Evaluate a New Shigella Sonnei Vaccine Administered Either by Intradermal, Intranasal or Intramuscular Route in Healthy Adults

• Register: ClinicalTrials.gov
• Last refreshed on: 4 July 2016
• Main ID: NCT02034500
• Date of registration: 02/01/2014
• Prospective Registration: Yes
• Primary sponsor: GSK Vaccines Institute For Global Health S.r.l.
• Public title: Evaluate a New Shigella Sonnei Vaccine Administered Either by Intradermal, Intranasal or Intramuscular Route in Healthy Adults
• Scientific title: A Phase 1, Randomized, Placebo Controlled, Single Center, Dose Escalation Study to Evaluate the Safety and Immunogenicity of 3 Vaccinations With Shigella Sonnei Vaccine (1790GAHB) Administered Either by Intradermal, Intranasal or Intramuscular Route in Healthy Adults.
• Date of first enrolment: March 2014
• Target sample size: 52
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02034500
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
• Phase: Phase 1

Countries of recruitment

United Kingdom

Contacts

• Name: David JM Lewis, MD
• Affiliation: University of Surrey, Guildford, GU2 7XP United Kingdom

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Males and females of age =18 years to =45 years.

2. Individuals who, after the nature of the study have been explained to them, have
given written consent according to local regulatory requirements.

3. Individuals in good health as determined by the outcome of medical history, physical
examination, hematology, renal, bone and liver panels (including negative for
agglutination testing of S. sonnei), urinalysis and clinical judgment of the
investigator.

4. If women of childbearing potential, have a negative pregnancy test prior to study
vaccination and willingness to use acceptable contraceptive measures for the entire
study duration.

5. Individuals available for follow-up for the duration of the study.

6. Individuals registered with a general practitioner.

Exclusion Criteria:

1. Individuals with a history of recurrent wheezing, asthma, respiratory allergies,
allergic rhinitis, nasal surgery or significant nasal abnormalities (e.g. polyps),
and Bell's palsy. Presence of nasal piercings. Symptoms of upper respiratory tract
infection within 3 days of intended study vaccination is a temporary exclusion
criterion.

2. Individuals unwilling to abstain from medications or other agents that are applied
via the nasal route from 24 hours prior to each nasal dosing through to the safety
assessment 1 week later.

3. 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.

4. Individuals with any progressive or severe neurological disorder, seizure disorder or
Guillain-Barré syndrome.

5. Individuals who are not able to understand and to follow all required study
procedures for the whole period of the study.

6. 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.

7. Individuals with human leukocyte antigen (HLA) -B27 positive and/or with history of
reactive arthritis

8. Individuals with known HIV, HBV and HCV infection or HIV related disease, with
history of an autoimmune disorder or any other known or suspected impairment
/alteration of the immune system, or under immunosuppressive therapy including use of
systemic corticosteroids or chronic use of inhaled high-potency corticosteroids
within the previous 30 days, or were in chemotherapy treatment within the past 6
months.

9. Individuals with a known bleeding diathesis, or any condition that may be associated
with a prolonged bleeding time.

10. Individuals with any serious chronic or progressive disease according to judgment of
the investigator (e.g., neoplasm, insulin dependent diabetes, cardiac, renal or
hepatic disease).

11. Individuals who have any malignancy or lymphoproliferative disorder.

12. Individuals with history of allergy to vaccine components.

13. Individuals participating in any clinical trial with another investigational product
90 days prior to first study visit or intent to participate in another clinical study
at any time during the conduct of this study.

14. Individuals who received any other vaccines within 4 weeks prior to enrollment in
this study or who are planning to receive any vaccine within the entire study
duration except influenza vaccination, which is not allowed within the period
included between 4 weeks before 1st vaccination and 4 weeks after 3rd vaccination

15. Individuals who have received blood, blood products and/or plasma derivatives
including parenteral immunoglobulin preparations in the past 12 weeks.

16. Individuals who are part of study personnel or close family members to the personnel
conducting this study or employees of the clinical trial site institution.

17. Individuals with body temperature > 38.0 degrees Celsius within 3 days of intended
study vaccination.

18. BMI > 30 kg/m2.

19. Individuals with history of substance or alcohol abuse within the past 2 years.

20. Women who are pregnant or breast-feeding or of childbearing age who have not used or
do not plan to use acceptable birth control measures, for the duration of the study.

21. Females with history of stillbirth, neonatal loss, or previous infant with anomaly.

22. Individuals who have a previously ascertained or suspected disease caused by S.
sonnei or positive S. sonnei serology at screening

23. Individuals who have had household contact with/and or intimate exposure to an
individual with laboratory confirmed S. sonnei

24. Any condition, which, in the opinion of the investigator may pose an increased and
unreasonable safety risk to the subject if participating to the present study



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Shigellosis

Intervention(s)

Biological: Placebo

Biological: S. sonnei 1790GAHB

Primary Outcome(s)

Number of subjects with Neutrophils results below and above the normal [Time Frame: At Day 36]

Number of subjects with Neutrophils results below and above the normal [Time Frame: At Day 57]

Number of subjects with solicited local reaction after any vaccination [Time Frame: During a 7-day (Days 1-7) post vaccination period following any injection]

Number of subjects with Neutrophils results below and above the normal ranges [Time Frame: At Day 8]

Number of subjects with Neutrophils results below and above the normal [Time Frame: At Day 64]

Number of subjects with Neutrophils results below and above the normal [Time Frame: At Day 85]

Number of subjects with Neutrophils results below and above the normal [Time Frame: At Day 225]

Number of subjects with solicited systemic reaction after any vaccination [Time Frame: During a 7-day (Days 1 to 7) post vaccination period following any injection]

Secondary Outcome(s)

Anti-LPS S. sonnei serum IgG Geometric mean concentration (GMCs) [Time Frame: At baseline, at 28 days after each vaccination and at 168 days after last vaccination]

Number of subjects with seroresponse for anti-LPS S. sonnei [Time Frame: At 28 days after each vaccination and 168 days after last vaccination]

Number of subjects with high seroresponse for anti-LPS S. sonnei (IgG ELISA =121 EU) [Time Frame: At baseline, at 28 days after each vaccination and at 168 days after last vaccination]

Secondary ID(s)

H03_02TP

Source(s) of Monetary Support

Please refer to primary and secondary sponsors