Status:
COMPLETED
Na-GST-1/Alhydrogel With or Without CpG 10104 in Gabonese Adults
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
Centre de Recherche Médicale de Lambaréné
George Washington University
Conditions:
Hookworm Infection
Hookworm Disease
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
Na-GST-1 is a protein expressed during the adult stage of the Necator americanus hookworm life cycle that is thought to play a role in the parasite's degradation of host hemoglobin for use as an energ...
Detailed Description
Double blind, randomized, controlled, dose-escalation Phase 1 clinical trial in hookworm-exposed adults aged 18 to 50 years living in the area of Lambaréné, Gabon. Participants will receive three dose...
Eligibility Criteria
Inclusion
- Males or females between 18 and 50 years, inclusive, who are long-term residents of the study area.
- Good general health as determined by means of the screening procedure.
- Assumed availability for the duration of the trial (13 months).
- Willingness to participate in the study as evidenced by signing the informed consent document.
- Negative for hookworm during screening, or if found to be infected with hookworm, has completed a course of three doses of albendazole.
Exclusion
- Pregnancy as determined by a positive urine human choriogonadotropin (hCG) test (if female).
- Participant unwilling to use reliable contraception up until one month following the final immunization (if female and not surgically sterile, abstinent, at least 2 years post-menopausal, or determined otherwise by medical evaluation to be sterile).
- 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.
- Has a diagnosis of schizophrenia, bipolar disease or other major psychiatric condition that would make compliance with study visits/procedures difficult (e.g., subject with psychoses or history of suicide attempt or gesture in the 3 years before study entry, ongoing risk for suicide).
- 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 1+ protein, or glucose on urine dipstick testing).
- Laboratory evidence of hematologic disease (absolute leukocyte count \<3500/mm3; absolute leukocyte count \>11.0 x 103/mm3; hemoglobin \<10.0 g/dl \[females\] or \<12.0 g/dl \[males\]; or, platelet count \<140,000/mm3).
- Other condition that in the opinion of the investigator could jeopardize the safety or rights of a volunteer participating in the trial or would render them unable to comply with the protocol.
- Participation in another investigational vaccine or drug trial within 30 days of starting this study or for the duration of the study.
- History of a severe allergic reaction or anaphylaxis.
- Severe asthma as defined by the need for daily use of inhalers or emergency room/clinic visit or hospitalization within 6 months of the volunteer's planned first vaccination in the study.
- Positive for HCV.
- Positive for HBsAg.
- Positive for HIV infection.
- Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 30 days of starting this study or planned use up to one month after the volunteer's final vaccination.
- 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 6 months prior to entry into the study.
- Previous receipt of the Na-GST-1/Alhydrogel® vaccine.
- Pre-existing autoimmune or antibody-mediated diseases including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, autoimmune thrombocytopenia; or laboratory evidence of possible autoimmune disease determined by a positive anti-dsDNA titer, positive rheumatoid factor, proteinuria (greater than trace protein on urine dipstick testing) and/or a positive ANA.
Key Trial Info
Start Date :
February 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2019
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03373214
Start Date
February 1 2018
End Date
March 30 2019
Last Update
January 13 2021
Active Locations (1)
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1
Centre de Récherches Médicales de Lambaréné
Lambaréné, Gabon