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CompletedNCT02839161Updated Jan 13, 2025Results posted

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

A Phase 1 interventional study of Na-GST-1/Alhydrogel and Na-APR-1 (M74)/Alhydrogel in Hookworm Disease and Hookworm Infection, sponsored by Baylor College of Medicine. Completed at 1 site in Gabon. Open to participants aged 6 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-13.

Sponsored by Baylor College of Medicine · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
6 Years to 10 Years
Sex
All
01

Study 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.

Read the detailed description

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 assigned vaccine(s) delivered intramuscularly (deltoid) on approximately Days 0, 56, and 112 or 180.

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 third 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 (see Appendix A); the functional activity of vaccine-induced antibodies will be assessed by in vitro enzyme neutralization assays; the induction of B cell memory will be measured by antigen-specific memory B cell responses.

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

60 subjects will be enrolled into 3 groups of 20. The first 20 subjects will be assembled and enrolled into Group 1:

  1. Group 1 double-blind IP allocation (n=20):

    • 16 subjects will receive 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.

      • 8 will be vaccinated according to a 0,2,4-month schedule
      • 8 will be vaccinated according to a 0,2,6-month schedule

    • 4 subjects will receive hepatitis B vaccine comparator:

      • 2 will be vaccinated according to a 0,2,4-month schedule
      • 2 will be vaccinated according to a 0,2,6-month schedule

  2. Group 2 double-blind IP allocation (n=20):

    • 16 subjects will receive 30 µg Na-APR-1 (M74) plus 5 µg GLA-AF delivered by IM injection in the deltoid muscle, with 30µg Na-GST-1 administered IM in the alternate arm.

      • 8 will be vaccinated according to a 0,2,4-month schedule
      • 8 will be vaccinated according to a 0,2,6-month schedule

    • 4 subjects will receive hepatitis B vaccine comparator:

      • 2 will be vaccinated according to a 0,2,4-month schedule
      • 2 will be vaccinated according to a 0,2,6-month schedule

  3. Group 3 double-blind IP allocation (n=20):

    • 16 subjects will receive 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.

      • 8 will be vaccinated according to a 0,2,4-month schedule
      • 8 will be vaccinated according to a 0,2,6-month schedule

    • 4 subjects will receive hepatitis B vaccine comparator:

      • 2 will be vaccinated according to a 0,2,4-month schedule
      • 2 will be vaccinated according to a 0,2,6-month schedule
02

Conditions studied

  • Hookworm Disease
  • Hookworm Infection

Keywords

  • Hookworm
  • Vaccine
  • Na-GST-1
  • Na-APR-1
  • Necator americanus
03

In context

Ancylostomiasis

38 studies on the registry are indexed under Ancylostomiasis; 2 are open to participants now.

This study's enrollment of 60 is below the median of 87 across 37 interventional studies indexed under Ancylostomiasis.

Browse Ancylostomiasis studies →

Lead sponsor

Baylor College of Medicine is the lead sponsor of 747 studies on the registry; 111 are open to participants now.

Of its 84 completed or terminated interventional studies of FDA-regulated products, 45 (54%) have results posted.

Browse Baylor College of Medicine studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • 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

Interventions

  • BiologicalNa-GST-1/Alhydrogel
  • BiologicalNa-APR-1 (M74)/Alhydrogel
  • BiologicalHepatitis B Vaccine
06

What researchers measure

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.

    Time frame: Day 380

Secondary outcomes

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

    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.

    Time frame: 14 days after the third vaccination

Other outcomes

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

    To assess and compare the duration of the antibody responses of Na-GST-1 and Na-APR-1 (M74).

    Time frame: Day 380

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

    To assess the distribution of IgG subclass responses to Na-GST-1 and Na-APR-1 (M74).

    Time frame: Day 380

07

Results

Posted Jun 10, 2024

Participant flow

Recruitment and enrollment occurred on an ongoing basis, with each group being recruited and vaccinated in sequence.

