The Na-GST-1 antigen, a candidate for the first human hookworm vaccine developed by the Sabin Vaccine Institute (Sabin), has entered a Phase 1 human trial in Brazil, according to Sabin. For the vaccine product development partnership (PDP) headquartered at Sabin, the clinical trial is a considerable achievement.

Worldwide, almost 600 million individuals are infected by human hookworm. Sabin’s aim is to create a safe, effective and inexpensive vaccine, in order to reduce the worldwide burden of this parasite.

The trial is being conducted by a team based at the Oswaldo Cruz Foundation (FIOCRUZ) of the Brazilian Ministry of Health, a member of the Sabin PDP in Brazil, where the prevalence of hookworm infection is high in endemic regions.

Peter Hotez, M.D., Ph.D., president of the Sabin Vaccine Institute and director of the Texas Children’s Hospital Center for Vaccine Development, and dean of the National School of Tropical Medicine at Baylor College of Medicine, explained:

“This vaccine trial is monumental, not just for us, but also for the children living in poverty who bear the burden of hookworm infection.

After more than 10 years of research and development work and with the help of Sabin’s PDP partners, especially our partners in Brazil, we are about to show that it’s possible to produce a vaccine candidate using a relatively low-cost model. We are filling a gap to produce a vaccine for underrepresented populations, where no traditional commercial market currently exists.”

Over a four month period, 102 trial participants aged 18 to 45 years, will receive three injections. Each participant will then be followed for a further 12 months. During the 12 month follow-up, the researchers will monitor the safety of the vaccine and examine the participants’ immune responses.

A trial will be conducted in children (the age group that will ultimately be targeted to receive the vaccine), once the safety of the vaccine is confirmed in the adult human trial.

David Diemert, M.D., FRCP(C), of George Washington University, lead researcher of the trial, said:

“This trial has the potential to revolutionize the control of hookworm-related diseases. Typically, hookworm infection is treated by annual mass drug administration in pill form to school aged children in endemic countries.

The pill can cure current infections in children, but in heavily endemic areas, rapid re-infection throughout the child’s life and into adulthood can occur. Rather than treating children over and over again, a vaccine, in combination with drug treatment, would help to effectively control and prevent hookworm infection.”

Rodrigo Corrêa-Oliveira, Director of the Centro de Pesquisas René Rachou, a Regional Unit of FIOCRUZ, explained:

“The involvement of developing world institutions like FIOCRUZ in the development and testing of a hookworm vaccine reflects Sabin’s commitment to ensuring that a successful vaccine will be made available in the world’s impoverished regions.”

The Hookworm is a parasitic nematode that lives in the small intestine. The two most common hookworms to infect humans are Ancylostoma duodenale and Necator americanus. Hookworm infections remain prevalent in sub-tropical and tropical climates of Latin America, Africa and Asia. The most significant risk of hookworm is anemia, intestinal blood loss, as well as iron and protein deficiency, which can result in impaired physical and cognitive development in children if left untreated.

Written by Grace Rattue