Today marks the first day of vaccinations for Phase I, Part II clinical testing of Sabin's human hookworm vaccine in Brazil. The study advances testing of the Na-GST-1 vaccine candidate, currently undergoing Phase I clinical testing in both the United States and Brazil.
An independent Safety Monitoring Committee (SMC) recently reviewed results from Part I of the study and determined that no safety issues had been observed after vaccinating healthy adults who had never been exposed to hookworm. They concluded that these promising results were sufficient to allow researchers to proceed to the next stage of the trial, in which hookworm-exposed adults will receive the vaccine candidate.
Part II of the study is taking place in Americaninhas, a hookworm-endemic region of Brazil. The trial will enroll 66 healthy, hookworm-exposed adults between the ages of 18 and 45. Each volunteer will receive three injections over four months. Researchers will then follow each volunteer for 12 additional months, monitoring the vaccine’s safety and analyzing the recipients’ immune responses.
Sabin PDP researchers are enthusiastic about this important milestone in the development of the first ever human hookworm vaccine.
“Moving forward with this trial helps advance the Sabin PDP’s larger goal to develop safe, efficacious and low-cost vaccines for diseases of poverty,” said Dr. Peter Hotez, president of the Sabin Vaccine Institute. “A human hookworm vaccine will help more than 600 million people worldwide who currently suffer from the infection.”