Cholera Vaccination ReactionPhase 1DuoCholNCT07270796
Safety and Immunogenicity Study of the DuoChol Oral Cholera Vaccine in Healthy Participants
A Phase 1 study testing DuoChol and Dukoral® in people with Cholera Vaccination Reaction, run by International Vaccine Institute at 1 site in Sweden.
Trial summary
The goal of this phase I, open-label, randomized, active-controlled Trial is to evaluate the safety and immunogenicity of the DuoChol Oral Cholera Vaccine in 18 to 45 years old healthy participants in Sweden. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Cholera Vaccination Reaction
- What is being tested?
- DuoChol and Dukoral®
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2027to Jul 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Healthy male or female participants aged 18 to 45 years, inclusive, at the time of signing the informed consent.
- Must have a Swedish (or other nationality) identity card
- Must be able to understand the information included in the informed consent form and be willing to provide voluntary informed consent to participate in the study
- Must agree to not take any medication affecting gastric acidity (such as proton pump inhibitor, H2 receptor blocker, or antacid) for 7 days prior to and until 24 hours after each vaccination.
- Must be able to attend all scheduled study visits and comply with all study procedures.
- Must be in good general health and without clinically significant medical history, as determined by the study investigator using clinical judgement after review of medical history, physical examination, and laboratory screening tests (hematology, renal function, and liver function tests).
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- Female-Specific Criteria:
- Not currently pregnant or breastfeeding and not planning to become pregnant for at least 12 weeks after last vaccination.
- Negative urine pregnancy test at the time of vaccination.
- Agree to use at least one acceptable an adequate birth control method for at least 4 weeks prior to receipt of vaccine and for at least 12 weeks after receipt of the vaccine. Adequate birth control is defined as follows: Contraceptive medications delivered orally, intramuscularly, vaginally, or implanted underneath the skin, surgical methods (hysterectomy or bilateral tub l ligation), condoms, diaphragms, intrauterine device, or abstinence
- Male-Specific Criteria:
- Be willing to use an adequate birth control method during study participation and 12 weeks after the last vaccination.
- For non-vasectomized male participants with female partners of child- bearing potential this includes the use of condoms or abstinence and/or their partner's use of contraceptive medications delivered orally, intramuscularly, vaginally, or implanted underneath the skin, surgical methods (hysterectomy or bilateral tubal ligation), diaphragms, or intrauterine device.
Who cannot join
- Any clinically significant symptom of acute illness (e.g., cough, sore throat), febrile illness (tympanic temperature >38°C) within 72 hours prior to the enrollment. A prospective participant should not be included until 72 hours after the condition has completely resolved.
- Participant with diarrhea, abdominal pain or vomiting in the past 24 hours or with history of diarrhea lasting for more than 2 weeks in the past 6 months.
- Known history of any immunocompromised condition, including immunodeficiency disease, renal function disorder, malignancy, chronic inflammatory disease, etc.
- Use of systemic steroids within past 6 months (>10 mg/day prednisone equivalent for period exceeding 2 consecutive weeks), or history of having received chemotherapy, radiation therapy or other immunosuppressive drugs within the past 6 months.
- Participant who has ever received previous immunization with cholera vaccine, who has received any vaccine within 4 weeks prior to the first dose of study vaccination, or who plans to receive any other vaccine within 4 weeks following last dose of the investigational product.
- Participant concomitantly enrolled or scheduled to be enrolled in another trial.
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- Participant with previous history of confirmed cholera, salmonella, shigella or ETEC disease.
- Known history or allergy to vaccine components, or any other allergies deemed by the investigator to increase risk of an adverse event during trial participation.
- Individuals with a known bleeding disorder, or any condition that may be associated with a prolonged bleeding time resulting in contraindication for blood sample collection.
- Receipt of blood, blood-derived products, or immunoglobulin products in the past 3 months.
- Any abnormality or chronic disease which in the opinion of the investigator might be detrimental for the safety of the participant or interfere with the assessment of the study objectives.
- Any female participant who is lactating*, pregnant, or planning for pregnancy during study period.
- Individuals who are involved in DuoChol Clinical trial or family/household members of research staff.
- Any other condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives (e.g., alcohol or drug abuse, neurologic or psychiatric conditions etc.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site
Studieenheten Akademiskt Specialistcentrum
Stockholm
Helena H Askling, MD, PhD, helena.hervius.askling@ki.se
Helena H Askling, MD, PhD
About this study
Official title: A Phase I, Open-label, Randomized, Active-Controlled Trial to Evaluate the Safety and Immunogenicity of the DuoChol Oral Cholera Vaccine in 18 to 45 Years Old Healthy Participants in Sweden
The goal of this phase I, open-label, randomized, active-controlled Trial is to evaluate the safety and immunogenicity of the DuoChol Oral Cholera Vaccine in 18 to 45 years old healthy participants in Sweden. This first-in-human study is intended to obtain initial data on the DuoChol oral cholera vaccine safety and its effect on immune responses in a cholera non-endemic setting to guide future studies in cholera endemic population. The Investigators will evaluate the safety and immunogenicity after each dose vaccination of DuoChol Oral Cholera Vaccine/Dukoral®.
The participants will be randomly assigned to receive 2 vaccinations at 14-day intervals of DuoChol or Dukoral® in a 2:1 ratio. Participants in the DuoChol arm will receive one capsule of DuoChol on days 0 and 14. Participants in the Dukoral® arm will receive the standard dose as indicated in the Dukoral® package insert. The Investigators will follow-up the participants for 4 weeks after the second vaccination.
The study is funded by Wellcome Trust, grant number : 226726/Z/22/Z.
Read the detailed description
A total of 60 healthy participants aged 18-45 in Sweden will be recruited and randomly assigned in a 2:1 ratio: 40 participants will receive DuoChol, 20 participants will receive Dukoral®. Each person will receive two doses of DuoChol or Dukoral® orally. There participants will have 6 scheduled study visits, including blood sampling for immunogenicity testing and safety assessment.
Blood samples will be taken at screening, and then during the study, to check immune response and overall health status. Baseline tests include HIV, hepatitis, complete blood counts, and liver function test. Women of childbearing age will undergo pregnancy testing during screening and prior to each vaccination.
All participants will be observed after vaccination for immediate reactions. Serious adverse events will be reported, and followed up till resolution, and participants are instructed to contact the Investigator team if they experience any serious adverse event.
Study Objectives:
- Primary: To evaluate the safety after each dose vaccination of DuoChol Oral Cholera Vaccine.
- Secondary: To compare the immune response of DuoChol with the existing vaccine Dukoral® to assess whether DuoChol can generate a response in the immune system to protect against the disease.
Key Endpoints:
- Monitor for any serious adverse events like hospitalization, death, or significant disability that happen during the study that may or may not be related to the vaccines.
- Track immediate reactions within 1-2 hours after vaccination to detect allergic or other immediate responses.
- Record mild to moderate side effects such as nausea, fever, or diarrhea for up to 14 days after each dose.
- Measure immune response in the blood 14 days after each dose.
- Conditions
- Cholera Vaccination Reaction
- Being tested
- DuoChol, Dukoral®
- Keywords
- Oral Cholera Vaccine, DuoChol, Phase 1 Trial, V. cholerae O1 Inaba, V. cholerae O1 Ogawa, recombinant cholera toxin B-subunit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuoCholBiological
A lyophilized formulation in capsule form (approximately 150mg) contains: - 0.9 mg in 1:1 ratio of formalin inactivated bacteria of two isogenic V. cholerae O1 El Tor strains: serotype Inaba (MS1955) and serotype Ogawa (MS1987) - 0.9 mg of recombinant cholera toxin B subunit (rCTB).
Dukoral®Biological
3 ml of suspension in a vial contains:
- 31.25x10^9 bacteria* (approximately) of each of the following V. cholerae O1 strains: Inaba classical biotype (heat inactivated), Inaba El Tor biotype (formalin inactivated), Ogawa classical biotype (heat inactivated), Ogawa classical biotype (formalin inactivated)
- 1 mg Recombinant cholera toxin B subunit (rCTB)
5.6 g of effervescent powder (buffer) in a sachet contains Sodium hydrogen carbonate, citric acid, sodium carbonate, saccharin sodium, sodium citrate and raspberry flavor.
| Study group | Role | What they receive |
|---|---|---|
| DuoChol | Experimental | 2 doses of DuoChol capsule administered orally 14 days apart (Day 0 and Day 14). Receives: Biological: DuoChol |
| Dukoral® | Active comparator | 2 doses of Dukoral® administered orally 14 days apart (Day 0 and Day 14). Vaccine suspension is mixed with the buffer (sodium hydrogen carbonate) solution, supplied as effervescent powder. Receives: Biological: Dukoral® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of each investigational product dose at a specified duration
- Occurrence of any SAEs from the first dose vaccination until 28 days after the second dose vaccination.
- Occurrence of immediate adverse events within 2 hours after the first dose of vaccination for the sentinel cohort of participants, and within 1 hour for the rest of the participants
- Occurrence of solicited gastrointestinal and systemic adverse events within 7 days after each vaccination
- Occurrence of unsolicited adverse events within 14 days after each vaccination
- Occurrence of clinically significant changes in safety laboratory parameters after each vaccination
Measured: From enrollment to the end of study, approximately 6 weeks for each participant.
Secondary outcomes (6)
Proportion of participants achieving seroconversion of serum vibriocidal antibody titers against V. cholerae O1 Inaba and V. cholerae O1 Ogawa.
seroconversion of serum vibriocidal antibody titers defined as at least 4-fold increase
Measured: Baseline (prior to first vaccination) to 14 days after the first and second vaccination.
Geometric Mean Titer (GMT) of serum vibriocidal antibody titers against V. cholerae O1 Inaba and V. cholerae O1 Ogawa.
Measured: Baseline (prior to first vaccination) to 14 days after the first and second vaccination.
Geometric Mean Fold Rise (GMFR) of serum vibriocidal antibody titers against V. cholerae O1 Inaba and V. cholerae O1 Ogawa.
Measured: Baseline (prior to first vaccination) to 14 days after the first and second vaccination.
Proportion of participants achieving seroconversion of serum IgG anti-CTB antibodies.
seroconversion of serum IgG anti-CTB antibodies defined as at least 2-fold increase
Measured: Baseline (prior to first vaccination) to 14 days after the first and second vaccination.
Geometric Mean Titer (GMT) of serum IgG anti-CTB antibodies.
Measured: Baseline (prior to first vaccination) to 14 days after the first and second vaccination.
Geometric Mean Fold Rise (GMFR) of serum IgG anti-CTB antibodies.
Measured: Baseline (prior to first vaccination) to 14 days after the first and second vaccination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study startJan 2027 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholera Vaccination ReactionStudies 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
- Parallel groups
- Model description
- Enrollment will be initiated with a sentinel cohort of 5 participants randomized to receive DuoChol. The participants in sentinel cohort will be enrolled sequentially one after another after the 2-hour observation period is completed before the next participant is vaccinated. Once 5 participants have received DuoChol, enrollment will be paused until 24-hour safety data is available for all 5 and has been reviewed by the Safety Monitoring Committee (SMC). If no halting criteria defined in the study protocol have been met and the SMC gives approval, enrollment will continue unrestricted.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Vaccine Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica Cowden, MD, Principal investigator, International Vaccine Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07270796
- Sponsor's protocol ID
- IVI DuoChol 001
- Other IDs
- 226726/Z/22/Z, 2025-522633-57-00, 2025
- Acronym
- DuoChol
- Status last verified
- Mar 2026
- First submitted
- 18 Nov 2025
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Restrictions under data protection frameworks (e.g., GDPR) that impose strict requirements on the use, transfer, and sharing of health-related data. The informed consent form does not cover participant agreement for data sharing beyond the purpose or jurisdiction described in the participant's information sheet.
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Randomized, Active-Controlled Trial to Evaluate the Safety and Immunogenicity of the DuoChol Oral Cholera Vaccine in 18 to 45 Years Old Healthy Participants in Sweden
- ClinicalTrials.gov ID
- NCT07270796
- Acronym / sponsor ID
- DuoChol / IVI DuoChol 001
- Conditions
- Cholera Vaccination Reaction
- Keywords
- Oral Cholera Vaccine, DuoChol, Phase 1 Trial, V. cholerae O1 Inaba, V. cholerae O1 Ogawa, recombinant cholera toxin B-subunit
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- International Vaccine InstituteUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 8 Dec 2025 (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.
