History of HHVI

The suffering caused by hookworm, is not well known in the developed world, but in many countries it is all too prevalent. An estimated 576 million people in the developing nations of the tropics are infected with hookworm. The largest numbers of cases occur in impoverished rural areas of Sub-Saharan Africa, Southeast Asia, China, and Latin America.

Approximately 3.2 billion people are at risk for hookworm infection in these areas. The Human Hookworm Vaccine Initiative (HHVI) is a product development partnership based at the Sabin Vaccine Institute with support from the Bill & Melinda Gates Foundation to develop a vaccine against hookworm. A vaccine could provide a sustainable, effective means for controlling hookworm infection and protecting the world’s poor from this harmful infection.

Timeline

May 1993
Sabin Vaccine Institute is founded.

January 2000
Sabin’s 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 supports the identification, cloning, expression and preclinical testing of the lead candidate hookworm vaccine antigen, Na-ASP-2. In particular, it supports process development, manufacture, and quality control to obtain regulatory approval for beginning clinical testing of the Na-ASP-2 Hookworm Vaccine.

April 2003
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.

December 2004
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.

April 2005
Phase 1 clinical trial of the Na-ASP-2 Hookworm Vaccine initiated in the United States.

May 2005
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.

January 2006
cGMP manufacture of three new clinical lots of Na-ASP-2 Hookworm Vaccine in the United States is completed.

April 2006
Site selection study for Phase 1 clinical trial of Na-ASP-2 Hookworm Vaccine in Brazil is completed.

August 2006
Bill & Melinda Gates Foundation awards a 4-year, $13.8 million grant to support the development of an adult hookworm vaccine candidate. This includes two additional antigens, Na-APR-1 and Na-GST-1.

May 2007
The Americaninhas Vaccine Center in Minas Gerais, Brazil is opened.

June 2007
Phase 1 clinical trial of the Na-ASP-2 Hookworm Vaccine in a hookworm-endemic area of Brazil begins.

The Vaccine Development Program 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.

October 2007
First pilot-scale lot of Na-ASP-2 drug substance is manufactured with Brazilian partner, Instituto Butantan.

February 2008
cGMP manufacture of Na-GST-1 drug substance and skin test reagent at WRAIR.

March 2008
Skin testing for Na-ASP-2 hookworm antigen in U.S is initiated.

January 2009
Skin testing for Na-ASP-2 hookworm antigen in Brazil is initiated.