A Study of the Safety and Immune Response of 2 Doses of a New Shigella Vaccine in Kenyan Adults
Condition: Shigella Sonnei Infection
MeSH terms: Dysentery, Bacillary
Intervention: GVGH S. sonnei (1790GAHB) vaccine 25 μg; GVGH S. sonnei (1790GAHB) vaccine 100 μg; Menveo; Boostrix
Intervention description: Two injections of the study vaccine were administered 28 days apart.; Two injections of the study vaccine were administered 28 days apart.; One injection of Menveo was administered in subjects in the Control Group.; One injection of Boostrix was administered in subjects in the Control Group.
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 74.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the safety and the immunogenicity of two different
      doses of the GVGH S. sonnei vaccine in healthy adults and represents the first step towards
      testing of the GMMA vaccine in the vaccine target population of children from developing
      countries where shigellosis is endemic.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Individuals ≥18 years to ≤45 years of age on the day of informed consent who are
             resident in the study area and are not planning to leave during the study period.

          2. Individuals who, after the nature of the study has been explained, have voluntarily
             given written consent according to local regulatory requirements, prior to study
             entry.

          3. Individuals who can comply with study procedures including follow-up.

          4. Individuals in good health as determined by the outcome of medical history, physical
             examination, hematology, renal function, and liver function tests, urine
             dipstick/urinalysis and the clinical judgment of the investigator.

          5. Males Or Females of childbearing potential who are using an effective birth control
             method which they intend to use for the duration of the study Or Females without
             childbearing potential (i.e. irrespective of birth control method) Prior to receipt of
             second study vaccination, subjects must be evaluated to confirm that they are eligible
             for subsequent vaccination. If subjects do not meet any of the original inclusion
             criteria listed above, they should not receive additional vaccinations.

        Exclusion Criteria:

          1. Individuals with behavioral or cognitive impairment or psychiatric disease that, in
             the opinion of the investigator, may interfere with the subject's ability to
             participate in the study.

          2. Individuals with any progressive or severe neurological disorder, seizure disorder or
             previous Guillain-Barré syndrome.

          3. Individuals who, in the judgment of the investigator, may not be able to comply with
             all the required study procedures.

          4. Individuals with history of any illness that, in the opinion of the investigator,
             might interfere with the results of the study or pose additional risk to the subjects
             due to participation in the study.

          5. Individuals with history of reactive arthritis.

          6. Individuals with known HIV or hepatitis B virus infection or HIV related disease,
             history of an autoimmune disorder or any other known or suspected impairment
             /alteration of the immune system. Individuals under systemic administration of
             corticosteroids (PO/IV/IM) for more than 14 consecutive days within 90 days prior to
             screening.

          7. Individuals with a known bleeding diathesis, or any condition that may be associated
             with a prolonged bleeding time.

          8. Individuals with a neutrophil count lower than 1.8 x 10^9/L (applicable to the initial
             18 subjects) or lower than 1.0 x 10^9/L (applicable to the additional subjects if
             approved by DSMB) at screening

          9. Individuals with any serious chronic or progressive disease according to judgment of
             the investigator (e.g., neoplasm, insulin dependent diabetes, Type 2 diabetes
             mellitus, hypertension, cardiac, renal or hepatic disease and tuberculosis).

         10. Individuals who have any malignancy or lymphoproliferative disorder.

         11. Individuals with history of allergy to vaccines components or any other allergies
             deemed by the investigator to increase the risk of an adverse event if they were to
             participate in the trial.

         12. Individuals participating in any clinical trial with another investigational product
             within 28 days prior to the screening study visit or intent to participate in another
             clinical study at any time during the conduct of this study.

         13. Individuals who received vaccines containing meningococcal A, C, W, Y or tetanus,
             diphtheria or pertussis antigens within 12 months before screening, or any other
             vaccines within 4 weeks prior to screening in this study or who are planning to
             receive any vaccine within the entire study duration.

         14. Individuals who have received blood, blood products, and/or plasma derivatives
             including parenteral immunoglobulin preparations in the 12 weeks prior to the first
             dose of the study vaccine.

         15. Individuals who are study personnel or immediate family members (parents, children,
             spouse and brothers/sisters) to the personnel conducting this study.

         16. Individuals with body temperature > 38.0°C within 3 days of intended study vaccination
             is a reason for delay of vaccination

         17. Individuals with Body Mass Index (BMI)> 30 kg/m^2

         18. Individuals with history of substance or alcohol abuse within the past 2 years.

         19. Women who are pregnant or are breast-feeding, or are of childbearing age who have not
             used (for the two months preceding the 1st vaccination) and are not willing to use
             acceptable contraceptive measures, for the duration of the study. If subjects are
             women of childbearing potential, they must have a negative pregnancy test at screening
             visit and prior to enrollment (visit 1). For the purposes of this study acceptable
             methods of contraception are oral, injected or implantable contraceptives.

         20. Individuals who have a previously laboratory confirmed case of disease caused by S.
             sonnei.

         21. Any condition which, in the opinion of the investigator, may pose an increased and
             unreasonable safety risk to the subject if they participated in the study.

         22. Individuals with a previous history of Benign Ethnic Neutropenia or drug related
             neutropenia.

         23. Individuals who have or are likely to require concomitant treatment with neutropenic
             agents.