DysenteryPhase 1/2NCT01080716

Safety and Efficacy Study of WRSS1, a Shigella Sonnei Vaccine Candidate

A Phase 1/2 study testing Part 1/Arm 1 of Study: WRSS1 vaccine, Part 2/Arm 1 of Study: S. sonnei 53G and Part 2/Arm 2 of Study: S. sonnei 53G in people with Dysentery and Shigella, run by U.S. Army Medical Research and Development Command at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is an inpatient trial to determine the safety, immunogenicity and efficacy of the WRSS1 candidate vaccine in healthy Thai adult volunteers. Read more about this study

Who is it for?: Ages 20 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Dysentery, Shigella, Diarrhea
What is being tested?: Part 1/Arm 1 of Study: WRSS1 vaccine, Part 2/Arm 1 of Study: S. sonnei 53G and Part 2/Arm 2 of Study: S. sonnei 53G
Type of treatment: Vaccines, Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 1 siteThailand
Study dates: May 2010to Dec 2011
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 20 to 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

20-40 years old; male or female;
General good health as determined by a screening evaluation no greater than 30 days before admission;
Normal bowel habits (grade 1-2 stools - no more than one to two stools per day with at least one stool per 2 days;
Sexually active females willing to use birth control (birth control pills, injection hormonal contraceptive, implant hormonal contraceptive, hormonal patch, IUD, sterilization for effective contraceptive methods, spermicidal products and barrier methods are considered acceptable)during the entire study (starting from study day -30) and for 3 months after completion of the study (approximately a total of 6 months) or sexually inactive females (no sexual contact). Volunteers who take birth control pills will be required to use additional contraceptive methods for the remaining days of the cycle after discharge from the VTC (alteration of gastrointestinal functions from the oral vaccine or challenge strain may lead to unpredictable efficacy of pills);
Will be available and willing to continue participation in the second part of the study if he/she has been randomly selected;
Pass the Assessment of Understanding of the consent form.

Who cannot join

An acute or chronic medical condition or a clinically significant abnormality on physical exam that, in the opinion of the investigator, would render vaccination or challenge as unsafe;
Current use of iron or zinc supplements within the past 7 days; current use of antacids (H2 blockers, omeprazole, OTC agents) or immunosuppressive drug;
Unwillingness to follow the study procedures
Currently breastfeeding, pregnant (βHCG +) or planning to become pregnant within 3 months after the completion of the study;
Allergy to quinolone, sulfa, and penicillin classes of antibiotics;
History of any of the following conditions within the past 10 years:

Show all 23Show fewer

Arthritis (two or more episodes of joint pain and swelling),
Gastrointestinal disease (diagnosed by a doctor as having irritable bowel disease, Crohn's disease, ulcerative colitis (biopsy confirmed), celiac disease, stomach or intestinal ulcers), or
Dyspepsia (digestion or heartburn requiring medication more than once per week);
Lifetime previous history of known/suspected Shigella diarrhea (except for volunteers who receive vaccines from Part 1) ;
Lifetime history of, or active gallbladder disease;
HLA B27 Ag (+); Anti-HIV (+); HBsAg(+); Anti HCV IgG Ab(+); abnormal screening tests judged to be clinically significant as judged by PI or sub-PI (Values are out of the acceptable abnormal range from the table in the protocol) other than mild anemia in females (Hct = 0.33-0.36);
Lifetime history of participation in Shigella study (except for volunteers who receive vaccines from Part 1);
Concurrent participation in another experimental vaccine or drug study within the past 30 days(except for volunteers who receive vaccines from part1);
Serological positive for Shigella sonnei: anti-Shigella sonnei LPS IgG antibody titer in serum >800 (except for volunteers who receive vaccines from Part 1);
Receipt of antimicrobial drugs for any reason or acute illness or fever >=38 oC within 7 days before vaccination or challenge;
Individuals with household contacts that are immunocompromised;
History of major abdominal surgery or laparotomy for any reason in the past 3 years, or abdominal scar of unclear origin;
Presence of significant ova or parasite or Shigella bacteria in the stool;
Receipt of any of the following (does not include the WRSS1 vaccine):
a licensed live, attenuated vaccine within the 30 days of challenge
a licensed subunit or killed vaccine within the 14 days of the challenge
a blood product, including immunoglobulin, in the 90 days before the challenge

Trial locations and contacts

1 site in 1 country.

