Hookworm InfectionPhase 1NCT01717950
Safety and Immunogenicity of the Na-APR-1 Hookworm Vaccine in Healthy Adults
A Phase 1 study testing Na-APR-1 (M74)/Alhydrogel® and Gluco-Pyranosylphospho-Lipid A Aqueous Formulation in people with Hookworm Infection and Hookworm Disease, run by Baylor College of Medicine at 1 site in United States.
Trial summary
Hookworms digest hemoglobin from erythrocytes for use as an energy source via a proteolytic cascade that begins with the aspartic protease, APR-1. Vaccination with recombinant APR-1 has protected animals from infection in challenge studies. Read more about this study
- 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® and Gluco-Pyranosylphospho-Lipid A Aqueous Formulation
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Sep 2015
- 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.
- Good general health as determined by means of the screening procedure.
- Available for the duration of the trial (44 weeks).
- Willingness to participate in the study as evidenced by signing the informed consent document.
Who cannot join
- Pregnancy as determined by a positive urine human choriogonadotropin (hCG) (if female).
- Participant unwilling to use reliable contraception methods 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).
- 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).
Show all 23Show fewer
- 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 (hemoglobin <11.5 g/dl [females] or <12.5 g/dl [males]; absolute leukocyte count <3600/mm3 or >10.7 x 103/mm3; absolute neutrophil count [ANC] <1700/ mm3; absolute lymphocyte count <700/mm3; or platelet count <140,000/mm3).
- Laboratory evidence of a coagulopathy (PTT or PT INR greater than 1.1-times the upper reference limit).
- Serum glucose (random) greater than 1.2-times the upper reference limit.
- 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.
- 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 clinic visit or hospitalization within 6 months of the volunteer's expected first vaccination in the study.
- Positive ELISA for hepatitis B surface antigen (HBsAg).
- Positive confirmatory test for HIV infection.
- Positive confirmatory test for hepatitis C virus (HCV) infection.
- Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 30 days of the volunteer's expected first vaccination in this study.
- Receipt of a live vaccine within 4 weeks or a killed vaccine within 2 weeks prior to the volunteer's expected first vaccination in the study.
- History of a surgical splenectomy.
- Receipt of blood products within the past 6 months.
- History of previous infection with hookworm or residence for more than 6 months in a hookworm-endemic area.
Trial locations and contacts
1 site in 1 country.
United States1 site
George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, 20036
About this study
Official title: Phase 1 Study of the Safety and Immunogenicity of Na-APR-1 (M74)/Alhydrogel® in Healthy Adults
Hookworms digest hemoglobin from erythrocytes for use as an energy source via a proteolytic cascade that begins with the aspartic protease, APR-1. Vaccination with recombinant APR-1 has protected animals from infection in challenge studies. This study will evaluate the safety and immunogenicity of two formulations of Na-APR-1 (M74) in healthy adult volunteers when co-administered with different concentrations of the immunostimulant GLA-AF.
Read the detailed description
Open-label, dose-escalation phase 1 clinical trial in healthy, hookworm-naïve adults:
- Study site: George Washington Medical Faculty Associates, Washington, DC
- Number of participants: 40 in 2 cohorts of 20.
In Cohort 1 five (5) volunteers will receive 30 µg Na-APR-1 (M74) /Alhydrogel®, five (5) will receive 30 µg Na-APR-1 (M74)/Alhydrogel® plus 2.5 µg GLA-AF, and ten (10) will receive 30 µg Na-APR-1 (M74) /Alhydrogel® plus 5 µg GLA-AF. In Cohort 2 five (5) volunteers will receive 100 µg Na-APR-1 (M74)/Alhydrogel®, five (5) will receive 100 µg Na-APR-1 (M74) /Alhydrogel® plus 2.5 µg GLA-AF, and ten (10) will receive 100 µg Na-APR-1 (M74)/Alhydrogel® plus 5 µg GLA-AF.
The cohorts will be enrolled in a staggered fashion with safety data assessed prior to the Na-APR-1 dose escalation from 30 to 100 µg. In addition, within each cohort, vaccinations will be staggered such that formulations containing 0, 2.5, and 5 µg GLA-AF will be tested sequentially: for example, those receiving Na-APR-1 (M74)/Alhydrogel® in combination with 2.5 µg GLA-AF will be vaccinated no sooner than 3 days after the last volunteer is vaccinated with the formulation containing no GLA-AF, whereas those vaccinated with Na-APR-1 (M74)/Alhydrogel® plus 5 µg GLA-AF will be vaccinated no sooner than 7 days after the last one receives the 2.5 µg GLA-AF formulation.
