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

This is an interventional prevention trial for Schistosomiasis focused on measuring Schistosomiasis, Vaccine, sm14 Read More

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)