenicity events at a scale (none or mild or moderate or severe) or an absolute value:
- Temperature: degrees Celsius (°C)
- Nausea: none/mild/moderate/severe
- Vomiting: none/mild/moderate/severe
- Diarrhea: none/mild/moderate/severe
- Number of stools: discrete value
- Abdominal pain: none/mild/moderate/severe
- Muscle/joint aches: none/mild/moderate/severe
- Tiredness/fatigue/malaise: none/mild/moderate/severe
- Headache: none/mild/moderate/severe
- Loss of appetite: none/mild/moderate/severe
- Chills: none/mild/moderate/severe
- Difficulty sleeping: none/mild/moderate/severe
- Dizziness: none/mild/moderate/severe
- Difficulty swallowing: none/mild/moderate/severe
Measured: Days 0 to 6
Secondary outcomes (3)
Immunogenicity assessment - serum
Serum IgA and IgG response to ShigETEC lysate, LTB and ST by ELISA
Measured: Day 0 and days 6, 10, 28, 60 after the last vaccination
Immunogenicity assessment - ALS
ALS IgA response to ShigETEC lysate, LTB and ST by ELISA
Measured: Day 0 and days 6, 10 after the last vaccination
Immunogenicity assessment - stool extract
Fecal IgA response to ShigETEC lysate, LTB and ST by ELISA; Fecal total IgA content by ELISA
Measured: Day 0 and days 10, 28 after the last vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start16 Sep 2020
- Primary completion21 Jun 2021
- Study completion21 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diarrheal Disease, InfectiousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eveliqure Biotechnologies GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dénes Páll, MD, PhD, Principal investigator, University of Debrecen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05409196
- Sponsor's protocol ID
- EVQ 101
- Status last verified
- Jun 2022
- First submitted
- 18 Oct 2021
- Last updated
- 8 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Harutyunyan S, Neuhauser I, Mayer A, Aichinger M, Szijarto V, Nagy G, Nagy E, Girardi P, Malinoski FJ, Henics T. Characterization of ShigETEC, a Novel Live Attenuated Combined Vaccine against Shigellae and ETEC. Vaccines (Basel). 2020 Nov 16;8(4):689. doi: 10.3390/vaccines8040689.
PubMed 33207794
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Two Stage Randomized, Double-blind, Placebo Controlled Dose- and Schedule Ranging Trial to Assess the Acute Safety, Tolerability, and Immunogenicity of a Live, Attenuated Shigella/ETEC Combination Vaccine Delivered Orally to Healthy Adults Age 18 to 45 Years Old
- ClinicalTrials.gov ID
- NCT05409196
- Acronym / sponsor ID
- EVQ 101
- Keywords
- Shigellosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Eveliqure Biotechnologies GmbHIndustry (pharma, biotech, devices)
- Study start
- 16 Sep 2020 (actual)
- Primary completion
- 21 Jun 2021 (actual)
- Study completion
- 21 Jun 2021 (actual)
- First posted
- 8 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1 dose escalating study to assess the safety, tolerability, and immunogenicity of ShigETEC, a live, attenuated Shigella/ETEC combination vaccine given orally to healthy European adults 18 to 45 years of age.
The major aim is the development of an efficacious and safe vaccine that prevents diarrhea caused by Shigella and ETEC in travelers, military personal visiting endemic countries and children of the developing world.
This Phase 1 safety and immunogenicity study used a double-blind, placebo-control design and was conducted in two stages, a single ascending and a multiple ascending stage.
Detailed description
ShigETEC vaccine is intended to stimulate an immune response in which protective antibodies are generated that prevent infection if a vaccinee is subsequently exposed to Shigella and ETEC.
Main objective of the study:
In Stage 1 is to determine Maximum Tolerated Single Dose of ShigETEC vaccine. Determine optimal immunogenicity of single dose in dose escalation.
In Stage 2 is to determine safety of multiple dose regimens of ShigETEC Determine number of doses for maximum immune response to Shigella and ETEC.
In both stages to determine the duration of shedding.
