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Study of Co-administered Na-APR-1 (M74) and Na-GST-1 in Gabonese Children

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ClinicalTrials.gov Identifier: NCT02839161
Recruitment Status : Recruiting
First Posted : July 20, 2016
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Maria Elena Bottazzi PhD, Baylor College of Medicine

Brief Summary:
Double blind, randomized, controlled, dose-escalation Phase 1 clinical trial in hookworm-exposed children aged 6 to 10 years living in the area of Lambaréné, Gabon. Children will receive three doses of the Na-GST-1/Alhydrogel hookworm vaccine co-administered with the Na-APR-1 (M74)/Alhydrogel hookworm vaccine or the hepatitis B vaccine co-administered with sterile saline. All injections will be delivered intramuscularly (deltoid) on approximately Days 0, 56, and 112 or 180.

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

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized, Controlled, Phase 1 Study to Assess Safety and Immunogenicity of Co-administered Hookworm Vaccine Candidates Na-APR-1 (M74)/Alhydrogel® and Na-GST-1/ Alhydrogel® in Gabonese Children
Actual Study Start Date : January 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Algeldrate

Arm Intervention/treatment
Experimental: Low-dose (0,2,4 months)
10 µg Na-APR-1 (M74) plus 5 µg GLA-AF delivered by IM injection in the deltoid muscle, with 10 µg Na-GST-1 administered IM in the alternate arm. Injections at 0, 2, and 4 months.
Biological: Na-GST-1/Alhydrogel
Biological: Na-APR-1 (M74)/Alhydrogel
Experimental: Low-dose (0,2,6 months)
10 µg Na-APR-1 (M74) plus 5 µg GLA-AF delivered by IM injection in the deltoid muscle, with 10 µg Na-GST-1 administered IM in the alternate arm. Injections at 0, 2, and 6 months.
Biological: Na-GST-1/Alhydrogel
Biological: Na-APR-1 (M74)/Alhydrogel
Experimental: Medium-dose (0,2,4 months)
30 µg Na-APR-1 (M74) plus 5 µg GLA-AF delivered by IM injection in the deltoid muscle, with 30 µg Na-GST-1 administered IM in the alternate arm. Injections at 0, 2, and 4 months.
Biological: Na-GST-1/Alhydrogel
Biological: Na-APR-1 (M74)/Alhydrogel
Experimental: Medium-dose (0,2,6 months)
30 µg Na-APR-1 (M74) plus 5 µg GLA-AF delivered by IM injection in the deltoid muscle, with 30 µg Na-GST-1 administered IM in the alternate arm. Injections at 0, 2, and 6 months.
Biological: Na-GST-1/Alhydrogel
Biological: Na-APR-1 (M74)/Alhydrogel
Experimental: High-dose (0,2,4 months)
100 µg Na-APR-1 (M74) plus 5 µg GLA-AF delivered by IM injection in the deltoid muscle, with 100 µg Na-GST-1 administered IM in the alternate arm. Injections at 0, 2, and 4 months.
Biological: Na-GST-1/Alhydrogel
Biological: Na-APR-1 (M74)/Alhydrogel
Experimental: High-dose (0,2,6 months)
100 µg Na-APR-1 (M74) plus 5 µg GLA-AF delivered by IM injection in the deltoid muscle, with 100 µg Na-GST-1 administered IM in the alternate arm. Injections at 0, 2, and 6 months.
Biological: Na-GST-1/Alhydrogel
Biological: Na-APR-1 (M74)/Alhydrogel
Active Comparator: Comparator (0,2,4 months)
Hepatitis B vaccine delivered by IM injection in the deltoid muscle, with sterile saline solution administered IM in the alternate arm. Injections at 0, 2, and 4 months.
Biological: Hepatitis B Vaccine
Active Comparator: Comparator (0,2,6 months)
Hepatitis B vaccine delivered by IM injection in the deltoid muscle, with sterile saline solution administered IM in the alternate arm. Injections at 0, 2, and 6 months.
Biological: Hepatitis B Vaccine



Primary Outcome Measures :
  1. Vaccine-related Adverse Events [ Time Frame: Day 380 ]
    To evaluate the safety and reactogenicity of three different dose concentrations of Na-APR-1 (M74)/Alhydrogel® co-administered with Na-GST-1/Alhydrogel® in healthy Gabonese children.


