Safety and Immunogenicity Study of IP-QSV Vaccine in Healthy Adults/Adolescents, Children and Infants

NCT07666750 | Not Yet Recruiting Phase 1

• 1 other identifier: IVI IP QSV
• Study Type: interventional
• Target: 370
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Shigella Infection

Keywords

Shigella vaccine

Outcome Measures

Primary Outcomes (6)

• 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

  through study completion, an average of 6 months

• Immediate adverse events

  Occurrence of immediate adverse events within 30 minutes after each dose vaccination

  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

  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.

  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

  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

  at 4 weeks and at 6 months post primary IP administration series

Secondary Outcomes (8)

• 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

  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

  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

  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

  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

  Baseline, at 4 weeks and at 6 months post primary and full IP administration series

Study Arms (7)

Group A

EXPERIMENTAL

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

Group B

EXPERIMENTAL

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

Group C

EXPERIMENTAL

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

Group D

PLACEBO COMPARATOR

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

Group E

EXPERIMENTAL

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

Group F

EXPERIMENTAL

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

Group G

EXPERIMENTAL

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

Interventions

30μg IP-QSV BIOLOGICAL

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.

Group A; Group C; Group G

Placebo OTHER

Sterile 0.9% sodium chloride.

Group A; Group B; Group C; Group D; Group E; Group F; Group G

10μg IP-QSV BIOLOGICAL

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.

Group B; Group E; Group F

2μg IP-QSV BIOLOGICAL

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.

Group D

Eligibility Criteria

• Age: 6 Months - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Individuals aged 18-45 years in Group A, 2-5 years in Groups B and C, 6-8 months in Groups D, E and G , and 9-11 months in Group F
• Participants/ Participants' Legally Acceptable representative (LAR) willing to provide written informed consent to participate in the study voluntarily
• Participants who can comply with the study requirements
• Individuals in good health as determined by the outcome of medical history, physical examination, and the clinical judgment of the investigator

You may not qualify if:

• Known history or allergy to investigational vaccine components or other medications, or any other allergies deemed by the investigator to increase the risk of an adverse event if they were to participate in the trial
• Individuals with major congenital abnormalities, developmental disorders, genetic defects, or severe malnutrition, among other conditions which in the opinion of investigator may affect the participant's participation in the study
• Known history of immune function disorders including immunodeficiency diseases (known HIV infection¥ or other immune function disorders) which in the opinion of investigator may affect the participant's participation in the study or interfere with the assessment of the study objectives
• Use of systemic steroids within past 6 months (\>10 mg/day prednisone equivalent for periods exceeding 2 consecutive weeks), or receive chemotherapy, radiation therapy or other immunosuppressive drugs within the past 6 months
• Any abnormality or chronic disease which in the opinion of the investigator might be detrimental for the safety of the participant and interfere with the assessment of the study objectives
• Individuals with behavioral or cognitive impairment or psychiatric disease or neural disorders that, in the opinion of the investigator, could interfere with the participant's ability to participate in the trial
• Individuals with splenectomy
• Individuals with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time resulting in contraindication for IM injections/blood extractions
• Receipt of blood, blood-derived products, or immunoglobulin products in the past 3 months
• Individuals who have received other vaccines from 4 weeks prior to the first dose of investigational product administration or planned to receive any vaccine within 4 weeks post any dose of the investigational product
• Individuals with active or known previous culture-proven Shigella infection
• Individuals who have household contact with/and /or intimate exposure to an individual with laboratory confirmed Shigella infection
• Previous participation in any study in which a Shigella-vaccine candidate was administered
• Individuals with a history of severe diarrhea in the last 6 months requiring care at a medical facility lasting 24 hours or more
• Individuals with a history of clinically significant gastrointestinal disorders or with any history of frequent diarrhea, nausea or emesis, within the last 6 months

Sponsors & Collaborators

• International Vaccine Institute: lead
• Institut Pasteur: collaborator

MeSH Terms

Conditions

Dysentery, Bacillary

Condition Hierarchy (Ancestors)

Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Dysentery; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Samba Sow, MD

  CVD-Mali

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tarun Saluja, MD

CONTACT

+82 2 8811 236; tarun.saluja@ivi.int

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple (Participant, Investigator, Outcomes Assessor)k.
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2025
• First Posted: June 24, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): November 1, 2028
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share