- Immunization schedule: Study days 0, 56 and 112.
- Route: IM in the deltoid muscle.
- Doses of Na-APR-1 (M74) to be tested: 30 and 100 µg.
- Doses of Alhydrogel®: 240 and 800 µg for the 30 and 100 µg doses of Na-APR-1 (M74), respectively.
- Doses of GLA-AF to be tested: 2.5 µg and 5 µg.
- Study duration: 44 weeks (10 months) per study participant; total duration of the study estimated at approximately 13 months.
- Conditions
- Hookworm Infection, Hookworm Disease
- Being tested
- Na-APR-1 (M74)/Alhydrogel®, Gluco-Pyranosylphospho-Lipid A Aqueous Formulation
- Keywords
- Human Hookworm, Necator americanus, Hookworm, Hookworm Disease, Iron-deficiency anemia, Soil-transmitted helminth infection, Neglected Tropical Disease, Na-APR-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
Also called Na-APR-1, Necator americanus Aspartic Protease-1
The Na-APR-1 (M74) candidate vaccine contains the recombinant Na-APR-1 (M74) protein expressed by Nicotiana plants. Purified Na-APR-1 (M74) was subsequently adsorbed onto aluminum hydroxide gel (Alhydrogel®) and suspended in a solution containing 10 mM imidazole, 150 mM sodium chloride and 0.3% Empigen BB, with pH 7.4 ± 0.1. The final concentration of Na-APR-1 (M74) in the drug product is 0.1 mg/ml, whereas that of Alhydrogel® is 0.8 mg/ml. Different doses of Na-APR-1 (M74) will be delivered by injecting different volumes of the 0.1 mg/ml Na-APR-1 (M74) preparation.
Gluco-Pyranosylphospho-Lipid A Aqueous FormulationBiological
Also called GLA-AF
GLA-AF contains a synthetic monophosphoryl lipid A (MPL) molecule that has Toll-Like Receptor-4 agonist activity. MPL is itself derived from the lipopolysaccharide (LPS) of Salmonella minnesota, a natural TLR4 agonist that is pyrogenic and can induce toxic shock. LPS, and more specifically, its lipid A component, has long been known for its strong adjuvant effects; however, its high toxicity has precluded its use in a vaccine formulation.
| Study group | Role | What they receive |
|---|---|---|
| 30 µg Na-APR-1 (M74)/Alhydrogel® | Experimental | Not described Receives: Biological: Na-APR-1 (M74)/Alhydrogel® |
| 30 µg Na-APR-1 (M74)/Alhydrogel® plus 2.5 µg GLA-AF | Experimental | Not described Receives: Biological: Na-APR-1 (M74)/Alhydrogel®; Biological: Gluco-Pyranosylphospho-Lipid A Aqueous Formulation |
| 30 µg Na-APR-1 (M74)/Alhydrogel® plus 5.0 µg GLA-AF | Experimental | Not described Receives: Biological: Na-APR-1 (M74)/Alhydrogel®; Biological: Gluco-Pyranosylphospho-Lipid A Aqueous Formulation |
| 100 µg Na-APR-1 (M74)/Alhydrogel® | Experimental | Not described Receives: Biological: Na-APR-1 (M74)/Alhydrogel® |
| 100 µg Na-APR-1 (M74)/Alhydrogel® plus 2.5 µg GLA-AF | Experimental | Not described Receives: Biological: Na-APR-1 (M74)/Alhydrogel®; Biological: Gluco-Pyranosylphospho-Lipid A Aqueous Formulation |
| 100 µg Na-APR-1 (M74)/Alhydrogel® plus 5.0 µg GLA-AF | Experimental | Not described Receives: Biological: Na-APR-1 (M74)/Alhydrogel®; Biological: Gluco-Pyranosylphospho-Lipid A Aqueous Formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccine-related Adverse Events
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 3, 7, 14, and 28 days following each vaccination. In addition, study participants will be asked to complete symptom diaries for the 7 days after each vaccination.
Measured: Day 290
Secondary outcomes (3)
IgG antibody response to Na-APR-1
Dose and formulation of Na-APR-1 that generates the highest IgG antibody response at Day 126 (14 days after final vaccination), as determined by an indirect enzyme-linked immunosorbent assay (ELISA).
