ShigellosisPhase 1NCT02797236
SF2a-TT15 Conjugate Vaccine in Healthy Adult Volunteers
A Phase 1 study testing SF2a-TT15 vaccine and SF2a-TT15 vaccine + adjuvant in people with Shigellosis and Bacillary Dysentery, run by Institut Pasteur at 1 site in Israel.
Trial summary
This is a first-in-human, single-center, single-blinded, observer-masked randomized, dose escalation (two doses), placebo-controlled study in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Shigellosis, Bacillary Dysentery
- What is being tested?
- SF2a-TT15 vaccine and SF2a-TT15 vaccine + adjuvant
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2016to Dec 2017
- 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
- Subjects in general good health in the opinion of the investigator as determined by medical history, vital signs and a physical examination.
- Negative human leukocyte antigen (HLA) -B27 and no history of reactive arthritis
- Negative HIV, Hepatitis B and Hepatitis C serology tests.
- Blood levels of Shigella flexneri 2a LPS IgG antibodies ≤ percentile 80
- No known history of alcohol abuse
Who cannot join
- Subjects with a history of clinically significant gastrointestinal disorders or with any history of frequent diarrhea, nausea or emesis, regardless of etiology.
- Individuals with immunosuppressive diseases or under immunosuppressive therapy
- History of culture-proven S. flexneri.
- Individuals who have household contact with/and /or intimate exposure to an individual with laboratory confirmed S. flexneri.
- Having travelled in countries/areas highly endemic for S. flexneri within 3 months prior to enrolment.
- Previous participation in any study in which a Shigella-vaccine candidate was administered.
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- Known contraindication, hypersensitivity and/or allergy to the investigational product or its excipients.
- Known hypersensitivity and/or allergy to any drug or vaccine
- Women who are pregnant or are breast-feeding, or are of childbearing age who have not used or do not plan to use acceptable birth control measures, for the duration of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Dose Escalation Study to Assess the Safety and Immunogenicity of the SF2a-TT15 Conjugate Vaccine Against S. Flexneri 2a in Healthy Adult Volunteers
This is a first-in-human, single-center, single-blinded, observer-masked randomized, dose escalation (two doses), placebo-controlled study in healthy volunteers.
Read the detailed description
Subjects will be assigned to one of two cohorts.
- Cohort 1 will receive the lower dose of 2 μg vaccine (with or without alum adjuvant) or matching placebo.
- Cohort 2 will receive the higher dose of 10 μg vaccine (with or without alum adjuvant) or matching placebo.
Eligible subjects will be randomized to receive the 2 μg dose or 10 µg without or with alum or matching placebo, at a ratio of 3:1, as three single IM injections. There will be an interval of 28(±3) days) between each treatment.
The study will be conducted in a stepwise approach in which a "Pioneer" Group of 2 subjects (one receiving the active vaccine and one receiving the matching placebo) will receive the first injection. These subjects will remain in-house for a 24-hours medical observation after the first injection (not required in the subsequent injections) Once it has been established that there are no safety concerns in the non-adjuvanted "Pioneer" Groups (and after no less than 48 hrs), the next "Pioneer" group (one subject receiving adjuvanted 2 μg vaccine and one receiving the matching alum placebo) will be injected.
If no safety concerns are raised in this group also, after no less than 48 hrs, the rest of the subjects may receive the first injection.
- Conditions
- Shigellosis, Bacillary Dysentery
- Being tested
- SF2a-TT15 vaccine, SF2a-TT15 vaccine + adjuvant, Placebo, Placebo + adjuvant
- Keywords
- Phase I, conjugate vaccine, Shigella flexneri 2a, safety, Immunogenicity, Healthy adults
- Medical subject headings
- Dysentery, Bacillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SF2a-TT15 vaccineBiological
SF2a-TT15 vaccine + adjuvantBiological
PlaceboBiological
Placebo + adjuvantBiological
| Study group | Role | What they receive |
|---|---|---|
| vaccine dose 1 | Experimental | SF2a-TT15 vaccine, 2 μg Receives: Biological: SF2a-TT15 vaccine |
| vaccine dose 1+ adjuvant | Experimental | SF2a-TT15 vaccine, 2 μg + alum Receives: Biological: SF2a-TT15 vaccine + adjuvant |
| vaccine dose 2 | Experimental | SF2a-TT15 vaccine, 10 μg Receives: Biological: SF2a-TT15 vaccine |
| vaccine dose 2 + adjuvant | Experimental | SF2a-TT15 vaccine, 10 μg + alum Receives: Biological: SF2a-TT15 vaccine + adjuvant |
| Placebo | Placebo comparator | Tris buffer Receives: Biological: Placebo |
| Placebo + adjuvant | Placebo comparator | Tris buffer + Alum Receives: Biological: Placebo + adjuvant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event
Safety: Occurrence, frequency, severity, and duration of local and systemic adverse events (AEs) including clinically significant laboratory abnormalities, after administration of the SF2a-TT15 vaccine.
Measured: 12 months
Secondary outcomes (1)
Immunogenicity - humoral Immune response
Serum antibody response (IgG IgM, IgA) to S. flexneri 2a LPS, following the administration of the various vaccine doses and antibody secreting cells to S. flexneri 2a LPS, following the administration of the various vaccine doses
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2016 (estimated)
- Study startSep 2016
- Primary completionJun 2017
- Study completionDec 2017
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 ShigellosisStudies of the same condition, open and under way.
- More trials run by Institut PasteurThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02797236
- Sponsor's protocol ID
- 2015-060
- Status last verified
- Apr 2018
- First submitted
- 18 Apr 2016
- Last updated
- 11 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cohen D, Atsmon J, Artaud C, Meron-Sudai S, Gougeon ML, Bialik A, Goren S, Asato V, Ariel-Cohen O, Reizis A, Dorman A, Hoitink CWG, Westdijk J, Ashkenazi S, Sansonetti P, Mulard LA, Phalipon A. Safety and immunogenicity of a synthetic carbohydrate conjugate vaccine against Shigella flexneri 2a in healthy adult volunteers: a phase 1, dose-escalating, single-blind, randomised, placebo-controlled study. Lancet Infect Dis. 2021 Apr;21(4):546-558. doi: 10.1016/S1473-3099(20)30488-6. Epub 2020 Nov 10.
PubMed 33186516
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose Escalation Study to Assess the Safety and Immunogenicity of the SF2a-TT15 Conjugate Vaccine Against S. Flexneri 2a in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT02797236
- Acronym / sponsor ID
- 2015-060
- Conditions
- Shigellosis, Bacillary Dysentery
- Keywords
- Phase I, conjugate vaccine, Shigella flexneri 2a, safety, Immunogenicity, Healthy adults
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- Study start
- Sep 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 13 Jun 2016 (estimated)
- 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 first-in-human, single-center, single-blinded, observer-masked randomized, dose escalation (two doses), placebo-controlled study in healthy volunteers.
Detailed description
Subjects will be assigned to one of two cohorts.
- Cohort 1 will receive the lower dose of 2 μg vaccine (with or without alum adjuvant) or matching placebo.
- Cohort 2 will receive the higher dose of 10 μg vaccine (with or without alum adjuvant) or matching placebo.
Eligible subjects will be randomized to receive the 2 μg dose or 10 µg without or with alum or matching placebo, at a ratio of 3:1, as three single IM injections. There will be an interval of 28(±3) days) between each treatment.
The study will be conducted in a stepwise approach in which a "Pioneer" Group of 2 subjects (one receiving the active vaccine and one receiving the matching placebo) will receive the first injection. These subjects will remain in-house for a 24-hours medical observation after the first injection (not required in the subsequent injections) Once it has been established that there are no safety concerns in the non-adjuvanted "Pioneer" Groups (and after no less than 48 hrs), the next "Pioneer" group (one subject receiving adjuvanted 2 μg vaccine and one receiving the matching alum placebo) will be injected.
If no safety concerns are raised in this group also, after no less than 48 hrs, the rest of the subjects may receive the first injection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| vaccine dose 1 | Experimental | Biological: SF2a-TT15 vaccineSF2a-TT15 vaccine, 2 μg |
| vaccine dose 1+ adjuvant | Experimental | Biological: SF2a-TT15 vaccine + adjuvantSF2a-TT15 vaccine, 2 μg + alum |
| vaccine dose 2 | Experimental | Biological: SF2a-TT15 vaccineSF2a-TT15 vaccine, 10 μg |
| vaccine dose 2 + adjuvant | Experimental | Biological: SF2a-TT15 vaccine + adjuvantSF2a-TT15 vaccine, 10 μg + alum |
| Placebo | Placebo comparator | Biological: PlaceboTris buffer |
| Placebo + adjuvant | Placebo comparator | Biological: Placebo + adjuvantTris buffer + Alum |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subjects in general good health in the opinion of the investigator as determined by medical history, vital signs and a physical examination.
- Negative human leukocyte antigen (HLA) -B27 and no history of reactive arthritis
- Negative HIV, Hepatitis B and Hepatitis C serology tests.
- Blood levels of Shigella flexneri 2a LPS IgG antibodies ≤ percentile 80
- No known history of alcohol abuse
Key exclusion criteria (9 listed)
- Subjects with a history of clinically significant gastrointestinal disorders or with any history of frequent diarrhea, nausea or emesis, regardless of etiology.
- Individuals with immunosuppressive diseases or under immunosuppressive therapy
- History of culture-proven S. flexneri.
- Individuals who have household contact with/and /or intimate exposure to an individual with laboratory confirmed S. flexneri.
- Having travelled in countries/areas highly endemic for S. flexneri within 3 months prior to enrolment.
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 |
|---|---|---|
| SF2a-TT15 vaccine | Biological | vaccine dose 1, vaccine dose 2 |
| SF2a-TT15 vaccine + adjuvant | Biological | vaccine dose 1+ adjuvant, vaccine dose 2 + adjuvant |
| Placebo | Biological | Placebo |
| Placebo + adjuvant | Biological | Placebo + adjuvant |
Primary outcome
Adverse Event
Time frame: 12 months
Safety: Occurrence, frequency, severity, and duration of local and systemic adverse events (AEs) including clinically significant laboratory abnormalities, after administration of the SF2a-TT15 vaccine.
1 secondary outcome
Immunogenicity - humoral Immune response
Time frame: 12 months
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 11 Apr 2018.
- Derived from this study: PubMed 33186516Cohen D, Atsmon J, Artaud C, Meron-Sudai S, Gougeon ML, Bialik A, Goren S, Asato V, Ariel-Cohen O, Reizis A, Dorman A, Hoitink CWG, Westdijk J, Ashkenazi S, Sansonetti P, Mulard LA, Phalipon A. Safety and immunogenicity of a synthetic carbohydrate conjugate vaccine against Shigella flexneri 2a in healthy adult volunteers: a phase 1, dose-escalating, single-blind, randomised, placebo-controlled study. Lancet Infect Dis. 2021 Apr;21(4):546-558. doi: 10.1016/S1473-3099(20)30488-6. Epub 2020 Nov 10.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 SF2a-TT15 vaccine and SF2a-TT15 vaccine + adjuvant in people with Shigellosis and Bacillary Dysentery, run by Institut Pasteur at 1 site in Israel.
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 9 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 11 Apr 2018. 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 Israel. 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?
Adverse Event (time frame: 12 months). 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 NCT02797236, 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 11 Apr 2018.