Phase 2b Challenge Study With the Bioconjugate Vaccine Flexyn2a
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02646371 |
Recruitment Status :
Completed
First Posted : January 5, 2016
Results First Posted : January 27, 2021
Last Update Posted : January 27, 2021
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Condition or disease | Intervention/treatment | Phase |
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Shigellosis | Biological: Flexyn2a Biological: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 67 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Prevention |
Official Title: | Phase 2b, Double-blind, Placebo-controlled Efficacy Challenge Study With a Candidate Bioconjugate Vaccine Against Shigella Flexneri 2a |
Actual Study Start Date : | December 2015 |
Actual Primary Completion Date : | September 2016 |
Actual Study Completion Date : | July 2017 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Flexyn2a
2 doses of 10 μg of Flexyn2a will be injected intramuscularly 4 weeks apart
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Biological: Flexyn2a
2 doses of 10 μg of Flexyn2a will be injected intramuscularly 4 weeks apart |
Placebo Comparator: Placebo
2 doses of TBS solution will be injected intramuscularly 4 weeks apart
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Biological: Placebo
2 doses of TBS solution will be injected intramuscularly 4 weeks apart |
- Attack Rate of Shigellosis in Vaccinated Subjects. [ Time Frame: Between Day 56 and Day 64 ]The attack rate of shigellosis after challenge in vaccine group versus in placebo group was analyzed.

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Male or female age 18-50 years (inclusive)
- Good health, without clinically significant medical history or physical examination findings.
- Negative serum pregnancy test at screening, and negative urine before each vaccination and before challenge for female subjects of childbearing potential.
- Females of childbearing potential must agree to avoid pregnancy by use of effective contraception. Abstinence is not acceptable as effective contraception. Female subjects unable to bear children must have this documented (e.g. tubal ligation or hysterectomy).
- Willingness to participate in the study after all aspects of the protocol have been explained and written informed consent obtained.
- Completion of a training session and demonstrated comprehension of the protocol procedures, knowledge of Shigella-associated illness, and a passing score of 70% or better on a written examination.
- Availability for the study duration, including all planned follow-up visits.
- Willingness to refrain from participating in other studies of investigational products until completion of the last study visit.
Exclusion Criteria:
- Women currently nursing.
- Presence of a significant medical or psychiatric condition which in the opinion of the investigator precludes participation in the study.
- Clinically significant abnormalities in screening hematology or serum chemistry as determined by PI or PI in consultation with the research monitor and sponsor.
- Presence in the serum of HIV antibody, HBs-Ag, or HCV antibody (if confirmed positive by HepC confirmatory test, i.e. RIBA, PCR)
- Evidence of IgA deficiency (serum IgA < 7 mg/dl or limit of detection of assay).
- Evidence of current excessive alcohol consumption or drug dependence.
- Evidence of impaired immune function.
- BMI <19 and ≥35
- Recent vaccination or receipt of an investigational product (within 30 days before vaccination and until last study visit).
- Personal history of an inflammatory arthritis.
- Positive blood test for HLA-B27.
- Personal history of irritable bowel syndrome as defined by Rome III criteria.
- Treatment with immunoglobulins or blood products within 3 months from first candidate vaccine injection.
- Regularly abnormal stool pattern (fewer than 3 per week or more than 3 per day) or loose or liquid stools
- Regular use of laxatives, antacids, or other agents to lower stomach acidity.
- Use of any medication known to affect the immune function (e.g., systemic steroids) within 30 days preceding the first vaccination or planned use during the entire study period.
- Known allergy to any of the following antibiotics: ciprofloxacin, trimethoprim-sulfamethoxazole or penicillin.
- Symptoms consistent with Traveler's Diarrhea concurrent with travel to countries where Shigella infection is endemic (most of the developing world) within two years prior to dosing, OR planned travel to endemic countries during the length of the study.
- Vaccination for or ingestion of Shigella within 3 years prior to vaccination.
- Use of antibiotics during the 7 days before vaccination and challenge
- Use of proton pump inhibitors, H2 blockers or antacids within 48 hours prior to challenge.
- Serum IgG titer to Shigella flexneri 2a LPS ≥ 2500
- Current occupation involving handling of Shigella bacteria
- History of allergy to any vaccine or to soy
- Any other criteria which, in the investigator's opinion, would compromise the ability of the subject to participate in the study, the safety of the study, or the results of the study

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02646371
United States, Maryland | |
Johns Hopkins Bloomberg School of Public Health, CIR | |
Baltimore, Maryland, United States, 21205 |
Principal Investigator: | Kawsar R Talaat, MD | Johns Hopkins Bloomberg School of Public Health | |
Study Director: | Patricia Martin, PhD | LimmaTech Biologics AG |
Responsible Party: | LimmaTech Biologics AG |
ClinicalTrials.gov Identifier: | NCT02646371 |
Other Study ID Numbers: |
SF2A-2B |
First Posted: | January 5, 2016 Key Record Dates |
Results First Posted: | January 27, 2021 |
Last Update Posted: | January 27, 2021 |
Last Verified: | January 2021 |
Dysentery, Bacillary Enterobacteriaceae Infections Gram-Negative Bacterial Infections Bacterial Infections Dysentery |
Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |