Phase 2 Study to Assess the Safety, Efficacy and Immunogenicity of Na-GST-1/Alhydrogel Co-administered With Different Toll-Like Receptor Agonists in Hookworm- Naïve Adults

This study evaluates the efficacy, safety and immunogenicity of different formulations of the Na-GST-1 hookworm vaccine using a controlled human hookworm infection model in healthy, hookworm-naive adults.

Start Date01 Mar 2018

Sponsor / Collaborator

Baylor College of Medicine

[+2]

NCT03373214 / CompletedPhase 1IIT

Randomized, Controlled, Phase 1 Study to Assess Safety and Immunogenicity of Na-GST-1/Alhydrogel®, With or Without a CPG ODN Adjuvant, in Gabonese Adults

Na-GST-1 is a protein expressed during the adult stage of the Necator americanus hookworm life cycle that is thought to play a role in the parasite's degradation of host hemoglobin for use as an energy source. Vaccination with recombinant Na-GST-1 has protected dogs and hamsters from infection in challenge studies. This study will evaluate the safety and immunogenicity of administering Na-GST-1 with or without the CpG 10104 immunostimulant to healthy Gabonese adults living in an area of endemic hookworm infection.

Start Date01 Feb 2018

Sponsor / Collaborator

Baylor College of Medicine

[+1]

100 Clinical Results associated with Na-GST-1 vaccine(Baylor College of Medicine)

100 Translational Medicine associated with Na-GST-1 vaccine(Baylor College of Medicine)

100 Patents (Medical) associated with Na-GST-1 vaccine(Baylor College of Medicine)

Literatures (Medical) associated with Na-GST-1 vaccine(Baylor College of Medicine)

PLOS Neglected Tropical DiseasesQ2 · MEDICINE

Safety and immunogenicity of the Na-GST-1 hookworm vaccine in Brazilian and American adults

Q2 · MEDICINE

ArticleOA

Author: Hotez, Peter ; Li, Guangzhao ; Campbell, Doreen ; Enk, Martin ; Bethony, Jeffrey ; Brelsford, Jill ; Fraga, Carlo Geraldo ; Gazzinelli, Maria Flávia ; Correa-Oliveira, Rodrigo ; Bottazzi, Maria Elena ; Hamilton, Robert ; Yakovleva, Anna ; Periago, Maria Victoria ; Diemert, David J ; Jariwala, Amar ; Peng, Jin ; Freire, Janaína ; Grahek, Shannon ; Valente, Vanderson ; Talles, Frederico

Necator americanus Glutathione-S-Transferase-1 (Na-GST-1) plays a role in the digestion of host hemoglobin by adult N. americanus hookworms. Vaccination of laboratory animals with recombinant Na-GST-1 is associated with significant protection from challenge infection. Recombinant Na-GST-1 was expressed in Pichia pastoris and adsorbed to aluminum hydroxide adjuvant (Alhydrogel) according to current Good Manufacturing Practice. Two Phase 1 trials were conducted in 142 healthy adult volunteers in the United States and Brazil, first in hookworm-naïve individuals and then in residents of a N. americanus endemic area in Brazil. Volunteers received one of three doses of recombinant Na-GST-1 (10, 30, or 100 μg) adjuvanted with Alhydrogel, adjuvanted with Alhydrogel and co-administered with an aqueous formulation of Glucopyranosyl Lipid A (GLA-AF), or the hepatitis B vaccine. Vaccinations were administered via intramuscular injection on days 0, 56, and 112. Na-GST-1/Alhydrogel was well tolerated in both hookworm-naïve and hookworm-exposed adults, with the most common adverse events being mild to moderate injection site pain and tenderness, and mild headache and nausea; no vaccine-related severe or serious adverse events were observed. Antigen-specific IgG antibodies were induced in a dose-dependent fashion, with increasing levels observed after each vaccination in both trials. The addition of GLA-AF to Na-GST-1/Alhydrogel did not result in significant increases in specific IgG responses. In both the US and Brazil studies, the predominant IgG subclass induced against Na-GST-1 was IgG1, with lesser amounts of IgG3. Vaccination of both hookworm-naïve and hookworm-exposed adults with recombinant Na-GST-1 was safe, well tolerated, and resulted in significant antigen-specific IgG responses. Based on these results, this vaccine will be advanced into clinical trials in children and eventual efficacy studies.TRIAL REGISTRATIONClinicalTrials.gov (NCT01261130 for the Brazil trial and NCT01385189 for the US trial).

100 Deals associated with Na-GST-1 vaccine(Baylor College of Medicine)

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Indication	Highest Phase	Country/Location	Organization	Date
Hookworm Infections	Phase 2	US	-	01 Mar 2018

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