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.
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
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
Sequential
30μg IP-QSV
Biological/VaccineA 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.
Placebo
Other interventionSterile 0.9% sodium chloride.
10μg IP-QSV
Biological/VaccineA 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.
2μg IP-QSV
Biological/VaccineA 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.
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Treatment groupsSee each treatment group below.
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
Immediate adverse events
Occurrence of immediate adverse events within 30 minutes after each dose vaccination
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
Unsolicited adverse events
Occurrence of unsolicited adverse events from the time of each study vaccination through 28 days after each study vaccination.
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
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
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
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
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International Vaccine Institute
Lead sponsor
Institut Pasteur
Collaborator
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