Recombinant Na-ASP-2 has been expressed in yeast colonies, Pichia pastoris, and artificially modified to increase expression and yield. Antibodies collected from serum samples vaccinated laboratory animals recognize the larval antigen and inhibit larval migration. Furthermore, radiographic crystallographic analysis shows that the recombinant protein produces the same pathogenesis-related-1 domain as the natural ASP-2 antigen. Therefore, the data suggests that recombinant -Na-ASP-2 has structural conformations similar to those of native ASP-2. 

Tulane University

Pre-clinical testing and manufacture of Na-ASP-2 from N. americanus were finalized in 2004. Clinical testing was expected to take place in 2005 following approval from the FDA. This vaccine will be developed in the nonprofit sector and distribution will be targeted to populations of susceptible individuals in moderately and/or heavily impacted regions. 

Vaccine Development Process

Stanley Plotkin, David J. Diemert, Jeffrey M. Bethony, Peter J. Hotez, Hookworm Vaccines, Clinical Infectious Diseases, Volume 46, Issue 2, 15 January 2008, Pages 282–288, https://doi.org/10.1086/524070

Hookworm Vaccines

Development of Na-ASP-2

A phase 1 study, conducted in the United States, of adults that had not been exposed to hookworm was performed from 2005-2006. 
Sample: 
- 36 healthy adults

Methods:
- randomized, double-blind, placebo-controlled study 
- 3 different concentrations of Na-ASP-2 were used
- patients were observed after 6 months of administering the vaccine

Safety Profile:
The vaccine was efficacious and safe. Adverse events included injection site reactions, swelling, erythema and pruritus. 


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