Hookworm InfectionPhase 1NCT02126462

Safety and Immunogenicity of Co-Administered Hookworm Vaccine Candidates Na-GST-1 and Na-APR-1 in Gabonese Adults

A Phase 1 study testing Na-APR-1 (M74)/Alhydrogel®, Na-GST-1/Alhydrogel® and Hepatitis B vaccine in people with Hookworm Infection and Hookworm Disease, run by Baylor College of Medicine at 1 site in Gabon.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Hookworm Infection, Hookworm Disease
What is being tested?: Na-APR-1 (M74)/Alhydrogel®, Na-GST-1/Alhydrogel® and Hepatitis B vaccine
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteGabon
Study dates: Nov 2014to Jun 2016
Phase: Phase 1
Are there results?: None posted in the registry

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 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Males or females between 18 and 50 years, inclusive, who are long-term residents of Gabon.
Good general health as determined by means of the screening procedure.
Assumed availability for the duration of the trial (12 months).
Willingness to participate in the study as evidenced by signing the informed consent document.
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

Pregnancy as determined by a positive urine hCG (if female).
Participant unwilling to use reliable contraception up until one month following the third immunization (if female and not surgically sterile, abstinent or at least 2 years post-menopausal).
Currently lactating and breast-feeding (if female).
Inability 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.

Show all 22Show fewer

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 trace protein or blood on urine dipstick testing).
Laboratory evidence of hematologic disease (absolute leukocyte count <3500/mm3; absolute leukocyte count >11.0 x 103/mm3; hemoglobin <10.000 g/dl [females] or <12.0 g/dl [males]; or, platelet count <140,000/mm3).
Other condition that in the opinion of the investigator would jeopardize the safety or rights of a volunteer participating in the trial or would render the subject 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.
Volunteer has had medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months.
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 volunteer's planned first vaccination in the study.
Positive for HCV
Positive ELISA 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 of any hepatitis B vaccine.

Trial locations and contacts

1 site in 1 country.

Gabon1 site

Centre de Recherches Médicales de Lambaréné Albert Schweitzer Hospital
Lambaréné, BP: 118

Other trials in Gabon

About this study

Official title: Randomized, Controlled, Phase 1 Study to Assess Safety and Immunogenicity of Co-administered Hookworm Vaccine Candidates Na-GST-1 and Na-APR-1 Adjuvanted With Alhydrogel® and Gluco-pyranosylphospho-lipid A in Gabonese Adults

Na-GST-1 and Na-APR-1 are proteins expressed during the adult stage of the Necator americanus hookworm life cycle that are thought to play a role in the parasite's degradation of host hemoglobin for use as an energy source. Vaccination with recombinant GST-1 or APR-1 has protected dogs and hamsters from infection in challenge studies. This study will evaluate the safety and immunogenicity of co-administering Na-GST-1 and Na-APR-1 to healthy Gabonese adults living in an area of endemic hookworm infection.

Read the detailed description

Double-blind, randomized, controlled dose-escalation Phase 1 clinical trial in hookworm exposed adults.

Study site: Centre de Recherches Médicales de Lambaréné Number of participants: 32 in 2 cohorts of 16

Doses of Na-GST-1 to be tested: 30 and 100 μg Doses of Na-APR-1 to be tested: 30 and 100 μg Dose of GLA-AF: 5 μg per antigen

Cohort 1: 30 μg of each of the two antigens (Na-GST-1/Alhydrogel® and Na-APR-1 (M74)/Alhydrogel®) or hepatitis B vaccine; Cohort 2: 100 μg of each of the two antigens (Na-GST- 1/Alhydrogel® and Na-APR-1 (M74) /Alhydrogel®) or hepatitis B vaccine.

Randomization: Cohort 1: 30 μg Na-GST-1 + 30 μg Na-APR-1 (M74) (n = 12) versus Hepatitis B Vaccine/placebo (n = 4) Cohort 2: 100 μg Na-GST-1 + 100 μg Na-APR-1 (M74) (n = 12) versus Hepatitis B Vaccine + placebo (n = 4)

The cohorts will be enrolled in a staggered fashion with safety data assessed prior to the Na-GST-1 and Na-APR-1 dose escalation from 30 to 100 µg.

Pre-treatment: Albendazole (400 mg) at least 2 weeks prior to first vaccination

Immunization schedule: Study days 0, 28 and 180 Route: Intramuscular in the deltoid muscle

Study duration: approximately 20 months; each participant will be followed for a total of 12 months.

Conditions: Hookworm Infection, Hookworm Disease
Being tested: Na-APR-1 (M74)/Alhydrogel®, Na-GST-1/Alhydrogel®, Hepatitis B vaccine
Keywords: Human Hookworm, Necator americanus, Hookworm, Hookworm Disease, Iron-deficiency anemia, Soil-transmitted helminth infection, Neglected Tropical Disease, Na-APR-1, Na-GST-1
Medical subject headings: Hookworm Infections, Ancylostomiasis, Anemia, Iron-Deficiency, Neglected Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Na-APR-1 (M74)/Alhydrogel®Biological
Na-GST-1/Alhydrogel®Biological
Hepatitis B vaccineBiological
Hepatitis B vaccine co-administered with saline

Study groups in NCT02126462
Study group	Role	What they receive
30 µg Na-GST-1 + 30 µg Na-APR-1 (M74)	Experimental	30 µg Na-GST-1/Alhydrogel plus 5 µg GLA-AF co-administered with 30 µg Na-APR-1 (M74)/Alhydrogel plus 5 µg GLA-AF Receives: Biological: Na-APR-1 (M74)/Alhydrogel®; Biological: Na-GST-1/Alhydrogel®
Hepatitis B vaccine	Active comparator	Hepatitis B vaccine co-administered with saline Receives: Biological: Hepatitis B vaccine
100 µg Na-GST-1 plus 100 µg Na-APR-1 (M74)	Experimental	100 µg Na-GST-1/Alhydrogel plus 5 µg GLA-AF co-administered with 100 µg Na-APR-1 (M74)/Alhydrogel plus 5 µg GLA-AF Receives: Biological: Na-APR-1 (M74)/Alhydrogel®; Biological: Na-GST-1/Alhydrogel®

What is being measured

The primary outcome is the main question the study is designed to answer.

Vaccine-related Adverse Events
To estimate the frequency of vaccine-related adverse events, graded by severity, for each dose of co-administered Na-GST-1 and Na-APR-1 (M74).
The frequency of immediate, systemic, and local injection site adverse events will be summarized. Adverse events will be assessed by study team members at 1 hour post-vaccination as well as 1, 3, 7, 14, and 28 days following each vaccination.
Measured: Day 360

Secondary outcomes (3)

IgG response to Na-GST-1 and Na-APR-1 (M74)
To determine the doses of Na-GST-1 and Na-APR-1 (M74) that generate the highest IgG antibody responses at Day 194, as determined by indirect enzyme-linked immunosorbent assays (ELISA)
Measured: Day 194
Duration of antibody response to Na-GST-1 and Na-APR-1 (M74)
To assess and compare the duration of antibody responses to Na- GST-1 and Na-APR-1 (M74).
Measured: Day 14, 28, 42, 56, 180, 194, 208, 270, 360
Exploratory studies of memory B-cell responses
Exploratory studies of memory B-cell responses against the metabolomics changes before and after Na-GST-1 and NA-APR-1 (M74) vaccine antigens.
Measured: Days 14, 28, 42, 56, 180, 194, 208, 270, 360

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2014Jun 2016

First posted30 Apr 2014 (estimated)
Study startNov 2014
Primary completionFeb 2016
Study completionJun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Hookworm InfectionStudies 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02126462
Sponsor's protocol ID: HV-001
Other IDs: 602843-2
Status last verified: May 2017
First submitted: 28 Apr 2014
Last updated: 31 May 2017
Results posted: No
Data monitoring committee: Yes
Individual data sharing: Undecided

