A study to expand safety and immunogenicity data with the second generation of the Shigella bioconjugate tetravalent (Shigella4V2) in 9-month-old Kenyan infants.
- Conditions
- Shigellosis
- Registration Number
- PACTR202408653853505
- Lead Sponsor
- immaTech Biologics AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 110
1. Female or male aged 9 months (± 1 month) old at the time of the first vaccination.
2. Born full-term (i.e., after a gestation period of 37 to less than 42 full weeks).
3. 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.
4. Seronegative for HIV, hepatitis B and C (as per screening laboratory tests).
5. Resident of Siaya County during the whole trial period.
6. 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.
7. 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.
8. 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).
1. Any clinically significant deviation from the normal range in biochemistry or hematological blood tests.
2. 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
3. Clinical conditions representing a contraindication to intramuscular vaccination and blood draws
4. Any confirmed or suspected immunosuppressive or immune-deficient condition.
5. 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.
6. 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
7. Known exposure to Shigella during lifetime of the study participant
8. 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).
9. Acute illness with or without fever is a temporary exclusion criterium. Positive malaria test is a temporary exclusion criterion.
10. History of any malignancy of lymphoproliferative disorder
11. Parent/guardian known to be part of study personnel or being a close family member to the personnel conducting this study.
12. Previous history of significant persistent neutropenia, or drug related Neutropenia
13. Weight-for-age Z score less than -3SD.
14. History of any chronic or p
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and tolerability of the candidate vaccine Shigella4V2 as determined by occurrence, severity, and relationship of solicited AEs;Safety and tolerability of the candidate vaccine Shigella4V2 as determined by occurrence, severity, and relationship of unsolicited AEs;Safety and tolerability of the candidate vaccine Shigella4V2 as determined by occurrence, severity, and relationship of SAEs;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
- Secondary Outcome Measures
Name Time Method Measuring clinically significant changes in hematological and biochemical safety parameters comparing values before injection (baseline) and 7 days following each vaccine administration;Evaluation of geometric mean titers (GMT) for serum IgG against the four Shigella serotypes included in Shigella4V2 at 6 months post 2nd vaccination;Serum IgG responses and fold-increases between baseline and post-vaccination samples against the four Shigella serotypes included in the Shigella4V2 bioconjugate;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