Measured: 14 days after final vaccination
B cell response to Na-APR-1
Dose and formulation of the Na-APR-1 (M74) vaccine that results in the highest production of Na-APR-1 (M74) specific B cells and subtypes (memory or plasma).
Measured: Study Days 14, 70, 126, 140 and 290
Exploratory cellular immune response to Na-APR-1
Exploratory studies of the cellular immune responses to the Na APR-1 (M74) antigen both before and after immunization.
Measured: Study Days 14, 70, 126, 140 and 290
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2012 (estimated)
- Study startSep 2013
- Primary completionJun 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- George Washington University
- Responsible party
- Principal investigator, Maria Elena Bottazzi PhD, Baylor College of Medicine
- Investigators
- David J Diemert, MD, Principal investigator, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01717950
- Sponsor's protocol ID
- SVI-12-01
- Status last verified
- Jul 2019
- First submitted
- 25 Oct 2012
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of the Safety and Immunogenicity of Na-APR-1 (M74)/Alhydrogel® in Healthy Adults
- ClinicalTrials.gov ID
- NCT01717950
- Acronym / sponsor ID
- SVI-12-01
- 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
- 40 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- George Washington University
- Study start
- Sep 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 31 Oct 2012 (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.
Hookworms digest hemoglobin from erythrocytes for use as an energy source via a proteolytic cascade that begins with the aspartic protease, APR-1. Vaccination with recombinant APR-1 has protected animals from infection in challenge studies. This study will evaluate the safety and immunogenicity of two formulations of Na-APR-1 (M74) in healthy adult volunteers when co-administered with different concentrations of the immunostimulant GLA-AF.
Detailed description
Open-label, dose-escalation phase 1 clinical trial in healthy, hookworm-naïve adults:
- Study site: George Washington Medical Faculty Associates, Washington, DC
- Number of participants: 40 in 2 cohorts of 20.
In Cohort 1 five (5) volunteers will receive 30 µg Na-APR-1 (M74) /Alhydrogel®, five (5) will receive 30 µg Na-APR-1 (M74)/Alhydrogel® plus 2.5 µg GLA-AF, and ten (10) will receive 30 µg Na-APR-1 (M74) /Alhydrogel® plus 5 µg GLA-AF. In Cohort 2 five (5) volunteers will receive 100 µg Na-APR-1 (M74)/Alhydrogel®, five (5) will receive 100 µg Na-APR-1 (M74) /Alhydrogel® plus 2.5 µg GLA-AF, and ten (10) will receive 100 µg Na-APR-1 (M74)/Alhydrogel® plus 5 µg GLA-AF.
The cohorts will be enrolled in a staggered fashion with safety data assessed prior to the Na-APR-1 dose escalation from 30 to 100 µg. In addition, within each cohort, vaccinations will be staggered such that formulations containing 0, 2.5, and 5 µg GLA-AF will be tested sequentially: for example, those receiving Na-APR-1 (M74)/Alhydrogel® in combination with 2.5 µg GLA-AF will be vaccinated no sooner than 3 days after the last volunteer is vaccinated with the formulation containing no GLA-AF, whereas those vaccinated with Na-APR-1 (M74)/Alhydrogel® plus 5 µg GLA-AF will be vaccinated no sooner than 7 days after the last one receives the 2.5 µg GLA-AF formulation.
- Immunization schedule: Study days 0, 56 and 112.
- Route: IM in the deltoid muscle.
- Doses of Na-APR-1 (M74) to be tested: 30 and 100 µg.
- Doses of Alhydrogel®: 240 and 800 µg for the 30 and 100 µg doses of Na-APR-1 (M74), respectively.
- Doses of GLA-AF to be tested: 2.5 µg and 5 µg.
