Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00120081
Status:
COMPLETED
Last Update Posted:
2017-05-31
First Post:
2005-07-07
Brief Title:
Study of Na-ASP-2 Human Hookworm Vaccine in Healthy Adults Without Evidence of Hookworm Infection
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 65000 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None