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| Sponsor: | Albert B. Sabin Vaccine Institute |
|---|---|
| Collaborator: |
Bill and Melinda Gates Foundation |
| Information provided by: | Albert B. Sabin Vaccine Institute |
| ClinicalTrials.gov Identifier: | NCT00120081 |
Purpose
The primary objective of this clinical trial is to determine the safety and tolerability of the Na-ASP-2 Hookworm Vaccine in healthy subjects following the administration of 3 intramuscular (IM) injections of the vaccine over 16 weeks using 3 different doses. The secondary objective is to make a preliminary evaluation of the immunogenicity of each of the 3 doses of the vaccine in healthy volunteers.
| Condition | Intervention | Phase |
|---|---|---|
|
Hookworm Infection |
Biological: Na-ASP-2/Alhydrogel Hookworm Vaccine Biological: Saline placebo |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Phase 1, Single-Center, Double-Blind, Placebo-Controlled, Randomized, Dose-Escalation Study to Compare the Safety, Tolerability, and Immunogenicity of Three Intramuscular Administrations of Na-ASP-2 Hookworm Vaccine in Healthy Adults Without Evidence of Hookworm Infection |
| Enrollment: | 36 |
| Study Start Date: | April 2005 |
| Study Completion Date: | September 2006 |
| Primary Completion Date: | September 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Low dose
10 mcg Na-ASP-2/Alhydrogel
|
Biological: Na-ASP-2/Alhydrogel Hookworm Vaccine
The recombinant hookworm protein Na-ASP-2 formulated on aluminum hydroxide adjuvant (Alhydrogel), in one of three dose concentrations, compared to a saline placebo control.
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|
Experimental: Medium dose
50 mcg Na-ASP-2/Alhydrogel
|
Biological: Na-ASP-2/Alhydrogel Hookworm Vaccine
The recombinant hookworm protein Na-ASP-2 formulated on aluminum hydroxide adjuvant (Alhydrogel), in one of three dose concentrations, compared to a saline placebo control.
|
|
Experimental: High dose
100 mcg Na-ASP-2/Alhydrogel
|
Biological: Na-ASP-2/Alhydrogel Hookworm Vaccine
The recombinant hookworm protein Na-ASP-2 formulated on aluminum hydroxide adjuvant (Alhydrogel), in one of three dose concentrations, compared to a saline placebo control.
|
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Placebo Comparator: Saline placebo
Saline placebo
|
Biological: Saline placebo
Inactive saline placebo control
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There is an urgent need for new tools to control human hookworm infection and to reduce its burden of disease in developing countries. This is especially true for children and women of reproductive age who represent populations that are highly vulnerable to the effects of hookworm disease. Up to 65,000 deaths annually have been attributed to human hookworm infection. However, the mortality estimates of hookworm pale in comparison to global disease burden estimates.
The primary approach to hookworm control worldwide has been the frequent and periodic use of benzimidazole anthelminthics for school-age children. However, school-based anthelminthic chemotherapy programs miss populations highly vulnerable to hookworm, including adolescent and adult women. In addition, high rates of hookworm re-infection occur within 4-12 months following anthelminthic chemotherapy, and there is evidence for diminished efficacy of benzimidazoles with frequent and periodic use, possibly because of emerging drug resistance. These concerns have prompted interest in developing alternative tools for hookworm control. Vaccination to prevent high intensity hookworm infection would alleviate the public health deficiencies of drug treatment alone.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, District of Columbia | |
| George Washington University Medical Center | |
| Washington, District of Columbia, United States, 20037 | |
| Principal Investigator: | Gary Simon, M.D., Ph.D | George Washington University |
More Information
| Responsible Party: | Ami Shah Brown, Director of Vaccine Operations, Albert B. Sabin Vaccine Institute |
| ClinicalTrials.gov Identifier: | NCT00120081 History of Changes |
| Other Study ID Numbers: | SVI-04-01 |
| Study First Received: | July 7, 2005 |
| Last Updated: | June 21, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Vaccine Hookworm Phase 1 Human Hookworm Infection Na-ASP-2 |
|
Hookworm Infections Ancylostomiasis Strongylida Infections Secernentea Infections Nematode Infections Helminthiasis Parasitic Diseases |
Aluminum Hydroxide Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antacids Molecular Mechanisms of Pharmacological Action |