Publications

Mouwenda YD, Betouke Ongwe ME, Sonnet F, Stam KA, Labuda LA, De Vries S, Grobusch MP, Zinsou FJ, Honkpehedji YJ, Dejon Agobe JC, Diemert DJ, van Leeuwen R, Bottazzi ME, Hotez PJ, Kremsner PG, Bethony JM, Jochems SP, Adegnika AA, Massinga Loembe M, Yazdanbakhsh M. Characterization of T cell responses to co-administered hookworm vaccine candidates Na-GST-1 and Na-APR-1 in healthy adults in Gabon. PLoS Negl Trop Dis. 2021 Oct 1;15(10):e0009732. doi: 10.1371/journal.pntd.0009732. eCollection 2021 Oct.
PubMed 34597297
Adegnika AA, de Vries SG, Zinsou FJ, Honkepehedji YJ, Dejon Agobe JC, Vodonou KG, Bikangui R, Bouyoukou Hounkpatin A, Bache EB, Massinga Loembe M, van Leeuwen R, Molemans M, Kremsner PG, Yazdanbakhsh M, Hotez PJ, Bottazzi ME, Li G, Bethony JM, Diemert DJ, Grobusch MP; HookVac Consortium. Safety and immunogenicity of co-administered hookworm vaccine candidates Na-GST-1 and Na-APR-1 in Gabonese adults: a randomised, controlled, double-blind, phase 1 dose-escalation trial. Lancet Infect Dis. 2021 Feb;21(2):275-285. doi: 10.1016/S1473-3099(20)30288-7. Epub 2020 Sep 11.
PubMed 32926834

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 31 May 2017. 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-GST-1 and Na-APR-1 Adjuvanted With Alhydrogel® and Gluco-pyranosylphospho-lipid A in Gabonese Adults
ClinicalTrials.gov ID: NCT02126462
Acronym / sponsor ID: HV-001
Conditions: Hookworm Infection, Hookworm Disease
Keywords: Human Hookworm, Necator americanus, Hookworm, Hookworm Disease, Iron-deficiency anemia, Soil-transmitted helminth infection, Neglected Tropical Disease, Na-APR-1
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Baylor College of MedicineUniversity, hospital or other
Study start: Nov 2014
Primary completion: Feb 2016 (actual)
Study completion: Jun 2016 (actual)
First posted: 30 Apr 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Double-blind, randomized, controlled dose-escalation Phase 1 clinical trial in hookworm exposed adults.

Study site: Centre de Recherches Médicales de Lambaréné Number of participants: 32 in 2 cohorts of 16

Doses of Na-GST-1 to be tested: 30 and 100 μg Doses of Na-APR-1 to be tested: 30 and 100 μg Dose of GLA-AF: 5 μg per antigen

The cohorts will be enrolled in a staggered fashion with safety data assessed prior to the Na-GST-1 and Na-APR-1 dose escalation from 30 to 100 µg.

Pre-treatment: Albendazole (400 mg) at least 2 weeks prior to first vaccination

Immunization schedule: Study days 0, 28 and 180 Route: Intramuscular in the deltoid muscle

Study duration: approximately 20 months; each participant will be followed for a total of 12 months.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
30 µg Na-GST-1 + 30 µg Na-APR-1 (M74)	Experimental	Biological: Na-APR-1 (M74)/Alhydrogel®, Biological: Na-GST-1/Alhydrogel®30 µg Na-GST-1/Alhydrogel plus 5 µg GLA-AF co-administered with 30 µg Na-APR-1 (M74)/Alhydrogel plus 5 µg GLA-AF
Hepatitis B vaccine	Active comparator	Biological: Hepatitis B vaccineHepatitis B vaccine co-administered with saline
100 µg Na-GST-1 plus 100 µg Na-APR-1 (M74)	Experimental	Biological: Na-APR-1 (M74)/Alhydrogel®, Biological: Na-GST-1/Alhydrogel®100 µg Na-GST-1/Alhydrogel plus 5 µg GLA-AF co-administered with 100 µg Na-APR-1 (M74)/Alhydrogel plus 5 µg GLA-AF