The goal of this phase I, open-label, randomized, active-controlled Trial is to evaluate the safety and immunogenicity of the DuoChol Oral Cholera Vaccine in 18 to 45 years old healthy participants in Sweden. This first-in-human study is intended to obtain initial data on the DuoChol oral cholera vaccine safety and its effect on immune responses in a cholera non-endemic setting to guide future studies in cholera endemic population. The Investigators will evaluate the safety and immunogenicity after each dose vaccination of DuoChol Oral Cholera Vaccine/Dukoral®.
The participants will be randomly assigned to receive 2 vaccinations at 14-day intervals of DuoChol or Dukoral® in a 2:1 ratio. Participants in the DuoChol arm will receive one capsule of DuoChol on days 0 and 14. Participants in the Dukoral® arm will receive the standard dose as indicated in the Dukoral® package insert. The Investigators will follow-up the participants for 4 weeks after the second vaccination.
The study is funded by Wellcome Trust, grant number : 226726/Z/22/Z.
Detailed description
A total of 60 healthy participants aged 18-45 in Sweden will be recruited and randomly assigned in a 2:1 ratio: 40 participants will receive DuoChol, 20 participants will receive Dukoral®. Each person will receive two doses of DuoChol or Dukoral® orally. There participants will have 6 scheduled study visits, including blood sampling for immunogenicity testing and safety assessment.
Blood samples will be taken at screening, and then during the study, to check immune response and overall health status. Baseline tests include HIV, hepatitis, complete blood counts, and liver function test. Women of childbearing age will undergo pregnancy testing during screening and prior to each vaccination.
All participants will be observed after vaccination for immediate reactions. Serious adverse events will be reported, and followed up till resolution, and participants are instructed to contact the Investigator team if they experience any serious adverse event.
Study Objectives:
- Primary: To evaluate the safety after each dose vaccination of DuoChol Oral Cholera Vaccine.
- Secondary: To compare the immune response of DuoChol with the existing vaccine Dukoral® to assess whether DuoChol can generate a response in the immune system to protect against the disease.
Key Endpoints:
- Monitor for any serious adverse events like hospitalization, death, or significant disability that happen during the study that may or may not be related to the vaccines.
- Track immediate reactions within 1-2 hours after vaccination to detect allergic or other immediate responses.
- Record mild to moderate side effects such as nausea, fever, or diarrhea for up to 14 days after each dose.
- Measure immune response in the blood 14 days after each dose.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Enrollment will be initiated with a sentinel cohort of 5 participants randomized to receive DuoChol. The participants in sentinel cohort will be enrolled sequentially one after another after the 2-hour observation period is completed before the next participant is vaccinated. Once 5 participants have received DuoChol, enrollment will be paused until 24-hour safety data is available for all 5 and has been reviewed by the Safety Monitoring Committee (SMC). If no halting criteria defined in the study protocol have been met and the SMC gives approval, enrollment will continue unrestricted.
| Arm | Type | Receives |
|---|---|---|
| DuoChol | Experimental | Biological: DuoChol2 doses of DuoChol capsule administered orally 14 days apart (Day 0 and Day 14). |
| Dukoral® | Active comparator | Biological: Dukoral®2 doses of Dukoral® administered orally 14 days apart (Day 0 and Day 14). Vaccine suspension is mixed with the buffer (sodium hydrogen carbonate) solution, supplied as effervescent powder. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Healthy male or female participants aged 18 to 45 years, inclusive, at the time of signing the informed consent.
- Must have a Swedish (or other nationality) identity card
- Must be able to understand the information included in the informed consent form and be willing to provide voluntary informed consent to participate in the study
- Must agree to not take any medication affecting gastric acidity (such as proton pump inhibitor, H2 receptor blocker, or antacid) for 7 days prior to and until 24 hours after each vaccination.
- Must be able to attend all scheduled study visits and comply with all study procedures.
Key exclusion criteria (14 listed)
- Any clinically significant symptom of acute illness (e.g., cough, sore throat), febrile illness (tympanic temperature >38°C) within 72 hours prior to the enrollment. A prospective participant should not be included until 72 hours after the condition has completely resolved.
- Participant with diarrhea, abdominal pain or vomiting in the past 24 hours or with history of diarrhea lasting for more than 2 weeks in the past 6 months.
