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Safety and Immunogenicity of a Human Hookworm Candidate Vaccine With Different Doses of a Novel Adjuvant

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01385189
First Posted: June 30, 2011
Last Update Posted: June 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Children's Research Institute
George Washington University
Information provided by (Responsible Party):
Maria Elena Bottazzi PhD, Baylor College of Medicine
  Purpose
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.

Condition Intervention Phase
Hookworm Infection Hookworm Disease Biological: 10 μg Na-GST-1/Alhydrogel Biological: 30 μg Na-GST-1/Alhydrogel Biological: 100 μg Na-GST-1/Alhydrogel Biological: 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) Biological: 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) Biological: 30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg) Biological: 100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg) Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Maria Elena Bottazzi PhD, Baylor College of Medicine:

Primary Outcome Measures:
  • Immediate Vaccine Related Adverse Events [ Time Frame: 2 hours post vaccination ]
    Frequency of vaccine-related AEs, graded by severity, for each dose and formulation of Na-GST-1


Secondary Outcome Measures:
  • IgG Antibody Response to Na-GST-1 [ Time Frame: 126 days post dose 1 ]
    Dose and formulation of Na-GST-1 that generates the highest IgG antibody response at Day 126, as determined by an indirect enzyme-linked immunosorbent assay (ELISA)


Enrollment: 40
Study Start Date: May 2012
Study Completion Date: June 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
10 μg Na-GST-1/Alhydrogel vs. 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)
Biological: 10 μg Na-GST-1/Alhydrogel
3 doses 10 μg Na-GST-1/Alhydrogel administered at 56 day intervals
Biological: 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)
3 doses 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) administered at 56 day intervals
Experimental: Cohort 2
30 μg Na-GST-1/Alhydrogel vs. 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)
Biological: 30 μg Na-GST-1/Alhydrogel
3 doses 30 μg Na-GST-1/Alhydrogel administered at 56 day intervals
Biological: 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)
3 doses of 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) administered at 56 day intervals
Experimental: Cohort 3
30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)
Biological: 30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)
3 doses 30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg) administered at 56 day intervals
Experimental: Cohort 4
100 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)
Biological: 100 μg Na-GST-1/Alhydrogel
3 doses 100 μg Na-GST-1/Alhydrogel administered at 56 day intervals
Experimental: Cohort 5
100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)
Biological: 100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)
3 doses 100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg) administered at 56 day intervals

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Positive ELISA for HBsAg.
  • Positive ELISA and confirmatory Western blot tests for HIV-1.
  • Positive ELISA and confirmatory immunoblot tests for HCV.
  • Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 30 days of starting this study.
  • Receipt of a live vaccine within past 4 weeks or a killed vaccine within past 2 weeks prior to entry into the study.
  • History of a surgical splenectomy.
  • Receipt of blood products within the past 6 months.
  • History of allergy to yeast.
  • History of previous infection with hookworm or residence for more than 6 months in a hookworm-endemic area.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01385189


Locations
United States, District of Columbia
Children's National Medical Center
Washington, D.C., District of Columbia, United States, 20010
Sponsors and Collaborators
Baylor College of Medicine
Children's Research Institute
George Washington University
Investigators
Study Director: David Diemert, MD Albert B. Sabin Vaccine Institute
  More Information

Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site

Responsible Party: Maria Elena Bottazzi PhD, Sponsor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01385189     History of Changes
Other Study ID Numbers: SVI-11-01
First Submitted: June 28, 2011
First Posted: June 30, 2011
Results First Submitted: January 13, 2017
Results First Posted: April 20, 2017
Last Update Posted: June 22, 2017
Last Verified: March 2017

Keywords provided by Maria Elena Bottazzi PhD, Baylor College of Medicine:
Human Hookworm Vaccine Initiative
HHVI
Human Hookworm
Hookworm
Hookworm Disease
N. americanus
Soil-transmitted helminth infection
Intestinal blood loss
Iron deficiency anemia

Additional relevant MeSH terms:
Hookworm Infections
Ancylostomiasis
Strongylida Infections
Secernentea Infections
Nematode Infections
Helminthiasis
Parasitic Diseases
Aluminum Hydroxide
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents


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