A Study to Investigate the Safety and Immunogenicity of the SF2a-TT15 Synthetic Carbohydrate-based Conjugate Vaccine Against Shigella Flexneri 2a
NCT ID: NCT04602975
Last Updated: 2024-04-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
248 participants
INTERVENTIONAL
2020-10-06
2023-11-15
Brief Summary
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Detailed Description
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The vaccine will be tested in adults first, then in children and eventually in infants in Kenya (where Shigella infection is present), based on the safety/tolerability in each group before to moving to the other. Participants will be randomly assigned to receive the study vaccine or a placebo control (same solution but without the vaccine component). The participants will have to go through all the trial procedures including the 14 visits (3 injections and 11 follow-up) during a 16 months period.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Adults cohort 1 vaccinees
Eligible subjects (adults - 18 to 50 yr-old) will be randomized to receive 3 intramuscular (IM) injections with the 10μg OS adjuvanted dose (or matching placebo), at a ratio of 3:1.
Injection SF2A-TT15 10 µg Adjuvanted
Intramuscular injection of experimental vaccine (adjuvanted 10 µg)
Adults cohort 1 placebo recipients
Eligible subjects (adults - 18 to 50 yr-old) will be randomized to receive 3 IM injections with the adjuvanted matching placebo.
Injection Adjuvanted Placebo
Intramuscular injection of Placebo with alhydrogel
Children cohort 2 vaccinees
Eligible subjects (Children 2 to 5 yr-old) will be randomized to receive 3 IM injections of the 10 μg OS dose with Alhydrogel (or matching placebo) at a ratio of 3:1.
Injection SF2A-TT15 10 µg Adjuvanted
Intramuscular injection of experimental vaccine (adjuvanted 10 µg)
Children cohort 2 placebo recipients
Eligible subjects (Children 2 to 5 yr-old) will be randomized to receive 3 IM injections of the matching placebo with Alhydrogel.
Injection Adjuvanted Placebo
Intramuscular injection of Placebo with alhydrogel
Infants cohort 3A vaccinees (-)
Eligible subjects (9 mo-old +/- 1mo infants) will be randomized to receive 3 IM injections of the not adjuvanted 2 μg dose (or of matching placebo), at a ratio of 4:1.
Injection SF2A-TT15 2 µg
Intramuscular injection of experimental vaccine (not adjuvanted 2 µg)
Infants cohort 3A placebo recipients (-)
Eligible subjects (9 mo-old +/- 1mo infants) will be randomized to receive 3 IM injections of the not adjuvanted matching placebo.
Injection Placebo
Intramuscular injection of the not adjuvanted Placebo
Infants cohort 3A vaccinees (+)
Eligible subjects (9 mo-old +/- 1mo infants) will be randomized to receive 3 IM injections of the adjuvanted 2 μg dose (or of matching placebo), at a ratio of 4:1.
Injection SF2A-TT15 2 µg Adjuvanted
Intramuscular injection of experimental vaccine (adjuvanted 2 µg)
Infants cohort 3A placebo recipients (+)
Eligible subjects (9 mo-old +/- 1mo infants) will be randomized to receive 3 IM injections of the adjuvanted matching placebo.
Injection Adjuvanted Placebo
Intramuscular injection of Placebo with alhydrogel
Infants cohort 3B vaccinees (-)
Eligible subjects (9 mo-old +/- 1mo infants) will be randomized to receive 3 IM injections of the not adjuvanted 10 μg dose (or of matching placebo), at a ratio of 4:1.
Injection SF2A-TT15 10 µg
Intramuscular injection of experimental vaccine (not adjuvanted 10 µg)
Infants cohort 3B placebo recipients (-)
Eligible subjects (9 mo-old +/- 1mo infants) will be randomized to receive 3 IM injections of the not adjuvanted matching placebo.
Injection Placebo
Intramuscular injection of the not adjuvanted Placebo
Infants cohort 3B vaccinees (+)
Eligible subjects (9 mo-old +/- 1mo infants) will be randomized to receive 3 IM injections of the adjuvanted 10 μg dose (or of matching placebo), at a ratio of 4:1.