- Study duration: 44 weeks (10 months) per study participant; total duration of the study estimated at approximately 13 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 30 µg Na-APR-1 (M74)/Alhydrogel® | Experimental | Biological: Na-APR-1 (M74)/Alhydrogel® |
| 30 µg Na-APR-1 (M74)/Alhydrogel® plus 2.5 µg GLA-AF | Experimental | Biological: Na-APR-1 (M74)/Alhydrogel®, Biological: Gluco-Pyranosylphospho-Lipid A Aqueous Formulation |
| 30 µg Na-APR-1 (M74)/Alhydrogel® plus 5.0 µg GLA-AF | Experimental | Biological: Na-APR-1 (M74)/Alhydrogel®, Biological: Gluco-Pyranosylphospho-Lipid A Aqueous Formulation |
| 100 µg Na-APR-1 (M74)/Alhydrogel® | Experimental | Biological: Na-APR-1 (M74)/Alhydrogel® |
| 100 µg Na-APR-1 (M74)/Alhydrogel® plus 2.5 µg GLA-AF | Experimental | Biological: Na-APR-1 (M74)/Alhydrogel®, Biological: Gluco-Pyranosylphospho-Lipid A Aqueous Formulation |
| 100 µg Na-APR-1 (M74)/Alhydrogel® plus 5.0 µg GLA-AF | Experimental | Biological: Na-APR-1 (M74)/Alhydrogel®, Biological: Gluco-Pyranosylphospho-Lipid A Aqueous Formulation |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Males or females between 18 and 50 years, inclusive.
- Good general health as determined by means of the screening procedure.
- Available for the duration of the trial (44 weeks).
- Willingness to participate in the study as evidenced by signing the informed consent document.
Key exclusion criteria (23 listed)
- Pregnancy as determined by a positive urine human choriogonadotropin (hCG) (if female).
- Participant unwilling to use reliable contraception methods 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).
- 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.
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®Also: Na-APR-1, Necator americanus Aspartic Protease-1The Na-APR-1 (M74) candidate vaccine contains the recombinant Na-APR-1 (M74) protein expressed by Nicotiana plants. Purified Na-APR-1 (M74) was subsequently adsorbed onto aluminum hydroxide gel (Alhydrogel®) and suspended in a solution containing 10 mM imidazole, 150 mM sodium chloride and 0.3% Empigen BB, with pH 7.4 ± 0.1. The final concentration of Na-APR-1 (M74) in the drug product is 0.1 mg/ml, whereas that of Alhydrogel® is 0.8 mg/ml. Different doses of Na-APR-1 (M74) will be delivered by injecting different volumes of the 0.1 mg/ml Na-APR-1 (M74) preparation. | Biological | 100 µg Na-APR-1 (M74)/Alhydrogel®, 100 µg Na-APR-1 (M74)/Alhydrogel® plus 2.5 µg GLA-AF, 100 µg Na-APR-1 (M74)/Alhydrogel® plus 5.0 µg GLA-AF, 30 µg Na-APR-1 (M74)/Alhydrogel®, 30 µg Na-APR-1 (M74)/Alhydrogel® plus 2.5 µg GLA-AF, 30 µg Na-APR-1 (M74)/Alhydrogel® plus 5.0 µg GLA-AF |
| Gluco-Pyranosylphospho-Lipid A Aqueous FormulationAlso: GLA-AFGLA-AF contains a synthetic monophosphoryl lipid A (MPL) molecule that has Toll-Like Receptor-4 agonist activity. MPL is itself derived from the lipopolysaccharide (LPS) of Salmonella minnesota, a natural TLR4 agonist that is pyrogenic and can induce toxic shock. LPS, and more specifically, its lipid A component, has long been known for its strong adjuvant effects; however, its high toxicity has precluded its use in a vaccine formulation. | Biological | 100 µg Na-APR-1 (M74)/Alhydrogel® plus 2.5 µg GLA-AF, 100 µg Na-APR-1 (M74)/Alhydrogel® plus 5.0 µg GLA-AF, 30 µg Na-APR-1 (M74)/Alhydrogel® plus 2.5 µg GLA-AF, 30 µg Na-APR-1 (M74)/Alhydrogel® plus 5.0 µg GLA-AF |
Primary outcome
Vaccine-related Adverse Events
Time frame: Day 290
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 3, 7, 14, and 28 days following each vaccination. In addition, study participants will be asked to complete symptom diaries for the 7 days after each vaccination.
3 secondary outcomes
IgG antibody response to Na-APR-1
Time frame: 14 days after final vaccination
B cell response to Na-APR-1
Time frame: Study Days 14, 70, 126, 140 and 290
Exploratory cellular immune response to Na-APR-1
Time frame: Study Days 14, 70, 126, 140 and 290
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 Jul 2019.
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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.
David J Diemert, MD principal investigator
George Washington University
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-APR-1 (M74)/Alhydrogel® and Gluco-Pyranosylphospho-Lipid A Aqueous Formulation in people with Hookworm Infection and Hookworm Disease, run by Baylor College of Medicine at 1 site in United States.
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 4 inclusion and 23 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 Jul 2019. 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 United States. 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 290). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2019.