Clinical Trials

The following clinical trials are currently being conducted and evaluated:

1) Safety and Immunogenicity of the Human Hookworm Candidate Vaccine Na-GST-1 With or Without CPG
Phase 1 Study of the Safety and Immunogenicity of Na-GST-1/Alhydrogel, with or without a CpG ODN Adjuvant, in Healthy Adults living in the Washington DC area who have not been infected with or exposed to hookworms.

ClinicalTrials.gov Identifier:  NCT02143518
Study Site: George Washington Medical Faculty Associates; Washington, D.C.

 

2) Experimental Infection of Hookworm-naïve Adults With Dermally-applied Infectious Necator Americanus Hookworm Larvae
Experimental infection of hookworm-naïve adults with dermally applied infectious Necator americanus hookworm larvae.

An experimental hookworm infection model is being developed to provide early proof-of-concept that a hookworm vaccine targeting the blood-feeding pathway of adult hookworms is feasible and efficacious. The proposed model consists of vaccinating healthy, hookworm-naïve adults with a candidate hookworm vaccine, followed by challenging them with the investigational product, Necator americanus Larval Inoculum to assess the effect of vaccination on infection. The first proposed study will be a feasibility study that will consist of administering different doses of the Necator americanus Larval Inoculum to healthy adult volunteers to determine the optimal dose (i.e., number of infectious larvae) that is safe, well-tolerated and results in consistent infection.

ClinicalTrials.gov Identifier: NCT01940757
Study Site: George Washington Medical Faculty Associates, Washington, D.C.

 

3) Safety and Immunogenicity of Na-APR-1 Vaccine Co-administered With Na-GST-1 Vaccine in Brazilian Adults
Phase 1 Study of the Safety and Immunogenicity of Na-APR-1 (M74)/Alhydrogel® Co-administered With Na-GST-1/Alhydrogel® in Brazilian Adults

ClinicalTrials.gov Identifier: NCT02476773
Study Site: Americaninhas Vaccine Center, Americaninhas, Minas Gerais, Brazil

 

The following Phase 1 clinical trials have been completed:

 

1) Safety and Immunogenicity of the Human Hookworm Candidate Vaccine Na-GST-1 With or Without Additional Adjuvant in Brazilian Adults
Phase 1 Study of the Safety and Immunogenicity of Na-GST-1/Alhydrogel® with or without GLA-AF in Brazilian Adults. This two-part study evaluates the safety and immunogenicity of two formulations of Na-GST-1, first in hookworm-naïve individuals using an open-label design, and then in adults living in an area of endemic hookworm infection using a randomized, double-blind design. The two formulations to be evaluated are Na-GST-1 adsorbed to an adjuvant, Alhydrogel®, and Na-GST-1 adsorbed to Alhydrogel® and administered with GLA-AF.

ClinicalTrials.gov Identifier: NCT01261130
Study Site: Belo Horizonte, Brazil (urban area, non-endemic)
Americaninhas, Minas Gerais, Brazil (rural area, endemic)

Please see the following article on SciDevNet.

 

2) Safety and Immunogenicity of the Human Hookworm Candidate Vaccine Na-GST-1 With Different Doses of a Novel Adjuvant
Phase I Study of the Safety and Immunogenicity of Na-GST-1/Alhydrogel® With Different Doses of the Novel Immunostimulant GLA-AF in Healthy Adults living in the Washington DC area who have not been infected with or exposed to hookworms.

ClinicalTrials.gov Identifier: NCT01385189
Study Site: Children’s National Health System; Washington, D.C.

 

3) Safety and Immunogenicity of the Na-APR-1 Hookworm Vaccine in Healthy Adults
Phase 1 Study of the Safety and Immunogenicity of Na-APR-1 (M74)/Alhydrogel® when co-administered with different concentrations of the immunostimulant GLA-AF in Healthy Adults living in the Washington DC area who have not been infected with or exposed to hookworms.

ClinicalTrials.gov Identifier: NCT01717950
Study Site:  George Washington Medical Faculty Associates; Washington, D.C.

 

4) Safety and Immunogenicity of Co-Administered Hookworm Vaccine Candidates Na-GST-1 and Na-APR-1 in Gabonese Adults
This study will evaluate the safety and immunogenicity of co-administering Na-GST-1 and Na-APR-1 to healthy Gabonese adults living in an area of endemic hookworm infection.

ClinicalTrials.gov Identifier: NCT02126462
Study Site: Centre de Recherches Médicales de Lambaréné, Gabon