![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
Sponsors and Collaborators: |
Albert B. Sabin Vaccine Institute Oswaldo Cruz Foundation George Washington University London School of Hygiene and Tropical Medicine |
---|---|
Information provided by: | Albert B. Sabin Vaccine Institute |
ClinicalTrials.gov Identifier: | NCT00473967 |
Na-ASP-2 is a protein expressed during the larval stage of the N. americanus hookworm life cycle. Vaccination with recombinant ASP-2 has protected dogs and hamsters from infection in challenge studies. In a clinical study in hookworm-uninfected adults in the USA, Na-ASP-2 Hookworm Vaccine was safe and immunogenic. This study will evaluate its safety and immunogenicity in individuals living in an area of endemic hookworm infection.
Condition | Intervention | Phase |
---|---|---|
Hookworm Infection |
Biological: Na-ASP-2 Hookworm Vaccine |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Single Group Assignment, Safety Study |
Official Title: | Double-Blind, Randomized, Controlled Phase 1 Study of the Safety and Immunogenicity of Na-ASP-2 Hookworm Vaccine in Previously-Infected Brazilian Adults |
Estimated Enrollment: | 48 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | May 2008 |
Estimated Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Na-ASP-2 Hookworm Vaccine
|
Biological: Na-ASP-2 Hookworm Vaccine
Injections of one of three different dose concentrations of the Na-ASP-2 vaccine (10, 50, or 100 mcg) vs. the hepatitis B vaccine, delivered at 0, 2, and 4 months by intramuscular injection.
|
2: Active Comparator
Hepatitis B Vaccine
|
Biological: Na-ASP-2 Hookworm Vaccine
Injections of one of three different dose concentrations of the Na-ASP-2 vaccine (10, 50, or 100 mcg) vs. the hepatitis B vaccine, delivered at 0, 2, and 4 months by intramuscular injection.
|
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Brazil | |
Centro de Pesquisas Rene Rachou | |
Belo Horizonte, Brazil |
Principal Investigator: | David J Diemert, MD | Albert B. Sabin Vaccine Institute |
Responsible Party: | Albert B. Sabin Vaccine Institute ( Ami Shah Brown, PhD/Director of Vaccine Operations ) |
Study ID Numbers: | SVI-06-02 |
Study First Received: | May 14, 2007 |
Last Updated: | February 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00473967 History of Changes |
Health Authority: | United States: Food and Drug Administration; Brazil: National Health Surveillance Agency; Brazil: Ministry of Health |
Vaccine Hookworm Phase 1 Na-ASP-2 |
Ancylostoma Duodenale Hookworm Infections Parasitic Diseases Nematode Infections Helminthiasis |
Strongylida Infections Hookworm Infections Parasitic Diseases Nematode Infections |
Infection Helminthiasis Secernentea Infections |