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

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.
 
ClinicalTrials.gov Identifier: NCT03373214
Recruitment Status : Completed
First Posted : December 14, 2017
Last Update Posted : February 5, 2020
Sponsor:
Collaborators:
Centre de Recherche Médicale de Lambaréné
George Washington University
Leiden University Medical Center
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Amsterdam Institute for Global Health and Development
Information provided by (Responsible Party):
Maria Elena Bottazzi PhD, Baylor College of Medicine

Tracking Information
First Submitted Date  ICMJE December 6, 2017
First Posted Date  ICMJE December 14, 2017
Last Update Posted Date February 5, 2020
Actual Study Start Date  ICMJE February 1, 2018
Actual Primary Completion Date February 28, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 8, 2017)
Vaccine-related Adverse Events [ Time Frame: Day 380 ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03373214 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2017)
Anti-Na-GST-1 IgG Antibody Level on Day 126 [ Time Frame: Day 126 ]
1. To determine the dose/formulation that results in the highest level of anti-Na-GST-1 IgG antibody approximately 14 days after the final vaccination.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 8, 2017)
  • Duration of antibody response to Na-GST-1 [ Time Frame: Day 14, 28, 42, 56, 180, 194, 208, 270, 380 ]
    1. To assess and compare the duration of the antibody responses to Na-GST-1 by dose and formulation.
  • IgG Subclass Distribution to Na-GST-1 [ Time Frame: Day 14, 28, 42, 56, 180, 194, 208, 270, 380 ]
    2. To assess the distribution of IgG subclass responses to Na-GST-1 by dose and formulation.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Na-GST-1/Alhydrogel With or Without CpG 10104 in Gabonese Adults
Official Title  ICMJE Randomized, Controlled, Phase 1 Study to Assess Safety and Immunogenicity of Na-GST-1/Alhydrogel®, With or Without a CPG ODN Adjuvant, in Gabonese Adults
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.
Detailed Description

Double blind, randomized, controlled, dose-escalation Phase 1 clinical trial in hookworm-exposed adults aged 18 to 50 years living in the area of Lambaréné, Gabon. Participants will receive three doses of the assigned vaccine(s) delivered intramuscularly (deltoid) on approximately Days 0, 56, and 112.

Safety will be measured from the time of each study vaccination (Day 0) through 14 days after each study vaccination by the occurrence of solicited injection site and systemic reactogenicity events.

Unsolicited non-serious adverse events (AEs) will be collected from the time of the first study vaccination through approximately 1 month after each study vaccination. New-onset chronic medical conditions and Serious Adverse Events (SAEs) will be collected from the time of the first study vaccination through approximately 9 months after the final study vaccination (final visit). Clinical laboratory evaluations for safety will be performed on venous blood collected approximately 14 days after each vaccination.

Immunogenicity testing will include IgG antibody responses to each vaccine antigen, by a qualified indirect enzyme-linked immunosorbent assay (ELISA), on serum or plasma obtained prior to each study vaccination and at time points after each vaccination; the functional activity of vaccine-induced antibodies will be assessed by in vitro enzyme neutralization assays.

Recruitment and enrollment into the study will occur on an ongoing basis, with each group being recruited and vaccinated in sequence.

24 subjects will be enrolled into 2 groups:

  • Group 1 (n=12):

    • 8 subjects will receive 30 µg Na-GST-1 plus 500 µg CPG 10104 delivered by IM injection in the deltoid muscle
    • 4 subjects will receive 100 µg Na-GST-1 delivered by IM injection in the deltoid muscle
  • Group 2 (n=12):

    • 8 subjects will receive 100 µg Na-GST-1 plus 500 µg CPG 10104 delivered by IM injection in the deltoid muscle
    • 4 subjects will receive 100 µg Na-GST-1 delivered by IM injection in the deltoid muscle
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Hookworm Infection
  • Hookworm Disease
Intervention  ICMJE
  • Biological: Na-GST-1
    Na-GST-1/Alhydrogel®
  • Biological: CPG 10104
    CPG 10104
Study Arms  ICMJE
  • Experimental: 30 µg Na-GST-1 + CPG 10104
    Interventions:
    • Biological: Na-GST-1
    • Biological: CPG 10104
  • Experimental: 100 µg Na-GST-1 + CPG 10104
    Interventions:
    • Biological: Na-GST-1
    • Biological: CPG 10104
  • Experimental: 100 µg Na-GST-1
    Intervention: Biological: Na-GST-1
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 8, 2017)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 30, 2019
Actual Primary Completion Date February 28, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  1. Pregnancy as determined by a positive urine human choriogonadotropin (hCG) test (if female).
  2. 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).
  3. Currently lactating and breast-feeding (if female).
  4. Inability to correctly answer all questions on the informed consent comprehension questionnaire.
  5. Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, diabetes, or renal disease by history, physical examination, and/or laboratory studies.
  6. 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).
  7. Known or suspected immunodeficiency.
  8. Laboratory evidence of liver disease (alanine aminotransferase [ALT] greater than 1.25-times the upper reference limit).
  9. 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).
  10. 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).
  11. 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.
  12. Participation in another investigational vaccine or drug trial within 30 days of starting this study or for the duration of the study.
  13. History of a severe allergic reaction or anaphylaxis.
  14. 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.
  15. Positive for HCV.
  16. Positive for HBsAg.
  17. Positive for HIV infection.
  18. Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 30 days of starting this study or planned use up to one month after the volunteer's final vaccination.
  19. Receipt of a live vaccine within past 4 weeks or a killed vaccine within past 2 weeks prior to entry into the study.
  20. History of a surgical splenectomy.
  21. Receipt of blood products within the 6 months prior to entry into the study.
  22. Previous receipt of the Na-GST-1/Alhydrogel® vaccine.
  23. Pre-existing autoimmune or antibody-mediated diseases including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, autoimmune thrombocytopenia; or laboratory evidence of possible autoimmune disease determined by a positive anti-dsDNA titer, positive rheumatoid factor, proteinuria (greater than trace protein on urine dipstick testing) and/or a positive ANA.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Gabon
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03373214
Other Study ID Numbers  ICMJE HV-03
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Maria Elena Bottazzi PhD, Baylor College of Medicine
Study Sponsor  ICMJE Baylor College of Medicine
Collaborators  ICMJE
  • Centre de Recherche Médicale de Lambaréné
  • George Washington University
  • Leiden University Medical Center
  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • Amsterdam Institute for Global Health and Development
Investigators  ICMJE
Principal Investigator: Ayola Adegnika, MD Centre de Recherches Medicales de Lambarené
PRS Account Baylor College of Medicine
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP