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HealthyPhase 2GlycoShig3NCT04602975

A Study to Investigate the Safety and Immunogenicity of the SF2a-TT15 Synthetic Carbohydrate-based Conjugate Vaccine Against Shigella Flexneri 2a

A Phase 2 study testing Injection SF2A-TT15 10 µg Adjuvanted, Injection SF2A-TT15 10 µg and Injection SF2A-TT15 2 µg Adjuvanted in people with Healthy, run by Institut Pasteur at 1 site in Kenya.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A study among adults, children and infants in Kenya to determine if a new type of glycoconjugate vaccine incorporating a synthetic carbohydrate component is safe and induces immunity against Shigella. Read more about this study

Who is it for?
Ages 8 months to 50 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Injection SF2A-TT15 10 µg Adjuvanted, Injection SF2A-TT15 10 µg and Injection SF2A-TT15 2 µg Adjuvanted
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
248 participants
Where
1 siteKenya
Study dates
6 Oct 2020to 15 Nov 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 months to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • For adults:
  • Healthy men and women between 18 and 50 (inclusive) years of age.
  • Subjects who provide written informed consent or thumb print in the presence of a witness to participate in the study
  • 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:
  • Healthy boys and girls between 2 and 5 years of age for the children group (cohort 2)
Show all 14Show fewer
  • Healthy boys and girls 9 mo-old (+/- 1 month) for the infant group (cohort 3)
  • Parents or legally acceptable representatives, as appropriate, who are willing and able to provide signed/thumb printed informed consent for children and infants.
  • 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:
  • 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.
  • Subjects in general good health in the opinion of the Investigator as determined by medical history, vital signs and a physical examination.
  • No clinically significant abnormalities in hematology, blood chemistry, or urinalysis laboratory tests at screening.
  • Negative HIV, Hepatitis B and Hepatitis C serology tests and malaria test.

Who cannot join

  • Subjects with a history of clinically significant gastrointestinal disorders (e.g. gastroesophageal reflux disease, peptic ulcer, celiac disease, inflammatory bowel disease).
  • Individuals with immunosuppressive diseases or under immunosuppressive therapy.
  • Previous participation in any study in which a Shigella-vaccine candidate was administered.
  • 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.
  • 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.
  • 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.
  • 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.
  • Participation in another clinical trial with drugs within 3 months prior first study injection.

Trial locations and contacts

1 site in 1 country.

Kenya1 site

  • KEMRI / Henry M. Jackson Foundation Medical Research International

    Kericho

Other trials in Kenya

About this study

Official title: A Phase 2a Age Descending Study to Investigate the Safety and Immunogenicity of the SF2a-TT15 Synthetic Carbohydrate-based Conjugate Vaccine Against Shigella Flexneri 2a in Adults, Children, and Infant Target Population in Endemic Countries.

A study among adults, children and infants in Kenya to determine if a new type of glycoconjugate vaccine incorporating a synthetic carbohydrate component is safe and induces immunity against Shigella.

Read the detailed description

The purpose of this study is to examine the safety and immunogenicity of two doses of the parenteral synthetic carbohydrate-based conjugate vaccine against Shigella flexneri 2a (Shigella flexneri 2a-Tetanus Toxoid15 (SF2a-TT15)) adjuvanted or not with Alhydrogel in infants in an endemic country (Kenya), the target population for the vaccine, using an age-descending approach. In total, 232 participants will be enrolled in the study: 16 adults (18-50 years-old), 16 children (2-5 years-old) and 200 infants (9 months-old +/ 1 mo).

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
Healthy
Being tested
Injection SF2A-TT15 10 µg Adjuvanted, Injection SF2A-TT15 10 µg, Injection Adjuvanted Placebo, Injection Placebo, Injection SF2A-TT15 2 µg Adjuvanted
Keywords
vaccine, anti-shigella, shigella, diarrheic disease, Kenya
Medical subject headings
Dysentery, Bacillary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Injection SF2A-TT15 10 µg AdjuvantedBiological

    Also called SF2A-TT15 10 µg Adjuvanted, Anti-shigella experimental vaccine (10µg with alhydrogel)

    Intramuscular injection of experimental vaccine (adjuvanted 10 µg)

  • Injection SF2A-TT15 10 µgBiological

    Also called SF2A-TT15 10 µg not adjuvanted, Anti-shigella experimental vaccine (10µg without alhydrogel)

    Intramuscular injection of experimental vaccine (not adjuvanted 10 µg)

  • Injection Adjuvanted PlaceboBiological

    Also called Placebo with Alhydrogel injection

    Intramuscular injection of Placebo with alhydrogel

  • Injection PlaceboBiological

    Also called Placebo without alhydrogel injection

    Intramuscular injection of the not adjuvanted Placebo

  • Injection SF2A-TT15 2 µg AdjuvantedBiological

    Also called SF2A-TT15 2 µg Adjuvanted, Anti-shigella experimental vaccine (2µg with alhydrogel)

    Intramuscular injection of experimental vaccine (adjuvanted 2 µg)

  • Injection SF2A-TT15 2 µgBiological

    Also called SF2A-TT15 2 µg not adjuvanted, Anti-shigella experimental vaccine (2µg without alhydrogel)

    Intramuscular injection of experimental vaccine (not adjuvanted 2 µg)

Study groups in NCT04602975
Study groupRoleWhat they receive
Adults cohort 1 vaccineesExperimentalEligible 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.
Receives: Biological: Injection SF2A-TT15 10 µg Adjuvanted
Adults cohort 1 placebo recipientsPlacebo comparatorEligible subjects (adults - 18 to 50 yr-old) will be randomized to receive 3 IM injections with the adjuvanted matching placebo.
Receives: Biological: Injection Adjuvanted Placebo
Children cohort 2 vaccineesExperimentalEligible 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.
Receives: Biological: Injection SF2A-TT15 10 µg Adjuvanted
Children cohort 2 placebo recipientsPlacebo comparatorEligible subjects (Children 2 to 5 yr-old) will be randomized to receive 3 IM injections of the matching placebo with Alhydrogel.
Receives: Biological: Injection Adjuvanted Placebo
Infants cohort 3A vaccinees (-)ExperimentalEligible 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.
Receives: Biological: Injection SF2A-TT15 2 µg
Infants cohort 3A placebo recipients (-)Placebo comparatorEligible subjects (9 mo-old +/- 1mo infants) will be randomized to receive 3 IM injections of the not adjuvanted matching placebo.
Receives: Biological: Injection Placebo
Infants cohort 3A vaccinees (+)ExperimentalEligible 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.
Receives: Biological: Injection SF2A-TT15 2 µg Adjuvanted
Infants cohort 3A placebo recipients (+)Placebo comparatorEligible subjects (9 mo-old +/- 1mo infants) will be randomized to receive 3 IM injections of the adjuvanted matching placebo.
Receives: Biological: Injection Adjuvanted Placebo
Infants cohort 3B vaccinees (-)ExperimentalEligible 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.
Receives: Biological: Injection SF2A-TT15 10 µg
Infants cohort 3B placebo recipients (-)Placebo comparatorEligible subjects (9 mo-old +/- 1mo infants) will be randomized to receive 3 IM injections of the not adjuvanted matching placebo.
Receives: Biological: Injection Placebo
Infants cohort 3B vaccinees (+)ExperimentalEligible 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.
Receives: Biological: Injection SF2A-TT15 10 µg Adjuvanted
Infants cohort 3B placebo recipients (+)Placebo comparatorEligible subjects (9 mo-old +/- 1mo infants) will be randomized to receive 3 IM injections of the adjuvanted matching placebo.
Receives: Biological: Injection Adjuvanted Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number, proportion,severity and relatedness of adverse events (AEs) to measure the safety and tolerability of SF2a-TT15 vaccine (2 μg OS and 10 μg OS) in each cohort.

    Solicited reactions, AEs, SAEs assessed post-vaccination using targeted physical examinations, vital signs, and clinical laboratory tests

    Measured: 15 months

  2. Analyses of the serum anti-S. flexneri 2a lipopolysaccharide (LPS) IgG antibody response in the infant target population to assess the immunogenicity of the vaccine.

    Proportion of responders (4-fold increases over baseline) in serum anti-S. flexneri 2a LPS IgG antibody response

    Measured: 15 months

Secondary outcomes (3)

  1. The number and proportion of responders, the geometric mean titer (GMT), mean fold-rises (compared to baseline), and peak-post-vaccination of the serum bactericidal activity (SBA) antibody (functionality of SF2a-specific IgGs antibodies in infants).

    Proportion of responders (4-fold increases over baseline) in serum bactericidal activity (SBA) antibody

    Measured: 15 months

  2. Analyses of the serum anti-S. flexneri 2a LPS Immunoglobulins G (IgG) antibody response in the adult and children cohorts.

    Proportion of responders (4-fold increases over baseline) in serum anti-S. flexneri 2a LPS IgG antibody response

    Measured: 15 months

  3. Comparison of the Measle-Rubella (MR) vaccine immune response in SF2a-TT15 vaccinees and placebo groups for the infant cohort.

    The antibody titer to the MR vaccine will be compared between SF2a-TT15 vaccinees and placebo groups to assess whether the SF2a-TT15 Shigella vaccine candidate impacts on the immunogenicity of the MR vaccine.

    Measured: 15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2020
  2. Study start6 Oct 2020
  3. Primary completion12 Apr 2023
  4. Study completion15 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, age descending (3 cohorts), with dose escalation in the target cohort
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
248 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04602975
Sponsor's protocol ID
2018-017
Acronym
GlycoShig3
Status last verified
Apr 2024
First submitted
24 Sep 2020
Last updated
23 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: This study is a part of a development program, Data will stay confidential and possibly shared only with program partners.

Publications

  • Sawe F, Koech L, Neffati S, Korir B, Laird RM, Odundo E, Kirui M, Clarkson KA, Artaud C, Ait-Ahmed M, Kaminski RW, Suvarnapunya AE, Cohen D, Mulard LA, Gerke C, Phalipon A. Safety and immunogenicity of the synthetic carbohydrate conjugate vaccine, SF2a-TT15, against Shigella flexneri 2a in infants in Kenya: a phase 2a, age-descending, dose-escalating, double-blind, randomised, placebo-controlled study. Lancet Infect Dis. 2026 Aug 19:S1473-3099(26)00307-5. doi: 10.1016/S1473-3099(26)00307-5. Online ahead of print.

    PubMed 42617627

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Injection SF2A-TT15 10 µg Adjuvanted, Injection SF2A-TT15 10 µg and Injection SF2A-TT15 2 µg Adjuvanted in people with Healthy, run by Institut Pasteur at 1 site in Kenya.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number, proportion,severity and relatedness of adverse events (AEs) to measure the safety and tolerability of SF2a-TT15 vaccine (2 μg OS and 10 μg OS) in each cohort. (time frame: 15 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04602975, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.

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