Stage 1 is conducted in an inpatient hospital setting at a single site through Day 6. A total of 48 subjects (2 vaccine recipients to each placebo recipient) are to be enrolled sequentially in 4 different ascending dose groups (12 subjects per group) to receive a single oral dose of the ShigETEC vaccine starting at a dose in the first group of 1 x 10^9 Colony Forming Units (CFU) of vaccine or a placebo. Each group will have baseline serum and stool samples collected at the time of admission, but in any case, before vaccination. Following 12-16 hours, they would receive oral immunization followed by evaluation of acute safety and tolerability for 6 days. Provided that no stopping rules are met through 6 days of follow-up for the entire group then the next group would be enrolled until all 4 groups were enrolled and evaluated through 6 days of assessment. Subjects in each group would be discharged to outpatient follow-up 6 days after dosing (7 days in hospital) if they were asymptomatic for shigellosis-like illness. Any subject with symptomatic illness would be treated with an appropriate course of antibiotic at the time of discharge. Daily stools will be tested for the presence of the ShigETEC vaccine until at least 2 sequential specimens are negative. If shedding persists through 14 days then the participant would be treated with antibiotics regardless of any symptomatology. All subjects would then be followed through 60 days following immunization to collect adverse events and blood samples.
Stage 2 of the study is an outpatient double-blind, placebo-controlled study. In this stage, a total of 36 subjects (2 vaccine recipients to each placebo recipient) will be enrolled in 3 different groups (12 subjects per group). The optimal dose and schedule of ShigETEC will be determined by analysis of the safety, shedding, and immunogenicity of each of the immunization schedules and interval of 3 days between doses (e.g dosing on days 1, 4, 7 and 10 for four doses.) Each group will be enrolled and followed for acute safety and tolerability from the first dose of vaccine through 6 days following the last dose of vaccine administered in their schedule and then for 60 days following the last dose of vaccine for other adverse events. Blood for serum immunogenicity studies will be obtained pre-immunization and at 6, 10, 28, and 60 days following the last immunization. Stool samples for evaluation of vaccine shedding will be collected as available (with a target of daily) through up to 14 days following the last dose of vaccine/placebo. Stool samples pre immunization and at or nearest to days 10 and 28 after the last vaccine dose for each group were evaluated for IgA titers to vaccine components. Collection of stool samples for determining vaccine shedding were terminated after two sequential negative samples after day 6 following the last dose.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ShigETEC vaccine | Experimental | Biological: ShigETEC live, attenuated, oral vaccineIn Stage 1 subjects will be allocated randomly to one of four study cohorts to receive a single oral dose of one of four escalating dose levels of ShigETEC vaccine (ShigETEC 1x10^9 CFU, ShigETEC 1x10^10 CFU, ShigETEC 5x10^10 CFU, ShigETEC 2x10^11 CFU). 8 subjects per dose group will be administered. Subjects in Stage 2 will be enrolled sequentially by group and allocated randomly to one of three study cohorts determined from Stage 1 to receive either two, three or four doses of the 5x10^10 ShigETEC vaccine at 3-day interval. 8 subjects per dose group will be administered. |
| Placebo | Placebo comparator | Drug: PlaceboIn Stage 1: 4 subjects in each dose group will receive a single oral dose of placebo In Stage 2: 4 subjects in each cohort will either receive 2, 3 or 4 doses of placebo at 3-day intervals. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Generally healthy male and non-pregnant, non-nursing female adults aged 18 to 45 years
- Who are determined by medical history, physical examination and clinical judgment to be eligible for this study;
- Who provide written informed consent after the nature of the study had been explained;
- Who are available for the two to three months duration of follow-up (from enrolment to study completion);
- Who are available to be interviewed by study staff for the 2-month post-immunization follow-up;
Key exclusion criteria (20 listed)
- Subjects who are perceived to be unavailable or difficult to contact for evaluation or study visits during the study period;
- Who have a known or suspected disease of cancer (excluding healed skin lesions), the immune system, or those who are receiving immunosuppressive therapy, including systemic corticosteroids or cytotoxic agents;
- Who have received any blood products, including immunoglobulin, in the period from six months prior to vaccination or are anticipated to receive such products through to the conclusion of the study;
- Who have ever received a cholera vaccine;
- Who are receiving antibiotics or completed antibiotic therapy in previous 7 days;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ShigETEC live, attenuated, oral vaccineVaccine or placebo will be delivered orally as a single dose in Stage 1 and between 2 and 4 doses at 3-day intervals in Stage 2 of the Study. | Biological | ShigETEC vaccine |
| PlaceboVaccine or placebo will be delivered orally as a single dose in Stage 1 and between 2 and 4 doses at 3-day intervals in Stage 2 of the Study. | Drug | Placebo |
Primary outcome
Number and percentage of participants with treatment related acute adverse events post vaccination
Time frame: Day 1-6 following each vaccination
Acute gastrointestinal and systemic illness symptoms following immunization(s)- treatment related Adverse events according to CTCAE v4.0 including nausea, vomiting, diarrhoea, abdominal pain, fever, joint ache, muscle/joint aches, fatigue/malaise, headache, loss of appetite.
