ShigellaPhase 1NCT01531530
Safety and Efficacy Study of CVD 1208S, a Live, Attenuated Oral Vaccine to Prevent Shigella Infection Using cGMP
A Phase 1 study testing CVD 1208S, a Shigella flexneri 2a live, oral vaccine in people with Shigella, run by University of Maryland, Baltimore at 2 sites in United States.
Trial summary
The purpose of this study is to determine whether CVD 1208S (a live, attenuated, oral vaccine) is safe and effective in the prevention of Shigella infection. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Shigella
- What is being tested?
- CVD 1208S, a Shigella flexneri 2a live, oral vaccine
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2011to Sep 2012
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 to 45 years, inclusive.
- Good general health
- Expressed interest and availability to fulfill study requirements
- Informed, written consent.
- Agrees to indefinite storage of unused clinical specimens at the CVD for use in future research
- Agrees not to participate in another investigational vaccine or drug trial during the study
- Has no childbearing potential or agrees to abstain from becoming pregnant from the day of screening (at least 14 days before vaccination) until 6 weeks after the final vaccination by using birth control
- Agrees not to donate blood to a blood bank for 12 months after receiving the vaccine.
Who cannot join
- An acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses.
- Any current illness requiring daily medication (vitamins, birth control pills, nasal or topical medications, allowed);
- Blood in stool on >2 occasions (other than small amounts from straining) in past 12 months;
- Recurrent diarrhea (>5 episodes in past 6 months, each lasting 3 days or more).
- Immunosuppression
- Long term (greater than 2 weeks) use of oral or injected steroids, or high-dose inhaled steroids (>800 micrograms/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (Nasal and topical steroids are allowed).
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- History of abdominal surgery
- Medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months.
- Known allergy or intolerance to ciprofloxacin, trimethoprim/sulfamethoxazole (or other sulfa antibiotic), ampicillin (for women) or corn.
- History of shigellosis or Shigella vaccination or challenge or a laboratory worker with known exposure to Shigella.
- Anticipates any of the following during the first 84 days (12 weeks) of the study (28 days, or 4 weeks for Cohort 1):
- Shares a household with a child <3 years of age, a pregnant woman or a woman who plans to become pregnant during this time;
- Household or sexual contact with someone who has weakened immunity (such as someone with HIV infection, someone receiving treatment for cancer, or an elderly person > 70 yrs);
- Occupation as a food-handler, childcare (for children <3 years), or health care worker with direct patient contact.
- A clinically significant abnormality on physical examination
- Results of blood tests as defined by protocol
- Positive pregnancy test during medical screening or within 24 hours of inoculation or current breast feeding (women).
- Failure to attain a score of at least 70% on the written examination (two attempts permitted)
- During the past 3 years, developed diarrhea during travel to a developing country, or within 1 week of returning home.
- Receipt of any of the following:
- Any vaccine or investigational drug within 30 days of study vaccine
- A live, attenuated vaccine within 30 days of the study vaccine
- A subunit or killed vaccine within 14 days of the study vaccine
- A blood product in the 90 days before the study vaccine
- Receipt of antibiotics within 7 days of inoculation (or within 21 days if the antibiotic was azithromycin).
- Loose stools or any other acute illness such as fever >100.0 degrees F during the 48 hours before vaccination.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Shin Nippon Biomedical Laboratories, LTD. (SNBL) Inpatient Facility
Baltimore, Maryland, 21201
University of Maryland, Baltimore Center for Vaccine Development
Baltimore, Maryland, 21201
About this study
Official title: Safety, Clinical Tolerance, and Immunogenicity of CVD 1208S, a Delta guaBA, Delta Sen, Delta Set, Live, Oral Shigella Flexneri 2a Vaccine Manufactured Using cGMP
The purpose of this study is to determine whether CVD 1208S (a live, attenuated, oral vaccine) is safe and effective in the prevention of Shigella infection.
Read the detailed description
There are two purposes for conducting this Vaccine Study to evaluate an experimental vaccine called CVD 1208S (Center for Vaccine Development 1208S): 1) to learn whether CVD 1208S causes side effects, and 2) to learn whether the CVD 1208S gives people immunity to Shigella.
- Conditions
- Shigella
- Being tested
- CVD 1208S, a Shigella flexneri 2a live, oral vaccine, Placebo
- Keywords
- Shigella, Vaccine, Mucosal immunity
- Medical subject headings
- Dysentery, Bacillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CVD 1208S, a Shigella flexneri 2a live, oral vaccineBiological
The vaccine is mixed with salt water and given by mouth.
PlaceboOther
Corn starch and baking soda are mixed with salt water and given by mouth.
| Study group | Role | What they receive |
|---|---|---|
| Vaccine-recipients | Experimental | Not described Receives: Biological: CVD 1208S, a Shigella flexneri 2a live, oral vaccine |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with reactions and adverse events
occurence of diarrhea, dysentery and fever.
Measured: Reactions are evaluated for 7 days after each dose. Adverse events are evaluated for the entire study participation (6 months for cohort 1 and 8 months for all other cohorts).
Number of participants who receive the vaccine who get immunity to shigella
It is hoped that the vaccine will trigger the body's immune system to make specific responses such as antibodies (special proteins) and antibody-producing cells that are believed to protect against illness if a person is exposed to certain illness-causing Shigella in the future.
