Safety and Reactogenicity of Bioconjugate Vaccine to Prevent Shigella

Shigellosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01069471
• Other study ID #: SD 133
• Status: Completed
• Phase: Phase 1
• First received: February 15, 2010
• Last updated: October 11, 2010
• Start date: February 2010
• Est. completion date: October 2010

Study information

• Verified date: October 2010
• Source: GlycoVaxyn AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: EthikkommissionSwitzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Shigellosis

Intervention

Biological:
• Shigella vaccine
Two intramuscular injections of bioconjugate vaccine will be administrated at D0 and D60.

Locations

Country	Name	City	State
Switzerland	Institute of Social and Preventive Medicine	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
GlycoVaxyn AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and reactogenicity of the bioconjugate vaccine, GVXN SD133		Each study visits and at the and of the study	Yes
Secondary	Humoral immunogenicity		at day 0, 30, 60, 90 and 150	No