A Phase 1/2 interventional study of 30μg IP-QSV and Placebo in Shigella Infection, sponsored by International Vaccine Institute. Not yet recruiting. Open to participants aged 6 Months to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-24.
Sponsored by International Vaccine Institute · Phase 1/2, Interventional, and Prevention
The goal of this phase 1/2a, randomized, observer-blind, age-descending, dose-finding trial is to evaluate the safety and immunogenicity of a quadrivalent synthetic oligosaccharide-based Shigella vaccine (adjuvanted IP-QSV) in adults, children, and infants in Mali. This first-in-human study is intended to obtain initial data on the safety of the adjuvanted IP-QSV vaccine and its effect on immune responses in a Shigella-endemic region.
this is phase 1/2a, randomized, observer-blind, age-descending, dose-finding trial to evaluate the safety and immunogenicity of a quadrivalent synthetic oligosaccharide-based Shigella vaccine (adjuvanted IP-QSV) in adults, children, and infants in Mali
A total of 370 healthy participants aged 6 months to 45 years in Mali will be enrolled and randomly assigned in a 2:1 or 2:2:1 ratio. The study groups are as follow
The DSMB must review the safety data of each group and approve study continuation before investigational product administration of the next group is initiated.
Participants will attend between 5 and 11 scheduled study visits, including blood sampling for immunogenicity assessments and safety evaluations. Blood samples will be collected at screening and at multiple time points throughout the study to assess immune responses and overall health status. Baseline laboratory assessments will include HIV testing, hepatitis screening, complete blood counts, and renal and liver function tests. Women of childbearing potential will undergo pregnancy testing at screening.
Serious adverse events (SAEs) will be reported and followed until resolution or stabilization. Participants will be instructed to contact the study team immediately if they experience any serious adverse event.
The study will monitor for SAEs, including hospitalization, death, or significant disability, occurring during the study, regardless of whether they are considered related to the study vaccine. Immediate reactions occurring within 0.5 - 1 hours after vaccination will be monitored to detect allergic or other acute responses. Solicited mild to moderate adverse events, such as nausea, fever, and diarrhea, will be recorded for up to 7 days after each vaccination.
61 studies on the registry are indexed under Dysentery, Bacillary; 6 are open to participants now.
This study's planned enrollment of 370 is above the median of 76 across 54 interventional studies indexed under Dysentery, Bacillary.
Browse Dysentery, Bacillary studies →International Vaccine Institute is the lead sponsor of 47 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A total of 30 participants aged 18-45 years will receive one dose of 30 µg IP-QSV or placebo.
Biological: 30μg IP-QSV · Other: Placebo
A total of 30 participants aged 2-5 years will receive two doses of 10 µg IP-QSV or placebo at 3 months interval.
Other: Placebo · Biological: 10μg IP-QSV
A total of 30 participants aged 2-5 years will receive one dose of 30 µg IP-QSV or placebo
Biological: 30μg IP-QSV · Other: Placebo
A total of 60 participants aged 6-8 months will receive three doses of 2 µg IP-QSV or placebo at Months 0, 3, and 9.
Other: Placebo · Biological: 2μg IP-QSV
A total of 100 participants aged 6-8 months will receive three doses of 10 µg IP-QSV or placebo at Months 0, 3, and 9.
Other: Placebo · Biological: 10μg IP-QSV
A total of 60 participants aged 9-11 months will receive two doses of 10 µg IP-QSV or placebo at 6 months interval
Other: Placebo · Biological: 10μg IP-QSV
A total of 60 participants aged 6-8 months will receive two doses of 30 µg IP-QSV or placebo at 9 months interval
Biological: 30μg IP-QSV · Other: Placebo
A mix of the four synthetic OS-based conjugates, each independently targeting SF 2a, 3a, 6, or Sson, and using tetanus toxoid as carrier protein. 30 ㎍ of IP-QSV adjuvanted with Aluminum phosphate.
Sterile 0.9% sodium chloride.
A mix of the four synthetic OS-based conjugates, each independently targeting SF 2a, 3a, 6, or Sson, and using tetanus toxoid as carrier protein. 30 ㎍ of IP-QSV adjuvanted with Aluminum phosphate.
