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Safety and Immunogenicity of Co-Administered Hookworm Vaccine Candidates Na-GST-1 and Na-APR-1 in Gabonese Adults

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ClinicalTrials.gov Identifier: NCT02126462
Recruitment Status : Completed
First Posted : April 30, 2014
Last Update Posted : May 31, 2017
Sponsor:
Information provided by (Responsible Party):
Maria Elena Bottazzi PhD, Baylor College of Medicine

Brief Summary:
Na-GST-1 and Na-APR-1 are proteins expressed during the adult stage of the Necator americanus hookworm life cycle that are thought to play a role in the parasite's degradation of host hemoglobin for use as an energy source. Vaccination with recombinant GST-1 or APR-1 has protected dogs and hamsters from infection in challenge studies. This study will evaluate the safety and immunogenicity of co-administering Na-GST-1 and Na-APR-1 to healthy Gabonese adults living in an area of endemic hookworm infection.

Condition or disease Intervention/treatment Phase
Hookworm Infection Hookworm Disease Biological: Na-APR-1 (M74)/Alhydrogel® Biological: Na-GST-1/Alhydrogel® Biological: Hepatitis B vaccine Phase 1

Detailed Description:

Double-blind, randomized, controlled dose-escalation Phase 1 clinical trial in hookworm exposed adults.

Study site: Centre de Recherches Médicales de Lambaréné Number of participants: 32 in 2 cohorts of 16

Doses of Na-GST-1 to be tested: 30 and 100 μg Doses of Na-APR-1 to be tested: 30 and 100 μg Dose of GLA-AF: 5 μg per antigen

Cohort 1: 30 μg of each of the two antigens (Na-GST-1/Alhydrogel® and Na-APR-1 (M74)/Alhydrogel®) or hepatitis B vaccine; Cohort 2: 100 μg of each of the two antigens (Na-GST- 1/Alhydrogel® and Na-APR-1 (M74) /Alhydrogel®) or hepatitis B vaccine.

Randomization: Cohort 1: 30 μg Na-GST-1 + 30 μg Na-APR-1 (M74) (n = 12) versus Hepatitis B Vaccine/placebo (n = 4) Cohort 2: 100 μg Na-GST-1 + 100 μg Na-APR-1 (M74) (n = 12) versus Hepatitis B Vaccine + placebo (n = 4)

The cohorts will be enrolled in a staggered fashion with safety data assessed prior to the Na-GST-1 and Na-APR-1 dose escalation from 30 to 100 µg.

Pre-treatment: Albendazole (400 mg) at least 2 weeks prior to first vaccination

Immunization schedule: Study days 0, 28 and 180 Route: Intramuscular in the deltoid muscle

Study duration: approximately 20 months; each participant will be followed for a total of 12 months.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Randomized, Controlled, Phase 1 Study to Assess Safety and Immunogenicity of Co-administered Hookworm Vaccine Candidates Na-GST-1 and Na-APR-1 Adjuvanted With Alhydrogel® and Gluco-pyranosylphospho-lipid A in Gabonese Adults
Study Start Date : November 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Algeldrate

Arm Intervention/treatment
Experimental: 30 µg Na-GST-1 + 30 µg Na-APR-1 (M74)
30 µg Na-GST-1/Alhydrogel plus 5 µg GLA-AF co-administered with 30 µg Na-APR-1 (M74)/Alhydrogel plus 5 µg GLA-AF
Biological: Na-APR-1 (M74)/Alhydrogel®
Biological: Na-GST-1/Alhydrogel®
Active Comparator: Hepatitis B vaccine
Hepatitis B vaccine co-administered with saline
Biological: Hepatitis B vaccine
Hepatitis B vaccine co-administered with saline

Experimental: 100 µg Na-GST-1 plus 100 µg Na-APR-1 (M74)
100 µg Na-GST-1/Alhydrogel plus 5 µg GLA-AF co-administered with 100 µg Na-APR-1 (M74)/Alhydrogel plus 5 µg GLA-AF
Biological: Na-APR-1 (M74)/Alhydrogel®
Biological: Na-GST-1/Alhydrogel®



Primary Outcome Measures :
  1. Vaccine-related Adverse Events [ Time Frame: Day 360 ]

    To estimate the frequency of vaccine-related adverse events, graded by severity, for each dose of co-administered Na-GST-1 and Na-APR-1 (M74).

    The frequency of immediate, systemic, and local injection site adverse events will be summarized. Adverse events will be assessed by study team members at 1 hour post-vaccination as well as 1, 3, 7, 14, and 28 days following each vaccination.



Secondary Outcome Measures :
  1. IgG response to Na-GST-1 and Na-APR-1 (M74) [ Time Frame: Day 194 ]
    To determine the doses of Na-GST-1 and Na-APR-1 (M74) that generate the highest IgG antibody responses at Day 194, as determined by indirect enzyme-linked immunosorbent assays (ELISA)

  2. Duration of antibody response to Na-GST-1 and Na-APR-1 (M74) [ Time Frame: Day 14, 28, 42, 56, 180, 194, 208, 270, 360 ]
    To assess and compare the duration of antibody responses to Na- GST-1 and Na-APR-1 (M74).

  3. Exploratory studies of memory B-cell responses [ Time Frame: Days 14, 28, 42, 56, 180, 194, 208, 270, 360 ]
    Exploratory studies of memory B-cell responses against the metabolomics changes before and after Na-GST-1 and NA-APR-1 (M74) vaccine antigens.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males or females between 18 and 50 years, inclusive, who are long-term residents of Gabon.
  • Good general health as determined by means of the screening procedure.
  • Assumed availability for the duration of the trial (12 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.

Exclusion Criteria:

  • Pregnancy as determined by a positive urine hCG (if female).
  • Participant unwilling to use reliable contraception up until one month following the third immunization (if female and not surgically sterile, abstinent or at least 2 years post-menopausal).
  • 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 <3500/mm3; absolute leukocyte count >11.0 x 103/mm3; hemoglobin <10.000 g/dl [females] or <12.0 g/dl [males]; or, platelet count <140,000/mm3).
  • 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 or for the duration of the 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 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
  • Positive ELISA for HBsAg.
  • Positive for HIV infection
  • Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 30 days of starting this study or expect to use for the duration of the 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 6 months prior to entry into the study.
  • Previous receipt of a primary series of any hepatitis B vaccine.

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): NCT02126462


Locations
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Gabon
Centre de Recherches Médicales de Lambaréné Albert Schweitzer Hospital
Lambaréné, Gabon, BP: 118
Sponsors and Collaborators
Baylor College of Medicine
Investigators
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Principal Investigator: Ayola Adegnika, MD Centre de Recherches Medicales de Lambarené

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Responsible Party: Maria Elena Bottazzi PhD, Sponsor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT02126462     History of Changes
Other Study ID Numbers: HV-001
602843-2 ( Other Grant/Funding Number: European Commission )
First Posted: April 30, 2014    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Maria Elena Bottazzi PhD, Baylor College of Medicine:
Human Hookworm
Necator americanus
Hookworm
Hookworm Disease
Iron-deficiency anemia
Soil-transmitted helminth infection
Neglected Tropical Disease
Na-APR-1
Na-GST-1
Additional relevant MeSH terms:
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Hookworm Infections
Ancylostomiasis
Strongylida Infections
Secernentea Infections
Nematode Infections
Helminthiasis
Parasitic Diseases
Aluminum Hydroxide
Vaccines
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents