ShigellosisPhase 1NCT02388009
Safety and Tolerability of a Bioconjugate Vaccine Against Shigella Flexneri 2a
A Phase 1 study testing Flexyn2a and Flexyn2a plus adjuvant in people with Shigellosis, run by LimmaTech Biologics AG at 1 site in United States.
Trial summary
This is a phase I, single-blind, randomized, placebo-controlled, single-center study in healthy subjects using a staggered approach to dosing. 30 subjects will be randomized to receive 10 μg Flexyn2a candidate vaccine with or without adjuvant or placebo. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Shigellosis
- What is being tested?
- Flexyn2a and Flexyn2a plus adjuvant
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Sep 2015
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female volunteers, age of 18 to 50 years (inclusive) at the time of enrollment.
- Signed informed consent form.
- Completion and review of comprehension test (achieved >70% accuracy)
- Available for the required follow-up period and scheduled clinic visits.
- Women: negative pregnancy test with understanding (through informed consent process) to not become pregnant or or breastfeed during the study or within twelve (12) weeks after the last vaccine dose.
Who cannot join
- Health condition that, in the opinion of the investigator, may interfere with optimal participation in the study or place the volunteer at increased risk of adverse Events (AEs). Study clinicians, in consultation with the PI, will use clinical judgment on a case by-case basis to assess safety risks under this criterion. The PI will consult with the Research Monitor as appropriate.
- Clinically significant abnormalities on physical examination.
- Clinically significant abnormalities on basic laboratory screening.
- Presence of significant unexplained laboratory abnormalities that, in the opinion of the PI, may potentially confound the analysis of the study results
- Regular use of constipation, antacid or anti-diarrheal medications or treatments.
- Abnormal stool pattern (fewer than 3 stools per week or more than 3 per day) or loose/liquid stools more than occasionally.
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- Use of immunosuppressive drugs such as corticosteroids or chemotherapeutics that may influence antibody development.
- Women currently nursing.
- Participation in research involving another investigational product (defined as receipt of investigational product or exposure to invasive investigational device) within 30 days of planned date of first vaccination or anytime throughout the duration of the study.
- Positive blood test for HBsAg, hepatitis C Virus (HCV), HIV-1.
- Positive blood test for HLA-B27.
- Immunosuppressive illness or immunoglobulin deficiency (serum immunoglobulin A level < 7 mg/dL or limit of detection of assay).
- Family history of congenital or hereditary immunodeficiency.
- Treatment with immunoglobulins or blood products within 3 months from first candidate vaccine injection.
- History of microbiologically confirmed Shigella infection.
- Personal or family history of inflammatory arthritis.
- Personal or family history of irritable bowel syndrome.
- Received previous experimental Shigella vaccine or live Shigella challenge.
- Have had diarrhea while traveling outside the United States or lived for 2 or more months during the past 3 years in a country with potentially higher Shigella infection rates, including Africa, South America, Central America, and Asia (except Japan).
- Occupation involving handling of Shigella bacteria currently, or in the past 3 years.
- History of allergy to any vaccine.
- History of allergy to aluminum hydroxide.
- Serum immunoglobulin G endpoint titer ≥ 2500 to Shigella Lipopolysaccharide.
Trial locations and contacts
1 site in 1 country.
United States1 site
WRAIR Clinical Trial Center (CTC)
Silver Spring, Maryland, 20910
About this study
Official title: Safety and Tolerability of a Candidate Bioconjugate Vaccine Against Shigella Flexneri 2a When Administered to Adult Volunteers
This is a phase I, single-blind, randomized, placebo-controlled, single-center study in healthy subjects using a staggered approach to dosing.
30 subjects will be randomized to receive 10 μg Flexyn2a candidate vaccine with or without adjuvant or placebo.
Read the detailed description
A total of 30 subjects will be randomly assigned to one of 3 different arms in order to evaluate the safety, tolerability and immunogenicity of a candidate vaccine, formulated with or without adjuvant, and the outcome compared to a placebo control group.
For each active treatment group, 12 subjects will be injected twice with 10 μg Flexyn2a candidate vaccine 4 weeks apart. A control group with 6 subjects will be injected following the same schedule with a placebo solution.
- Conditions
- Shigellosis
- Being tested
- Flexyn2a, Placebo, Flexyn2a plus adjuvant
- Keywords
- bioconjugate vaccine, safety, immunogenicity, shigellosis
- Medical subject headings
- Dysentery, Bacillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexyn2aBiological
Intramuscular doses of 0.5 mL
PlaceboBiological
Intramuscular doses of 0.5 mL
Flexyn2a plus adjuvantBiological
Intramuscular doses of 0.5 mL
| Study group | Role | What they receive |
|---|---|---|
| Flexyn2a | Active comparator | 2 doses of 10 μg of Flexyn2a will be injected intramuscularly 4 weeks apart Receives: Biological: Flexyn2a |
| Flexyn2a plus adjuvant | Active comparator | 2 doses of 10 μg of Flexyn2a plus adjuvant will be injected intramuscularly 4 weeks apart Receives: Biological: Flexyn2a plus adjuvant |
| Placebo | Placebo comparator | 2 doses of saline buffer plus adjuvant will be injected intramuscularly 4 weeks apart Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence and severity of adverse events
Number and severity of local site injection and general adverse events will be collected and compared between the different arms of the study
Measured: until Day 56
Secondary outcomes (2)
Evaluation of antigen-specific antibodies between baseline (D0) and after injection for all groups.
