Phase 2b Challenge Study With the Bioconjugate Vaccine Flexyn2a

NCT02646371 | Completed Phase 2 Results

• 1 other identifier: SF2A-2B
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

In this proof of concept challenge study, the bioconjugate candidate vaccine Flexyn2a will be tested for its ability to induce an immune response that protects healthy adult volunteers from infection with a wild-type Shigella flexneri 2a strain compared to subjects receiving placebo.

Conditions

Shigellosis

Outcome Measures

Primary Outcomes (1)

• Attack Rate of Shigellosis in Vaccinated Subjects.

  The attack rate of shigellosis after challenge in vaccine group versus in placebo group was analyzed.

  Between Day 56 and Day 64

Study Arms (2)

Flexyn2a

ACTIVE COMPARATOR

2 doses of 10 μg of Flexyn2a will be injected intramuscularly 4 weeks apart

Biological: Flexyn2a

Placebo

PLACEBO COMPARATOR

2 doses of TBS solution will be injected intramuscularly 4 weeks apart

Biological: Placebo

Interventions

Flexyn2a BIOLOGICAL

2 doses of 10 μg of Flexyn2a will be injected intramuscularly 4 weeks apart

Flexyn2a

Placebo BIOLOGICAL

2 doses of TBS solution will be injected intramuscularly 4 weeks apart

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• LimmaTech Biologics AG: lead
• Johns Hopkins Bloomberg School of Public Health: collaborator

Study Sites (1)

Johns Hopkins Bloomberg School of Public Health, CIR

Baltimore, Maryland, 21205, United States

Location

Related Publications (1)

• Talaat KR, Alaimo C, Martin P, Bourgeois AL, Dreyer AM, Kaminski RW, Porter CK, Chakraborty S, Clarkson KA, Brubaker J, Elwood D, Frolich R, DeNearing B, Weerts H, Feijoo BL, Halpern J, Sack D, Riddle MS, Fonck VG. Human challenge study with a Shigella bioconjugate vaccine: Analyses of clinical efficacy and correlate of protection. EBioMedicine. 2021 Apr;66:103310. doi: 10.1016/j.ebiom.2021.103310. Epub 2021 Apr 13.

  PMID: 33862589 DERIVED

MeSH Terms

Conditions

Dysentery, Bacillary

Condition Hierarchy (Ancestors)

Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Dysentery; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: LimmaTech Biologics AG

info@lmtbio.com

+41 44 733 8585

Study Officials

• Kawsar R Talaat, MD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

• Patricia Martin, PhD

  LimmaTech Biologics AG

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2015
• First Posted: January 5, 2016
• Study Start: December 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: July 1, 2017
• Last Updated: January 27, 2021
• Results First Posted: January 27, 2021

Record last verified: 2021-01

Locations

US (1)