Who is sponsoring NCT05658614?

NCT05658614 is sponsored by Oswaldo Cruz Foundation.

What drugs are being tested in NCT05658614?

Interventions in NCT05658614: Sm14 recombinant vaccine+ GLA-SE adjuvant.

What condition does NCT05658614 study?

NCT05658614 studies Schistosomiasis Mansoni, Schistosomiasis Haematobium, Vaccination; Infection.

Is NCT05658614 still recruiting?

NCT05658614 is currently status unknown. Last updated 21 December 2022.

Last reviewed 2022-12-21 · How we verify

NCT05658614

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Anti-Schistosomiasis Sm14-vaccine in Senegal

Status unknown Phase 2 Last updated 21 December 2022

What this trial tests

Phase 2 trial testing Sm14 recombinant vaccine+ GLA-SE adjuvant in Schistosomiasis Mansoni in 120 participants. Status unknown.

Timeline

1 July 2022

Primary endpoint
15 September 2023

31 December 2023

Quick facts

Lead sponsor	Oswaldo Cruz Foundation
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	120
Start date	1 July 2022
Primary completion	15 September 2023
Estimated completion	31 December 2023
Sites	1 location across Senegal

Drugs / interventions tested

Sm14 recombinant vaccine+ GLA-SE adjuvant — full drug profile →

Conditions studied

Schistosomiasis Mansoni — all drugs for Schistosomiasis Mansoni →
Schistosomiasis Haematobium — all drugs for Schistosomiasis Haematobium →
Vaccination; Infection — all drugs for Vaccination; Infection →

Sponsor

Oswaldo Cruz Foundation

Who can join

Adults 18 to 49, male only, with Schistosomiasis Mansoni or Schistosomiasis Haematobium. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Advances in vaccine adjuvant development and future perspectives.
Sinani G, Şenel S. · · 2025 · cited 10× · PMID 40536024 · DOI 10.1080/10717544.2025.2517137
From cercariae to chronic inflammation: understanding schistosome infection and host immune responses.
Torsello A, Cattani C, Napoli C, Cavani A, et al · · 2025 · PMID 41607785 · DOI 10.3389/fimmu.2025.1729394
Exploring the immune responses triggered by vaccine formulations containing the recombinant Schistosoma mansoni 14kDa fatty acid-binding protein.
Maciel PS, Almeida GG, Carvalho GBF, Silva-Pereira RAD, et al · · 2025 · PMID 41359538 · DOI 10.1371/journal.pone.0338310

Verify or expand the search:

Other Oswaldo Cruz Foundation trials

Trials by the same sponsor.

NCT06203925 — Hepatitis C Virus Self-testing (HCVST) in Sexual and Gender Minorities in Rio de Janeiro · unknown
NCT06306300 — Safety and Efficacy of Decentralized HCV Treatment vs Standard-of-Care in Rio de Janeiro (Brazil) · Phase 4 · unknown
NCT05507671 — The Role of BCG Vaccine in the Clinical Evolution of COVID-19 and in the Efficacy of Anti-SARS-CoV-2 Vaccines · Phase 3 · active not recruiting
NCT04191018 — GastrOesophageal Varices After Sustained Virological Response · unknown
NCT03799510 — Anti-Schistosomiasis Vaccine: Sm14 Phase 2b-Sn in School Children · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05658614 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Oswaldo Cruz Foundation
Last refreshed: 21 December 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05658614.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing