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Shigella InfectionPhase 1NCT04634513

Shigella CVD 31000: Study of Responses With Shigella-ETEC Vaccine Strain CVD 1208S-122

A Phase 1 study testing strain CVD 1208S-122 in people with Shigella Infection and Enterotoxigenic Escherichia Coli Infection, run by University of Maryland, Baltimore at 1 site in United States.

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

The purpose of this study is to determine whether a live, oral, combined Shigella-ETEC vaccine candidate, known as strain CVD 1208S-122, is safe and immunogenic. Read more about this study

Who is it for?
Ages 18 to 49 yearsHealthy volunteers can take part
What is being tested?
strain CVD 1208S-122
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
53 participants
Where
1 siteUnited States
Study dates
29 Sep 2022to 1 Oct 2024
Phase
Phase 1
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 18 to 49 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Male or female, 18 - 49 years of age
  • Written informed consent provided
  • Determined to be in good health* based on medical history and review of concomitant medications
  • Good health as defined by an absence of an active chronic medical condition which requires daily prescription medication(s). Participants may be eligible if the medical condition only requires infrequent as needed (PRN) medication and if the investigator determines that the condition does not pose a risk to participant safety or the assessment of reactogenicity and immunogenicity. Any chronic medical condition which does not require a daily prescription medication but might pose a risk to a participant with rapid dehydration (i.e., rapid intravascular volume changes) would be ineligible to participate.
  • Documented acceptable results from screening laboratory work (defined in Appendix B), including:
  • Complete blood count (CBC) with differential for total white blood cell count (WBC), absolute neutrophil count (ANC), hemoglobin (Hg), platelet count
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  • Creatinine, alanine aminotransferase (ALT), total bilirubin
  • Serum Immunoglobulin A (IgA) level
  • Human immunodeficiency virus (HIV) antibody, Hepatitis B surface antigen (HBsAg), Hepatitis C virus antibody (HCV)
  • HLA-B27 histocompatibility testing
  • Serum Beta human chorionic gonadotropin (β-HCG) test, if the participant is a woman of child-bearing potential
  • A passing score (≥70%) on a Comprehension Assessment Tool
  • Agrees not to participate in another clinical trial during the study period
  • Females of child-bearing potential† agree to use an acceptable form of birth control‡ from enrollment and through at least 4 weeks after vaccination
  • †Females of child-bearing potential, defined as having not been sterilized via tubal ligation, bilateral oophorectomy, salpingectomy, hysterectomy, or successful Essure® placement (permanent, non-surgical, non-hormonal sterilization) with documented radiological confirmation test at least 90 days after the procedure, and still menstruating or <1 year has passed since the last menses, if menopausal.
  • ‡Acceptable birth control includes barrier methods such as condoms or diaphragms/cervical cap with spermicide; effective intrauterine devices; NuvaRing®; and licensed hormonal methods such as implants, injectables or oral contraceptives ("the pill") or alternatively, monogamous relationship with a vasectomized partner who has been vasectomized for 180 days or more prior to the subject receiving the study vaccination, abstinence from sexual intercourse with a male partner, or sexual relationships with non-male partners.
  • Available for up to a 6-day inpatient stay
  • For Participants of Cohorts 1-3 during the time when a U.S. Public Health Emergency for COVID-19 exists, SARS-CoV-2 testing must be performed upon admission to the inpatient ward and must document a negative test result prior to vaccination.

