NCT01261130

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2011

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

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

December 14, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 16, 2010

Completed
11 months until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

May 31, 2017

Status Verified

May 1, 2017

Enrollment Period

2.8 years

First QC Date

December 14, 2010

Last Update Submit

May 30, 2017

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 (3)

  • IgG antibody response to Na-GST-1

    126 days post dose 1

  • Duration of antibody response to Na-GST-1

    290 days post dose 1

  • Exploratory cellular immune response to Na-GST-1

    Up to 290 days post dose 1

Study Arms (13)

Part I-A: 10μgNaGST1/Alhydrogel

EXPERIMENTAL

Part I (non-endemic area), Formulation A

Biological: 10 μg Na-GST-1/Alhydrogel

Part I-B: 30μgNaGST1/Alhydrogel

EXPERIMENTAL

Part I (non-endemic area), Formulation B

Biological: 30 μg Na-GST-1/Alhydrogel

Part I-C: 100μgNaGST1/Alhydrogel

EXPERIMENTAL

Part I (non-endemic area), Formulation C

Biological: 100 μg Na-GST-1/Alhydrogel

Part I-D: 10μgNaGST1/Alhydrogel/GLA

EXPERIMENTAL

Part I (non-endemic area), Formulation D

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

Part I-E: 30μgNaGST1/Alhydrogel/GLA

EXPERIMENTAL

Part I (non-endemic area), Formulation E

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

Part I-F: 100μgNaGST1/Alhydrogel/GLA

EXPERIMENTAL

Part I (non-endemic area), Formulation F

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

Part II-A: 10μgNaGST1/Alhydrogel

EXPERIMENTAL

Part II (endemic area), Formulation A

Biological: 10 μg Na-GST-1/Alhydrogel

Part II-B: 30μgNaGST1/Alhydrogel

EXPERIMENTAL

Part II (endemic area), Formulation B

Biological: 30 μg Na-GST-1/Alhydrogel

Part II-C: 100μgNaGST1/Alhydrogel

EXPERIMENTAL

Part II (endemic), Formulation C

Biological: 100 μg Na-GST-1/Alhydrogel

Part II-D: 10μgNaGST1/Alhydrogel/GLA

EXPERIMENTAL

Part II (endemic area), Formulation D

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

Part II-E: 30μgNaGST1/Alhydrogel/GLA

EXPERIMENTAL

Part II (endemic area), Formulation E

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

Part II-F: 100μgNaGST1/Alhydrogel/GLA

EXPERIMENTAL

Part II (endemic area), Formulation F

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

Part II-G: Butang® hepatitis B vaccine

ACTIVE COMPARATOR

Part II (endemic), HepB comparator

Biological: Butang® hepatitis B vaccine

Interventions

10 μg Na-GST-1/AlhydrogelBIOLOGICAL

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

Also known as: Formulation A
Part I-A: 10μgNaGST1/AlhydrogelPart II-A: 10μgNaGST1/Alhydrogel
30 μg Na-GST-1/AlhydrogelBIOLOGICAL

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

Also known as: Formulation B
Part I-B: 30μgNaGST1/AlhydrogelPart II-B: 30μgNaGST1/Alhydrogel
100 μg Na-GST-1/AlhydrogelBIOLOGICAL

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

Also known as: Formulation C
Part I-C: 100μgNaGST1/AlhydrogelPart II-C: 100μgNaGST1/Alhydrogel
10 μg Na-GST-1/ Alhydrogel/GLA-AFBIOLOGICAL

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

Also known as: Formulation D
Part I-D: 10μgNaGST1/Alhydrogel/GLAPart II-D: 10μgNaGST1/Alhydrogel/GLA
30 μg Na-GST-1/Alhydrogel/GLA-AFBIOLOGICAL

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

Also known as: Formulation E
Part I-E: 30μgNaGST1/Alhydrogel/GLAPart II-E: 30μgNaGST1/Alhydrogel/GLA
100 μg Na-GST-1/Alhydrogel/GLA-AFBIOLOGICAL

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

Also known as: Formulation F
Part I-F: 100μgNaGST1/Alhydrogel/GLAPart II-F: 100μgNaGST1/Alhydrogel/GLA
Butang® hepatitis B vaccineBIOLOGICAL

3 doses Butang® hepatitis B vaccine administered at 56 day intervals

Part II-G: Butang® hepatitis B vaccine

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 (42 weeks).
  • Willingness to participate in the study as evidenced by signing the informed consent document.
  • If found to be infected with hookworm during screening, has completed a course of three doses of albendazole.

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).
  • 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.
  • 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 (absolute leukocyte count \<3000/mm3 or \>12.5 x 103/mm3; hemoglobin \<10.3 g/dl or \<11.0 g/dl \[females in Americaninhas and Belo Horizonte, respectively\] or \<11.0 g/dl or \<12.0 \[males in Americaninhas and Belo Horizonte, respectively); absolute lymphocyte count \<900/mm3; or platelet count \<120,000/mm3).
  • Laboratory evidence of a coagulopathy (PTT or PT INR greater than 1.1-times the upper reference limit \[in Belo Horizonte\] or PT INR greater than 1.3 \[Americaninhas\]).
  • 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.
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Americaninhas Vaccine Center

Americaninha, Minas Gerais, Brazil

Location

Centro de Pesquisas René Rachou - FIOCRUZ

Belo Horizonte, Minas Gerais, Brazil

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

Interventions

D-WormGranuflex E

Condition Hierarchy (Ancestors)

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

Study Officials

  • David Diemert, MD

    Albert B. Sabin Vaccine Institute

    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
Sponsor

Study Record Dates

First Submitted

December 14, 2010

First Posted

December 16, 2010

Study Start

November 1, 2011

Primary Completion

August 1, 2014

Study Completion

December 1, 2014

Last Updated

May 31, 2017

Record last verified: 2017-05

Locations

BR(2)