Hookworm InfectionPhase 1NCT00120081
Study of Na-ASP-2 Human Hookworm Vaccine in Healthy Adults Without Evidence of Hookworm Infection
A Phase 1 study testing Na-ASP-2/Alhydrogel Hookworm Vaccine in people with Hookworm Infection, run by Baylor College of Medicine at 1 site in United States.
Trial summary
The primary objective of this clinical trial is to determine the safety and tolerability of the Na-ASP-2 Hookworm Vaccine in healthy subjects following the administration of 3 intramuscular (IM) injections of the vaccine over 16 weeks using 3 different doses. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Hookworm Infection
- What is being tested?
- Na-ASP-2/Alhydrogel Hookworm Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Sep 2006
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults 18 to 45 years of age.
- Signed informed consent.
- History, physical exam, and laboratory tests indicating good general health obtained prior to the first injection.
- All females must have a negative pregnancy test (FDA-approved test for β human chorionic gonadotropin [β-HCG]) on the day of the first injection.
- Serologic tests for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) are negative at screening.
- All subjects must agree to use an acceptable method of birth control from the start of screening until 2 weeks after the third injection. Acceptable methods for female subjects include hormonal contraceptives, intrauterine device (IUD), diaphragm with spermicide, condoms, abstinence, surgically sterile (hysterectomy), and surgically sterile partner. Acceptable methods for male subjects include surgical sterilization, condoms, partner who uses an acceptable method of birth control, and abstinence.
Who cannot join
- Any history of anaphylaxis or allergy to vaccine components or allergy to insect stings, including bee stings.
- A past or current history of hookworm infection.
- BMI < 18.0 or > 30.0.
- Recent (< 72 hours) history of febrile illness at the time of vaccination (temperature > 99.6°F or equivalent).
- Received any immune globulin or blood product 3 months prior to injection or scheduled within 4 weeks thereafter.
- Had vaccination with a live virus vaccine within 4 weeks before receipt of the vaccine or scheduled within 4 weeks thereafter.
Show all 15Show fewer
- Had vaccination with a killed vaccine, or allergy treatment with antigen injections within 14 days of initial study injection.
- Received an investigational agent within 4 weeks of initial study injection.
- Known or suspected impairment of immunologic function including, but not limited to clinically significant liver disease, diabetes mellitus, moderate to severe kidney impairment (creatinine > 1.5), any history of malignancy (except squamous cell or basal cell skin cancer), HIV infection or autoimmune diseases, or concomitant immunosuppressive medication such as glucocorticosteroids.
- A history of essential hypertension, gastrointestinal abnormalities such as peptic ulcer disease, cardiac (ECG abnormalities), pulmonary, hepatic, renal, pancreatic, or neurologic disease.
- Taken prescription medications with the exception of subjects on a stable regimen (> 30 days) of: (1) hormone replacement therapy, (2) use of nasal steroids, (3) topical therapy, (4) certain classes of antidepressants (i.e., selective serotonin re-uptake inhibitors), (5) oral contraceptives, (6) nonsteroidal anti-inflammatory agents, or (7) antihistamines or decongestants for seasonal allergies taken as needed.
- Contraindication to IM injection such as anti-coagulant therapy or thrombocytopenia.
- Pregnant, nursing, or expecting to conceive during the study.
- Any history of chronic alcohol or drug abuse or current treatment with any known prescribed or over-the-counter supplements that may be hepatotoxins.
- Any subject who, in the Investigator's opinion, will be unable to adhere to protocol requirements.
Trial locations and contacts
1 site in 1 country.
United States1 site
George Washington University Medical Center
Washington D.C., District of Columbia, 20037
About this study
Official title: Phase 1, Single-Center, Double-Blind, Placebo-Controlled, Randomized, Dose-Escalation Study to Compare the Safety, Tolerability, and Immunogenicity of Three Intramuscular Administrations of Na-ASP-2 Hookworm Vaccine in Healthy Adults Without Evidence of Hookworm Infection
The primary objective of this clinical trial is to determine the safety and tolerability of the Na-ASP-2 Hookworm Vaccine in healthy subjects following the administration of 3 intramuscular (IM) injections of the vaccine over 16 weeks using 3 different doses. The secondary objective is to make a preliminary evaluation of the immunogenicity of each of the 3 doses of the vaccine in healthy volunteers.
Read the detailed description
There is an urgent need for new tools to control human hookworm infection and to reduce its burden of disease in developing countries. This is especially true for children and women of reproductive age who represent populations that are highly vulnerable to the effects of hookworm disease. Up to 65,000 deaths annually have been attributed to human hookworm infection. However, the mortality estimates of hookworm pale in comparison to global disease burden estimates.
The primary approach to hookworm control worldwide has been the frequent and periodic use of benzimidazole anthelminthics for school-age children. However, school-based anthelminthic chemotherapy programs miss populations highly vulnerable to hookworm, including adolescent and adult women. In addition, high rates of hookworm re-infection occur within 4-12 months following anthelminthic chemotherapy, and there is evidence for diminished efficacy of benzimidazoles with frequent and periodic use, possibly because of emerging drug resistance. These concerns have prompted interest in developing alternative tools for hookworm control. Vaccination to prevent high intensity hookworm infection would alleviate the public health deficiencies of drug treatment alone.
- Conditions
- Hookworm Infection
- Being tested
- Na-ASP-2/Alhydrogel Hookworm Vaccine, Saline placebo
- Keywords
- Vaccine, Hookworm, Phase 1, Human Hookworm Infection, Na-ASP-2
- Medical subject headings
- Hookworm Infections, Ancylostomiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Na-ASP-2/Alhydrogel Hookworm VaccineBiological
The recombinant hookworm protein Na-ASP-2 formulated on aluminum hydroxide adjuvant (Alhydrogel), in one of three dose concentrations, compared to a saline placebo control.
Saline placeboBiological
Inactive saline placebo control
| Study group | Role | What they receive |
|---|---|---|
| Low dose | Experimental | 10 mcg Na-ASP-2/Alhydrogel Receives: Biological: Na-ASP-2/Alhydrogel Hookworm Vaccine |
| Medium dose | Experimental | 50 mcg Na-ASP-2/Alhydrogel Receives: Biological: Na-ASP-2/Alhydrogel Hookworm Vaccine |
| High dose | Experimental | 100 mcg Na-ASP-2/Alhydrogel Receives: Biological: Na-ASP-2/Alhydrogel Hookworm Vaccine |
| Saline placebo | Placebo comparator | Saline placebo Receives: Biological: Saline placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of three different doses of the Na-ASP-2 hookworm vaccine in healthy volunteers
Measured: For the duration of the study
Secondary outcomes (1)
To determine the immunogenicity, both humoral and cellular, of the vaccine at specified time points following vaccination
Measured: 2, 8, 10, 16, 18, 24, and 48 weeks after the first injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2005 (estimated)
- Study startApr 2005
- Primary completionSep 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Principal investigator, Maria Elena Bottazzi PhD, Baylor College of Medicine
- Investigators
- Gary Simon, M.D., Ph.D, Principal investigator, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00120081
- Sponsor's protocol ID
- SVI-04-01
- Status last verified
- May 2017
- First submitted
- 7 Jul 2005
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bethony JM, Simon G, Diemert DJ, Parenti D, Desrosiers A, Schuck S, Fujiwara R, Santiago H, Hotez PJ. Randomized, placebo-controlled, double-blind trial of the Na-ASP-2 hookworm vaccine in unexposed adults. Vaccine. 2008 May 2;26(19):2408-17. doi: 10.1016/j.vaccine.2008.02.049. Epub 2008 Mar 11.
PubMed 18396361
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
- Phase 1, Single-Center, Double-Blind, Placebo-Controlled, Randomized, Dose-Escalation Study to Compare the Safety, Tolerability, and Immunogenicity of Three Intramuscular Administrations of Na-ASP-2 Hookworm Vaccine in Healthy Adults Without Evidence of Hookworm Infection
- ClinicalTrials.gov ID
- NCT00120081
- Acronym / sponsor ID
- SVI-04-01
- Conditions
- Hookworm Infection
- Keywords
- Vaccine, Hookworm, Phase 1, Human Hookworm Infection, Na-ASP-2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- Apr 2005
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 15 Jul 2005 (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.
