NCT02839161

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2017

Typical duration for phase_1

Geographic Reach
1 country

1 active site

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

July 18, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 20, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2019

Completed
5.2 years until next milestone

Results Posted

Study results publicly available

June 10, 2024

Completed
Last Updated

January 13, 2025

Status Verified

January 1, 2025

Enrollment Period

1.9 years

First QC Date

July 18, 2016

Results QC Date

January 3, 2024

Last Update Submit

January 2, 2025

Conditions

Hookworm DiseaseHookworm Infection

Keywords

HookwormVaccineNa-GST-1Na-APR-1Necator americanus

Outcome Measures

Primary Outcomes (1)

  • Vaccine-Related Adverse Events

    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.

    Day 380

Secondary Outcomes (1)

  • IgG Response to Na-GST-1 and Na-APR-1 (M74)

    14 days after the third vaccination

Other Outcomes (2)

  • Duration of Antibody Response to Na-GST-1 and Na-APR-1 (M74)

    Day 380

  • IgG Subclass Response to Na-GST-1 and Na-APR-1 (M74)

    Day 380

Study Arms (8)

Low-dose (0,2,4 months)

EXPERIMENTAL

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/AlhydrogelBiological: Na-APR-1 (M74)/Alhydrogel

Low-dose (0,2,6 months)

EXPERIMENTAL

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/AlhydrogelBiological: Na-APR-1 (M74)/Alhydrogel

Medium-dose (0,2,4 months)

EXPERIMENTAL

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/AlhydrogelBiological: Na-APR-1 (M74)/Alhydrogel

Medium-dose (0,2,6 months)

EXPERIMENTAL

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/AlhydrogelBiological: Na-APR-1 (M74)/Alhydrogel

High-dose (0,2,4 months)

EXPERIMENTAL

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/AlhydrogelBiological: Na-APR-1 (M74)/Alhydrogel

High-dose (0,2,6 months)

EXPERIMENTAL

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/AlhydrogelBiological: Na-APR-1 (M74)/Alhydrogel

Comparator (0,2,4 months)

ACTIVE COMPARATOR

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

Comparator (0,2,6 months)

ACTIVE COMPARATOR

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

Interventions

Na-GST-1/AlhydrogelBIOLOGICAL
High-dose (0,2,4 months)High-dose (0,2,6 months)Low-dose (0,2,4 months)Low-dose (0,2,6 months)Medium-dose (0,2,4 months)Medium-dose (0,2,6 months)
Na-APR-1 (M74)/AlhydrogelBIOLOGICAL
High-dose (0,2,4 months)High-dose (0,2,6 months)Low-dose (0,2,4 months)Low-dose (0,2,6 months)Medium-dose (0,2,4 months)Medium-dose (0,2,6 months)
Hepatitis B VaccineBIOLOGICAL
Comparator (0,2,4 months)Comparator (0,2,6 months)

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Males or females between 6 and 10 years, inclusive, who are long-term residents of the study area.
  • Good general health as determined by means of the screening procedure.
  • Assumed availability for the duration of the trial (up to 15 months).
  • 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.
  • Negative for hookworm during screening, or if found to be infected with hookworm, has completed a course of three doses of albendazole.

You may not qualify if:

  • Inability of parent/legal guardian 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 1+ protein, or more than trace blood on urine dipstick testing with the exception of greater than trace blood detected in females during menses).
  • 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).
  • 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.
  • Participation in another investigational vaccine or drug trial within 30 days of starting this study or for the duration of the study.
  • 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 child's planned first vaccination in the study.
  • Positive for HCV.
  • Positive 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.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de Recherches Médicales de Lambaréné

Lambaréné, Gabon

Location

Related Publications (1)

  • Zinsou JF, Diemert DJ, Dejon-Agobe JC, Adegbite BR, Honkpehedji YJ, Vodonou KG, Bikangui R, Edoa JR, Massinga Loembe M, Li G, Yazdanbakhsh M, Bottazzi ME, van Leeuwen R, Kremsner PG, Hotez PJ, Bethony JM, Grobusch MP, Adegnika AA. Safety and immunogenicity of the co-administered Na-APR-1 and Na-GST-1 hookworm vaccines in school-aged children in Gabon: a randomised, controlled, observer-blind, phase 1, dose-escalation trial. Lancet Infect Dis. 2024 Jul;24(7):760-774. doi: 10.1016/S1473-3099(24)00104-X. Epub 2024 Mar 18.

    PMID: 38513684DERIVED

MeSH Terms

Conditions

AncylostomiasisHookworm Infections

Interventions

Hepatitis B Vaccines

Condition Hierarchy (Ancestors)

Strongylida InfectionsSecernentea InfectionsNematode InfectionsHelminthiasisParasitic DiseasesInfections

Intervention Hierarchy (Ancestors)

Viral Hepatitis VaccinesViral VaccinesVaccinesBiological ProductsComplex Mixtures

Results Point of Contact

Title
David J. Diemert, MD
Organization
George Washington University
ddiemert@gwu.edu
202-994-2909

Study Officials

  • Ayola Adegnika, MD

    Centre de Recherches Medicales de Lambaréné

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Sponsor

Study Record Dates

First Submitted

July 18, 2016

First Posted

July 20, 2016

Study Start

January 1, 2017

Primary Completion

December 13, 2018

Study Completion

March 28, 2019

Last Updated

January 13, 2025

Results First Posted

June 10, 2024

Record last verified: 2025-01

Locations

GA(1)