Hookworm Infection Clinical Trial
Official title:
Randomized, Controlled, Phase 1 Study to Assess Safety and Immunogenicity of Co-administered Hookworm Vaccine Candidates Na-APR-1 (M74)/Alhydrogel® and Na-GST-1/ Alhydrogel® in Gabonese Children
NCT number | NCT02839161 |
Other study ID # | HV-002 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | January 2017 |
Est. completion date | March 28, 2019 |
Verified date | April 2019 |
Source | Baylor College of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Double blind, randomized, controlled, dose-escalation Phase 1 clinical trial in hookworm-exposed children aged 6 to 10 years living in the area of Lambaréné, Gabon. Children will receive three doses of the Na-GST-1/Alhydrogel hookworm vaccine co-administered with the Na-APR-1 (M74)/Alhydrogel hookworm vaccine or the hepatitis B vaccine co-administered with sterile saline. All injections will be delivered intramuscularly (deltoid) on approximately Days 0, 56, and 112 or 180.
Status | Completed |
Enrollment | 60 |
Est. completion date | March 28, 2019 |
Est. primary completion date | December 13, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: 1. Males or females between 6 and 10 years, inclusive, who are long-term residents of the study area. 2. Good general health as determined by means of the screening procedure. 3. Assumed availability for the duration of the trial (up to 15 months). 4. Willingness of parent or legal guardian for child to participate in the study as evidenced by signing the informed consent document in combination with the child assent form. 5. Negative for hookworm during screening, or if found to be infected with hookworm, has completed a course of three doses of albendazole. Exclusion Criteria: 1. Inability of parent/legal guardian to correctly answer all questions on the informed consent comprehension questionnaire. 2. Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, diabetes, or renal disease by history, physical examination, and/or laboratory studies. 3. Known or suspected immunodeficiency. 4. Laboratory evidence of liver disease (alanine aminotransferase [ALT] greater than 1.25-times the upper reference limit). 5. Laboratory evidence of renal disease (serum creatinine greater than 1.25-times the upper reference limit, or more than 1+ protein, or more than trace blood on urine dipstick testing with the exception of greater than trace blood detected in females during menses). 6. Laboratory evidence of hematologic disease (absolute leukocyte count <4500/mm3; absolute leukocyte count >13.0 x 103/mm3; hemoglobin <9.5 g/dl; or, platelet count <140,000/mm3). 7. Other condition that in the opinion of the investigator could jeopardize the safety or rights of a child participating in the trial or would render the child unable to comply with the protocol. 8. Participation in another investigational vaccine or drug trial within 30 days of starting this study or for the duration of the study. 9. History of a severe allergic reaction or anaphylaxis. 10. Severe asthma as defined by the need for daily use of inhalers or emergency room/clinic visit or hospitalization within 6 months of the child's planned first vaccination in the study. 11. Positive for HCV. 12. Positive for HBsAg. 13. Positive for HIV infection. 14. Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 30 days of starting this study or expect to use for the duration of the study. 15. Receipt of a live vaccine within past 4 weeks or a killed vaccine within past 2 weeks prior to entry into the study. 16. History of a surgical splenectomy. 17. Receipt of blood products within the 6 months prior to entry into the study. 18. Previous receipt of a primary series (three doses according to a 0, 1, and 6 -12 month schedule) of the hepatitis B vaccine. |
Country | Name | City | State |
---|---|---|---|
Gabon | Centre de Recherches Médicales de Lambaréné | Lambaréné |
Lead Sponsor | Collaborator |
---|---|
Baylor College of Medicine |
Gabon,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Duration of antibody response to Na-GST-1 and Na-APR-1 (M74) | To assess and compare the duration of the antibody responses of Na-GST-1 and Na-APR-1 (M74). | Day 380 | |
Other | IgG subclass response to Na-GST-1 and Na-APR-1 (M74) | To assess the distribution of IgG subclass responses to Na-GST-1 and Na-APR-1 (M74). | Day 380 | |
Primary | Vaccine-related Adverse Events | To evaluate the safety and reactogenicity of three different dose concentrations of Na-APR-1 (M74)/Alhydrogel® co-administered with Na-GST-1/Alhydrogel® in healthy Gabonese children. | Day 380 | |
Secondary | IgG response to Na-GST-1 and Na-APR-1 (M74) | To determine the doses of co-administered Na-APR-1 (M74) and Na-GST-1 that result in the highest levels of IgG antibody approximately 14 days after the third vaccination. | 14 days after the third vaccination |
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