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

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Brief Title

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

Official Title

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

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 (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 Phase

Phase 1

Study Type

Interventional


Primary Outcome

Safety of the vaccine

Secondary Outcome

 Proportion of seroconversion

Condition

Schistosomiasis

Intervention

sm14 antigen plus adjuvant GLA

Study Arms / Comparison Groups

 single arm
Description:  3 doses of the vaccine, on days 0, 30 and 60.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

20

Start Date

March 2011

Completion Date

April 2014

Primary Completion Date

April 2014

Eligibility 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)
      

Gender

All

Ages

18 Years - 49 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Marilia S Oliveira, MD, MsC, , 

Location Countries

Brazil

Location Countries

Brazil

Administrative Informations


NCT ID

NCT01154049

Organization ID

sm14-CT001P1


Responsible Party

Sponsor

Study Sponsor

Oswaldo Cruz Foundation

Collaborators

 Financiadora de Estudos e Projetos

Study Sponsor

Marilia S Oliveira, MD, MsC, Principal Investigator, Instituto de Pesquisa Clínica Evandro Chagas (IPEC)


Verification Date

August 2016