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Males or females between 18 and 50 years, inclusive, who are long-term residents of Gabon.
Good general health as determined by means of the screening procedure.
Assumed availability for the duration of the trial (12 months).
Willingness to participate in the study as evidenced by signing the informed consent document.
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 (22 listed)

Pregnancy as determined by a positive urine hCG (if female).
Participant unwilling to use reliable contraception up until one month following the third immunization (if female and not surgically sterile, abstinent or at least 2 years post-menopausal).
Currently lactating and breast-feeding (if female).
Inability 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.

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-APR-1 (M74)/Alhydrogel®	Biological	100 µg Na-GST-1 plus 100 µg Na-APR-1 (M74), 30 µg Na-GST-1 + 30 µg Na-APR-1 (M74)
Na-GST-1/Alhydrogel®	Biological	100 µg Na-GST-1 plus 100 µg Na-APR-1 (M74), 30 µg Na-GST-1 + 30 µg Na-APR-1 (M74)
Hepatitis B vaccineHepatitis B vaccine co-administered with saline	Biological	Hepatitis B vaccine

Primary outcome

Vaccine-related Adverse Events
Time frame: Day 360
To estimate the frequency of vaccine-related adverse events, graded by severity, for each dose of co-administered Na-GST-1 and Na-APR-1 (M74). The frequency of immediate, systemic, and local injection site adverse events will be summarized. Adverse events will be assessed by study team members at 1 hour post-vaccination as well as 1, 3, 7, 14, and 28 days following each vaccination.

3 secondary outcomes

IgG response to Na-GST-1 and Na-APR-1 (M74)
Time frame: Day 194
Duration of antibody response to Na-GST-1 and Na-APR-1 (M74)
Time frame: Day 14, 28, 42, 56, 180, 194, 208, 270, 360
Exploratory studies of memory B-cell responses
Time frame: Days 14, 28, 42, 56, 180, 194, 208, 270, 360

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
Derived from this study: PubMed 34597297Mouwenda YD, Betouke Ongwe ME, Sonnet F, Stam KA, Labuda LA, De Vries S, Grobusch MP, Zinsou FJ, Honkpehedji YJ, Dejon Agobe JC, Diemert DJ, van Leeuwen R, Bottazzi ME, Hotez PJ, Kremsner PG, Bethony JM, Jochems SP, Adegnika AA, Massinga Loembe M, Yazdanbakhsh M. Characterization of T cell responses to co-administered hookworm vaccine candidates Na-GST-1 and Na-APR-1 in healthy adults in Gabon. PLoS Negl Trop Dis. 2021 Oct 1;15(10):e0009732. doi: 10.1371/journal.pntd.0009732. eCollection 2021 Oct.
Derived from this study: PubMed 32926834Adegnika AA, de Vries SG, Zinsou FJ, Honkepehedji YJ, Dejon Agobe JC, Vodonou KG, Bikangui R, Bouyoukou Hounkpatin A, Bache EB, Massinga Loembe M, van Leeuwen R, Molemans M, Kremsner PG, Yazdanbakhsh M, Hotez PJ, Bottazzi ME, Li G, Bethony JM, Diemert DJ, Grobusch MP; HookVac Consortium. Safety and immunogenicity of co-administered hookworm vaccine candidates Na-GST-1 and Na-APR-1 in Gabonese adults: a randomised, controlled, double-blind, phase 1 dose-escalation trial. Lancet Infect Dis. 2021 Feb;21(2):275-285. doi: 10.1016/S1473-3099(20)30288-7. Epub 2020 Sep 11.
Individual participant dataSharing planned: Undecided

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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 Lambarené

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 22 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 31 May 2017. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 360). 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 NCT02126462, which also lists 2 linked publications.

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 31 May 2017.