Shigella InfectionPhase 2NCT00210288
Healthy Adult Volunteer Study for Two Doses of a Shigella Vaccine
A Phase 2 study testing SC599 in people with Shigella Infection, run by Institut Pasteur at 2 sites in 2 countries.
Trial summary
The purpose of this study is to assess the immune response produced by two doses of SC599 vaccine compared to placebo. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Shigella Infection
- What is being tested?
- SC599
- How many people
- 111 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2005to Apr 2007
- Phase
- Phase 2
- 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
- Adult volunteers age 18 to 50
- Signed Informed Consent form following a detailed written explanation of participation in the protocol
- Volunteers who are in good health as determined by medical history, physical examination and clinical judgement
- Volunteers who will be available and "normally reside within the M25" (England) or in Paris and Paris suburb (France) and not leave England or France for the duration of the study
- Women who agree to have a pregnancy test immediately before immunisation and to use effective contraception during the study period
- Volunteers eligible for free NHI treatment (England), volunteers who are covered by social security (France)
Who cannot join
- Individuals who have hypersensitivity to any component of the vaccines used in this study.
- Individuals who have hypersensitivity to ciprofloxacin
- Individuals who are found to be HIV or HCV antibody positive or Hepatitis B surface antigen positive at the time of initial screening
- Individuals who are found to have HLA-B27 tissue type at the time of initial screening
- Individuals with a known or suspected history of gastrointestinal disease or abnormality
- Concomitant therapy with antibiotics, iron, zinc, H2-receptor antagonists or proton pump inhibitors
Show all 22Show fewer
- Individuals who have received any vaccine against Shigella or had proven or suspected shigellosis (bloody diarrhoea with fever) within 6 months prior to study entry
- Individuals with a significant level of immunity against Shigella detected at the screening visit (defined as serum ELISA anti-LPS IgG antibody titre greater than 3 S.D. above the mean background activity of a bank of healthy human sera)
- A Clinically significant amount of protein or haemoglobin in the urine sample at the screening visit
- A Clinically significant abnormality in the haematological or biochemical assays (an abnormal value will be defined by the ranges quoted in each centre) at the screening visit
- A positive Shigella stool culture at the screening visit
- Individuals with a known impairment of immune function or those receiving immunosuppressive therapy (including systemic corticosteroids). Inhaled or topical steroid preparation are not a non-inclusion criterion
- Individuals with acute infections (including fever > 37.5°C oral temperature)at the time of immunisation or any chronic disease
- Women capable of becoming pregnant who do not agree to have pregnancy testing before immunisation, or who do not agree to take effective contraception during the study period
- Breastfeeding women
- Individuals with a current problem with substance abuse or with a history of substance abuse which in the opinion of the investigator, might interfere with participation in the study
- Individuals with any condition which, in the opinion of the investigator, might interfere with the evaluation with the study objectives
- Individuals who have received an investigational product within 30 days prior to entry
- Individuals who cannot read, speak fluent French or English according to the investigational site setting
- Individuals who are planning to leave England or France prior to the end of the study period or who are likely not to complete the study
- Individuals who have persons living with them who in the opinion of the investigator may be at risk of disease if exposed to the vaccine strain or whose occupation may bring them into contact with persons at risk of disease or who are food handlers by occupation
- Individuals with close household contact with child younger than 5 years or a person with immunodeficiency
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United Kingdom1 site
Dept of Cellular and Molecular Medicine, St George's Hospital Vaccine Institute
London, SW17 0QT
About this study
Official title: A Comparative Double Blind Placebo-Controlled Study of Immunogenicity and Safety of Two Doses 10^5 and 10^7 CFU of SC599 Oral Vaccine, a Live Attenuated Shigella Dysenteriae 1 Vaccine Strain in Healthy Human Adult Volunteers
The purpose of this study is to assess the immune response produced by two doses of SC599 vaccine compared to placebo.
