Safety and Reactogenicity of Bioconjugate Vaccine to Prevent Shigella

This study has been completed.
Sponsor:
Information provided by:
GlycoVaxyn AG
ClinicalTrials.gov Identifier:
NCT01069471
First received: February 15, 2010
Last updated: October 11, 2010
Last verified: October 2010
  Purpose

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.


Condition Intervention Phase
Shigellosis
Biological: Shigella vaccine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Safety and Reactogenicity of a Candidate Vaccine Against S. Dysenteriae When Administered to Healthy Adults

Resource links provided by NLM:


Further study details as provided by GlycoVaxyn AG:

Primary Outcome Measures:
  • Safety and reactogenicity of the bioconjugate vaccine, GVXN SD133 [ Time Frame: Each study visits and at the and of the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Humoral immunogenicity [ Time Frame: at day 0, 30, 60, 90 and 150 ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: February 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01069471

Locations
Switzerland
Institute of Social and Preventive Medicine
Zurich, Switzerland
Sponsors and Collaborators
GlycoVaxyn AG
Investigators
Principal Investigator: Christoph Hatz, Prof. Dr. Institute of Social and Preventive Medicine
  More Information

No publications provided

Responsible Party: Veronica Gambillara, GlycoVaxyn AG
ClinicalTrials.gov Identifier: NCT01069471     History of Changes
Other Study ID Numbers: SD 133
Study First Received: February 15, 2010
Last Updated: October 11, 2010
Health Authority: Switzerland: Ethikkommission
Switzerland: Swissmedic

Keywords provided by GlycoVaxyn AG:
S.dysenteriae
Healthy volunteers
Conjugate vaccine
Safety
Immunogenicity
Dose scaling

ClinicalTrials.gov processed this record on September 30, 2014