Hookworm InfectionPhase 1NCT03373214
Na-GST-1/Alhydrogel With or Without CpG 10104 in Gabonese Adults
A Phase 1 study testing Na-GST-1 and CPG 10104 in people with Hookworm Infection and Hookworm Disease, run by Baylor College of Medicine at 1 site in Gabon.
Trial summary
Na-GST-1 is a protein expressed during the adult stage of the Necator americanus hookworm life cycle that is thought to play a role in the parasite's degradation of host hemoglobin for use as an energy source. Vaccination with recombinant Na-GST-1 has protected dogs and hamsters 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-GST-1 and CPG 10104
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteGabon
- Study dates
- 1 Feb 2018to 30 Mar 2019
- 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 the study area.
- Good general health as determined by means of the screening procedure.
- Assumed availability for the duration of the trial (13 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 human choriogonadotropin (hCG) test (if female).
- Participant unwilling to use reliable contraception up until one month following the final immunization (if female and not surgically sterile, abstinent, at least 2 years post-menopausal, or determined otherwise by medical evaluation to be sterile).
- 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.
- Has a diagnosis of schizophrenia, bipolar disease or other major psychiatric condition that would make compliance with study visits/procedures difficult (e.g., subject with psychoses or history of suicide attempt or gesture in the 3 years before study entry, ongoing risk for suicide).
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- 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 glucose on urine dipstick testing).
- Laboratory evidence of hematologic disease (absolute leukocyte count <3500/mm3; absolute leukocyte count >11.0 x 103/mm3; hemoglobin <10.0 g/dl [females] or <12.0 g/dl [males]; or, platelet count <140,000/mm3).
- Other condition that in the opinion of the investigator could jeopardize the safety or rights of a volunteer participating in the trial or would render them 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 volunteer'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 planned use up to one month after the volunteer's final vaccination.
- 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 the Na-GST-1/Alhydrogel® vaccine.
- Pre-existing autoimmune or antibody-mediated diseases including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, autoimmune thrombocytopenia; or laboratory evidence of possible autoimmune disease determined by a positive anti-dsDNA titer, positive rheumatoid factor, proteinuria (greater than trace protein on urine dipstick testing) and/or a positive ANA.
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 Na-GST-1/Alhydrogel®, With or Without a CPG ODN Adjuvant, in Gabonese Adults
Na-GST-1 is a protein expressed during the adult stage of the Necator americanus hookworm life cycle that is thought to play a role in the parasite's degradation of host hemoglobin for use as an energy source. Vaccination with recombinant Na-GST-1 has protected dogs and hamsters from infection in challenge studies. This study will evaluate the safety and immunogenicity of administering Na-GST-1 with or without the CpG 10104 immunostimulant 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 aged 18 to 50 years living in the area of Lambaréné, Gabon. Participants will receive three doses of the assigned vaccine(s) delivered intramuscularly (deltoid) on approximately Days 0, 56, and 112.
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 final 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; the functional activity of vaccine-induced antibodies will be assessed by in vitro enzyme neutralization assays.
Recruitment and enrollment into the study will occur on an ongoing basis, with each group being recruited and vaccinated in sequence.
24 subjects will be enrolled into 2 groups:
- Group 1 (n=12):
- 8 subjects will receive 30 µg Na-GST-1 plus 500 µg CPG 10104 delivered by IM injection in the deltoid muscle
- 4 subjects will receive 100 µg Na-GST-1 delivered by IM injection in the deltoid muscle
- Group 2 (n=12):
- 8 subjects will receive 100 µg Na-GST-1 plus 500 µg CPG 10104 delivered by IM injection in the deltoid muscle
- 4 subjects will receive 100 µg Na-GST-1 delivered by IM injection in the deltoid muscle
- Conditions
- Hookworm Infection, Hookworm Disease
- Being tested
- Na-GST-1, CPG 10104
- Keywords
- Human Hookworm, Necator americanus, Hookworm, Hookworm Disease, Iron-deficiency anemia, Soil-transmitted helminth infection, Neglected Tropical Disease, Na-GST-1, CpG
- 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-GST-1Biological
Na-GST-1/Alhydrogel®
CPG 10104Biological
CPG 10104
| Study group | Role | What they receive |
|---|---|---|
| 30 µg Na-GST-1 + CPG 10104 | Experimental | Not described Receives: Biological: Na-GST-1; Biological: CPG 10104 |
| 100 µg Na-GST-1 + CPG 10104 | Experimental | Not described Receives: Biological: Na-GST-1; Biological: CPG 10104 |
| 100 µg Na-GST-1 | Experimental | Not described Receives: Biological: Na-GST-1 |
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 two different dose concentrations of Na-GST-1/Alhydrogel® administered with or without CPG 10104 in healthy Gabonese adults.
Measured: Day 380
Secondary outcomes (1)
Anti-Na-GST-1 IgG Antibody Level on Day 126
- To determine the dose/formulation that results in the highest level of anti-Na-GST-1 IgG antibody approximately 14 days after the final vaccination.
Measured: Day 126
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2017
- Study start1 Feb 2018
- Primary completion28 Feb 2019
- Study completion30 Mar 2019
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche Médicale de Lambaréné, George Washington University, Leiden University Medical Center, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Amsterdam Institute for Global Health and Development
- Responsible party
- Principal investigator, Maria Elena Bottazzi PhD, Baylor College of Medicine
- Investigators
- Ayola Adegnika, MD, Principal investigator, Centre de Recherches Medicales de Lambarené
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03373214
- Sponsor's protocol ID
- HV-03
- Status last verified
- Jan 2021
- First submitted
- 6 Dec 2017
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. 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 Na-GST-1/Alhydrogel®, With or Without a CPG ODN Adjuvant, in Gabonese Adults
- ClinicalTrials.gov ID
- NCT03373214
- Acronym / sponsor ID
- HV-03
- Conditions
- Hookworm Infection, Hookworm Disease
- Keywords
- Human Hookworm, Necator americanus, Hookworm, Hookworm Disease, Iron-deficiency anemia, Soil-transmitted helminth infection, Neglected Tropical Disease, Na-GST-1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Centre de Recherche Médicale de Lambaréné, George Washington University, Leiden University Medical Center, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Amsterdam Institute for Global Health and Development
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 14 Dec 2017 (actual)
- 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.
Na-GST-1 is a protein expressed during the adult stage of the Necator americanus hookworm life cycle that is thought to play a role in the parasite's degradation of host hemoglobin for use as an energy source. Vaccination with recombinant Na-GST-1 has protected dogs and hamsters from infection in challenge studies. This study will evaluate the safety and immunogenicity of administering Na-GST-1 with or without the CpG 10104 immunostimulant to healthy Gabonese adults living in an area of endemic hookworm infection.
Detailed description
Double blind, randomized, controlled, dose-escalation Phase 1 clinical trial in hookworm-exposed adults aged 18 to 50 years living in the area of Lambaréné, Gabon. Participants will receive three doses of the assigned vaccine(s) delivered intramuscularly (deltoid) on approximately Days 0, 56, and 112.
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 final 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; the functional activity of vaccine-induced antibodies will be assessed by in vitro enzyme neutralization assays.
Recruitment and enrollment into the study will occur on an ongoing basis, with each group being recruited and vaccinated in sequence.
24 subjects will be enrolled into 2 groups:
- Group 1 (n=12):
- 8 subjects will receive 30 µg Na-GST-1 plus 500 µg CPG 10104 delivered by IM injection in the deltoid muscle
- 4 subjects will receive 100 µg Na-GST-1 delivered by IM injection in the deltoid muscle
- Group 2 (n=12):
- 8 subjects will receive 100 µg Na-GST-1 plus 500 µg CPG 10104 delivered by IM injection in the deltoid muscle
- 4 subjects will receive 100 µg Na-GST-1 delivered by IM injection in the deltoid muscle
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 30 µg Na-GST-1 + CPG 10104 | Experimental | Biological: Na-GST-1, Biological: CPG 10104 |
| 100 µg Na-GST-1 + CPG 10104 | Experimental | Biological: Na-GST-1, Biological: CPG 10104 |
| 100 µg Na-GST-1 | Experimental | Biological: Na-GST-1 |
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 the study area.
- Good general health as determined by means of the screening procedure.
- Assumed availability for the duration of the trial (13 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 (23 listed)
- Pregnancy as determined by a positive urine human choriogonadotropin (hCG) test (if female).
- Participant unwilling to use reliable contraception up until one month following the final immunization (if female and not surgically sterile, abstinent, at least 2 years post-menopausal, or determined otherwise by medical evaluation to be sterile).
- 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-GST-1Na-GST-1/Alhydrogel® | Biological | 100 µg Na-GST-1, 100 µg Na-GST-1 + CPG 10104, 30 µg Na-GST-1 + CPG 10104 |
| CPG 10104CPG 10104 | Biological | 100 µg Na-GST-1 + CPG 10104, 30 µg Na-GST-1 + CPG 10104 |
Primary outcome
Vaccine-related Adverse Events
Time frame: Day 380
1. To evaluate the safety and reactogenicity of two different dose concentrations of Na-GST-1/Alhydrogel® administered with or without CPG 10104 in healthy Gabonese adults.
1 secondary outcome
Anti-Na-GST-1 IgG Antibody Level on Day 126
Time frame: Day 126
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 13 Jan 2021.
- 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?
A Phase 1 study testing Na-GST-1 and CPG 10104 in people with Hookworm Infection and Hookworm Disease, 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 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 13 Jan 2021. 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 380). 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 13 Jan 2021.