Hookworm DiseasePhase 1NCT02839161
Study of Co-administered Na-APR-1 (M74) and Na-GST-1 in Gabonese Children
A Phase 1 study testing Na-GST-1/Alhydrogel, Na-APR-1 (M74)/Alhydrogel and Hepatitis B Vaccine in people with Hookworm Disease and Hookworm Infection, run by Baylor College of Medicine at 1 site in Gabon.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Hookworm Disease, Hookworm Infection
- What is being tested?
- Na-GST-1/Alhydrogel, Na-APR-1 (M74)/Alhydrogel and Hepatitis B Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGabon
- Study dates
- Jan 2017to 28 Mar 2019
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
- 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 (three doses according to a 0, 1, and 6 -12 month schedule) of the hepatitis B vaccine.
Trial locations and contacts
1 site in 1 country.
About this study
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
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:
- 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
- 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
- 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
- Conditions
- Hookworm Disease, Hookworm Infection
- Being tested
- Na-GST-1/Alhydrogel, Na-APR-1 (M74)/Alhydrogel, Hepatitis B Vaccine
- Keywords
- Hookworm, Vaccine, Na-GST-1, Na-APR-1, Necator americanus
- Medical subject headings
- Ancylostomiasis, Hookworm Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Na-GST-1/AlhydrogelBiological
Na-APR-1 (M74)/AlhydrogelBiological
Hepatitis B VaccineBiological
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Na-GST-1/Alhydrogel; Biological: 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. Receives: Biological: Na-GST-1/Alhydrogel; Biological: 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. Receives: Biological: Na-GST-1/Alhydrogel; Biological: 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. Receives: Biological: Na-GST-1/Alhydrogel; Biological: 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. Receives: Biological: Na-GST-1/Alhydrogel; Biological: 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. Receives: Biological: Na-GST-1/Alhydrogel; Biological: 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. Receives: 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. Receives: Biological: Hepatitis B Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 14 days after the third vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startJan 2017
- Primary completion13 Dec 2018
- Study completion28 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hookworm DiseaseStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Elena Bottazzi PhD, Baylor College of Medicine
- Investigators
- Ayola Adegnika, MD, Principal investigator, Centre de Recherches Medicales de Lambaréné
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02839161
- Sponsor's protocol ID
- HV-002
- Status last verified
- Jan 2025
- First submitted
- 18 Jul 2016
- Last updated
- 13 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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 at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02839161
- Acronym / sponsor ID
- HV-002
- Conditions
- Hookworm Disease, Hookworm Infection
- Keywords
- Hookworm, Vaccine, Na-GST-1, Na-APR-1, Necator americanus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- 13 Dec 2018 (actual)
- Study completion
- 28 Mar 2019 (actual)
- First posted
- 20 Jul 2016 (estimated)
- Results
- Posted 10 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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
- 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
- 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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Low-dose (0,2,4 months) | Experimental | Biological: Na-GST-1/Alhydrogel, Biological: Na-APR-1 (M74)/Alhydrogel10 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. |
| Low-dose (0,2,6 months) | Experimental | Biological: Na-GST-1/Alhydrogel, Biological: Na-APR-1 (M74)/Alhydrogel10 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. |
| Medium-dose (0,2,4 months) | Experimental | Biological: Na-GST-1/Alhydrogel, Biological: Na-APR-1 (M74)/Alhydrogel30 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. |
| Medium-dose (0,2,6 months) | Experimental | Biological: Na-GST-1/Alhydrogel, Biological: Na-APR-1 (M74)/Alhydrogel30 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. |
| High-dose (0,2,4 months) | Experimental | Biological: Na-GST-1/Alhydrogel, Biological: Na-APR-1 (M74)/Alhydrogel100 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. |
| High-dose (0,2,6 months) | Experimental | Biological: Na-GST-1/Alhydrogel, Biological: Na-APR-1 (M74)/Alhydrogel100 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. |
| Comparator (0,2,4 months) | Active comparator | Biological: Hepatitis B VaccineHepatitis 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. |
| Comparator (0,2,6 months) | Active comparator | Biological: Hepatitis B VaccineHepatitis 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. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (18 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Na-GST-1/Alhydrogel | Biological | 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)/Alhydrogel | Biological | 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 Vaccine | Biological | Comparator (0,2,4 months), Comparator (0,2,6 months) |
Primary outcome
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.
1 secondary outcome
IgG Response to Na-GST-1 and Na-APR-1 (M74)
Time frame: 14 days after the third vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38513684Zinsou 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayola Adegnika, MD principal investigator
Centre de Recherches Medicales de Lambaréné
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Na-GST-1/Alhydrogel, Na-APR-1 (M74)/Alhydrogel and Hepatitis B Vaccine in people with Hookworm Disease and Hookworm Infection, run by Baylor College of Medicine at 1 site in Gabon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Gabon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaccine-Related Adverse Events (time frame: Day 380). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02839161, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.