Na-GST-1/Alhydrogel With or Without CpG 10104 in Gabonese Adults

NCT03373214 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: HV-03
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hookworm Infection; Hookworm Disease

Keywords

Human Hookworm; Necator americanus; Hookworm; Hookworm Disease; Iron-deficiency anemia; Soil-transmitted helminth infection; Neglected Tropical Disease; Na-GST-1; CpG

Outcome Measures

Primary Outcomes (1)

• Vaccine-related Adverse Events

  1\. To evaluate the safety and reactogenicity of two different dose concentrations of Na-GST-1/Alhydrogel® administered with or without CPG 10104 in healthy Gabonese adults.

  Day 380

Secondary Outcomes (1)

• Anti-Na-GST-1 IgG Antibody Level on Day 126

  Day 126

Other Outcomes (2)

• Duration of antibody response to Na-GST-1

  Day 14, 28, 42, 56, 180, 194, 208, 270, 380

• IgG Subclass Distribution to Na-GST-1

  Day 14, 28, 42, 56, 180, 194, 208, 270, 380

Study Arms (3)

30 µg Na-GST-1 + CPG 10104

EXPERIMENTAL

Biological: Na-GST-1; Biological: CPG 10104

100 µg Na-GST-1 + CPG 10104

EXPERIMENTAL

Biological: Na-GST-1; Biological: CPG 10104

100 µg Na-GST-1

EXPERIMENTAL

Biological: Na-GST-1

Interventions

Na-GST-1 BIOLOGICAL

Na-GST-1/Alhydrogel®

100 µg Na-GST-1; 100 µg Na-GST-1 + CPG 10104; 30 µg Na-GST-1 + CPG 10104

CPG 10104 BIOLOGICAL

CPG 10104

100 µg Na-GST-1 + CPG 10104; 30 µg Na-GST-1 + CPG 10104

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males or females between 18 and 50 years, inclusive, who are long-term residents of the study area.
• Good general health as determined by means of the screening procedure.
• Assumed availability for the duration of the trial (13 months).
• Willingness to participate in the study as evidenced by signing the informed consent document.
• Negative for hookworm during screening, or if found to be infected with hookworm, has completed a course of three doses of albendazole.

You may not qualify if:

• Pregnancy as determined by a positive urine human choriogonadotropin (hCG) test (if female).
• Participant unwilling to use reliable contraception up until one month following the final immunization (if female and not surgically sterile, abstinent, at least 2 years post-menopausal, or determined otherwise by medical evaluation to be sterile).
• Currently lactating and breast-feeding (if female).
• Inability to correctly answer all questions on the informed consent comprehension questionnaire.
• Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, diabetes, or renal disease by history, physical examination, and/or laboratory studies.
• Has a diagnosis of schizophrenia, bipolar disease or other major psychiatric condition that would make compliance with study visits/procedures difficult (e.g., subject with psychoses or history of suicide attempt or gesture in the 3 years before study entry, ongoing risk for suicide).
• Known or suspected immunodeficiency.
• Laboratory evidence of liver disease (alanine aminotransferase \[ALT\] greater than 1.25-times the upper reference limit).
• Laboratory evidence of renal disease (serum creatinine greater than 1.25-times the upper reference limit, or more than 1+ protein, or glucose on urine dipstick testing).
• Laboratory evidence of hematologic disease (absolute leukocyte count \<3500/mm3; absolute leukocyte count \>11.0 x 103/mm3; hemoglobin \<10.0 g/dl \[females\] or \<12.0 g/dl \[males\]; or, platelet count \<140,000/mm3).
• Other condition that in the opinion of the investigator could jeopardize the safety or rights of a volunteer participating in the trial or would render them unable to comply with the protocol.
• Participation in another investigational vaccine or drug trial within 30 days of starting this study or for the duration of the study.
• History of a severe allergic reaction or anaphylaxis.
• Severe asthma as defined by the need for daily use of inhalers or emergency room/clinic visit or hospitalization within 6 months of the volunteer's planned first vaccination in the study.
• Positive for HCV.

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Centre de Recherche Médicale de Lambaréné: collaborator
• George Washington University: collaborator
• Leiden University Medical Center: collaborator
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator
• Amsterdam Institute for Global Health and Development: collaborator

Study Sites (1)

Centre de Récherches Médicales de Lambaréné

Lambaréné, Gabon

Location

MeSH Terms

Conditions

Hookworm Infections; Ancylostomiasis; Anemia, Iron-Deficiency; Neglected Diseases

Condition Hierarchy (Ancestors)

Strongylida Infections; Secernentea Infections; Nematode Infections; Helminthiasis; Parasitic Diseases; Infections; Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ayola Adegnika, MD

  Centre de Recherches Medicales de Lambarené

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 6, 2017
• First Posted: December 14, 2017
• Study Start: February 1, 2018
• Primary Completion: February 28, 2019
• Study Completion: March 30, 2019
• Last Updated: January 13, 2021

Record last verified: 2021-01

Locations

GA (1)