Measured: Immunity in the blood will be assessed using serial samples collected during the 84 days after the first vaccination. Immunity at the intestinal level will be assessed by collecting seral stool samples for 14 days after each vaccination.
Secondary outcomes (2)
Number of participants who pass the vaccine in their stool
Volunteers' stool will be tested to see if the vaccine is present. This will tell whether the vaccine is able to stick to the intestine and grow there. We will see whether this information predicts the strength of the immune responses to the vaccine and whether the vaccine could potentially be passed to close contacts.
Measured: The first 84 days after vaccination
The number of participants who develop various types of immune responses
We will look at the ability of the vaccine to evoke different types of responses in blood and stool that might protect them against Shigella infections in the future.
Measured: The first 84 days of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2012 (estimated)
- Study startJul 2011
- Primary completionSep 2012
- Study completionSep 2012
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 ShigellaStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- PATH
- Responsible party
- Principal investigator, Karen Kotloff, University of Maryland, Baltimore
- Investigators
- Karen L. Kotloff, M.D., Principal investigator, University of Maryland,Baltimore Center for Vaccine Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01531530
- Sponsor's protocol ID
- HP-00049727
- Other IDs
- Shigella CVD 28000
- Status last verified
- Apr 2021
- First submitted
- 26 Oct 2011
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Toapanta FR, Bernal PJ, Kotloff KL, Levine MM, Sztein MB. T cell mediated immunity induced by the live-attenuated Shigella flexneri 2a vaccine candidate CVD 1208S in humans. J Transl Med. 2018 Mar 13;16(1):61. doi: 10.1186/s12967-018-1439-1.
PubMed 29534721
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Clinical Tolerance, and Immunogenicity of CVD 1208S, a Delta guaBA, Delta Sen, Delta Set, Live, Oral Shigella Flexneri 2a Vaccine Manufactured Using cGMP
- ClinicalTrials.gov ID
- NCT01531530
- Acronym / sponsor ID
- HP-00049727
- Conditions
- Shigella
- Keywords
- Shigella, Vaccine, Mucosal immunity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- PATH
- Study start
- Jul 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 13 Feb 2012 (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 determine whether CVD 1208S (a live, attenuated, oral vaccine) is safe and effective in the prevention of Shigella infection.
Detailed description
There are two purposes for conducting this Vaccine Study to evaluate an experimental vaccine called CVD 1208S (Center for Vaccine Development 1208S): 1) to learn whether CVD 1208S causes side effects, and 2) to learn whether the CVD 1208S gives people immunity to Shigella.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccine-recipients | Experimental | Biological: CVD 1208S, a Shigella flexneri 2a live, oral vaccine |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age 18 to 45 years, inclusive.
- Good general health
- Expressed interest and availability to fulfill study requirements
- Informed, written consent.
- Agrees to indefinite storage of unused clinical specimens at the CVD for use in future research
Key exclusion criteria (26 listed)
- An acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses.
- Any current illness requiring daily medication (vitamins, birth control pills, nasal or topical medications, allowed);
- Blood in stool on >2 occasions (other than small amounts from straining) in past 12 months;
- Recurrent diarrhea (>5 episodes in past 6 months, each lasting 3 days or more).
- Immunosuppression
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 |
|---|---|---|
| CVD 1208S, a Shigella flexneri 2a live, oral vaccineThe vaccine is mixed with salt water and given by mouth. | Biological | Vaccine-recipients |
| PlaceboCorn starch and baking soda are mixed with salt water and given by mouth. | Other | Placebo |
Primary outcome
Number of participants with reactions and adverse events
Time frame: Reactions are evaluated for 7 days after each dose. Adverse events are evaluated for the entire study participation (6 months for cohort 1 and 8 months for all other cohorts).
occurence of diarrhea, dysentery and fever.
Number of participants who receive the vaccine who get immunity to shigella
Time frame: Immunity in the blood will be assessed using serial samples collected during the 84 days after the first vaccination. Immunity at the intestinal level will be assessed by collecting seral stool samples for 14 days after each vaccination.
It is hoped that the vaccine will trigger the body's immune system to make specific responses such as antibodies (special proteins) and antibody-producing cells that are believed to protect against illness if a person is exposed to certain illness-causing Shigella in the future.
2 secondary outcomes
Number of participants who pass the vaccine in their stool
Time frame: The first 84 days after vaccination
The number of participants who develop various types of immune responses
Time frame: The first 84 days of the study
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 30 Apr 2021.
- Derived from this study: PubMed 29534721Toapanta FR, Bernal PJ, Kotloff KL, Levine MM, Sztein MB. T cell mediated immunity induced by the live-attenuated Shigella flexneri 2a vaccine candidate CVD 1208S in humans. J Transl Med. 2018 Mar 13;16(1):61. doi: 10.1186/s12967-018-1439-1.
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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.
Karen L. Kotloff, M.D. principal investigator
University of Maryland,Baltimore Center for Vaccine Development
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CVD 1208S, a Shigella flexneri 2a live, oral vaccine in people with Shigella, run by University of Maryland, Baltimore at 2 sites in United States.
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 8 inclusion and 26 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 30 Apr 2021. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Number of participants with reactions and adverse events (time frame: Reactions are evaluated for 7 days after each dose. Adverse events are evaluated for the entire study participation (6 months for cohort 1 and 8 months for all other cohorts).). The study lists 2 primary outcomes in all. 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 NCT01531530, 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 30 Apr 2021.