Study of Safety and Immune Response of the Sm14 Vaccine in Adults of Endemic Regions

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Brief Title

Study of Safety and Immune Response of the Sm14 Vaccine in Adults of Endemic Regions

Official Title

Safety and Immunogenicity Evaluation of the Vaccine Candidate Sm14 in Combination With the Adjuvant Glucopyranosyl Lipid A (GLA-SE) in Adults Living in Endemic Regions for S. Mansoni and S. Haematobium in Senegal. A Comparative, Randomized, Open-label Trial

Brief Summary

      The clinical trial phase 2a is designed to assess the safety of the active ingredient
      (protein + adjuvant) and secondarily its immunogenicity in healthy male adults from 18 to 49
      years of age with a history of infection with intestinal and urinary schistosomiasis, living
      in the Valley of the Senegal River, a highly endemic area for schistosomiasis. Two arms in
      the study will test different doses of GLA-SE adjuvant (2.5 and 5 μg). This phase IIA in
      adults is considered to be a preliminary step in safety before starting trials in children in
      endemic areas to S. mansoni or S. haematobium, target population of the vaccine.
    

Detailed Description

      A phase 2a trial, self-contained, open-label, randomized, dose-escalation study in two
      parallel arms receiving three (3) injections at D0, D28, D56; both groups receiving 50 μg
      Sm14 vaccine candidate solution, either combined with 2.5µg GLA-SE for the first group and
      5µg for the second one in adults living in a S. mansoni and S. haematobium endemic area.

      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 then 7 days after each injections and at W13 and W21 during the follow-up.

      Blood samples for immune response analysis at time of each injection, and then W12 and W20.
    

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:  Adults with an infectious history of S. haematobium and S. mansoni and pretreated with 1 dose of Praziquantel (3 weeks prior to the first vaccine injection) 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

30

Start Date

December 6, 2016

Completion Date

June 2, 2017

Primary Completion Date

April 6, 2017

Eligibility Criteria

        Inclusion Criteria:

          -  Adults, male, 18 to 49 years old (inclusive) at the time of inclusion.

          -  Living in one of selected villages in Saint-Louis Region (Senegal).

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

          -  Written informed consent to participate obtained

          -  Treated with 40mg/kg Praziquantel (PZQ) before inclusion (W-5 to W-4 before the first
             injection) in case of infection with S. mansoni and S. haematobium

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

        Exclusion Criteria:

          -  Adult who does not respond to one of the inclusion criteria

          -  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

          -  Acute disease at time of enrollment.

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

          -  Non residence in the study area or intent to move during the study period
      

Gender

Male

Ages

18 Years - 49 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Miriam Tendler, MD, PhD, , 

Location Countries

Senegal

Location Countries

Senegal

Administrative Informations


NCT ID

NCT03041766

Organization ID

Sm14-2a-Sn


Responsible Party

Principal Investigator

Study Sponsor

Oswaldo Cruz Foundation

Collaborators

 Orygen Biotecnologia SA

Study Sponsor

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


Verification Date

January 2017