NCT01385189

Brief Summary

This study is designed to evaluate the safety, reactogenicity, and immunogenicity of Na-GST-1 adsorbed to Alhydrogel® with or without two different dose concentrations of a novel adjuvant, GLA-AF (1 µg or 5 μg) among healthy adult volunteers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2012

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 30, 2011

Completed
10 months until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

April 20, 2017

Completed
Last Updated

January 6, 2025

Status Verified

January 1, 2025

Enrollment Period

2.7 years

First QC Date

June 28, 2011

Results QC Date

January 13, 2017

Last Update Submit

January 2, 2025

Conditions

Hookworm InfectionHookworm Disease

Keywords

Human Hookworm Vaccine InitiativeHHVIHuman HookwormHookwormHookworm DiseaseN. americanusSoil-transmitted helminth infectionIntestinal blood lossIron deficiency anemia

Outcome Measures

Primary Outcomes (1)

  • Immediate Vaccine Related Adverse Events

    Frequency of vaccine-related AEs, graded by severity, for each dose and formulation of Na-GST-1

    2 hours post vaccination

Secondary Outcomes (1)

  • IgG Antibody Response to Na-GST-1

    126 days post dose 1

Study Arms (5)

Cohort 1

EXPERIMENTAL

10 μg Na-GST-1/Alhydrogel vs. 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)

Biological: 10 μg Na-GST-1/AlhydrogelBiological: 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)

Cohort 2

EXPERIMENTAL

30 μg Na-GST-1/Alhydrogel vs. 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)

Biological: 30 μg Na-GST-1/AlhydrogelBiological: 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)

Cohort 3

EXPERIMENTAL

30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)

Biological: 30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)

Cohort 4

EXPERIMENTAL

100 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)

Biological: 100 μg Na-GST-1/Alhydrogel

Cohort 5

EXPERIMENTAL

100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)

Biological: 100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)

Interventions

10 μg Na-GST-1/AlhydrogelBIOLOGICAL

3 doses 10 μg Na-GST-1/Alhydrogel administered at 56 day intervals

Cohort 1
30 μg Na-GST-1/AlhydrogelBIOLOGICAL

3 doses 30 μg Na-GST-1/Alhydrogel administered at 56 day intervals

Cohort 2
100 μg Na-GST-1/AlhydrogelBIOLOGICAL

3 doses 100 μg Na-GST-1/Alhydrogel administered at 56 day intervals

Cohort 4
10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)BIOLOGICAL

3 doses 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) administered at 56 day intervals

Cohort 1
30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)BIOLOGICAL

3 doses of 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) administered at 56 day intervals

Cohort 2
30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)BIOLOGICAL

3 doses 30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg) administered at 56 day intervals

Cohort 3
100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)BIOLOGICAL

3 doses 100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg) administered at 56 day intervals

Cohort 5

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Males or females between 18 and 45 years, inclusive.
  • Good general health as determined by means of the screening procedure.
  • Available for the duration of the trial (16 months).
  • Willingness to participate in the study as evidenced by signing the informed consent document.

You may not qualify if:

  • Pregnancy as determined by a positive urine β-hCG (if female).
  • Participant unwilling to use reliable contraception methods up until one month following the third immunization (if female).
  • Currently lactating and breast-feeding (if female).
  • Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, diabetes, or renal disease by history, physical examination, and/or laboratory studies.
  • 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 trace protein or blood on urine dipstick testing).
  • Laboratory evidence of hematologic disease (hemoglobin \<12.5 g/dl \[females\] or \<13.5 g/dl \[males\]; absolute leukocyte count \<3500/mm-cubed or \>10.5 x 103/mm-cubed; absolute neutrophil count \[ANC\] \<2000/ mm-cubed; absolute lymphocyte count \<1100/mm-cubed; or platelet count \<140,000/mm-cubed).
  • Laboratory evidence of a coagulopathy (PTT or PT INR greater than 1.1-times the upper reference limit).
  • Serum glucose (random) greater than 1.2-times the upper reference limit.
  • Other condition that in the opinion of the investigator would jeopardize the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol.
  • Participation in another investigational vaccine or drug trial within 30 days of starting this study.
  • Volunteer has had medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months.
  • History of a severe allergic reaction or anaphylaxis.
  • Severe asthma as defined by the need for regular use of inhalers or emergency clinic visit or hospitalization within the last 6 months.
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Related Publications (1)

  • Diemert DJ, Freire J, Valente V, Fraga CG, Talles F, Grahek S, Campbell D, Jariwala A, Periago MV, Enk M, Gazzinelli MF, Bottazzi ME, Hamilton R, Brelsford J, Yakovleva A, Li G, Peng J, Correa-Oliveira R, Hotez P, Bethony J. Safety and immunogenicity of the Na-GST-1 hookworm vaccine in Brazilian and American adults. PLoS Negl Trop Dis. 2017 May 2;11(5):e0005574. doi: 10.1371/journal.pntd.0005574. eCollection 2017 May.

    PMID: 28464026DERIVED

MeSH Terms

Conditions

Hookworm InfectionsAncylostomiasisAnemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Strongylida InfectionsSecernentea InfectionsNematode InfectionsHelminthiasisParasitic DiseasesInfectionsAnemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Results Point of Contact

Title
Dr. David J. Diemert, Associate Professor
Organization
George Washington University
ddiemert@gwu.edu
202.994.2909

Study Officials

  • David Diemert, MD

    Albert B. Sabin Vaccine Institute

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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
Sponsor

Study Record Dates

First Submitted

June 28, 2011

First Posted

June 30, 2011

Study Start

May 1, 2012

Primary Completion

January 1, 2015

Study Completion

June 1, 2015

Last Updated

January 6, 2025

Results First Posted

April 20, 2017

Record last verified: 2025-01

Locations

US(1)