- Conditions
- Shigella Infection
- Being tested
- SC599
- Keywords
- Healthy Volunteer, Shigella, Oral Vaccine, Double Blind, Placebo, Immunogenicity, Safety
- Medical subject headings
- Dysentery, Bacillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SC599Biological
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune response assessed by the proportion of Immunoglobulin A (IgA) anti-Lipopolysaccharide (LPS) Antibody-Secreting Cells (ASC) responders.
Secondary outcomes (7)
1) Immune Response:
-Proportion of volunteers who have a B subunit antibody response
-Proportion of volunteers who have a LPS response
2) SC599 Shedding
-Proportion of volunteers who will excrete the vaccine strain and by the duration of the SC5999 shedding, defined as the time (days) between the first an last stool that were positive for SC599.
3) Safety Assessment
-The safety will be evaluated by the proportions of clinical and biological adverse events. Illness after vaccination will be defined as either diarrhoea or fever.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startMay 2005
- Primary completionSep 2006
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shigella InfectionStudies of the same condition, open and under way.
- More trials run by Institut PasteurThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dr Odile Launay, MD, Principal investigator, Hôpital Cochin - Bâtiment Modulaire, FranceDr David Lewis, MD, Principal investigator, St George's Hospital Vaccine Institute, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00210288
- Sponsor's protocol ID
- RBM 2004.20
- Status last verified
- Mar 2010
- First submitted
- 13 Sep 2005
- Last updated
- 8 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Double Blind Placebo-Controlled Study of Immunogenicity and Safety of Two Doses 10^5 and 10^7 CFU of SC599 Oral Vaccine, a Live Attenuated Shigella Dysenteriae 1 Vaccine Strain in Healthy Human Adult Volunteers
- ClinicalTrials.gov ID
- NCT00210288
- Acronym / sponsor ID
- RBM 2004.20
- Conditions
- Shigella Infection
- Keywords
- Healthy Volunteer, Shigella, Oral Vaccine, Double Blind, Placebo, Immunogenicity, Safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- Sep 2006 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 21 Sep 2005 (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.
The purpose of this study is to assess the immune response produced by two doses of SC599 vaccine compared to placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adult volunteers age 18 to 50
- Signed Informed Consent form following a detailed written explanation of participation in the protocol
- Volunteers who are in good health as determined by medical history, physical examination and clinical judgement
- Volunteers who will be available and "normally reside within the M25" (England) or in Paris and Paris suburb (France) and not leave England or France for the duration of the study
- Women who agree to have a pregnancy test immediately before immunisation and to use effective contraception during the study period
Key exclusion criteria (22 listed)
- Individuals who have hypersensitivity to any component of the vaccines used in this study.
- Individuals who have hypersensitivity to ciprofloxacin
- Individuals who are found to be HIV or HCV antibody positive or Hepatitis B surface antigen positive at the time of initial screening
- Individuals who are found to have HLA-B27 tissue type at the time of initial screening
- Individuals with a known or suspected history of gastrointestinal disease or abnormality
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 |
|---|---|---|
| SC599 | Biological | – |
Primary outcome
Immune response assessed by the proportion of Immunoglobulin A (IgA) anti-Lipopolysaccharide (LPS) Antibody-Secreting Cells (ASC) responders.
7 secondary outcomes
1) Immune Response:
-Proportion of volunteers who have a B subunit antibody response
-Proportion of volunteers who have a LPS response
2) SC599 Shedding
-Proportion of volunteers who will excrete the vaccine strain and by the duration of the SC5999 shedding, defined as the time (days) between the first an last stool that were positive for SC599.
3) Safety Assessment
-The safety will be evaluated by the proportions of clinical and biological adverse events. Illness after vaccination will be defined as either diarrhoea or fever.
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 8 Aug 2018.
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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.
Dr Odile Launay, MD principal investigator
Hôpital Cochin - Bâtiment Modulaire, France
Dr David Lewis, MD principal investigator
St George's Hospital Vaccine Institute, UK
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SC599 in people with Shigella Infection, run by Institut Pasteur at 2 sites in 2 countries.
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 22 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 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, United Kingdom. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Immune response assessed by the proportion of Immunoglobulin A (IgA) anti-Lipopolysaccharide (LPS) Antibody-Secreting Cells (ASC) responders.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Aug 2018.