Number and percentage of participants with any adverse event.
Time frame: until 60 days after the last vaccination (max 60 days in stage 1)
Number and percentage of participants with adverse event according to CTCAE v4.0 occuring during the entire study period
Number and percentage of participants with any adverse event.
Time frame: until 60 days after the last vaccination (max 110 days in stage 2)
Number and percentage of participants with adverse event according to CTCAE v4.0 occuring during the entire study period
Number and percentage of participants with serious adverse event.
Time frame: until 60 days after the last vaccination (max 60 days in stage 1)
Number and percentage of participants with serious adverse event occurring during the entire study period in stage 1
Number and percentage of participants with serious adverse event.
Time frame: until 60 days after the last vaccination (max 110 days in stage 2)
Number and percentage of participants with serious adverse event occurring during the entire study period in stage 2
Number and percentage of participants with Vaccine Shedding
Time frame: 14 days after last immunization
Fecal shedding of vaccine - duration of detectable presence of ShigETEC in stool by polymerase chain reaction (PCR) and/or culture.
Reactogenicity
Time frame: Days 0 to 6
Reactogenicity events accumulated through day 6 for acute safety and tolerability in acute changes in reactogenicity events at a scale (none or mild or moderate or severe) or an absolute value: * Temperature: degrees Celsius (°C) * Nausea: none/mild/moderate/severe * Vomiting: none/mild/moderate/severe * Diarrhea: none/mild/moderate/severe * Number of stools: discrete value * Abdominal pain: none/mild/moderate/severe * Muscle/joint aches: none/mild/moderate/severe * Tiredness/fatigue/malaise: none/mild/moderate/severe * Headache: none/mild/moderate/severe * Loss of appetite: none/mild/moderate/severe * Chills: none/mild/moderate/severe * Difficulty sleeping: none/mild/moderate/severe * Dizziness: none/mild/moderate/severe * Difficulty swallowing: none/mild/moderate/severe
3 secondary outcomes
Immunogenicity assessment - serum
Time frame: Day 0 and days 6, 10, 28, 60 after the last vaccination
Immunogenicity assessment - ALS
Time frame: Day 0 and days 6, 10 after the last vaccination
Immunogenicity assessment - stool extract
Time frame: Day 0 and days 10, 28 after the last vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
- Results publication: PubMed 33207794Harutyunyan S, Neuhauser I, Mayer A, Aichinger M, Szijarto V, Nagy G, Nagy E, Girardi P, Malinoski FJ, Henics T. Characterization of ShigETEC, a Novel Live Attenuated Combined Vaccine against Shigellae and ETEC. Vaccines (Basel). 2020 Nov 16;8(4):689. doi: 10.3390/vaccines8040689.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dénes Páll, MD, PhD principal investigator
University of Debrecen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ShigETEC live, attenuated, oral vaccine in people with Diarrheal Disease, Infectious and Gastrointestinal Disease, run by Eveliqure Biotechnologies GmbH at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and percentage of participants with treatment related acute adverse events post vaccination (time frame: Day 1-6 following each vaccination). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05409196, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2022.