Status:
COMPLETED
Study to Evaluate the Safety of the Vaccine Prepared sm14 Against Schistosomiasis
Lead Sponsor:
Oswaldo Cruz Foundation
Collaborating Sponsors:
Financiadora de Estudos e Projetos
Conditions:
Schistosomiasis
Eligibility:
All Genders
18-49 years
Phase:
PHASE1
Brief Summary
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 (...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01154049
Start Date
March 1 2011
End Date
April 1 2014
Last Update
August 10 2016
Active Locations (1)
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1
Instituto de Pesquisa Clínica Evandro Chagas (IPEC) - Fiocruz
Rio de Janeiro, Rio de Janeiro, Brazil, 21040900