Phase 1 Study of the Safety and Immunogenicity of Na-GST-1/Alhydrogel® With or Without GLA-AF in Brazilian Adults

NCT01261130 Phase 1 COMPLETED

This two part study will evaluate 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.

Details

Lead sponsor	Baylor College of Medicine
Phase	Phase 1
Status	COMPLETED
Enrolment	102
Start date	2011-11
Completion	2014-12

Conditions

• Hookworm Infection
• Hookworm Disease

Interventions

• 10 μg Na-GST-1/Alhydrogel
• 30 μg Na-GST-1/Alhydrogel
• 100 μg Na-GST-1/Alhydrogel
• 10 μg Na-GST-1/ Alhydrogel/GLA-AF
• 30 μg Na-GST-1/Alhydrogel/GLA-AF
• 100 μg Na-GST-1/Alhydrogel/GLA-AF
• Butang® hepatitis B vaccine

Primary outcomes

• Immediate vaccine related adverse events — 2 hours post vaccination
  Frequency of vaccine-related AEs, graded by severity, for each dose and formulation of Na-GST-1

Countries

Brazil