Safety and Reactogenicity of Bioconjugate Vaccine to Prevent Shigella

Safety and Reactogenicity of a Candidate Vaccine Against S. Dysenteriae When Administered to Healthy Adults

Healthy volunteers will receive a 2-dose vaccination with Shigella dysenteriae candidate vaccine spaced 8 weeks apart. The objective is to demonstrate the safety and reactogenicity of the Shigella dysenteriae bioconjugate vaccine (GVXN SD133) alone or in combination with an adjuvant (Aluminium Hydroxide). The safety and reactogenicity of the GVXN SD133 vaccine will be also evaluated at two different concentrations of antigen, Shigella polysaccharide O1. Blood samples will be collected at intervals to examine systemic vaccine antigen-specific immune responses.

Study Overview

• Status: Completed
• Conditions: Shigellosis
• Intervention / Treatment: Biological: Shigella vaccine

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland
    • Institute of Social and Preventive Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects of both sexes, aged between 18 and 50 years.
• Subjects who have undergone a detailed medical history, clinical checkup and are in good health.
• Subjects who have understood the purpose of the study and have freely signed the informed consent.
• Subjects who consent with repeated blood samples taking.
• Subjects who will be available to perform the follow-up visits, are reachable by telephone, and are able to complete the diary cards throughout the study duration.
• For female volunteers, a negative pregnancy test and an adequate contraception throughout the study duration.

Exclusion Criteria:

• Known history of recent contact Shigella infection or long-term residence in a Shigella endemic region (Central America, Africa, and India).
• Known history of hypersensitivity to any component of the vaccine (EPA; Aluminium Hydroxide).
• Subjects with compromised immune system.
• Family history of congenital or hereditary immunodeficiency.
• Chronic administration of an immunosuppressive treatment or other immune-modifying drugs within six months prior to the first vaccine dose.
• Subjects that received any other vaccine during the 1 month preceding the 1st injection and may receive before the 2nd injection. If the subject needs to be vaccinated during this period, he/she will be withdrawn from the study.
• Subjects suffering of a disease at the time of enrolment. 'Disease' is defined as the presence of a mild or severe illness with or without fever.
• Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
• Any laboratory data collected during the screening phase found to be outside the normal range defined by the laboratory.
• Positive test for HIV, and evidence of HBV or HCV.
• Pregnant or breast-feeding women.
• History of alcohol, drug or psychotropic drug abuse (which interferes with a normal lifestyle) during the previous year.
• Subjects for which follow-up is compromised due to socio-cultural, geographic or psychological reasons.
• Any other significant finding that in the opinion of the Investigator that would increase the risk of having an adverse outcome from participating in the study.
• Subjects that are participating or have participated in another clinical trial in the last 6 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HHD O1-EPA plus adjuvant; 10 ug of Shigella dysenteriae polysaccharide O1 conjugated to EPA adjuvanted to aluminium hydroxide	Biological: Shigella vaccine; Two intramuscular injections of bioconjugate vaccine will be administrated at D0 and D60.
Experimental: HHD O1-EPA; 10 ug of Shigella dysenteriae polysaccharide O1 conjugated to EPA	Biological: Shigella vaccine; Two intramuscular injections of bioconjugate vaccine will be administrated at D0 and D60.
Experimental: LHD O1-EPA adjuvanted; 2 ug of Shigella dysenteriae polysaccharide O1 conjugated to EPA adjuvanted to aluminium hydroxide	Biological: Shigella vaccine; Two intramuscular injections of bioconjugate vaccine will be administrated at D0 and D60.
Experimental: LHD O1-EPA; 2 ug of Shigella dysenteriae polysaccharide O1 conjugated to EPA	Biological: Shigella vaccine; Two intramuscular injections of bioconjugate vaccine will be administrated at D0 and D60.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety and reactogenicity of the bioconjugate vaccine, GVXN SD133	Each study visits and at the and of the study

Secondary Outcome Measures

Outcome Measure	Time Frame
Humoral immunogenicity	at day 0, 30, 60, 90 and 150

Collaborators and Investigators

• Sponsor: GlycoVaxyn AG
• Investigators: Principal Investigator: Christoph Hatz, Prof. Dr., Institute of Social and Preventive Medicine

Publications and helpful links

General Publications

• Hatz CF, Bally B, Rohrer S, Steffen R, Kramme S, Siegrist CA, Wacker M, Alaimo C, Fonck VG. Safety and immunogenicity of a candidate bioconjugate vaccine against Shigella dysenteriae type 1 administered to healthy adults: A single blind, partially randomized Phase I study. Vaccine. 2015 Aug 26;33(36):4594-601. doi: 10.1016/j.vaccine.2015.06.102. Epub 2015 Jul 7.

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: February 15, 2010
• First Submitted That Met QC Criteria: February 16, 2010
• First Posted (Estimate): February 17, 2010

Study Record Updates

• Last Update Posted (Estimate): October 13, 2010
• Last Update Submitted That Met QC Criteria: October 11, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: Healthy volunteers; Safety; Immunogenicity; S.dysenteriae; Conjugate vaccine; Dose scaling
• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Enterobacteriaceae Infections; Dysentery; Dysentery, Bacillary
• Other Study ID Numbers: SD 133

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No