Who cannot join

  • A positive pregnancy test at screening or within 24 h prior to study product dosing
  • A female who is breastfeeding
  • Poor venous access, as defined by inability to obtain venous blood, for screening labs, after 3 venipuncture attempts
  • Abnormal vital signs, defined as:
  • Systolic BP >150 mmHg or Diastolic BP >90 mmHg
  • Resting heart rate >100 bpm
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  • Oral temperature ≥38.0°C
  • Having received prior vaccines for or have had prior infection with ETEC, LT, cholera, or Shigella, within the past 3 years
  • History of diarrhea during travel to a developing country within the past 3 years
  • History of chronic gastrointestinal illness, including severe dyspepsia, lactose intolerance, or another significant gastrointestinal tract disease (e.g., irritable bowel syndrome, inflammatory bowel syndrome, gastric ulcer disease)
  • Regular use (≥once weekly) of laxatives, anti-diarrheal agents, anti-constipation agents, or antacid therapies
  • History of major gastrointestinal surgery (uncomplicated laparoscopic appendectomy or cholecystectomy >1-year prior is permitted)
  • Abnormal bowel habits, as defined by <3 stools per week or >2 stools per day in the past 6 months
  • Use of systemic antimicrobials§ within the past 2 weeks
  • use of topical (skin), otic, or ophthalmic antibiotics is acceptable, if those doses are not expected to result in significant systemic absorption levels
  • Use of oral, parenteral or high-dose inhaled steroids within 30 days
  • Use of any medication which might affect immune function# within 30 days
  • #examples include anti-cancer drugs, immunomodulating monoclonal antibody therapeutics, and rheumatologic therapies
  • Diagnosis of schizophrenia or other major psychiatric disease
  • Alcohol or drug abuse within last 5 years
  • Presence of immunosuppression, which could be due to active neoplastic disease or a history of any hematologic malignancy (excluding resolved non-melanoma skin cancers), radiation therapy, or primary or secondary immunodeficiencies
  • History of allergy to quinolone (e.g., ciprofloxacin) or sulpha drugs (e.g., trimethoprim-sulfamethoxazole)
  • Known history of seizure disorder (remote history of a childhood seizure disorder which has completely resolved is acceptable)
  • Occupation involving the handling of ETEC, cholera, or Shigella bacteria
  • Occupation in food handling industry or care of very young children (<2 years old), elderly (≥70 years), or immunocompromised
  • During the time when a U.S. Public Health Emergency for COVID-19 exists, within 14 days prior to the time of vaccination, the presence of 2 or more of any of the following symptoms: fever (≥38°C, chills, myalgia, headache, sore throat, or new olfactory and taste disorder
  • During the time when a U.S. Public Health Emergency for COVID-19 exists, within 14 days prior to the time of vaccination, the presence of 1 or more of any of the following respiratory symptoms: cough which cannot otherwise be explained, shortness of breath, or difficulty breathing
  • Any other criteria which, in the investigator's opinion, would compromise the safety of the study, the ability of a subject to participate, or the results of the study

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Maryland, Baltimore, University of Maryland School of Medicine, Center for Vaccine Development and Global Health

    Baltimore, Maryland, 21201

Other trials in United States

About this study

Official title: Phase 1 Study of the Safety, Tolerability, and Immunogenicity of Oral Doses of CVD 1208S-122, a Prototype Attenuated Shigella Flexneri 2a Live Vector Expressing Enterotoxigenic Escherichia Coli Antigens

The purpose of this study is to determine whether a live, oral, combined Shigella-ETEC vaccine candidate, known as strain CVD 1208S-122, is safe and immunogenic.

Read the detailed description

The purpose of this study is to determine whether a live, oral, combined Shigella-ETEC vaccine candidate, known as strain CVD 1208S-122, is safe and immunogenic. This will be a phase 1, double-blind, placebo-controlled, dose-escalating, single-center study, involving three vaccine dosage escalation cohorts (10^8, 10^9, and 10^10 cfu vaccine organisms). Each of the three dose-escalation cohorts will consist of 8 study participants who will be randomly allocated to receive either vaccine (n=6) or placebo (n=2), as a single, oral dose. An independent Safety Monitoring Committee (SMC) will review the available safety data for Cohorts 1 - 3 through 7 days post-vaccination before proceeding to the enrollment of the next cohort. The fourth cohort will be an adaptive design cohort consisting of 30 study participants to be randomly allocated to receive either two doses of vaccine (n=12), one dose of vaccine (n=12), or two doses of placebo (n=6), with the dosage selection based on the highest well-tolerated dose in the dose-escalation cohorts (1 - 3), as determined by the SMC.

Each of the dose-escalation cohorts (1 - 3) will receive the oral dose of blinded study product while in the inpatient setting. During the following subsequent 96 hours (4 days), participants will remain on the inpatient research isolation ward to be closely monitored, and each stool will be collected by study staff. The evaluation and monitoring of participants enrolled in the fourth cohort will be conducted entirely in the outpatient setting.

