Hookworm Infection Clinical Trial
Official title:
Phase 1 Study of the Safety and Immunogenicity of Na-APR-1 (M74)/Alhydrogel® in Healthy Adults
Verified date | July 2019 |
Source | Baylor College of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | September 2015 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | George Washington University Medical Faculty Associates | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Baylor College of Medicine | George Washington University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Vaccine-related Adverse Events | The frequency of immediate, systemic, and local injection site adverse events will be summarized. Adverse events will be assessed by study team members at 1 hour post-vaccination as well as 3, 7, 14, and 28 days following each vaccination. In addition, study participants will be asked to complete symptom diaries for the 7 days after each vaccination. | Day 290 | |
Secondary | IgG antibody response to Na-APR-1 | Dose and formulation of Na-APR-1 that generates the highest IgG antibody response at Day 126 (14 days after final vaccination), as determined by an indirect enzyme-linked immunosorbent assay (ELISA). | 14 days after final vaccination | |
Secondary | B cell response to Na-APR-1 | Dose and formulation of the Na-APR-1 (M74) vaccine that results in the highest production of Na-APR-1 (M74) specific B cells and subtypes (memory or plasma). | Study Days 14, 70, 126, 140 and 290 | |
Secondary | Exploratory cellular immune response to Na-APR-1 | Exploratory studies of the cellular immune responses to the Na APR-1 (M74) antigen both before and after immunization. | Study Days 14, 70, 126, 140 and 290 |
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