Thailand1 site

Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University
Bangkok, 10400

Other trials in Thailand

About this study

Official title: Safety, Immunogenicity, and Efficacy Studies of WRSS1, a Live Attenuated Shigella Sonnei Vaccine Candidate, in Healthy Thai Adults

This study is an inpatient trial to determine the safety, immunogenicity and efficacy of the WRSS1 candidate vaccine in healthy Thai adult volunteers.

Read the detailed description

This study is designed as 2 parts.

Part 1 is a blinded, placebo-controlled inpatient trial in a total of 20 volunteers (14 vaccinees and 6 controls) to determine the safety and immunogenicity. Volunteers will be vaccinated with a single oral dose of 104 colony forming unit (cfu) of WRSS1 or placebo given with bicarbonate buffer.
Part 2 will be started approximately 60 days after WRSS1 vaccination. This part is an inpatient phase II efficacy trial involving a challenge with the S.sonnei 53G of 10 vaccinees from the first part and 10 naïve controls.

Conditions: Dysentery, Shigella, Diarrhea
Being tested: Part 1/Arm 1 of Study: WRSS1 vaccine, Part 1/Arm 2 of Study: Placebo vaccine, Part 2/Arm 1 of Study: S. sonnei 53G, Part 2/Arm 2 of Study: S. sonnei 53G
Medical subject headings: Dysentery, Dysentery, Bacillary, Diarrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Part 1/Arm 1 of Study: WRSS1 vaccineBiological
Single, oral dose of WRSS1
Part 1/Arm 2 of Study: Placebo vaccineBiological
Placebo vaccine
Part 2/Arm 1 of Study: S. sonnei 53GBiological
Subject from Part 1/Arm 1 of Study are given 53G S. sonnei
Part 2/Arm 2 of Study: S. sonnei 53GBiological
10 naïve controls are given S. sonnei 53G

Study groups in NCT01080716
Study group	Role	What they receive
Part 1/Arm 1 of Study: WRSS1 vaccine	Experimental	WRSS1 is a live attenuated S. sonnei vaccine candidate derived from the Mosely strain of S.sonnei Receives: Biological: Part 1/Arm 1 of Study: WRSS1 vaccine
Part 1/Arm 2 of Study: Placebo vaccine	Placebo comparator	Placebo Receives: Biological: Part 1/Arm 2 of Study: Placebo vaccine
Part 2/Arm 1 of Study: S. sonnei 53G	Experimental	10 volunteers from Study Arm 1/Part 1 (WRSS1 vaccine) plus 4 alternates from Arm 1/Part 1 are given 53G S. sonnei Receives: Biological: Part 2/Arm 1 of Study: S. sonnei 53G
Part 2/Arm 2 of Study: S sonnei 53G	Active comparator	10 subjects (naïve controls) plus 4 alternates are give 53G S sonnei Receives: Biological: Part 2/Arm 2 of Study: S. sonnei 53G

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Adverse Events
Overview of AEs highlighting all AEs, withdrawals and deaths related to AEs
Measured: Up to 12 months
Number of Participants With Shigella Induced Clinical Disease in Part 2
Study Part 2-Frequency of Shigella induced clinical disease defined as one or more of diarrhea, dysentery or fever in vaccinees and controls following challenge with S. sonnei 53G. Transmissibility of disease will be evaluated by the presence of fecal shedding in control subjects.
Measured: 0-5 days

Secondary outcomes (1)

Count of Subjects With Normal and Abnormal Clinical Laboratory Values During Parts 1 and 2 of Study
Count of subjects in Parts 1 and 2 with normal and abnormal clinical laboratory values after samples taken on days 1, 7, 14, and 28. Abnormal lab values are determined clinically significant by the PI
Measured: Days 1, 7, 14, and 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2010Dec 2011

First posted4 Mar 2010 (estimated)
Study startMay 2010
Primary completionSep 2010
Study completionDec 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for DysenteryStudies 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 1/2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01080716
Sponsor's protocol ID: A-15647
Other IDs: 09-0021, 1609
Status last verified: Oct 2018
First submitted: 23 Dec 2009
Last updated: 13 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: Mahidol University and National Institutes of Health will have access to study data.

