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

Phase 1 Study to Evaluate the Safety of the Vaccine Prepared sm14 Against Schistosomiasis

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.

Study Overview

• Status: Completed
• Conditions: Schistosomiasis
• Intervention / Treatment: Biological: sm14 antigen plus adjuvant GLA

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• Brazil
  • Rio de Janeiro, Brazil, 21040900
    • Instituto de Pesquisa Clinica Evandro Chagas (IPEC) - Fiocruz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of the vaccine	Safety and tolerability of the vaccine (sm14 antigen plus GLA adjuvant) against schistosomiasis in health adults	4 months after the first dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of seroconversion	Proportion of seroconversion for sm14 antigen 30 days after the complete vaccinal schedule (3 doses, 30 days apart)	30 days after the third vaccine dose
Cellular immune response to sm-14 vaccination in health adults	Determine the cellular immune responses and their correlation to the development and magnitude of humoral responses	30 days after the third vaccine dose

Collaborators and Investigators

• Sponsor: Oswaldo Cruz Foundation
• Collaborators: Financiadora de Estudos e Projetos
• Investigators: Principal Investigator: Marilia S Oliveira, MD, MsC, Instituto de Pesquisa Clinica Evandro Chagas (IPEC)

Publications and helpful links

General Publications

• Santini-Oliveira M, Coler RN, Parra J, Veloso V, Jayashankar L, Pinto PM, Ciol MA, Bergquist R, Reed SG, Tendler M. Schistosomiasis vaccine candidate Sm14/GLA-SE: Phase 1 safety and immunogenicity clinical trial in healthy, male adults. Vaccine. 2016 Jan 20;34(4):586-594. doi: 10.1016/j.vaccine.2015.10.027. Epub 2015 Nov 10.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: June 29, 2010
• First Submitted That Met QC Criteria: June 29, 2010
• First Posted (Estimate): June 30, 2010

Study Record Updates

• Last Update Posted (Estimate): August 10, 2016
• Last Update Submitted That Met QC Criteria: August 9, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Vaccine; Schistosomiasis; sm14
• Additional Relevant MeSH Terms: Infections; Vector Borne Diseases; Parasitic Diseases; Helminthiasis; Trematode Infections; Schistosomiasis
• Other Study ID Numbers: sm14-CT001P1