PACTR202105845422919
Recruiting
Phase 1
Safety and immunogenicity of a travalent bioconjugate vaccine Shigella -: A phase1/2 randomized controlled and aged escending study including dose finding in 9 month old infants
immaTech Biologics AG0 sites592 target enrollmentMay 3, 2021
ConditionsShigelossis
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Shigelossis
- Sponsor
- immaTech Biologics AG
- Enrollment
- 592
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy by medical history, laboratory findings and physical examination before entering into the study (Participants with a minor illness (such as mild diarrhoea, 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 in the study area village during the whole trial period (Kilifi \-Kilifi Health and Demographic Surveillance System (Described in more detail in the SSA); (Kericho\-a 75km radius from the Kericho Clinical Research Centre).
- •Previously completed routine primary vaccinations (6,10 and 14 weeks or thereabouts) to the best knowledge of the participant/parent/guardian.
- •Signed/thumb written informed consent, in accordance with local practice, provided by adult volunteers (participants 18 years of age and older), parents or legal representatives for children and infants participants as applicable, who, in the opinion of the investigator, can and will comply with the requirements of the protocol
- •Demonstrated comprehension of the protocol procedures by passing score of 90% or better on a written/verbal comprehension test.
- •Female and male participants between, and including 18\-50 years at the time of first vaccination
- •Female participants of non\-childbearing potential may be enrolled in the study. Non\-childbearing potential is defined as pre\-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post\-menopause. Female volunteers of childbearing potential may be enrolled in the study if the participant: has a negative urine pregnancy test at the day of screening and vaccinations, respectively, andagree to use effective contraception for 30 days prior to vaccination and
- •agree to continue contraception at least for 2 months after completion of vaccination series.
- •Children and Infants
Exclusion Criteria
- •Any clinically significant deviation from the normal range in biochemistry or haematological 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 (for infants) / 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
- •Known exposure to Shigella during lifetime of the subject
- •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 disease and /or fever at the time of enrolment Note: enrolment may be postponed/delayed until such transient circumstances have terminated
- •History of any malignancy of lymphoproliferative disorder
Outcomes
Primary Outcomes
Not specified
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