Anti-Schistosomiasis Vaccine: Sm14 Phase 2b-Sn in School Children

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Brief Title

Anti-Schistosomiasis Vaccine: Sm14 Phase 2b-Sn in School Children

Official Title

Safety and Immunogenicity Evaluation of the Vaccine Candidate Sm14 Against Schistosomiasis in Senegalese School Children Healthy or Infected With S. Mansoni and/or S. Haematobium. A Comparative, Randomized, Controlled, Open-label Trial

Brief Summary

      The clinical trial phase 2b is designed to assess the safety and the specific immune response
      of the active ingredient (protein + adjuvant) in healthy and then in infected school children
      from 8 to 11 years of age with intestinal and/or urinary schistosomiasis, living in the
      Valley of the Senegal River, a highly endemic area for schistosomiasis.

Detailed Description

      A phase 2b trial, self-contained, open-label, controlled, randomized study in three parallel
      arms, two of them formed by groups of healthy or infected school children, both receiving
      three (3) injections at D0, W4 (Week 4), W8; both groups receiving 50 μg Sm14 vaccine
      candidate solution, combined with 2.5μg GLA-SE. The third group is composed by non-vaccinated
      infected school children.

      Sm14: recombinant protein produced in yeast following Good Manufacturing Practices (GMP)
      conditions, presented in vials containing 0.55 ml solution Sm14, 0.4 ml solution is diluted
      with 0.4 ml of GLA (Synthetic Glucopyranosyl lipid A) for intramuscular administration.

      Medical examinations are performed at D0 (before injection, 1 hr and 4 hr after), and a
      safety evaluation at 24 hrs and 48 hrs, after each injection.

      Blood analysis: Liver function tests - renal function tests - blood counts, at W-1 before
      inclusion, and at W9 and W21 during the follow-up.

      Blood samples for immune response analysis at D0, W12 and W21.

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Secondary Outcome

 Qualitative and quantitative assessment of the Immunogenicity

Condition

Schistosomiasis

Intervention

Sm14

Study Arms / Comparison Groups

 Group 1
Description:  Healthy school children with no infectious history of Schistosomiasis receiving three (3) intramuscular injections of 50 μg Sm14 with 2.5 μg GLA-SE solution at D0, W4, W8 (D=day; W=week). Three-month follow-up (W12, W20).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Biological

Estimated Enrollment

95

Start Date

December 13, 2018

Completion Date

August 7, 2019

Primary Completion Date

July 1, 2019

Eligibility Criteria

        Inclusion Criteria:

          -  School children, of public schools in villages of Saint Louis region (Senegal), female
             or male, 8 to 11 years old (inclusive) at the time of inclusion.

          -  Residence in the area during the period of the study.

          -  Free of obvious/severe health problems except schistosomiasis, as established by
             clinical examination.

          -  Written informed consent to participate obtained from subject's parents or legal
             guardian.

          -  Free of obvious/severe health problems except schistosomiasis, established by blood
             analysis, i.e. hematological exams, liver and renal function tests.

          -  Treated with 40mg/kg Praziquantel (PZQ) before inclusion (W-2 to W-4 before the first
             injection) in case of infection with S. mansoni and S. haematobium

          -  Children of Group 1: not infected, no schistosomiasis history and living in
             area/village free of Sm and Sh transmission.

          -  Children Groups 2 & 3: infected with mansoni or/and haematobium schistosomiasis.

        Exclusion Criteria:

          -  School child who does not respond to one of the inclusion criteria

          -  Child under 20kg of body weight

          -  Vaccination within 90 days preceding the first dose of Sm14 vaccine candidate, or
             planned use during the study period.

          -  Current or previous chronic administration (defined as more than 14 days) of
             immunosuppressive drugs or other immuno-modifying drugs.

          -  Known hypersensitivity to any component in the Sm14 vaccine or history of allergic
             disease.

          -  Knowledge of non-infectious chronic disease

          -  Known acute disease.

          -  Other conditions which in opinion of the PI may potentially represent a danger for the
             patient to be enrolled.

Gender

All

Ages

8 Years - 11 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Miriam Tendler, MD, PhD, ,

Location Countries

Senegal

Location Countries

Senegal

Administrative Informations

NCT ID

NCT03799510

Organization ID

Sm14 Phase 2b - Sn

Responsible Party

Sponsor

Study Sponsor

Oswaldo Cruz Foundation

Collaborators

 Orygen Biotecnologia SA

Study Sponsor

Miriam Tendler, MD, PhD, Study Chair, Oswaldo Cruz Foundation

Verification Date

December 2019