Publications

Pitisuttithum P, Islam D, Chamnanchanunt S, Ruamsap N, Khantapura P, Kaewkungwal J, Kittitrakul C, Luvira V, Dhitavat J, Venkatesan MM, Mason CJ, Bodhidatta L. Clinical Trial of an Oral Live Shigella sonnei Vaccine Candidate, WRSS1, in Thai Adults. Clin Vaccine Immunol. 2016 Jul 5;23(7):564-75. doi: 10.1128/CVI.00665-15. Print 2016 Jul.
PubMed 27146000

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dysentery trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety, Immunogenicity, and Efficacy Studies of WRSS1, a Live Attenuated Shigella Sonnei Vaccine Candidate, in Healthy Thai Adults
ClinicalTrials.gov ID: NCT01080716
Acronym / sponsor ID: A-15647
Conditions: Dysentery, Shigella, Diarrhea
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: U.S. Army Medical Research and Development CommandUS federal agency
Collaborators: Mahidol University, National Institutes of Health (NIH)
Study start: May 2010
Primary completion: Sep 2010 (actual)
Study completion: Dec 2011 (actual)
First posted: 4 Mar 2010 (estimated)
Results: Posted 13 Nov 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study is an inpatient trial to determine the safety, immunogenicity and efficacy of the WRSS1 candidate vaccine in healthy Thai adult volunteers.

Detailed description

This study is designed as 2 parts.

Part 1 is a blinded, placebo-controlled inpatient trial in a total of 20 volunteers (14 vaccinees and 6 controls) to determine the safety and immunogenicity. Volunteers will be vaccinated with a single oral dose of 104 colony forming unit (cfu) of WRSS1 or placebo given with bicarbonate buffer.
Part 2 will be started approximately 60 days after WRSS1 vaccination. This part is an inpatient phase II efficacy trial involving a challenge with the S.sonnei 53G of 10 vaccinees from the first part and 10 naïve controls.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4

Arm	Type	Receives
Part 1/Arm 1 of Study: WRSS1 vaccine	Experimental	Biological: Part 1/Arm 1 of Study: WRSS1 vaccineWRSS1 is a live attenuated S. sonnei vaccine candidate derived from the Mosely strain of S.sonnei
Part 1/Arm 2 of Study: Placebo vaccine	Placebo comparator	Biological: Part 1/Arm 2 of Study: Placebo vaccinePlacebo
Part 2/Arm 1 of Study: S. sonnei 53G	Experimental	Biological: Part 2/Arm 1 of Study: S. sonnei 53G10 volunteers from Study Arm 1/Part 1 (WRSS1 vaccine) plus 4 alternates from Arm 1/Part 1 are given 53G S. sonnei
Part 2/Arm 2 of Study: S sonnei 53G	Active comparator	Biological: Part 2/Arm 2 of Study: S. sonnei 53G10 subjects (naïve controls) plus 4 alternates are give 53G S sonnei

Who may qualify

Ages: 20 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

20-40 years old; male or female;
General good health as determined by a screening evaluation no greater than 30 days before admission;
Normal bowel habits (grade 1-2 stools - no more than one to two stools per day with at least one stool per 2 days;
Sexually active females willing to use birth control (birth control pills, injection hormonal contraceptive, implant hormonal contraceptive, hormonal patch, IUD, sterilization for effective contraceptive methods, spermicidal products and barrier methods are considered acceptable)during the entire study (starting from study day -30) and for 3 months after completion of the study (approximately a total of 6 months) or sexually inactive females (no sexual contact). Volunteers who take birth control pills will be required to use additional contraceptive methods for the remaining days of the cycle after discharge from the VTC (alteration of gastrointestinal functions from the oral vaccine or challenge strain may lead to unpredictable efficacy of pills);
Will be available and willing to continue participation in the second part of the study if he/she has been randomly selected;

Key exclusion criteria (23 listed)

An acute or chronic medical condition or a clinically significant abnormality on physical exam that, in the opinion of the investigator, would render vaccination or challenge as unsafe;
Current use of iron or zinc supplements within the past 7 days; current use of antacids (H2 blockers, omeprazole, OTC agents) or immunosuppressive drug;
Unwillingness to follow the study procedures
Currently breastfeeding, pregnant (βHCG +) or planning to become pregnant within 3 months after the completion of the study;
Allergy to quinolone, sulfa, and penicillin classes of antibiotics;