The primary objective of this clinical trial is to determine the safety and tolerability of the Na-ASP-2 Hookworm Vaccine in healthy subjects following the administration of 3 intramuscular (IM) injections of the vaccine over 16 weeks using 3 different doses. The secondary objective is to make a preliminary evaluation of the immunogenicity of each of the 3 doses of the vaccine in healthy volunteers.
Detailed description
There is an urgent need for new tools to control human hookworm infection and to reduce its burden of disease in developing countries. This is especially true for children and women of reproductive age who represent populations that are highly vulnerable to the effects of hookworm disease. Up to 65,000 deaths annually have been attributed to human hookworm infection. However, the mortality estimates of hookworm pale in comparison to global disease burden estimates.
The primary approach to hookworm control worldwide has been the frequent and periodic use of benzimidazole anthelminthics for school-age children. However, school-based anthelminthic chemotherapy programs miss populations highly vulnerable to hookworm, including adolescent and adult women. In addition, high rates of hookworm re-infection occur within 4-12 months following anthelminthic chemotherapy, and there is evidence for diminished efficacy of benzimidazoles with frequent and periodic use, possibly because of emerging drug resistance. These concerns have prompted interest in developing alternative tools for hookworm control. Vaccination to prevent high intensity hookworm infection would alleviate the public health deficiencies of drug treatment alone.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low dose | Experimental | Biological: Na-ASP-2/Alhydrogel Hookworm Vaccine10 mcg Na-ASP-2/Alhydrogel |
| Medium dose | Experimental | Biological: Na-ASP-2/Alhydrogel Hookworm Vaccine50 mcg Na-ASP-2/Alhydrogel |
| High dose | Experimental | Biological: Na-ASP-2/Alhydrogel Hookworm Vaccine100 mcg Na-ASP-2/Alhydrogel |
| Saline placebo | Placebo comparator | Biological: Saline placeboSaline placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy adults 18 to 45 years of age.
- Signed informed consent.
- History, physical exam, and laboratory tests indicating good general health obtained prior to the first injection.
- All females must have a negative pregnancy test (FDA-approved test for β human chorionic gonadotropin [β-HCG]) on the day of the first injection.
- Serologic tests for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) are negative at screening.
Key exclusion criteria (15 listed)
- Any history of anaphylaxis or allergy to vaccine components or allergy to insect stings, including bee stings.
- A past or current history of hookworm infection.
- BMI < 18.0 or > 30.0.
- Recent (< 72 hours) history of febrile illness at the time of vaccination (temperature > 99.6°F or equivalent).
- Received any immune globulin or blood product 3 months prior to injection or scheduled within 4 weeks thereafter.
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-ASP-2/Alhydrogel Hookworm VaccineThe recombinant hookworm protein Na-ASP-2 formulated on aluminum hydroxide adjuvant (Alhydrogel), in one of three dose concentrations, compared to a saline placebo control. | Biological | High dose, Low dose, Medium dose |
| Saline placeboInactive saline placebo control | Biological | Saline placebo |
Primary outcome
Safety and tolerability of three different doses of the Na-ASP-2 hookworm vaccine in healthy volunteers
Time frame: For the duration of the study
1 secondary outcome
To determine the immunogenicity, both humoral and cellular, of the vaccine at specified time points following vaccination
Time frame: 2, 8, 10, 16, 18, 24, and 48 weeks after the first injection
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.
- Results publication: PubMed 18396361Bethony JM, Simon G, Diemert DJ, Parenti D, Desrosiers A, Schuck S, Fujiwara R, Santiago H, Hotez PJ. Randomized, placebo-controlled, double-blind trial of the Na-ASP-2 hookworm vaccine in unexposed adults. Vaccine. 2008 May 2;26(19):2408-17. doi: 10.1016/j.vaccine.2008.02.049. Epub 2008 Mar 11.
- Sponsor's Web pageLink provided by the sponsor.
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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.
Gary Simon, M.D., Ph.D 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-ASP-2/Alhydrogel Hookworm Vaccine in people with Hookworm Infection, 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 6 inclusion and 15 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 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. Some participants in this study may receive a placebo. 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?
Safety and tolerability of three different doses of the Na-ASP-2 hookworm vaccine in healthy volunteers (time frame: For the duration of the study). 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 NCT00120081, 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 31 May 2017.