Anti-Schistosomiasis Sm14-vaccine in Senegal

NCT05658614 | Unknown Phase 2 DMC

• 1 other identifier: Sm14-2c-Sn
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Previous clinical trials have already demonstrated the safety of the candidate vaccine in adults as well as in children, in good health or infected with schistosomiasis. Regarding the induced immune response, more than 80% of vaccinated subjects were seroconverted after three vaccine injections. The induced immune response was substantial but transient. In order to obtain a more lasting immune response, the investigator will experiment with a new vaccination schedule (2 injections 1-month interval and the 3rd injection 5 months after the first dose), versus the vaccine schedule initially used (3 injections at 1-month interval). This trial will be the last phase 2 before testing the efficacy of the rSm14 vaccine candidate.

Conditions

Schistosomiasis Mansoni; Schistosomiasis Haematobium; Vaccination; Infection

Outcome Measures

Primary Outcomes (14)

• assessment of Immunogenicity 1

  The anti-Sm14 IgG isotypes (Total IgG; IgG1; IgG3; IgG4; IgE) antibody response using an indirect ELISA

  Day 1

• assessment of Immunogenicity 2

  The anti-Sm14 IgG isotypes (Total IgG; IgG1; IgG3; IgG4; IgE) antibody response using an indirect ELISA

  Day 56

• assessment of Immunogenicity 3

  The anti-Sm14 IgG isotypes (Total IgG; IgG1; IgG3; IgG4; IgE) antibody response using an indirect ELISA

  Day 84

• assessment of Immunogenicity 4

  The anti-Sm14 IgG isotypes (Total IgG; IgG1; IgG3; IgG4; IgE) antibody response using an indirect ELISA

  Day 140

• assessment of Immunogenicity 5

  The anti-Sm14 IgG isotypes (Total IgG; IgG1; IgG3; IgG4; IgE) antibody response using an indirect ELISA

  Day 168

• assessment of Immunogenicity 6

  The anti-Sm14 IgG isotypes (Total IgG; IgG1; IgG3; IgG4; IgE) antibody response using an indirect ELISA

  Day 224

• assessment of Immunogenicity 7

  The anti-Sm14 IgG isotypes (Total IgG; IgG1; IgG3; IgG4; IgE) antibody response using an indirect ELISA

  Day 308

• assessment of Immunogenicity 8

  The anti-Sm14 IgG isotypes (Total IgG; IgG1; IgG3; IgG4; IgE) antibody response using an indirect ELISA

  Day 392

• assessment of immunogenicity 9

  Measure expression change in membrane markers expression of PBMC under in vitro Sm14 antigen activation

  Day 1

• assessment of immunogenicity 10

  Measure expression change in membrane markers expression of PBMC under in vitro Sm14 antigen activation (for Group Vacc3)

  Day 84

• assessment of immunogenicity 11

  Measure expression change in membrane markers expression of PBMC under in vitro Sm14 antigen activation (for Group Vacc2+1)

  Day 168

• assessment of immunogenicity 12

  12\. Measure cytokine production (ELISA) by PBMC under in vitro Sm14 antigen activation

  Day 1

• assessment of immunogenicity 13

  12\. Measure cytokine production (ELISA) by PBMC under in vitro Sm14 antigen activation (for Group Vacc3)

  Day 84

• assessment of immunogenicity 14

  12\. Measure cytokine production (ELISA) by PBMC under in vitro Sm14 antigen activation (for Group Vacc2+1)

  Day 168

Secondary Outcomes (9)

• Safety of the vaccine candidate Sm14 -1

  from Day 1 to Day 442

• Safety of the vaccine candidate Sm14 - 2

  from Day 1 to Day 3

• Safety of the vaccine candidate Sm14 -3

  from Day 28 to Day 30

• Safety of the vaccine candidate Sm14 -4

  from Day 56 to Day 58

• Safety of the vaccine candidate Sm14 -5

  from Day 140 to Day 142

Study Arms (2)

Arm 1 (Group Vacc3)

ACTIVE COMPARATOR

Volunteers will receive three (3) intramuscular injections into the deltoid muscle of 0.5mL of of the Sm14+ GLA-SE vaccine on D0, W4 and W8. (D = Day; W = Week). (Vaccination schedule used in previous phases).

Biological: Sm14 recombinant vaccine+ GLA-SE adjuvant

Arm 2 (Group Vacc2+1)

EXPERIMENTAL

Volunteers will receive three (3) intramuscular injections of the Sm14+ GLA-SE vaccine into the deltoid muscle of 0.5mL of vaccine on D0, W4 and W20 (new vaccination schedule).

Biological: Sm14 recombinant vaccine+ GLA-SE adjuvant

Interventions

Sm14 recombinant vaccine+ GLA-SE adjuvant BIOLOGICAL

rSm14 - recombinant protein (GMP produced) - 50ug / injection GLA-SE- synthetic Glucopyranosyl lipid A in stable emulsion: 2.5ug / injection

Arm 1 (Group Vacc3); Arm 2 (Group Vacc2+1)

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Man living in villages in the Saint Louis region where schistosomiasis is endemic.
• Having an infectious history of schistosomiasis.
• Adult between 18 and 49 years old at the time of the first injection.
• Consent signed by the volunteer after information.
• Satisfactory state of health, confirmed on clinical examination and following biological assessment (Vpi / W-1).
• Available for the duration of the trial.
• To be negative to the Covid-19 antigenic test

You may not qualify if:

• Participation to a previous anti-schistosomiasis vaccine clinical trial.
• Participation in another ongoing clinical research
• Current or previous chronic administration (defined as more than 14 days) of immunosuppressive drugs or other immune modulating drugs.
• Known hypersensitivity to any component present in the Sm14 vaccine, or to any given vaccine, and / or history of allergic disease.
• Other conditions which, according to the PI, can potentially represent a danger to the subject to be included.

Sponsors & Collaborators

• Oswaldo Cruz Foundation: lead

Study Sites (1)

Biomedical Research Center EPLS

Saint-Louis, Senegal

RECRUITING

MeSH Terms

Conditions

Schistosomiasis mansoni; Schistosomiasis haematobia; Infections

Condition Hierarchy (Ancestors)

Schistosomiasis; Trematode Infections; Helminthiasis; Parasitic Diseases; Vector Borne Diseases; Urinary Tract Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Gilles RIVEAU, PharmD PhD

  Biomedical Research Center EPLS

  STUDY DIRECTOR

Central Study Contacts

Miriam TENDLER

CONTACT

+55 21 994 417 749; mtendler@ioc.fiocruz.br

Marilia SIRIANNI

CONTACT

+55 21 2562 1273; sirianni@ioc.fiocruz.br

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: open label
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: Main objective: to compare the immunological quality of the new vaccination schedule (amplitude and duration) versus the vaccination schedule used in the previous trials, by studying the Sm14 specific antibody response induced both quantitatively and qualitatively. The hypothesis is to obtain a mean response quantitatively higher with the new vaccine schedule. Secondary objective: safety profile of the two vaccine schedules studied.

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: December 21, 2022
• Study Start: July 1, 2022
• Primary Completion: September 15, 2023
• Study Completion: December 31, 2023
• Last Updated: December 21, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)