Participant flow — Overall Study
MilestoneLow-dose (0,2,4 Months)Low-dose (0,2,6 Months)Medium-dose (0,2,4 Months)Medium-dose (0,2,6 Months)High-dose (0,2,4 Months)High-dose (0,2,6 Months)Comparator (0,2,4 Months)Comparator (0,2,6 Months)
Started88888866
Completed88888866
Not completed00000000

Outcome measures

PrimaryVaccine-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.

Time frame:
Day 380
Reported as:
Count of participants · Participants
Vaccine-Related Adverse Events
ParticipantsLow-dose (0,2,4 Months)Low-dose (0,2,6 Months)Medium-dose (0,2,4 Months)Medium-dose (0,2,6 Months)High-dose (0,2,4 Months)High-dose (0,2,6 Months)Comparator (0,2,4 Months)Comparator (0,2,6 Months)
Number participants with at least 1 AE (any grade)88888846
Number participants with at least 1 injection site AE (any grade)78787725
Number participants with at least 1 grade 3 (severe) event22020300
SecondaryIgG Response to Na-GST-1 and Na-APR-1 (M74)

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.

Time frame:
14 days after the third vaccination
Reported as:
Geometric mean · Arbitrary Units
IgG Response to Na-GST-1 and Na-APR-1 (M74)
Arbitrary UnitsLow-dose (0,2,4 Months)Low-dose (0,2,6 Months)Medium-dose (0,2,4 Months)Medium-dose (0,2,6 Months)High-dose (0,2,4 Months)High-dose (0,2,6 Months)Comparator (0,2,4 Months)Comparator (0,2,6 Months)
IgG Response to Na-GST-1 and Na-APR-1 (M74)9.52 (4.36 to 20.78)9.08 (3.81 to 21.64)219.53 (13.05 to 3694.51)266.38 (84.44 to 840.35)726.89 (186.95 to 2826.33)2295.97 (2295.97 to 2295.97)2.36 (1.48 to 3.74)2.36 (1.48 to 3.74)
Other pre-specifiedDuration of Antibody Response to Na-GST-1 and Na-APR-1 (M74)

To assess and compare the duration of the antibody responses of Na-GST-1 and Na-APR-1 (M74).

Time frame:
Day 380

Results for this outcome have not been posted.

Other pre-specifiedIgG Subclass Response to Na-GST-1 and Na-APR-1 (M74)

To assess the distribution of IgG subclass responses to Na-GST-1 and Na-APR-1 (M74).

Time frame:
Day 380

Results for this outcome have not been posted.

Adverse events

Collected over The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Low-dose (0,2,4 Months)0/8 (0%)0/8 (0%)8/8 (100%)
Low-dose (0,2,6 Months)0/8 (0%)0/8 (0%)8/8 (100%)
Medium-dose (0,2,4 Months)0/8 (0%)1/8 (12.5%)8/8 (100%)
Medium-dose (0,2,6 Months)0/8 (0%)0/8 (0%)8/8 (100%)
High-dose (0,2,4 Months)0/8 (0%)0/8 (0%)8/8 (100%)
High-dose (0,2,6 Months)0/8 (0%)0/8 (0%)8/8 (100%)
Comparator (0,2,4 Months)0/6 (0%)0/6 (0%)4/6 (66.7%)
Comparator (0,2,6 Months)0/6 (0%)0/6 (0%)6/6 (100%)
Most frequent serious events
Most frequent serious events
EventLow-dose (0,2,4 Months)Low-dose (0,2,6 Months)Medium-dose (0,2,4 Months)Medium-dose (0,2,6 Months)High-dose (0,2,4 Months)High-dose (0,2,6 Months)Comparator (0,2,4 Months)Comparator (0,2,6 Months)
Inguinal herniaGastrointestinal disorders0/80/81/80/80/80/80/60/6
Most frequent other events
Showing 10 of 52
Most frequent other events
EventLow-dose (0,2,4 Months)Low-dose (0,2,6 Months)Medium-dose (0,2,4 Months)Medium-dose (0,2,6 Months)High-dose (0,2,4 Months)High-dose (0,2,6 Months)Comparator (0,2,4 Months)Comparator (0,2,6 Months)
Injection Site PainGeneral disorders7/88/87/88/87/86/82/65/6
Haemoglobin decreasedInvestigations1/80/81/83/84/85/81/61/6
CoughRespiratory, thoracic and mediastinal disorders5/81/80/80/80/81/80/60/6
Injection site swellingGeneral disorders1/82/81/80/84/84/81/61/6
PyrexiaGeneral disorders3/83/82/82/84/83/82/60/6
HeadacheNervous system disorders3/84/80/82/82/83/80/62/6
Platelet count decreasedInvestigations1/80/80/81/80/83/80/60/6
Injection site tendernessGeneral disorders2/80/80/80/80/82/80/60/6
VomitingGastrointestinal disorders2/80/80/80/81/81/80/61/6
HypokinesiaNervous system disorders0/80/80/80/80/82/80/60/6