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
Part 1/Arm 1 of Study: WRSS1 vaccineSingle, oral dose of WRSS1	Biological	Part 1/Arm 1 of Study: WRSS1 vaccine
Part 1/Arm 2 of Study: Placebo vaccinePlacebo vaccine	Biological	Part 1/Arm 2 of Study: Placebo vaccine
Part 2/Arm 1 of Study: S. sonnei 53GSubject from Part 1/Arm 1 of Study are given 53G S. sonnei	Biological	Part 2/Arm 1 of Study: S. sonnei 53G
Part 2/Arm 2 of Study: S. sonnei 53G10 naïve controls are given S. sonnei 53G	Biological	Part 2/Arm 2 of Study: S sonnei 53G

Primary outcome

Number of Participants With Adverse Events
Time frame: Up to 12 months
Overview of AEs highlighting all AEs, withdrawals and deaths related to AEs
Number of Participants With Shigella Induced Clinical Disease in Part 2
Time frame: 0-5 days
Study Part 2-Frequency of Shigella induced clinical disease defined as one or more of diarrhea, dysentery or fever in vaccinees and controls following challenge with S. sonnei 53G. Transmissibility of disease will be evaluated by the presence of fecal shedding in control subjects.

1 secondary outcome

Count of Subjects With Normal and Abnormal Clinical Laboratory Values During Parts 1 and 2 of Study
Time frame: Days 1, 7, 14, and 28

Results and safety

Results posted to the registry on 13 Nov 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm 1: WRSS1 Vaccine	14	13
Arm 1: Placebo Vaccine	6	6
Arm 2: S. Sonnei 53G	0	0
Arm 2: S. Sonnei 53G (Naive Subjects)	0	0

Primary outcome: Number of Participants With Adverse Events

Time frame: Up to 12 months. Count of participants. Unit: Participants

Measure	Part 1/Arm 1 of Study: WRSS1 Vaccine n = 13	Part 1/Arm 2 of Study: Placebo Vaccine n = 6	Part 2/Arm 1 of Study: S. Sonnei 53G n = 10	Part 2/Arm 2 of Study: S Sonnei 53G (Controls) n = 10
All Adverse Events	9	5	8	10
All Serious Adverse Events	0	0	0	0
Withdrawals Due to Adverse Events	0	0	0	0
Deaths	0	0	0	0

Primary outcome: Number of Participants With Shigella Induced Clinical Disease in Part 2

Time frame: 0-5 days. Count of participants. Unit: Participants

Measure	Part 2/Arm 1 of Study: S. Sonnei 53G n = 10	Part 2/Arm 2 of Study: S Sonnei 53G (Controls) n = 10
Diarrhea: Yes	1	1
Diarrhea: No	9	9
Dysentery: Yes	2	2
Dysentery: No	8	8
Fever: Yes	1	2
Fever: No	9	8
Abdominal Pain: Yes	1	2
Abdominal Pain: No	9	8

Population analysed: Number of participants in vaccine and controls following the challenge who experienced one or more clinical disease criteria

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 4 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part 1/Arm 1 of Study: WRSS1 Vaccine	0 of 13 (0%)	9 of 13 (69.2%)	Not reported
Part 1/Arm 2: Placebo	0 of 6 (0%)	5 of 6 (83.3%)	Not reported
Part 2/Arm 1 of Study: S. Sonnei 53G	0 of 10 (0%)	8 of 10 (80%)	Not reported
Part 2/Arm 2 of Study: S Sonnei 53G (Controls)	0 of 10 (0%)	10 of 10 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27146000Pitisuttithum P, Islam D, Chamnanchanunt S, Ruamsap N, Khantapura P, Kaewkungwal J, Kittitrakul C, Luvira V, Dhitavat J, Venkatesan MM, Mason CJ, Bodhidatta L. Clinical Trial of an Oral Live Shigella sonnei Vaccine Candidate, WRSS1, in Thai Adults. Clin Vaccine Immunol. 2016 Jul 5;23(7):564-75. doi: 10.1128/CVI.00665-15. Print 2016 Jul.
Individual participant dataSharing planned: Yes. Mahidol University and National Institutes of Health will have access to study data.

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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.

Ladaporn Bodhidatta, MD study director

Department of Enteric Diseases, Armed Forces Research Institute of Medical Sciences

Punnee Pitisuttithum, MBBS principal investigator

Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University

Carl Mason, MD study director

Department of Enteric Diseases, Armed Forces Research Institute of Medical Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 23 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 Nov 2018. 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 Thailand. 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 combined 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.

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?

Yes. Results are posted in the registry (first posted 13 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Adverse Events (time frame: Up to 12 months). 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 NCT01080716, 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 Nov 2018.