Being tested
strain CVD 1208S-122, Placebo
Keywords
vaccine, strain CVD 1208S-122
Medical subject headings
Dysentery, Bacillary

What participants receive

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

  • strain CVD 1208S-122Biological

    Live, attenuated, vaccine strain of S. flexneri 2a expressing CFA/I and LT of enterotoxigenic E. coli

  • PlaceboOther

    Sodium bicarbonate buffer

Study groups in NCT04634513
Study groupRoleWhat they receive
Cohort 1: Shigella Vaccine at 10^8 cfu or PlaceboExperimental3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
Receives: Biological: strain CVD 1208S-122; Other: Placebo
Cohort 2: Shigella Vaccine at 10^9 cfu or PlaceboExperimental3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
Receives: Biological: strain CVD 1208S-122; Other: Placebo
Cohort 3: Shigella Vaccine at 10^10 cfu or PlaceboExperimental3:1 randomization to one dose of vaccine or placebo (Cohort n=8)
Receives: Biological: strain CVD 1208S-122; Other: Placebo
Cohort 4: Shigella Vaccine or PlaceboExperimental2:2:1 randomization to receive either two doses of vaccine, 1 dose of vaccine and one dose of placebo, or two doses of placebo at Days 1 and 29 (Cohort n=30)
Receives: Biological: strain CVD 1208S-122; Other: Placebo

What is being measured

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

  1. Participants Experiencing Fever, Diarrhea, or Dysentery; Solicited Local Adverse Events; Solicited Systemic Adverse Events; and Clinical Safety Laboratory Adverse Events

    Participants experiencing fever, diarrhea, or dysentery; solicited local adverse events; solicited systemic adverse events; and clinical safety laboratory adverse events

    Measured: Solicited AEs: Cohorts 1-3 during 4 days of inpatient and memory aid for another 3 days; Cohort 4 memory aid over 7 days after each dose of study product Clinical Safety Labs: Cohorts 1-3: Day 1 and Day 8; Cohort 4: Days 1 and 29 and Days 8 and 36

  2. Vaccine Organisms Shed in Stools in Cohorts 1-3 - Cohorts 1-3

    Vaccine organisms shed in stools in Cohorts 1-3

    Measured: 7 days

  3. Vaccine Organisms Shed in Stools in Cohort 4

    Vaccine organisms shed in stools in Cohort 4

    Measured: 2 days

  4. Number of Participants With Genetically Stable Fecal Shed Organisms

    Fecal shed organisms found to be genetically stable, as defined as being PCR positive for Shigella (ipaH or virG), CFA/I (cfaB), and LTB (eltB)

    Measured: 7 days

Secondary outcomes (2)
  1. Participants With ELISA Antibody Responses

    Seroconversions (defined as 4-fold or higher compared to baseline) in antigen-specific ELISA antibody responses

    Measured: 28 days

  2. Participants With ASC Responses

    Responses (defined as ≥8 spot forming cells/10^6 PBMC) in antigen-specific ASC responses post-vaccination

    Measured: 7 days

Timeline

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

  1. First posted18 Nov 2020
  2. Study start29 Sep 2022
  3. Primary completion1 Oct 2024
  4. Study completion1 Oct 2024

Resources

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
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04634513
Sponsor's protocol ID
HP-00094148
Status last verified
Jan 2026
First submitted
11 Nov 2020
Last updated
2 Feb 2026
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Chen WH, Barry EM, Toapanta FR, Pasetti MF, Sztein MB, Permala-Booth J, Tennant SM, Ortiz JR, Thomas C, McGilvray M, Roane L, Datar R, Liang Y, Levine MM. Evaluation of the Safety, Genetic Stability, and Immunogenicity of an Attenuated Shigella Live Vector Expressing Enterotoxigenic Escherichia coli Antigens, Vaccine Strain CVD 1208S-122. J Infect Dis. 2026 Aug 3;234(1):9-19. doi: 10.1093/infdis/jiag220.

    PubMed 41999631

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing strain CVD 1208S-122 in people with Shigella Infection and Enterotoxigenic Escherichia Coli Infection, run by University of Maryland, Baltimore at 1 site 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 18 inclusion and 28 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 2 Feb 2026. 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 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. 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?

Yes. Results are posted in the registry (first posted 2 Feb 2026). 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?

Participants Experiencing Fever, Diarrhea, or Dysentery; Solicited Local Adverse Events; Solicited Systemic Adverse Events; and Clinical Safety Laboratory Adverse Events (time frame: Solicited AEs: Cohorts 1-3 during 4 days of inpatient and memory aid for another 3 days; Cohort 4 memory aid over 7 days after each dose of study product Clinical Safety Labs: Cohorts 1-3: Day 1 and Day 8; Cohort 4: Days 1 and 29 and Days 8 and 36). The study lists 4 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 NCT04634513, 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 2 Feb 2026.

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