Injection SF2A-TT15 10 µg Adjuvanted
Intramuscular injection of experimental vaccine (adjuvanted 10 µg)
Infants cohort 3B placebo recipients (+)
Eligible subjects (9 mo-old +/- 1mo infants) will be randomized to receive 3 IM injections of the adjuvanted matching placebo.
Injection Adjuvanted Placebo
Intramuscular injection of Placebo with alhydrogel
Interventions
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Injection SF2A-TT15 10 µg Adjuvanted
Intramuscular injection of experimental vaccine (adjuvanted 10 µg)
Injection SF2A-TT15 10 µg
Intramuscular injection of experimental vaccine (not adjuvanted 10 µg)
Injection Adjuvanted Placebo
Intramuscular injection of Placebo with alhydrogel
Injection Placebo
Intramuscular injection of the not adjuvanted Placebo
Injection SF2A-TT15 2 µg Adjuvanted
Intramuscular injection of experimental vaccine (adjuvanted 2 µg)
Injection SF2A-TT15 2 µg
Intramuscular injection of experimental vaccine (not adjuvanted 2 µg)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Healthy men and women between 18 and 50 (inclusive) years of age.
2. Subjects who provide written informed consent or thumb print in the presence of a witness to participate in the study
3. Women willing to use at least 1 reliable method of contraception during the study period, or are surgically sterilized, and agree to undergo repeated pregnancy tests (before each vaccination) and men willing to use an effective method of contraception (e.g. condom).
For children and infants:
1. Healthy boys and girls between 2 and 5 years of age for the children group (cohort 2)
2. Healthy boys and girls 9 mo-old (+/- 1 month) for the infant group (cohort 3)
3. Parents or legally acceptable representatives, as appropriate, who are willing and able to provide signed/thumb printed informed consent for children and infants.
4. Infant and children should have a normal nutritional Z score (-2 or greater) according to the mother and child health handbook of the republic of Kenya - Ministry of Health before entering the trial.
For all:
1. Signed/thumb written informed consent, in accordance with local practice, provided by adult volunteers (participants 18 years of age and older), parent(s) or legal representative(s) for children and infants participants as applicable, who, in the opinion of the Investigator, can and will comply with the requirements of the protocol.
2. Subjects in general good health in the opinion of the Investigator as determined by medical history, vital signs and a physical examination.
3. No clinically significant abnormalities in hematology, blood chemistry, or urinalysis laboratory tests at screening.
4. Negative HIV, Hepatitis B and Hepatitis C serology tests and malaria test.
Exclusion Criteria
2. Individuals with immunosuppressive diseases or under immunosuppressive therapy.
3. Previous participation in any study in which a Shigella-vaccine candidate was administered.
4. 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.
5. Use of any prescription or over-the-counter (OTC) medications, within 14 days prior vaccination. Paracetamol or ibuprofen for symptomatic relief of pain is allowed until 48 hours prior to vaccination.
6. Women who are pregnant, breast-feeding, or are of childbearing age and are not on or do not plan to use acceptable contraceptives for the duration of the study.
7. Subjects with any significant acute medical situation (e.g. acute infection) within 48 hrs prior to study entry, in the opinion of the Principal Investigator.
8. Participation in another clinical trial with drugs within 3 months prior first study injection.
8 Months
50 Years
ALL
Yes
Sponsors
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Wellcome Trust
OTHER
Gates Medical Research Institute
OTHER
Henry M. Jackson Foundation Medical Research International
UNKNOWN
Walter Reed Army Institute of Research (WRAIR)
FED
Parexel
INDUSTRY
ClinWin Research
UNKNOWN
Institut Pasteur
INDUSTRY
Responsible Party
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Principal Investigators
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Armelle Phalipon, PhD
Role: STUDY_CHAIR
Institut Pasteur
Laurence Mulard, PhD
Role: STUDY_CHAIR
Institut Pasteur
Christiane Gerke, PhD
Role: STUDY_CHAIR
Institut Pasteur (Consulting)
Fredrick Sawe, MBChB MMED
Role: PRINCIPAL_INVESTIGATOR
Kenya Medical Research Institute
Locations
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KEMRI / Henry M. Jackson Foundation Medical Research International
Kericho, , Kenya
Countries
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Other Identifiers
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2018-017
Identifier Type: -
Identifier Source: org_study_id
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