A mix of the four synthetic OS-based conjugates, each independently targeting SF 2a, 3a, 6, or Sson, and using tetanus toxoid as carrier protein. 30 ㎍ of IP-QSV adjuvanted with Aluminum phosphate.
Serious adverse events (SAEs) and adverse events of special interest (AESIs) and medically attended adverse event (MAAE)
Occurrence of any SAE / AESI / MAAE from the first dose vaccination throughout the final study visit
Time frame: through study completion, an average of 6 months
Immediate adverse events
Occurrence of immediate adverse events within 30 minutes after each dose vaccination
Time frame: Within 30 minutes post each dose
Solicited adverse events
Occurrence of solicited injection site and solicited systemic adverse events from the time of each study vaccination through 7 days after each study vaccination
Time frame: Within 7 days post each dose
Unsolicited adverse events
Occurrence of unsolicited adverse events from the time of each study vaccination through 28 days after each study vaccination.
Time frame: Within 28 days post each dose
GMT of serum IgG against SF 2a, SF3a, SF6 & Sson LPS at 4 weeks and at 6 months post primary IP administration of IP-QSV 2/10/30μg OS-equivalent dosages in infants aged 6-8 months
GMT of serum IgG antibodies to SF2a, SF3a, SF6 \& Sson LPSs (for each one of the four serotypes and combined serotypes (SF all)), after 2-dose primary series (0-3-month) of 2μg of IP-QSV / placebo, or 2-dose primary series (0-3-month) of 10μg of IP-QSV / placebo, or Single primary dose of 30μg of IP-QSV / placebo
Time frame: Baseline, at 4 weeks, and at 6 months post primary IP administration series
Seroconversion of serum IgG against SF 2a, SF3a, SF6 & Sson LPS at 4 weeks and at 6 months post primary IP administration of IP-QSV 2/10/30μg OS-equivalent dosages in infants aged 6-8 months
Percentage of seroconversion (defined as at least a 4-fold increase in anti-LPS IgG titer from baseline) for each one of the four serotypes and combined serotypes (SF2a, SF3a, SF6, Sson LPSs, SF all), after 2-dose primary series (0-3-month) of 2μg of IP-QSV / placebo or 2-dose primary series (0-3-month) of 10μg of IP-QSV / placebo or Single primary dose of 30μg of IP-QSV / placebo
Time frame: at 4 weeks and at 6 months post primary IP administration series
GMT of serum IgG against SF 2a, SF3a, SF6 & Sson LPS at 4 weeks and at 6 months post full IP administration of IP-QSV 2/10/30μg OS-equivalent dosages in infants aged 6-8 months
GMT of serum IgG antibodies to SF2a, SF3a, SF6 \& Sson LPSs, (for each one of the four serotypes and combined serotypes (SF all)), after 3 doses(0-3-9-month) of 2μg IP-QSV / placebo, or 3 doses ( 0-3-9-month) of 10μg IP-QSV / placebo, or 2 doses ( 0-9-month) of 30μg IP-QSV / placebo
Time frame: Baseline, at 4 weeks, and at 6 months post full IP administration series
Seroconversion of serum IgG against SF 2a, SF3a, SF6 & Sson LPS at 4 weeks and at 6 months post full IP administration of IP-QSV 2/10/30μg OS-equivalent dosages in infants aged 6-8 months
Percentage of seroconversion (defined as at least a 4-fold increase in anti-LPS IgG titer from baseline) for each one of the four serotypes (SF2a, SF3a, SF6 \& Sson LPSs, and combined serotypes (SF, all)), after 3 doses ( 0-3-9-month) of 2μg IP-QSV / placebo, or 3 doses ( 0-3-9-month)of 10μg IP-QSV / placebo, or 2 doses ( 0-9-month) of 30μg IP-QSV / placebo
Time frame: Baseline, at 4 weeks, and at 6 months post full IP administration series
GMT of serum IgG against SF 2a, SF3a, SF6 & Sson LPS at 4 weeks post each dose of full IP administration series and at 6 months post full IP administration of IP-QSV 10μg OS-equivalent dosages in infants aged 9-11 month
GMT of serum IgG antibodies to SF2a, SF3a, SF6 \& Sson LPSs(for each one of the four serotypes and combined serotypes (SF, all)), at 4 weeks after 1 and 2 doses ( 0-6-month) of 10μg of IP-QSV / placebo
Time frame: Baseline and at post each dose of full IP administration series
Seroconversion of serum IgG against SF 2a, SF3a, SF6 & Sson LPS at 4 weeks post each dose of full IP administration series and at 6 months post full IP administration of IP-QSV 10μg OS-equivalent dosages in infants aged 9-11 months
Percentage of Seroconversion (defined as at least a 4-fold increase in anti-LPS IgG titer from baseline) for each one of the four serotypes (SF2a, SF3a, SF6 \& Sson LPSs, and combined serotypes (SF, all)) at 4 weeks after 1 and 2 doses in 0-6-month dose schedule of 10μg IP-QSV / placebo
Time frame: at post each dose of full IP administration series
GMT of SF2a, SF3a, SF6 & Sson -specific serum bactericidal antibodies (SBA) at 4 weeks and at 6 months post primary IP and full IP administration of IP-QSV 2/10/30μg OS-equivalent dosages in infants aged 6-11 months
GMT of SBA to SF2a, SF3a, SF6 \& Sson, independently for each one of the four serotypes and combined serotypes (SF, all), after 2-dose primary series (0-3-month) of 2/10μg of IP-QSV / placebo in infants aged 6-8 months, or Single primary dose of 30μg of IP-QSV / placebo in infants aged 6-8 months, or 3 doses in 0-3-9-month dose schedule of 2/10μg IP-QSV / placebo in infants aged 6-8 months, or Single primary dose of 10μg of IP-QSV / placebo in infants aged 9-11 months, or 2 doses in 0-6-month dose schedule of 10μg IP-QSV / placebo in infants aged 9-11 months, or 2 doses in 0-9-month dose schedule of 30μg IP-QSV / placebo in infants aged 6-8 months
Time frame: Baseline, at 4 weeks and at 6 months post primary and full IP administration series
Seroconversion of SF2a, SF3a, SF6 & Sson -specific serum bactericidal antibodies (SBA) at 4 weeks and at 6 months post primary IP and full IP administration of IP-QSV 2/10/30μg OS-equivalent dosages in infants aged 6-11 months
Percentage of seroconversion of SBA to SF2a, SF3a, SF6 \& Sson, independently for each one of the four serotypes and combined serotypes (SF, all), after 2-dose primary series (0-3-month) of 2/10μg of IP-QSV / placebo in infants aged 6-8 months, or Single primary dose of 30μg of IP-QSV / placebo in infants aged 6-8 months, or 3 doses in 0-3-9-month dose schedule of 2/10μg IP-QSV / placebo in infants aged 6-8 months, or Single primary dose of 10μg of IP-QSV / placebo in infants aged 9-11 months, or 2 doses in 0-6-month dose schedule of 10μg IP-QSV / placebo in infants aged 9-11 months, or 2 doses in 0-9-month dose schedule of 30μg IP-QSV / placebo in infants aged 6-8 months
Time frame: at 4 weeks and at 6 months post primary and full IP administration series
GMT of serum IgG against SF2a, SF3a, SF6 & Sson LPS at 4 weeks post each dose of full IP administration series of IP-QSV 10/30μg OS-equivalent dosages in adults aged 18-45 years and children aged 2-5 years
GMT of serum IgG antibodies to SF2a, SF3a, SF6 \& Sson, and percentage of seroconversion, after 1 dose of 30μg in adults aged 18-45 years and in children aged 2-5 years or after each dose of 10μg in 0-3mo dose schedule in children aged 2-5 years
Time frame: Baseline and at 4 weeks post each dose of full IP administration series
Seroconversion of serum IgG against SF2a, SF3a, SF6 & Sson LPS at 4 weeks post each dose of full IP administration of IP-QSV 10/30μg OS-equivalent dosages in adults aged 18-45 years and children aged 2-5 years
Percentage of seroconversion of serum IgG antibodies to SF2a, SF3a, SF6 \& Sson, after 1 dose of 30μg in adults aged 18-45 years and in children aged 2-5 years or after each dose of 10μg in 0-3mo dose schedule in children aged 2-5 years
Time frame: at 4 weeks post each dose of full IP administration series
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
International Vaccine Institute