Safety and Reactogenicity of Bioconjugate Vaccine to Prevent Shigella

NCT01069471 | Completed Phase 1 DMC

• 1 other identifier: SD 133
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Shigellosis

Keywords

S.dysenteriae; Healthy volunteers; Conjugate vaccine; Safety; Immunogenicity; Dose scaling

Outcome Measures

Primary Outcomes (1)

• Safety and reactogenicity of the bioconjugate vaccine, GVXN SD133

  Each study visits and at the and of the study

Secondary Outcomes (1)

• Humoral immunogenicity

  at day 0, 30, 60, 90 and 150

Study Arms (4)

HHD O1-EPA plus adjuvant

EXPERIMENTAL

10 ug of Shigella dysenteriae polysaccharide O1 conjugated to EPA adjuvanted to aluminium hydroxide

Biological: Shigella vaccine

HHD O1-EPA

EXPERIMENTAL

10 ug of Shigella dysenteriae polysaccharide O1 conjugated to EPA

Biological: Shigella vaccine

LHD O1-EPA adjuvanted

EXPERIMENTAL

2 ug of Shigella dysenteriae polysaccharide O1 conjugated to EPA adjuvanted to aluminium hydroxide

Biological: Shigella vaccine

LHD O1-EPA

EXPERIMENTAL

2 ug of Shigella dysenteriae polysaccharide O1 conjugated to EPA

Biological: Shigella vaccine

Interventions

Shigella vaccine BIOLOGICAL

Two intramuscular injections of bioconjugate vaccine will be administrated at D0 and D60.

HHD O1-EPA; HHD O1-EPA plus adjuvant; LHD O1-EPA; LHD O1-EPA adjuvanted

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlycoVaxyn AG: lead

Study Sites (1)

Institute of Social and Preventive Medicine

Zurich, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 26162850 DERIVED

MeSH Terms

Conditions

Dysentery, Bacillary

Interventions

Shigella Vaccines

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

Intervention Hierarchy (Ancestors)

Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Christoph Hatz, Prof. Dr.

  Institute of Social and Preventive Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 15, 2010
• First Posted: February 17, 2010
• Study Start: February 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: October 13, 2010

Record last verified: 2010-10

Locations

CH (1)