A Study of the Safety and Immune Response of 2 Doses of a New Shigella Vaccine in Kenyan Adults

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-08

Study Completion Date

2017-03-10

Brief Summary

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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.

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Detailed Description

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Conditions

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Shigella Sonnei Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1790GAHB 25 μg Group

Subjects who received 2 injections of 1790GAHB vaccine containing 25 μg of S. sonnei.

Group Type EXPERIMENTAL

GVGH S. sonnei (1790GAHB) vaccine 25 μg

Intervention Type BIOLOGICAL

Two injections of the study vaccine were administered 28 days apart.

1790GAHB 100 μg Group

Subjects who received 2 injections of 1790GAHB vaccine containing 100 μg of S. sonnei.

Group Type EXPERIMENTAL

GVGH S. sonnei (1790GAHB) vaccine 100 μg

Intervention Type BIOLOGICAL

Two injections of the study vaccine were administered 28 days apart.

Control Group

Subjects who received one dose of Menveo vaccine and a second dose of Boostrix vaccine.

Group Type ACTIVE_COMPARATOR

Menveo

Intervention Type BIOLOGICAL

One injection of Menveo was administered in subjects in the Control Group.

Boostrix

Intervention Type BIOLOGICAL

One injection of Boostrix was administered in subjects in the Control Group.

Interventions

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GVGH S. sonnei (1790GAHB) vaccine 25 μg

Two injections of the study vaccine were administered 28 days apart.

Intervention Type BIOLOGICAL

GVGH S. sonnei (1790GAHB) vaccine 100 μg

Two injections of the study vaccine were administered 28 days apart.

Intervention Type BIOLOGICAL

Menveo

One injection of Menveo was administered in subjects in the Control Group.

Intervention Type BIOLOGICAL

Boostrix

One injection of Boostrix was administered in subjects in the Control Group.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes