ShigellosisPhase 2S4V02NCT06523231

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

A Phase 2 study testing Shigella4V2 and MenACWY in people with Shigellosis, run by LimmaTech Biologics AG at 1 site in Kenya.

Completed

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

Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?: Ages 8 to 10 monthsHealthy volunteers can take part
Conditions the study is for: Shigellosis
What is being tested?: Shigella4V2 and MenACWY
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 110 participants
Where: 1 siteKenya
Study dates: 7 Apr 2025to 22 Jan 2026
Phase: Phase 2
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 8 to 10 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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).

Who cannot join

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.

Show all 16Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Kenya1 site

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

Other trials in Kenya

About this study

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

Read the 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.

Conditions: Shigellosis
Being tested: Shigella4V2, MenACWY
Medical subject headings: Dysentery, Bacillary

What participants receive

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

Shigella4V2Biological
Adjuvanted Shigella4V2 administrated at 2 different doses: low and high.
MenACWYBiological
Control vaccine

Study groups in NCT06523231
Study group	Role	What they receive
low dose	Experimental	Participants receive 2 low-dose administrations of the investigational product Receives: Biological: Shigella4V2
high dose	Experimental	Participants receive 2 high-dose administrations of the investigational product Receives: Biological: Shigella4V2
Control	Other	Participants receive 2 administrations of MenACWY Receives: Biological: MenACWY

What is being measured

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

Safety - Solicited Local and Systemic Adverse Events (AEs)
Safety and tolerability of the candidate vaccine Shigella4V2 as determined by occurrence, severity, and relationship of solicited AEs
Measured: During 7 days following each vaccination
Safety - Unsolicited Adverse Events (AEs)
Safety and tolerability of the candidate vaccine Shigella4V2 as determined by occurrence, severity, and relationship of unsolicited AEs
Measured: During 28 days following each vaccination
Safety - Serious Adverse Events (SAEs)
Safety and tolerability of the candidate vaccine Shigella4V2 as determined by occurrence, severity, and relationship of SAEs
Measured: Throughout the study, up to 9 months
Immunology - change in serum immunoglobulin G (IgG)
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.
Measured: From first vaccination until 1 month following the second vaccination

Secondary outcomes (7)

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

Timeline

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

7 Apr 202522 Jan 2026

First posted26 Jul 2024
Study start7 Apr 2025
Primary completion27 Aug 2025
Study completion22 Jan 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (17)Papers the sponsor has linked to this study.
Other trials for ShigellosisStudies 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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 110 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06523231
Sponsor's protocol ID: S4V02
Acronym: S4V02
Status last verified: Feb 2026
First submitted: 19 Jul 2024
Last updated: 7 Aug 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 30266330
Bengtsson RJ, Simpkin AJ, Pulford CV, Low R, Rasko DA, Rigden DJ, Hall N, Barry EM, Tennant SM, Baker KS. Pathogenomic analyses of Shigella isolates inform factors limiting shigellosis prevention and control across LMICs. Nat Microbiol. 2022 Feb;7(2):251-261. doi: 10.1038/s41564-021-01054-z. Epub 2022 Jan 31.
PubMed 35102306
GBD 2015 LRI Collaborators. Estimates of the global, regional, and national morbidity, mortality, and aetiologies of lower respiratory tract infections in 195 countries: a systematic analysis for the Global Burden of Disease Study 2015. Lancet Infect Dis. 2017 Nov;17(11):1133-1161. doi: 10.1016/S1473-3099(17)30396-1. Epub 2017 Aug 23.
PubMed 28843578
Luby SP, Rahman M, Arnold BF, Unicomb L, Ashraf S, Winch PJ, Stewart CP, Begum F, Hussain F, Benjamin-Chung J, Leontsini E, Naser AM, Parvez SM, Hubbard AE, Lin A, Nizame FA, Jannat K, Ercumen A, Ram PK, Das KK, Abedin J, Clasen TF, Dewey KG, Fernald LC, Null C, Ahmed T, Colford JM Jr. Effects of water quality, sanitation, handwashing, and nutritional interventions on diarrhoea and child growth in rural Bangladesh: a cluster randomised controlled trial. Lancet Glob Health. 2018 Mar;6(3):e302-e315. doi: 10.1016/S2214-109X(17)30490-4. Epub 2018 Jan 29.
PubMed 29396217
Kotloff KL, Nataro JP, Blackwelder WC, Nasrin D, Farag TH, Panchalingam S, Wu Y, Sow SO, Sur D, Breiman RF, Faruque AS, Zaidi AK, Saha D, Alonso PL, Tamboura B, Sanogo D, Onwuchekwa U, Manna B, Ramamurthy T, Kanungo S, Ochieng JB, Omore R, Oundo JO, Hossain A, Das SK, Ahmed S, Qureshi S, Quadri F, Adegbola RA, Antonio M, Hossain MJ, Akinsola A, Mandomando I, Nhampossa T, Acacio S, Biswas K, O'Reilly CE, Mintz ED, Berkeley LY, Muhsen K, Sommerfelt H, Robins-Browne RM, Levine MM. Burden and aetiology of diarrhoeal disease in infants and young children in developing countries (the Global Enteric Multicenter Study, GEMS): a prospective, case-control study. Lancet. 2013 Jul 20;382(9888):209-22. doi: 10.1016/S0140-6736(13)60844-2. Epub 2013 May 14.
PubMed 23680352
Kotloff KL, Blackwelder WC, Nasrin D, Nataro JP, Farag TH, van Eijk A, Adegbola RA, Alonso PL, Breiman RF, Faruque AS, Saha D, Sow SO, Sur D, Zaidi AK, Biswas K, Panchalingam S, Clemens JD, Cohen D, Glass RI, Mintz ED, Sommerfelt H, Levine MM. The Global Enteric Multicenter Study (GEMS) of diarrheal disease in infants and young children in developing countries: epidemiologic and clinical methods of the case/control study. Clin Infect Dis. 2012 Dec;55 Suppl 4(Suppl 4):S232-45. doi: 10.1093/cid/cis753.
PubMed 23169936
O'Reilly CE, Jaron P, Ochieng B, Nyaguara A, Tate JE, Parsons MB, Bopp CA, Williams KA, Vinje J, Blanton E, Wannemuehler KA, Vulule J, Laserson KF, Breiman RF, Feikin DR, Widdowson MA, Mintz E. Risk factors for death among children less than 5 years old hospitalized with diarrhea in rural western Kenya, 2005-2007: a cohort study. PLoS Med. 2012;9(7):e1001256. doi: 10.1371/journal.pmed.1001256. Epub 2012 Jul 3.
PubMed 22802736
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.
PubMed 24958238
Samandari T, Okafor CN. Shigellosis. 2025 Dec 13. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482337/
PubMed 29493962
Khan WA, Griffiths JK, Bennish ML. Gastrointestinal and extra-intestinal manifestations of childhood shigellosis in a region where all four species of Shigella are endemic. PLoS One. 2013 May 17;8(5):e64097. doi: 10.1371/journal.pone.0064097. Print 2013.
PubMed 23691156
Shad AA, Shad WA. Shigella sonnei: virulence and antibiotic resistance. Arch Microbiol. 2021 Jan;203(1):45-58. doi: 10.1007/s00203-020-02034-3. Epub 2020 Sep 14.
PubMed 32929595
Puzari M, Sharma M, Chetia P. Emergence of antibiotic resistant Shigella species: A matter of concern. J Infect Public Health. 2018 Jul-Aug;11(4):451-454. doi: 10.1016/j.jiph.2017.09.025. Epub 2017 Oct 20.
PubMed 29066021
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.
PubMed 27581434
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.
PubMed 33862589
Cohen D, Ashkenazi S, Green M, Lerman Y, Slepon R, Robin G, Orr N, Taylor DN, Sadoff JC, Chu C, Shiloach J, Schneerson R, Robbins JB. Safety and immunogenicity of investigational Shigella conjugate vaccines in Israeli volunteers. Infect Immun. 1996 Oct;64(10):4074-7. doi: 10.1128/iai.64.10.4074-4077.1996.
PubMed 8926071

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

RecruitingPhase 2
Long-Term Immunogenicity of the altSonflex1-2-3 Shigella Vaccine in African Children
Diarrhoea
Not yet recruitingPhase 1/2
Safety and Immunogenicity Study of IP-QSV Vaccine in Healthy Adults/Adolescents, Children and Infants
Shigella Infection
Active, not recruitingPhase 3
Clinical Trial of the S. Flexneri-S. Sonnei Bivalent Conjugate Vaccine
Dysentery, Dysentery, Shigella
RecruitingPhase 2
The Impact of Shigellosis and Recommended Treatment in Children
Diarrhea Infectious, Shigella
RecruitingPhase 1
First in Human Dose Escalation Study Evaluating the Safety and Immunogenicity of IVT's Shigella-04 Vaccine in Healthy Young Adults
Shigella, Diarrhea