Baseline characteristics

Age, Continuous
Age, Continuous(years)Low-dose (0,2,4 Months)Low-dose (0,2,6 Months)Medium-dose (0,2,4 Months)Medium-dose (0,2,6 Months)High-dose (0,2,4 Months)High-dose (0,2,6 Months)Comparator (0,2,4 Months)Comparator (0,2,6 Months)Total
Median7 (6 to 7)8 (7 to 9)6.5 (6 to 8)8 (7 to 9)7.5 (6 to 9)7 (6 to 8)7.5 (7 to 9)6.5 (6 to 8)7 (6 to 8)
Sex: Female, Male
Sex: Female, Male(Participants)Low-dose (0,2,4 Months)Low-dose (0,2,6 Months)Medium-dose (0,2,4 Months)Medium-dose (0,2,6 Months)High-dose (0,2,4 Months)High-dose (0,2,6 Months)Comparator (0,2,4 Months)Comparator (0,2,6 Months)Total
Female1245273226
Male7643613434
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Low-dose (0,2,4 Months)Low-dose (0,2,6 Months)Medium-dose (0,2,4 Months)Medium-dose (0,2,6 Months)High-dose (0,2,4 Months)High-dose (0,2,6 Months)Comparator (0,2,4 Months)Comparator (0,2,6 Months)Total
American Indian or Alaska Native000000000
Asian000000000
Native Hawaiian or Other Pacific Islander000000000
Black or African American8888886660
White000000000
More than one race000000000
Unknown or Not Reported000000000
Region of Enrollment
Region of Enrollment(participants)Low-dose (0,2,4 Months)Low-dose (0,2,6 Months)Medium-dose (0,2,4 Months)Medium-dose (0,2,6 Months)High-dose (0,2,4 Months)High-dose (0,2,6 Months)Comparator (0,2,4 Months)Comparator (0,2,6 Months)Total
Gabon8888886660
08

Study locations

1 site
  • Centre de Recherches Médicales de Lambaréné
    Lambaréné, Gabon
09

References and documents

Publications

  • 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. PubMed 38513684 ↗

Study documents

  • Protocol and statistical analysis plan · Aug 8, 2018

Documents are hosted by the registry — open the source record to download them.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2017 to primary completion in Dec 2018, 23 months.

Results were first posted in Jun 2024, 5 years 5 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 18, 2016
First posted
Jul 20, 2016
StartActual
Jan 2017
Primary completionActual
Dec 13, 2018
CompletionActual
Mar 28, 2019
Results first posted
Jun 10, 2024
Last update
Jan 13, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02839161
Lead sponsor
Baylor College of Medicine
Responsible party
Maria Elena Bottazzi PhD (Sponsor, Baylor College of Medicine) — Principal investigator
First posted
Jul 20, 2016
Start date
Jan 2017
Primary completion
Dec 13, 2018
Completion
Mar 28, 2019
Results posted
Jun 10, 2024
Last update
Jan 13, 2025

Study contacts

Ayola Adegnika, MD
principal investigator · Centre de Recherches Medicales de Lambaréné

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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