Study to Evaluate the Safety of the Vaccine Prepared sm14 Against Schistosomiasis

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Financiadora de Estudos e Projetos
Information provided by (Responsible Party):
Oswaldo Cruz Foundation
ClinicalTrials.gov Identifier:
NCT01154049
First received: June 29, 2010
Last updated: October 30, 2013
Last verified: October 2013
  Purpose

This is a phase I, open-label, single arm trial, which aims to assess the safety of the vaccine prepared sm14 in healthy subjects. The product immunogenicity will be evaluated by conducting serology (anti-sm14 antibodies) and testing of cellular response to the antigen by the method ELI-SPOT. Each participant will remain in the study for approximately 4 months. The total study duration is 10 months, considering a period of 6 months for inclusion. Will be included in the study subjects male and female, between 18 and 49 years, that manifest their will to participate in the research by signing an Informed Consent Form. Eligible population for the study are subjects who do not present at screening significant changes in renal, cardiac and liver functions, complete blood count, clotting, present no acute or chronic illnesses, are not in the chronic use of any medication, do not have HIV infection or other immunodeficiency. Pregnant or breastfeeding women will not be included. Volunteers will receive three doses of vaccine prepared sm14, in doses containing 50 mcg of the antigen, associated with adjuvant GLA-SE at a dose of 10 mcg, with an interval of 30 days between each application. Twenty volunteers will be included in the study. This is a convenience sample, established for the first test of the product in humans, for the initial safety assessment.


Condition Intervention Phase
Schistosomiasis
Biological: sm14 antigen plus adjuvant GLA
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Phase 1 Study to Evaluate the Safety of the Vaccine Prepared sm14 Against Schistosomiasis

Resource links provided by NLM:


Further study details as provided by Oswaldo Cruz Foundation:

Primary Outcome Measures:
  • Safety of the vaccine [ Time Frame: 4 months after the first dose ] [ Designated as safety issue: Yes ]
    Safety and tolerability of the vaccine (sm14 antigen plus GLA adjuvant) against schistosomiasis in health adults


Secondary Outcome Measures:
  • Proportion of seroconversion [ Time Frame: 30 days after the third vaccine dose ] [ Designated as safety issue: No ]
    Proportion of seroconversion for sm14 antigen 30 days after the complete vaccinal schedule (3 doses, 30 days apart)

  • Cellular immune response to sm-14 vaccination in health adults [ Time Frame: 30 days after the third vaccine dose ] [ Designated as safety issue: No ]
    Determine the cellular immune responses and their correlation to the development and magnitude of humoral responses


Estimated Enrollment: 20
Study Start Date: March 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: single arm
3 doses of the vaccine, on days 0, 30 and 60.
Biological: sm14 antigen plus adjuvant GLA
Healthy adults will receive 3 doses of the vaccine, on days 0, 30 and 60.

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged between 18 and 49 years.
  • Available for follow-up throughout the study period (approximately 120 days).
  • Ability to understand and sign the informed consent form (IC).
  • HIV serology negative
  • Absence of helminth infections in general (nematodes, cestodes and trematodes, among which Schistosoma mansoni) at the inclusion in the study.
  • Patients who has not chronic use or have not used in the past 45 days any medication, except trifling as nasal saline and vitamins.
  • Be in good health without significant medical history.
  • Screening physical examination without clinical significant abnormalities.
  • Screening laboratory tests without significant abnormalities according to normal standards and the evaluation of investigators.
  • Additional criteria for females of childbearing potential: Negative pregnancy test at screening; consistent use of contraceptive methods (male or female condom, diaphragm, IUD and oral contraceptives or "patches").

Exclusion Criteria:

  • Women who are pregnant or breastfeeding.
  • Use of cytotoxic or immunosuppressive drugs in the last six months, except for spray nasal corticosteroids for allergic rhinitis or topical corticosteroids for uncomplicated dermatitis.
  • Immunoglobulin use 60 days prior to vaccination.
  • Use of any type of vaccine 30 days prior to vaccination.
  • Plan to receive any other vaccine during the period of participation in the study (four months)
  • Use any type of investigational medication in a period of 30 days prior to vaccination
  • Use of allergy shots with antigens within 14 days prior to vaccination.
  • Psychiatric illness that hinders adherence to the protocol, such as psychosis, obsessive-compulsive neurosis, bipolar disorder treatment, diseases that require treatment with lithium, and suicide thoughts in the last 5 years prior to inclusion.
  • Presence of neurological disease, liver disease or kidney disease (diseases which have led to hospitalization or prolonged treatment).
  • History of sickle cell anemia.
  • Asplenia (no spleen or its removal).
  • History of alcohol use/abuse (CAGE criterion) or illicit drugs.
  • Blood pressure above 140/90 mmHg at screening or hypertension requiring drug treatment.
  • Coagulopathy diagnosed by a doctor or report of capillary fragility (eg, bruising, bleeding, etc.) after injections or blood sampling.
  • Active malignancy (eg, any type of cancer) or treated so it may relapse during the study.
  • History of allergy to vaccines containing adjuvants composed of lipids (GLA or MPL)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01154049

Locations
Brazil
Instituto de Pesquisa Clínica Evandro Chagas (IPEC) - Fiocruz
Rio de Janeiro, Brazil, 21040900
Sponsors and Collaborators
Oswaldo Cruz Foundation
Financiadora de Estudos e Projetos
Investigators
Principal Investigator: Marilia S Oliveira, MD, MsC Instituto de Pesquisa Clínica Evandro Chagas (IPEC)
  More Information

No publications provided

Responsible Party: Oswaldo Cruz Foundation
ClinicalTrials.gov Identifier: NCT01154049     History of Changes
Other Study ID Numbers: sm14-CT001P1
Study First Received: June 29, 2010
Last Updated: October 30, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Oswaldo Cruz Foundation:
Schistosomiasis
Vaccine
sm14

Additional relevant MeSH terms:
Schistosomiasis
Trematode Infections
Helminthiasis
Parasitic Diseases

ClinicalTrials.gov processed this record on August 28, 2014