Study to Expand Safety and Immunogenicity Data With Shigella Bioconjugate Vaccine (Shigella4V2) in 9-month-old Infants.
NCT ID: NCT06523231
Last Updated: 2026-01-12
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
PHASE2
Total Enrollment
110 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-04-07
Study Completion Date
2026-02-28
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Shigellosis
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
This phase 2 trial is a single center, randomized, controlled, double-blind. Safety and immunogenicity of the vaccine will be evaluated in infants. Subjects will be vaccinated concurrently, with each group randomized to receive 1 of 2 different vaccine doses, or a control vaccine. Participants will be randomized at a ratio of 8:3, to receive the candidate vaccine (low dose : high dose 4:4) or the control vaccine.
Primary Study Purpose
PREVENTION
Blinding Strategy
DOUBLE
Participants
Investigators
Study Groups
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low dose
Participants receive 2 low-dose administrations of the investigational product
Group Type
EXPERIMENTAL
Shigella4V2
Intervention Type
BIOLOGICAL
Adjuvanted Shigella4V2 administrated at 2 different doses: low and high.
high dose
Participants receive 2 high-dose administrations of the investigational product
Group Type
EXPERIMENTAL
Shigella4V2
Intervention Type
BIOLOGICAL
Adjuvanted Shigella4V2 administrated at 2 different doses: low and high.
Control
Participants receive 2 administrations of MenACWY
Group Type
OTHER
MenACWY
Intervention Type
BIOLOGICAL
Control vaccine
Interventions
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Shigella4V2
Adjuvanted Shigella4V2 administrated at 2 different doses: low and high.
Intervention Type
BIOLOGICAL
MenACWY
Control vaccine
Intervention Type
BIOLOGICAL
Eligibility Criteria
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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).
* 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.
* 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.
Minimum Eligible Age
8 Months
Maximum Eligible Age
10 Months
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Kenya Medical Research Institute
OTHER
Sponsor Role
collaborator
LimmaTech Biologics AG
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Richard Omore, PhD
Role: PRINCIPAL_INVESTIGATOR
KEMRI - Center for Global Health Research
Locations
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KEMRI - Center for Global Health Research
Kisumu, , Kenya
Site Status
Countries
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Kenya
References
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Khalil IA, Troeger C, Blacker BF, Rao PC, Brown A, Atherly DE, Brewer TG, Engmann CM, Houpt ER, Kang G, Kotloff KL, Levine MM, Luby SP, MacLennan CA, Pan WK, Pavlinac PB, Platts-Mills JA, Qadri F, Riddle MS, Ryan ET, Shoultz DA, Steele AD, Walson JL, Sanders JW, Mokdad AH, Murray CJL, Hay SI, Reiner RC Jr. Morbidity and mortality due to shigella and enterotoxigenic Escherichia coli diarrhoea: the Global Burden of Disease Study 1990-2016. Lancet Infect Dis. 2018 Nov;18(11):1229-1240. doi: 10.1016/S1473-3099(18)30475-4. Epub 2018 Sep 25.
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Livio S, Strockbine NA, Panchalingam S, Tennant SM, Barry EM, Marohn ME, Antonio M, Hossain A, Mandomando I, Ochieng JB, Oundo JO, Qureshi S, Ramamurthy T, Tamboura B, Adegbola RA, Hossain MJ, Saha D, Sen S, Faruque AS, Alonso PL, Breiman RF, Zaidi AK, Sur D, Sow SO, Berkeley LY, O'Reilly CE, Mintz ED, Biswas K, Cohen D, Farag TH, Nasrin D, Wu Y, Blackwelder WC, Kotloff KL, Nataro JP, Levine MM. Shigella isolates from the global enteric multicenter study inform vaccine development. Clin Infect Dis. 2014 Oct;59(7):933-41. doi: 10.1093/cid/ciu468. Epub 2014 Jun 23.
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Riddle MS, Kaminski RW, Di Paolo C, Porter CK, Gutierrez RL, Clarkson KA, Weerts HE, Duplessis C, Castellano A, Alaimo C, Paolino K, Gormley R, Gambillara Fonck V. Safety and Immunogenicity of a Candidate Bioconjugate Vaccine against Shigella flexneri 2a Administered to Healthy Adults: a Single-Blind, Randomized Phase I Study. Clin Vaccine Immunol. 2016 Dec 5;23(12):908-917. doi: 10.1128/CVI.00224-16. Print 2016 Dec.
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Talaat KR, Alaimo C, Martin P, Bourgeois AL, Dreyer AM, Kaminski RW, Porter CK, Chakraborty S, Clarkson KA, Brubaker J, Elwood D, Frolich R, DeNearing B, Weerts H, Feijoo BL, Halpern J, Sack D, Riddle MS, Fonck VG. Human challenge study with a Shigella bioconjugate vaccine: Analyses of clinical efficacy and correlate of protection. EBioMedicine. 2021 Apr;66:103310. doi: 10.1016/j.ebiom.2021.103310. Epub 2021 Apr 13.
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Other Identifiers
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S4V02
Identifier Type: -
Identifier Source: org_study_id
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