All Shigellosis trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Immunogenicity of a Second Generation Shigella Bioconjugate Vaccine: a Phase II Randomized, Controlled, and Blinded Study in 9-month-old Infants
ClinicalTrials.gov ID: NCT06523231
Acronym / sponsor ID: S4V02 / S4V02
Conditions: Shigellosis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 110 participants (actual)
Lead sponsor: LimmaTech Biologics AGIndustry (pharma, biotech, devices)
Collaborators: Kenya Medical Research Institute
Study start: 7 Apr 2025 (actual)
Primary completion: 27 Aug 2025 (actual)
Study completion: 22 Jan 2026 (actual)
First posted: 26 Jul 2024 (actual)
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.

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 design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3
Model description: 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.

Arm	Type	Receives
low dose	Experimental	Biological: Shigella4V2Participants receive 2 low-dose administrations of the investigational product
high dose	Experimental	Biological: Shigella4V2Participants receive 2 high-dose administrations of the investigational product
Control	Other	Biological: MenACWYParticipants receive 2 administrations of MenACWY

Who may qualify

Ages: 8 to 10 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (16 listed)

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.

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
Shigella4V2Adjuvanted Shigella4V2 administrated at 2 different doses: low and high.	Biological	high dose, low dose
MenACWYControl vaccine	Biological	Control

Primary outcome

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
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
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
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.

7 secondary outcomes

Safety - clinically significant changes in cell blood count (CBC) with differentials
Time frame: 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
Safety - clinically significant changes in alanine aminotransferase (ALT) level
Time frame: 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
Immunogenicity - persistence of serum IgG
Time frame: 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
Immunogenicity - change in anti-Shigella lipopolysaccharide (LPS) antibody titers
Time frame: From first vaccination up to 1 month post 2nd vaccination

