ShigellosisPhase 1NCT01069471
Safety and Reactogenicity of Bioconjugate Vaccine to Prevent Shigella
A Phase 1 study testing Shigella vaccine in people with Shigellosis, run by GlycoVaxyn AG at 1 site in Switzerland.
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). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Shigellosis
- What is being tested?
- Shigella vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2010to Oct 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Shigellosis
- Being tested
- Shigella vaccine
- Keywords
- S.dysenteriae, Healthy volunteers, Conjugate vaccine, Safety, Immunogenicity, Dose scaling
- Medical subject headings
- Dysentery, Bacillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shigella vaccineBiological
Two intramuscular injections of bioconjugate vaccine will be administrated at D0 and D60.
| Study group | Role | What they receive |
|---|---|---|
| HHD O1-EPA plus adjuvant | Experimental | 10 ug of Shigella dysenteriae polysaccharide O1 conjugated to EPA adjuvanted to aluminium hydroxide Receives: Biological: Shigella vaccine |
| HHD O1-EPA | Experimental | 10 ug of Shigella dysenteriae polysaccharide O1 conjugated to EPA Receives: Biological: Shigella vaccine |
| LHD O1-EPA adjuvanted | Experimental | 2 ug of Shigella dysenteriae polysaccharide O1 conjugated to EPA adjuvanted to aluminium hydroxide Receives: Biological: Shigella vaccine |
| LHD O1-EPA | Experimental | 2 ug of Shigella dysenteriae polysaccharide O1 conjugated to EPA Receives: Biological: Shigella vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and reactogenicity of the bioconjugate vaccine, GVXN SD133
Measured: Each study visits and at the and of the study
Secondary outcomes (1)
Humoral immunogenicity
Measured: at day 0, 30, 60, 90 and 150
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ShigellosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlycoVaxyn AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Christoph Hatz, Prof. Dr., Principal investigator, Institute of Social and Preventive Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01069471
- Sponsor's protocol ID
- SD 133
- Status last verified
- Oct 2010
- First submitted
- 15 Feb 2010
- Last updated
- 13 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 26162850
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Reactogenicity of a Candidate Vaccine Against S. Dysenteriae When Administered to Healthy Adults
- ClinicalTrials.gov ID
- NCT01069471
- Acronym / sponsor ID
- SD 133
- Conditions
- Shigellosis
- Keywords
- S.dysenteriae, Healthy volunteers, Conjugate vaccine, Safety, Immunogenicity, Dose scaling
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- GlycoVaxyn AGIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 17 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HHD O1-EPA plus adjuvant | Experimental | Biological: Shigella vaccine10 ug of Shigella dysenteriae polysaccharide O1 conjugated to EPA adjuvanted to aluminium hydroxide |
| HHD O1-EPA | Experimental | Biological: Shigella vaccine10 ug of Shigella dysenteriae polysaccharide O1 conjugated to EPA |
| LHD O1-EPA adjuvanted | Experimental | Biological: Shigella vaccine2 ug of Shigella dysenteriae polysaccharide O1 conjugated to EPA adjuvanted to aluminium hydroxide |
| LHD O1-EPA | Experimental | Biological: Shigella vaccine2 ug of Shigella dysenteriae polysaccharide O1 conjugated to EPA |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shigella vaccineTwo intramuscular injections of bioconjugate vaccine will be administrated at D0 and D60. | Biological | HHD O1-EPA, HHD O1-EPA plus adjuvant, LHD O1-EPA, LHD O1-EPA adjuvanted |
Primary outcome
Safety and reactogenicity of the bioconjugate vaccine, GVXN SD133
Time frame: Each study visits and at the and of the study
1 secondary outcome
Humoral immunogenicity
Time frame: at day 0, 30, 60, 90 and 150
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2010.
- Derived from this study: PubMed 26162850Hatz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Hatz, Prof. Dr. principal investigator
Institute of Social and Preventive Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Shigella vaccine in people with Shigellosis, run by GlycoVaxyn AG at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and reactogenicity of the bioconjugate vaccine, GVXN SD133 (time frame: Each study visits and at the and of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01069471, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2010.