- Known history of any immunocompromised condition, including immunodeficiency disease, renal function disorder, malignancy, chronic inflammatory disease, etc.
- Use of systemic steroids within past 6 months (>10 mg/day prednisone equivalent for period exceeding 2 consecutive weeks), or history of having received chemotherapy, radiation therapy or other immunosuppressive drugs within the past 6 months.
- Participant who has ever received previous immunization with cholera vaccine, who has received any vaccine within 4 weeks prior to the first dose of study vaccination, or who plans to receive any other vaccine within 4 weeks following last dose of the investigational product.
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 |
|---|---|---|
| DuoCholA lyophilized formulation in capsule form (approximately 150mg) contains: - 0.9 mg in 1:1 ratio of formalin inactivated bacteria of two isogenic V. cholerae O1 El Tor strains: serotype Inaba (MS1955) and serotype Ogawa (MS1987) - 0.9 mg of recombinant cholera toxin B subunit (rCTB). | Biological | DuoChol |
| Dukoral®3 ml of suspension in a vial contains: * 31.25x10^9 bacteria* (approximately) of each of the following V. cholerae O1 strains: Inaba classical biotype (heat inactivated), Inaba El Tor biotype (formalin inactivated), Ogawa classical biotype (heat inactivated), Ogawa classical biotype (formalin inactivated) * 1 mg Recombinant cholera toxin B subunit (rCTB) 5.6 g of effervescent powder (buffer) in a sachet contains Sodium hydrogen carbonate, citric acid, sodium carbonate, saccharin sodium, sodium citrate and raspberry flavor. | Biological | Dukoral® |
Primary outcome
Safety of each investigational product dose at a specified duration
Time frame: From enrollment to the end of study, approximately 6 weeks for each participant.
1. Occurrence of any SAEs from the first dose vaccination until 28 days after the second dose vaccination. 2. Occurrence of immediate adverse events within 2 hours after the first dose of vaccination for the sentinel cohort of participants, and within 1 hour for the rest of the participants 3. Occurrence of solicited gastrointestinal and systemic adverse events within 7 days after each vaccination 4. Occurrence of unsolicited adverse events within 14 days after each vaccination 5. Occurrence of clinically significant changes in safety laboratory parameters after each vaccination
6 secondary outcomes
Proportion of participants achieving seroconversion of serum vibriocidal antibody titers against V. cholerae O1 Inaba and V. cholerae O1 Ogawa.
Time frame: Baseline (prior to first vaccination) to 14 days after the first and second vaccination.
Geometric Mean Titer (GMT) of serum vibriocidal antibody titers against V. cholerae O1 Inaba and V. cholerae O1 Ogawa.
Time frame: Baseline (prior to first vaccination) to 14 days after the first and second vaccination.
Geometric Mean Fold Rise (GMFR) of serum vibriocidal antibody titers against V. cholerae O1 Inaba and V. cholerae O1 Ogawa.
Time frame: Baseline (prior to first vaccination) to 14 days after the first and second vaccination.
Proportion of participants achieving seroconversion of serum IgG anti-CTB antibodies.
Time frame: Baseline (prior to first vaccination) to 14 days after the first and second vaccination.
Geometric Mean Titer (GMT) of serum IgG anti-CTB antibodies.
Time frame: Baseline (prior to first vaccination) to 14 days after the first and second vaccination.
Geometric Mean Fold Rise (GMFR) of serum IgG anti-CTB antibodies.
Time frame: Baseline (prior to first vaccination) to 14 days after the first and second vaccination.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: No. Restrictions under data protection frameworks (e.g., GDPR) that impose strict requirements on the use, transfer, and sharing of health-related data. The informed consent form does not cover participant agreement for data sharing beyond the purpose or jurisdiction described in the participant's information sheet.
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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.
Jessica Cowden, MD principal investigator
International Vaccine Institute
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 DuoChol and Dukoral® in people with Cholera Vaccination Reaction, run by International Vaccine Institute at 1 site in Sweden.
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 13 inclusion and 14 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: opening soon, as of the sponsor's last update on 1 Apr 2026. 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 Sweden. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Cowden, MD (+46732377579, jessica.cowden@ivi.int), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of each investigational product dose at a specified duration (time frame: From enrollment to the end of study, approximately 6 weeks for each participant.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2026.