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 7 Aug 2026.
Background: PubMed 30266330Khalil 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.
Background: PubMed 35102306Bengtsson RJ, Simpkin AJ, Pulford CV, Low R, Rasko DA, Rigden DJ, Hall N, Barry EM, Tennant SM, Baker KS. Pathogenomic analyses of Shigella isolates inform factors limiting shigellosis prevention and control across LMICs. Nat Microbiol. 2022 Feb;7(2):251-261. doi: 10.1038/s41564-021-01054-z. Epub 2022 Jan 31.
Background: PubMed 28843578GBD 2015 LRI Collaborators. Estimates of the global, regional, and national morbidity, mortality, and aetiologies of lower respiratory tract infections in 195 countries: a systematic analysis for the Global Burden of Disease Study 2015. Lancet Infect Dis. 2017 Nov;17(11):1133-1161. doi: 10.1016/S1473-3099(17)30396-1. Epub 2017 Aug 23.
Background: PubMed 29396217Luby SP, Rahman M, Arnold BF, Unicomb L, Ashraf S, Winch PJ, Stewart CP, Begum F, Hussain F, Benjamin-Chung J, Leontsini E, Naser AM, Parvez SM, Hubbard AE, Lin A, Nizame FA, Jannat K, Ercumen A, Ram PK, Das KK, Abedin J, Clasen TF, Dewey KG, Fernald LC, Null C, Ahmed T, Colford JM Jr. Effects of water quality, sanitation, handwashing, and nutritional interventions on diarrhoea and child growth in rural Bangladesh: a cluster randomised controlled trial. Lancet Glob Health. 2018 Mar;6(3):e302-e315. doi: 10.1016/S2214-109X(17)30490-4. Epub 2018 Jan 29.
Background: PubMed 23680352Kotloff KL, Nataro JP, Blackwelder WC, Nasrin D, Farag TH, Panchalingam S, Wu Y, Sow SO, Sur D, Breiman RF, Faruque AS, Zaidi AK, Saha D, Alonso PL, Tamboura B, Sanogo D, Onwuchekwa U, Manna B, Ramamurthy T, Kanungo S, Ochieng JB, Omore R, Oundo JO, Hossain A, Das SK, Ahmed S, Qureshi S, Quadri F, Adegbola RA, Antonio M, Hossain MJ, Akinsola A, Mandomando I, Nhampossa T, Acacio S, Biswas K, O'Reilly CE, Mintz ED, Berkeley LY, Muhsen K, Sommerfelt H, Robins-Browne RM, Levine MM. Burden and aetiology of diarrhoeal disease in infants and young children in developing countries (the Global Enteric Multicenter Study, GEMS): a prospective, case-control study. Lancet. 2013 Jul 20;382(9888):209-22. doi: 10.1016/S0140-6736(13)60844-2. Epub 2013 May 14.
Background: PubMed 23169936Kotloff KL, Blackwelder WC, Nasrin D, Nataro JP, Farag TH, van Eijk A, Adegbola RA, Alonso PL, Breiman RF, Faruque AS, Saha D, Sow SO, Sur D, Zaidi AK, Biswas K, Panchalingam S, Clemens JD, Cohen D, Glass RI, Mintz ED, Sommerfelt H, Levine MM. The Global Enteric Multicenter Study (GEMS) of diarrheal disease in infants and young children in developing countries: epidemiologic and clinical methods of the case/control study. Clin Infect Dis. 2012 Dec;55 Suppl 4(Suppl 4):S232-45. doi: 10.1093/cid/cis753.
Background: PubMed 22802736O'Reilly CE, Jaron P, Ochieng B, Nyaguara A, Tate JE, Parsons MB, Bopp CA, Williams KA, Vinje J, Blanton E, Wannemuehler KA, Vulule J, Laserson KF, Breiman RF, Feikin DR, Widdowson MA, Mintz E. Risk factors for death among children less than 5 years old hospitalized with diarrhea in rural western Kenya, 2005-2007: a cohort study. PLoS Med. 2012;9(7):e1001256. doi: 10.1371/journal.pmed.1001256. Epub 2012 Jul 3.
Background: PubMed 24958238Livio 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.
Background: PubMed 29493962Samandari T, Okafor CN. Shigellosis. 2025 Dec 13. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482337/
Background: PubMed 23691156Khan WA, Griffiths JK, Bennish ML. Gastrointestinal and extra-intestinal manifestations of childhood shigellosis in a region where all four species of Shigella are endemic. PLoS One. 2013 May 17;8(5):e64097. doi: 10.1371/journal.pone.0064097. Print 2013.
Background: PubMed 32929595Shad AA, Shad WA. Shigella sonnei: virulence and antibiotic resistance. Arch Microbiol. 2021 Jan;203(1):45-58. doi: 10.1007/s00203-020-02034-3. Epub 2020 Sep 14.
Background: PubMed 29066021Puzari M, Sharma M, Chetia P. Emergence of antibiotic resistant Shigella species: A matter of concern. J Infect Public Health. 2018 Jul-Aug;11(4):451-454. doi: 10.1016/j.jiph.2017.09.025. Epub 2017 Oct 20.
Individual participant dataSharing planned: No

Related trials for Shigellosis

RecruitingPhase 2
Long-Term Immunogenicity of the altSonflex1-2-3 Shigella Vaccine in African Children
Diarrhoea
Not yet recruitingPhase 1/2
Safety and Immunogenicity Study of IP-QSV Vaccine in Healthy Adults/Adolescents, Children and Infants
Shigella Infection
Active, not recruitingPhase 3
Clinical Trial of the S. Flexneri-S. Sonnei Bivalent Conjugate Vaccine
Dysentery, Dysentery, Shigella
RecruitingPhase 2
The Impact of Shigellosis and Recommended Treatment in Children
Diarrhea Infectious, Shigella
RecruitingPhase 1
First in Human Dose Escalation Study Evaluating the Safety and Immunogenicity of IVT's Shigella-04 Vaccine in Healthy Young Adults
Shigella, Diarrhea

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.

Richard Omore, PhD principal investigator

KEMRI - Center for Global Health Research

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Shigella4V2 and MenACWY in people with Shigellosis, run by LimmaTech Biologics AG at 1 site in Kenya.

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 16 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 7 Aug 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 Kenya. 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 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?

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?

Safety - Solicited Local and Systemic Adverse Events (AEs) (time frame: During 7 days following each vaccination). 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 NCT06523231, which also lists 17 linked publications.

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 7 Aug 2026.