Status:
COMPLETED
Safety and Immunogenicity of a Human Hookworm Candidate Vaccine With or Without Additional Adjuvant in Brazilian Adults
Lead Sponsor:
Baylor College of Medicine
Conditions:
Hookworm Infection
Hookworm Disease
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
This two part study will evaluate the safety and immunogenicity of two formulations of Na-GST-1, first in hookworm-naïve individuals using an open-label design, and then in adults living in an area of...
Detailed Description
Human hookworm infection is a soil-transmitted helminth infection caused by the nematode parasites Necator americanus and Ancylostoma duodenale. It is one of the most common chronic infections of huma...
Eligibility Criteria
Inclusion
- Males or females between 18 and 45 years, inclusive.
- Good general health as determined by means of the screening procedure.
- Available for the duration of the trial (42 weeks).
- Willingness to participate in the study as evidenced by signing the informed consent document.
- If found to be infected with hookworm during screening, has completed a course of three doses of albendazole.
Exclusion
- Pregnancy as determined by a positive urine β-hCG (if female).
- Participant unwilling to use reliable contraception methods up until one month following the third immunization (if female).
- Currently lactating and breast-feeding (if female).
- Inability to correctly answer all questions on the informed consent comprehension questionnaire.
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, diabetes, or renal disease by history, physical examination, and/or laboratory studies.
- Known or suspected immunodeficiency.
- Laboratory evidence of liver disease (alanine aminotransferase \[ALT\] greater than 1.25-times the upper reference limit).
- Laboratory evidence of renal disease (serum creatinine greater than 1.25-times the upper reference limit, or more than trace protein or blood on urine dipstick testing).
- Laboratory evidence of hematologic disease (absolute leukocyte count \<3000/mm3 or \>12.5 x 103/mm3; hemoglobin \<10.3 g/dl or \<11.0 g/dl \[females in Americaninhas and Belo Horizonte, respectively\] or \<11.0 g/dl or \<12.0 \[males in Americaninhas and Belo Horizonte, respectively); absolute lymphocyte count \<900/mm3; or platelet count \<120,000/mm3).
- Laboratory evidence of a coagulopathy (PTT or PT INR greater than 1.1-times the upper reference limit \[in Belo Horizonte\] or PT INR greater than 1.3 \[Americaninhas\]).
- Serum glucose (random) greater than 1.2-times the upper reference limit.
- Other condition that in the opinion of the investigator would jeopardize the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol.
- Participation in another investigational vaccine or drug trial within 30 days of starting this study.
- Volunteer has had medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months.
- History of a severe allergic reaction or anaphylaxis.
- Severe asthma as defined by the need for regular use of inhalers or emergency clinic visit or hospitalization within the last 6 months.
- Positive ELISA for HCV.
- Positive ELISA for HBsAg.
- Positive ELISA for HIV.
- Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 30 days of starting this study.
- Receipt of a live vaccine within past 4 weeks or a killed vaccine within past 2 weeks prior to entry into the study.
- History of a surgical splenectomy.
- Receipt of blood products within the past 6 months.
- History of allergy to yeast.
- Anti-Na-GST-1 IgE antibody level above 0.35 kUA/L by the ImmunoCAP method.
- For Part I only: history of previous infection with hookworm; residence for more than 6 months in a hookworm-endemic area; or, positive for hookworm infection on screening microscopic fecal examination.
- For Part II only: previous receipt of a primary series of any hepatitis B vaccine.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT01261130
Start Date
November 1 2011
End Date
December 1 2014
Last Update
May 31 2017
Active Locations (2)
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1
Americaninhas Vaccine Center
Americaninha, Minas Gerais, Brazil
2
Centro de Pesquisas René Rachou - FIOCRUZ
Belo Horizonte, Minas Gerais, Brazil