Secondary Outcome Measures :
  1. IgG response to Na-GST-1 and Na-APR-1 (M74) [ Time Frame: 14 days after the third vaccination ]
    To determine the doses of co-administered Na-APR-1 (M74) and Na-GST-1 that result in the highest levels of IgG antibody approximately 14 days after the third vaccination.


Other Outcome Measures:
  1. Duration of antibody response to Na-GST-1 and Na-APR-1 (M74) [ Time Frame: Day 380 ]
    To assess and compare the duration of the antibody responses of Na-GST-1 and Na-APR-1 (M74).

  2. IgG subclass response to Na-GST-1 and Na-APR-1 (M74) [ Time Frame: Day 380 ]
    To assess the distribution of IgG subclass responses to Na-GST-1 and Na-APR-1 (M74).



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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:

  1. Males or females between 6 and 10 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 (up to 15 months).
  4. Willingness of parent or legal guardian for child to participate in the study as evidenced by signing the informed consent document in combination with the child assent form.
  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. Inability of parent/legal guardian to correctly answer all questions on the informed consent comprehension questionnaire.
  2. Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, diabetes, or renal disease by history, physical examination, and/or laboratory studies.
  3. Known or suspected immunodeficiency.
  4. Laboratory evidence of liver disease (alanine aminotransferase [ALT] greater than 1.25-times the upper reference limit).
  5. Laboratory evidence of renal disease (serum creatinine greater than 1.25-times the upper reference limit, or more than 1+ protein, or more than trace blood on urine dipstick testing with the exception of greater than trace blood detected in females during menses).
  6. Laboratory evidence of hematologic disease (absolute leukocyte count <4500/mm3; absolute leukocyte count >13.0 x 103/mm3; hemoglobin <9.5 g/dl; or, platelet count <140,000/mm3).
  7. Other condition that in the opinion of the investigator could jeopardize the safety or rights of a child participating in the trial or would render the child unable to comply with the protocol.
  8. Participation in another investigational vaccine or drug trial within 30 days of starting this study or for the duration of the study.
  9. History of a severe allergic reaction or anaphylaxis.
  10. Severe asthma as defined by the need for daily use of inhalers or emergency room/clinic visit or hospitalization within 6 months of the child's planned first vaccination in the study.
  11. Positive for HCV.
  12. Positive for HBsAg.
  13. Positive for HIV infection.
  14. 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.
  15. Receipt of a live vaccine within past 4 weeks or a killed vaccine within past 2 weeks prior to entry into the study.
  16. History of a surgical splenectomy.
  17. Receipt of blood products within the 6 months prior to entry into the study.
  18. Previous receipt of a primary series (three doses according to a 0, 1, and 6 -12 month schedule) of the 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): NCT02839161


Contacts
Contact: Ayola Adegnika, MD +241-0740-6464 aadegnika@lambarene.org

Locations
Gabon
Centre de Recherches Médicales de Lambaréné Recruiting
Lambaréné, Gabon
Contact: Ayola Adegnika, MD         
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Principal Investigator: Ayola Adegnika, MD Centre de Recherches Medicales de Lambaréné

Responsible Party: Maria Elena Bottazzi PhD, Sponsor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT02839161     History of Changes
Other Study ID Numbers: HV-002
First Posted: July 20, 2016    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018

Keywords provided by Maria Elena Bottazzi PhD, Baylor College of Medicine:
Hookworm
Vaccine
Na-GST-1
Na-APR-1
Necator americanus

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