The suffering caused by hookworm is not well known in the developed world but in many countries it is all too prevalent. More than 700 million people are infected with hookworm. The largest number of cases occur in impoverished areas of Sub-Saharan Africa, Southeast Asia, China and Latin America. Globally, approximately 3.2 billion people are at risk for hookworm infection.
With financial support from the Bill & Melinda Gates Foundation and the Dutch Ministry of Foreign Affairs and the Brazilian Ministry of Health, the Sabin PDP is developing a vaccine against hookworm. A vaccine could provide a sustainable, effective means for controlling hookworm infection and protect the world’s poor from this harmful infection.
Clinical trial of Na-GST-1begins at Children’s National Medical Center in Washington, DC. The purpose of the trial is to quickly determine the optimal vaccine formulation for future clinical testing.
Phase 1 Clinical Trial of Na-GST-1 begins in Brazil.
cGMP manufacture of Na-APR-1 vaccine begins.
An IND application for the clinical development of Na-GST-1 hookworm vaccine is submitted.
Primary safety study of Na-GST-1 conducted in model animals.
First pilot-scale lot of Na-GST-1 vaccine manufactured at Aeras.
cGMP manufacture of Na-GST-1 drug substance and skin test reagent at Walter Reed Army Institute of Research (WRAIR).
Phase 1 clinical trial of the Na-ASP-2 Hookworm Vaccine in a hookworm-endemic area of Brazil begins. The trial was discontinued after some trial volunteers developed an allergic reaction to the vaccine.
The Sabin PDP develops new criteria for the selection of helminth antigens for consideration as vaccine candidates. This includes skin testing and seroepidemiological assessments of antibody responding to helminth antigens in individuals from endemic areas.
The Americaninhas Vaccine Center in Minas Gerais, Brazil is opened.
Bill & Melinda Gates Foundation awards a 4-year, $13.8 million grant to support the development of an adult hookworm vaccine candidate. Potential candidate antigens include Na-APR-1 and Na-GST-1.
Site selection study for Phase 1 clinical trial of Na-ASP-2 Hookworm Vaccine in Brazil is completed.
cGMP manufacture of three new clinical lots of Na-ASP-2 Hookworm Vaccine in the United States is completed.
Bill & Melinda Gates Foundation awards a 5-year, $21.8 million grant to support clinical development and evaluation of the Na-ASP-2 Hookworm Vaccine. Technology transfer of manufacturing and quality control processes commence with the aim of eventual industrial scale production of the vaccine in Brazil.
Phase 1 clinical trial of the Na-ASP-2 Hookworm Vaccine initiated in the United States.
An Investigational New Drug Application (IND) is submitted to the U.S Food and Drug Administration (FDA) for the clinical development of the Na-ASP-2 Hookworm Vaccine.
Na-ASP-2, a larval hookworm protein, is selected as the first candidate vaccine antigen.
cGMP manufacture of the Na-ASP-2 Hookworm Vaccine in the United States.
Sabin Vaccine Development program launches the Human Hookworm Vaccine Initiative (HHVI).
Bill & Melinda Gates Foundation awards a 5-year, $18 million dollar grant for the development of a human hookworm vaccine. The grant supported the identification, cloning, expression and preclinical testing of the candidate hookworm vaccine antigen, Na-ASP-2. In particular, it supported process development, manufacture and quality control to obtain regulatory approval for beginning clinical testing of the Na-ASP-2 Hookworm Vaccine.