Clinical Trial: Study of Na-ASP-2 Human Hookworm Vaccine in Healthy Adults Without Evidence of Hookworm Infection

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 H

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 Summary:

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.

Sponsor: Baylor College of Medicine

Current Primary Outcome: Safety and tolerability of three different doses of the Na-ASP-2 hookworm vaccine in healthy volunteers [ Time Frame: For the duration of the study ]

Original Primary Outcome: To evaluate the safety and tolerability of three different doses of the Na-ASP-2 hookworm vaccine in healthy volunteers.

Current Secondary Outcome: To determine the immunogenicity, both humoral and cellular, of the vaccine at specified time points following vaccination [ Time Frame: 2, 8, 10, 16, 18, 24, and 48 weeks after the first injection ]

Original Secondary Outcome: To determine the immunogenicity, both humoral and cellular, of the vaccine at specified time points.

Information By: Baylor College of Medicine

Dates:
Date Received: July 7, 2005
Date Started: April 2005
Date Completion:
Last Updated: May 30, 2017
Last Verified: May 2017