Study to Expand Safety and Immunogenicity Data With Shigella Bioconjugate Vaccine (Shigella4V2) in 9-month-old Infants. (S4V02)

February 5, 2026 updated by: LimmaTech Biologics AG

Safety and Immunogenicity of a Second Generation Shigella Bioconjugate Vaccine: a Phase II Randomized, Controlled, and Blinded Study in 9-month-old Infants

In this study, the second-generation tetravalent bioconjugate candidate vaccine Shigella4V2 will be tested to confirm data on its safety and immunogenicity in infants and to identify the best dose of Shigella4V2 in 9-month-old infants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Shigella4V2 is the second generation of a tetravalent bioconjugate vaccine including O-antigen-polysaccharides of the most predominant Shigella serotypes.

During the study, infants will be randomized to receive 1 of 2 different vaccine doses, or a control vaccine.

Participants will receive a 2-dose schedule. Each vaccine dose is formulated with Aluminium adjuvant.

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kenya
      • Kisumu, Kenya, 578,40100
        • KEMRI - Center for Global Health Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Female or male aged 9 months (± 1 month) old at the time of the first vaccination.
  • Born full-term (i.e., after a gestation period of 37 to less than 42 full weeks).
  • Healthy by medical history, laboratory findings and physical examination before entering into the study (Participants with a minor illness (such as mild diarrhea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
  • Seronegative for HIV, hepatitis B and C (as per screening laboratory tests)
  • Resident of Siaya County during the whole trial period.
  • Previously completed routine primary vaccinations (6,10 and 14 weeks or thereabouts) to the best knowledge of the participant's parent/guardian. This information will be abstracted from the maternal and child health booklet. All the participant's parent/guardian will be requested to carry this booklet whenever they visit the clinic.
  • Signed/thumb printed informed consent, in accordance with local practice, provided by participants' parents or guardian who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
  • Demonstrated comprehension (by the parent/guardian) of the protocol procedures through passing a written/verbal comprehension test with a score of 80% or higher (at least 10 out of 12 questions).

Exclusion Criteria:

  • Any clinically significant deviation from the normal range in biochemistry or hematological blood tests.
  • Suspected or known hypersensitivity (including allergy) to any of the vaccine components or to previous vaccine, or to medicinal products or medical equipment whose use is foreseen in this study.
  • Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
  • Any confirmed or suspected immunosuppressive or immune-deficient condition.
  • Systemic administration of corticosteroids (PO/IV/IM): prednisone ≥20 mg/day, or equivalent for more than 14 consecutive days from birth within 90 days prior to informed consent. Inhaled except for doses > 800 mg/day and topical steroids are allowed.
  • Administration of antineoplastic or radiotherapy from birth / within 90 days prior to informed consent. Participants may be on chronic or as needed medications if, in the opinion of the site principal investigator or appropriate sub-investigator, they pose no additional risk to participant safety or assessment of reactogenicity and immunogenicity and do not indicate a worsening of medical diagnosis or condition.
  • Known exposure to Shigella during lifetime of the study participant
  • Concurrently participating in another clinical study, or participation in the preceding month, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).
  • Acute illness with or without fever is a temporary exclusion criterium. Positive malaria test is a temporary exclusion criterion.
  • History of any malignancy of lymphoproliferative disorder.
  • Parent/guardian known to be part of study personnel or being a close family member to the personnel conducting this study.
  • Previous history of significant persistent neutropenia, or drug related Neutropenia.
  • Weight-for-age Z score less than -3 Standard Deviations (SD).
  • History of any chronic or progressive disease (e.g., neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease) that according to judgment of the investigator could interfere with the study outcomes or pose a threat to the participant's health.
  • Administration of immunoglobulin and/or any blood products within the three months preceding the first dose of study vaccine.
  • Any medical, social condition, or occupational reason that, in the judgment of the investigator, is a contraindication to protocol participation or impairs the parent's/guardian's ability to give informed consent, increases the risk to the potential participant because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: low dose
Participants receive 2 low-dose administrations of the investigational product
Biological: Shigella4V2
Adjuvanted Shigella4V2 administrated at 2 different doses: low and high.
Experimental: high dose
Participants receive 2 high-dose administrations of the investigational product
Biological: Shigella4V2
Adjuvanted Shigella4V2 administrated at 2 different doses: low and high.
Other: Control
Participants receive 2 administrations of MenACWY
Biological: MenACWY
Control vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety - Solicited Local and Systemic Adverse Events (AEs)
Time Frame: During 7 days following each vaccination
Safety and tolerability of the candidate vaccine Shigella4V2 as determined by occurrence, severity, and relationship of solicited AEs
During 7 days following each vaccination
Safety - Unsolicited Adverse Events (AEs)
Time Frame: During 28 days following each vaccination
Safety and tolerability of the candidate vaccine Shigella4V2 as determined by occurrence, severity, and relationship of unsolicited AEs
During 28 days following each vaccination
Safety - Serious Adverse Events (SAEs)
Time Frame: Throughout the study, up to 9 months
Safety and tolerability of the candidate vaccine Shigella4V2 as determined by occurrence, severity, and relationship of SAEs
Throughout the study, up to 9 months
Immunology - change in serum immunoglobulin G (IgG)
Time Frame: From first vaccination until 1 month following the second vaccination
Evaluation of geometric mean titers (GMT) and geometric mean ratios between baseline and 1-month post 2nd vaccination (GMR vs baseline) for serum IgG against the four Shigella serotypes included in the Shigella4V2 bioconjugate.
From first vaccination until 1 month following the second vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety - clinically significant changes in cell blood count (CBC) with differentials
Time Frame: From first vaccination until 7 days following each vaccination
Assess the safety of the candidate vaccine Shigella4V by measuring clinical significant changes in haematological safety parameters
From first vaccination until 7 days following each vaccination
Safety - clinically significant changes in creatinine level
Time Frame: From first vaccination until 7 days following each vaccination
Assess the safety of the candidate vaccine Shigella4V by measuring clinical significant changes in biochemical safety parameters
From first vaccination until 7 days following each vaccination
Safety - clinically significant changes in alanine aminotransferase (ALT) level
Time Frame: From first vaccination until 7 days following each vaccination
Assess the safety of the candidate vaccine Shigella4V by measuring clinical significant changes in biochemical safety parameters
From first vaccination until 7 days following each vaccination
Safety - clinically significant changes in aspartate aminotransferase (AST) level
Time Frame: From first vaccination until 7 days following each vaccination
Assess the safety of the candidate vaccine Shigella4V by measuring clinical significant changes in biochemical safety parameters
From first vaccination until 7 days following each vaccination
Immunogenicity - persistence of serum IgG
Time Frame: From first vaccination until 6 months post 2nd vaccination
Evaluation of geometric mean titers (GMT) for serum IgG against the four Shigella serotypes included in Shigella4V2 at 6 months post 2nd vaccination.
From first vaccination until 6 months post 2nd vaccination
Immunogenicity - change in serum IgG
Time Frame: From first vaccination until 6 months post 2nd vaccination
Serum IgG responses and fold-increases between baseline and post-vaccination samples against the four Shigella serotypes included in the Shigella4V2 bioconjugate
From first vaccination until 6 months post 2nd vaccination
Immunogenicity - change in anti-Shigella lipopolysaccharide (LPS) antibody titers
Time Frame: From first vaccination up to 1 month post 2nd vaccination
Percentage of study participants achieving at least a four-fold increase in anti-Shigella LPS antibody titers (sero-responders) 1-month post 2nd vaccination compared to baseline.
From first vaccination up to 1 month post 2nd vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LimmaTech Biologics AG

Collaborators

Kenya Medical Research Institute

Investigators

  • Principal Investigator: Richard Omore, PhD, KEMRI - Center for Global Health Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2025

Primary Completion (Actual)

August 27, 2025

Study Completion (Actual)

January 22, 2026

Study Registration Dates

First Submitted

July 19, 2024

First Submitted That Met QC Criteria

July 25, 2024

First Posted (Actual)

July 26, 2024

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S4V02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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