Immunogenicity will be evaluated after the first and second injection and compared to pre-immune levels
Measured: until Day 56
Evaluation of antigen-specific antibodies between subjects receiving the candidate vaccine with and without adjuvant
Immunogenicity will be compared between subjects receiving candidate vaccine with and without adjuvant after the first and second injection
Measured: until Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionMay 2015
- Study completionSep 2015
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.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- LimmaTech Biologics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Wellcome Trust, Naval Medical Research Center
- Responsible party
- Sponsor
- Investigators
- Mark S. Riddle, MD Dr Ph, Principal investigator, Navy Medical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02388009
- Sponsor's protocol ID
- SF2A-1
- Status last verified
- Dec 2015
- First submitted
- 23 Feb 2015
- Last updated
- 22 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Riddle MS, Kaminski RW, Di Paolo C, Porter CK, Gutierrez RL, Clarkson KA, Weerts HE, Duplessis C, Castellano A, Alaimo C, Paolino K, Gormley R, Gambillara Fonck V. Safety and Immunogenicity of a Candidate Bioconjugate Vaccine against Shigella flexneri 2a Administered to Healthy Adults: a Single-Blind, Randomized Phase I Study. Clin Vaccine Immunol. 2016 Dec 5;23(12):908-917. doi: 10.1128/CVI.00224-16. Print 2016 Dec.
PubMed 27581434
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Tolerability of a Candidate Bioconjugate Vaccine Against Shigella Flexneri 2a When Administered to Adult Volunteers
- ClinicalTrials.gov ID
- NCT02388009
- Acronym / sponsor ID
- SF2A-1
- Conditions
- Shigellosis
- Keywords
- bioconjugate vaccine, safety, immunogenicity, shigellosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- LimmaTech Biologics AGIndustry (pharma, biotech, devices)
- Collaborators
- Wellcome Trust, Naval Medical Research Center
- Study start
- Feb 2015
- Primary completion
- May 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 13 Mar 2015 (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 phase I, single-blind, randomized, placebo-controlled, single-center study in healthy subjects using a staggered approach to dosing.
30 subjects will be randomized to receive 10 μg Flexyn2a candidate vaccine with or without adjuvant or placebo.
Detailed description
A total of 30 subjects will be randomly assigned to one of 3 different arms in order to evaluate the safety, tolerability and immunogenicity of a candidate vaccine, formulated with or without adjuvant, and the outcome compared to a placebo control group.
For each active treatment group, 12 subjects will be injected twice with 10 μg Flexyn2a candidate vaccine 4 weeks apart. A control group with 6 subjects will be injected following the same schedule with a placebo solution.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Flexyn2a | Active comparator | Biological: Flexyn2a2 doses of 10 μg of Flexyn2a will be injected intramuscularly 4 weeks apart |
| Flexyn2a plus adjuvant | Active comparator | Biological: Flexyn2a plus adjuvant2 doses of 10 μg of Flexyn2a plus adjuvant will be injected intramuscularly 4 weeks apart |
| Placebo | Placebo comparator | Biological: Placebo2 doses of saline buffer plus adjuvant will be injected intramuscularly 4 weeks apart |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male or female volunteers, age of 18 to 50 years (inclusive) at the time of enrollment.
- Signed informed consent form.
- Completion and review of comprehension test (achieved >70% accuracy)
- Available for the required follow-up period and scheduled clinic visits.
- Women: negative pregnancy test with understanding (through informed consent process) to not become pregnant or or breastfeed during the study or within twelve (12) weeks after the last vaccine dose.
Key exclusion criteria (23 listed)
- Health condition that, in the opinion of the investigator, may interfere with optimal participation in the study or place the volunteer at increased risk of adverse Events (AEs). Study clinicians, in consultation with the PI, will use clinical judgment on a case by-case basis to assess safety risks under this criterion. The PI will consult with the Research Monitor as appropriate.
- Clinically significant abnormalities on physical examination.
- Clinically significant abnormalities on basic laboratory screening.
- Presence of significant unexplained laboratory abnormalities that, in the opinion of the PI, may potentially confound the analysis of the study results
- Regular use of constipation, antacid or anti-diarrheal medications or treatments.
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 |
|---|---|---|
| Flexyn2aIntramuscular doses of 0.5 mL | Biological | Flexyn2a |
| PlaceboIntramuscular doses of 0.5 mL | Biological | Placebo |
| Flexyn2a plus adjuvantIntramuscular doses of 0.5 mL | Biological | Flexyn2a plus adjuvant |
Primary outcome
Occurrence and severity of adverse events
Time frame: until Day 56
Number and severity of local site injection and general adverse events will be collected and compared between the different arms of the study
2 secondary outcomes
Evaluation of antigen-specific antibodies between baseline (D0) and after injection for all groups.
Time frame: until Day 56
Evaluation of antigen-specific antibodies between subjects receiving the candidate vaccine with and without adjuvant
Time frame: until Day 56
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 22 Dec 2015.
- Derived from this study: PubMed 27581434Riddle MS, Kaminski RW, Di Paolo C, Porter CK, Gutierrez RL, Clarkson KA, Weerts HE, Duplessis C, Castellano A, Alaimo C, Paolino K, Gormley R, Gambillara Fonck V. Safety and Immunogenicity of a Candidate Bioconjugate Vaccine against Shigella flexneri 2a Administered to Healthy Adults: a Single-Blind, Randomized Phase I Study. Clin Vaccine Immunol. 2016 Dec 5;23(12):908-917. doi: 10.1128/CVI.00224-16. Print 2016 Dec.
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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.
Mark S. Riddle, MD Dr Ph principal investigator
Navy Medical Research Center
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 Flexyn2a and Flexyn2a plus adjuvant in people with Shigellosis, run by LimmaTech Biologics AG at 1 site in United States.
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 23 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 22 Dec 2015. 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 United States. 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?
Occurrence and severity of adverse events (time frame: until Day 56). 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 NCT02388009, 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 22 Dec 2015.