Safety and Immunogenicity of the Na-APR-1 Hookworm Vaccine in Healthy Adults

Completed · Phase 1

Conditions studied: Hookworm Infection, Hookworm Disease

In brief

Hookworms digest hemoglobin from erythrocytes for use as an energy source via a proteolytic cascade that begins with the aspartic protease, APR-1. Vaccination with recombinant APR-1 has protected animals from infection in challenge studies. This study will evaluate the safety and immunogenicity of two formulations of Na-APR-1 (M74) in healthy adult volunteers when co-administered with different concentrations of the immunostimulant GLA-AF.

Key facts

Study ID

NCT01717950

Run by

Baylor College of Medicine

People needed

40

Starts

2013-09-01

Expected to finish

2015-09-01

Last updated by the study team

2019-07-31

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Males or females between 18 and 50 years, inclusive.
• Good general health as determined by means of the screening procedure.
• Available for the duration of the trial (44 weeks).
• Willingness to participate in the study as evidenced by signing the informed consent document.

You may not qualify if…

• Pregnancy as determined by a positive urine human choriogonadotropin (hCG) (if female).
• Participant unwilling to use reliable contraception methods up until one month following the third immunization (if female and not surgically sterile, abstinent or at least 2 years post-menopausal).
• Currently lactating and breast-feeding (if female).
• 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 (hemoglobin <11.5 g/dl [females] or <12.5 g/dl [males]; absolute leukocyte count <3600/mm3 or >10.7 x 103/mm3; absolute neutrophil count [ANC] <1700/ mm3; absolute lymphocyte count <700/mm3; or platelet count <140,000/mm3).
• Laboratory evidence of a coagulopathy (PTT or PT INR greater than 1.1-times the upper reference limit).
• 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 daily use of inhalers or emergency clinic visit or hospitalization within 6 months of the volunteer's expected first vaccination in the study.
• Positive ELISA for hepatitis B surface antigen (HBsAg).
• Positive confirmatory test for HIV infection.
• Positive confirmatory test for hepatitis C virus (HCV) infection.
• Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 30 days of the volunteer's expected first vaccination in this study.
• Receipt of a live vaccine within 4 weeks or a killed vaccine within 2 weeks prior to the volunteer's expected first vaccination in the study.
• History of a surgical splenectomy.
• Receipt of blood products within the past 6 months.
• History of previous infection with hookworm or residence for more than 6 months in a hookworm-endemic area.

Where it is running

• George Washington University Medical Faculty Associates — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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