Hookworm InfectionPhase 1NCT00473967
Phase 1 Trial of Na-ASP-2 Hookworm Vaccine in Previously Infected Brazilian Adults
A Phase 1 study testing Na-ASP-2 Hookworm Vaccine in people with Hookworm Infection, run by Albert B. Sabin Vaccine Institute at 1 site in Brazil.
Trial summary
Na-ASP-2 is a protein expressed during the larval stage of the N. americanus hookworm life cycle. Vaccination with recombinant ASP-2 has protected dogs and hamsters from infection in challenge studies. In a clinical study in hookworm-uninfected adults in the USA, Na-ASP-2 Hookworm Vaccine was safe and immunogenic. 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 Hookworm Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteBrazil
- Study dates
- May 2007to Mar 2009
- 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
- Males or females between 18 and 45 years, inclusive.
- Known residents of the Municipality of Novo Oriente de Minas, Minas Gerais, Brazil.
- Good general health as determined by means of the screening procedure.
- Completed a 3-dose albendazole treatment for documented hookworm infection during the previous 3 months.
- Available for the duration of the trial (42 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 β-hCG (if female).
- Participant unwilling to use reliable contraception methods up until one month following the third immunization (if female).
- 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, or renal disease by history, physical examination, and/or laboratory studies.
- Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the volunteer to understand and cooperate with the study protocol.
Show all 23Show fewer
- Laboratory evidence of liver disease (alanine aminotransferase [ALT] greater than 64 U/l [females] or greater than 58 U/l [males]).
- Laboratory evidence of renal disease (serum creatinine greater than 1.1 mg/dl [females] or greater than 1.3 mg/dl [males], or more than trace protein or blood on urine dipstick testing).
- Laboratory evidence of hematologic disease (absolute leukocyte count <3000/mm3 or >12.5 x 103/mm3; hemoglobin <10.3 g/dl [females] or <11.0 g/dl [males]; absolute lymphocyte count <900/mm3; or platelet count <120,000/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.
- 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 regular use of inhalers or emergency clinic visit or hospitalization within the last 6 months.
- Positive ELISA for HCV.
- Positive ELISA for HBsAg.
- Known immunodeficiency syndrome.
- Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 30 days of starting this 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 past 6 months.
- Previous receipt of a primary series of any hepatitis B vaccine.
- History of allergy to yeast.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blind, Randomized, Controlled Phase 1 Study of the Safety and Immunogenicity of Na-ASP-2 Hookworm Vaccine in Previously-Infected Brazilian Adults
Na-ASP-2 is a protein expressed during the larval stage of the N. americanus hookworm life cycle. Vaccination with recombinant ASP-2 has protected dogs and hamsters from infection in challenge studies. In a clinical study in hookworm-uninfected adults in the USA, Na-ASP-2 Hookworm Vaccine was safe and immunogenic. This study will evaluate its safety and immunogenicity in individuals living in an area of endemic hookworm infection.
Read the detailed description
- Double-blind, randomized, controlled Phase 1 clinical trial.
- Study site: Americaninhas, Minas Gerais, Brazil.
- Number of participants: 48 in three groups of 16, randomized to receive either Na-ASP-2 Hookworm Vaccine (n=36) or Butang® hepatitis B vaccine (n=12).
- Study duration: 48 weeks; each participant will be followed for a total of 42 weeks.
- Immunization schedule: Study days 0, 56 and 112.
- Route: IM in the deltoid muscle.
- Dose of Na-ASP-2: 10, 50 and 100 µg for the first, second and third dose cohort, respectively.
- Dose of Alhydrogel®: 800 µg for each dose of Na-ASP-2.
- Conditions
- Hookworm Infection
- Being tested
- Na-ASP-2 Hookworm Vaccine
- Keywords
- Vaccine, Hookworm, Phase 1, 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 Hookworm VaccineBiological
Injections of one of three different dose concentrations of the Na-ASP-2 vaccine (10, 50, or 100 mcg) vs. the hepatitis B vaccine, delivered at 0, 2, and 4 months by intramuscular injection.
| Study group | Role | What they receive |
|---|---|---|
| 10 mcg Na-ASP-2/Alhydrogel | Experimental | Na-ASP-2 Hookworm Vaccine Receives: Biological: Na-ASP-2 Hookworm Vaccine |
| Butang hepatitis B vaccine | Active comparator | Hepatitis B Vaccine - comparator vaccine Receives: Biological: Na-ASP-2 Hookworm Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the frequency of vaccine-related adverse events, graded by severity, for each dose of the Na-ASP-2 Hookworm Vaccine
Measured: For the duration of the study
Secondary outcomes (3)
To determine the dose of Na-ASP-2 that generates the highest antibody response as determined by an indirect enzyme-linked immunosorbent assay (ELISA)
Measured: 2 weeks after the third injection
To assess and compare the duration of antibody response to Na-ASP-2
Measured: For the duration of the study
To perform exploratory studies of the cellular immune responses to the Na-ASP-2 antigen both before and after immunization
Measured: For the duration of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2007 (estimated)
- Study startMay 2007
- Primary completionMar 2008
- Study completionMar 2009
Why it stopped: Occurrence of unacceptable adverse events.
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.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert B. Sabin Vaccine Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Oswaldo Cruz Foundation, George Washington University, London School of Hygiene and Tropical Medicine
- Responsible party
- Sponsor
- Investigators
- David J Diemert, MD, Principal investigator, Albert B. Sabin Vaccine Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00473967
- Sponsor's protocol ID
- SVI-06-02
- Status last verified
- Jul 2012
- First submitted
- 14 May 2007
- Last updated
- 9 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Diemert DJ, Pinto AG, Freire J, Jariwala A, Santiago H, Hamilton RG, Periago MV, Loukas A, Tribolet L, Mulvenna J, Correa-Oliveira R, Hotez PJ, Bethony JM. Generalized urticaria induced by the Na-ASP-2 hookworm vaccine: implications for the development of vaccines against helminths. J Allergy Clin Immunol. 2012 Jul;130(1):169-76.e6. doi: 10.1016/j.jaci.2012.04.027. Epub 2012 May 26.
PubMed 22633322
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Controlled Phase 1 Study of the Safety and Immunogenicity of Na-ASP-2 Hookworm Vaccine in Previously-Infected Brazilian Adults
- ClinicalTrials.gov ID
- NCT00473967
- Acronym / sponsor ID
- SVI-06-02
- Conditions
- Hookworm Infection
- Keywords
- Vaccine, Hookworm, Phase 1, Na-ASP-2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Occurrence of unacceptable adverse events.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Albert B. Sabin Vaccine InstituteUniversity, hospital or other
- Collaborators
- Oswaldo Cruz Foundation, George Washington University, London School of Hygiene and Tropical Medicine
- Study start
- May 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 16 May 2007 (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.
Na-ASP-2 is a protein expressed during the larval stage of the N. americanus hookworm life cycle. Vaccination with recombinant ASP-2 has protected dogs and hamsters from infection in challenge studies. In a clinical study in hookworm-uninfected adults in the USA, Na-ASP-2 Hookworm Vaccine was safe and immunogenic. This study will evaluate its safety and immunogenicity in individuals living in an area of endemic hookworm infection.
Detailed description
- Double-blind, randomized, controlled Phase 1 clinical trial.
- Study site: Americaninhas, Minas Gerais, Brazil.
- Number of participants: 48 in three groups of 16, randomized to receive either Na-ASP-2 Hookworm Vaccine (n=36) or Butang® hepatitis B vaccine (n=12).
- Study duration: 48 weeks; each participant will be followed for a total of 42 weeks.
- Immunization schedule: Study days 0, 56 and 112.
- Route: IM in the deltoid muscle.
- Dose of Na-ASP-2: 10, 50 and 100 µg for the first, second and third dose cohort, respectively.
- Dose of Alhydrogel®: 800 µg for each dose of Na-ASP-2.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10 mcg Na-ASP-2/Alhydrogel | Experimental | Biological: Na-ASP-2 Hookworm VaccineNa-ASP-2 Hookworm Vaccine |
| Butang hepatitis B vaccine | Active comparator | Biological: Na-ASP-2 Hookworm VaccineHepatitis B Vaccine - comparator vaccine |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Males or females between 18 and 45 years, inclusive.
- Known residents of the Municipality of Novo Oriente de Minas, Minas Gerais, Brazil.
- Good general health as determined by means of the screening procedure.
- Completed a 3-dose albendazole treatment for documented hookworm infection during the previous 3 months.
- Available for the duration of the trial (42 weeks).
Key exclusion criteria (23 listed)
- Pregnancy as determined by a positive urine β-hCG (if female).
- Participant unwilling to use reliable contraception methods up until one month following the third immunization (if female).
- 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, 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-ASP-2 Hookworm VaccineInjections of one of three different dose concentrations of the Na-ASP-2 vaccine (10, 50, or 100 mcg) vs. the hepatitis B vaccine, delivered at 0, 2, and 4 months by intramuscular injection. | Biological | 10 mcg Na-ASP-2/Alhydrogel, Butang hepatitis B vaccine |
Primary outcome
To determine the frequency of vaccine-related adverse events, graded by severity, for each dose of the Na-ASP-2 Hookworm Vaccine
Time frame: For the duration of the study
3 secondary outcomes
To determine the dose of Na-ASP-2 that generates the highest antibody response as determined by an indirect enzyme-linked immunosorbent assay (ELISA)
Time frame: 2 weeks after the third injection
To assess and compare the duration of antibody response to Na-ASP-2
Time frame: For the duration of the study
To perform exploratory studies of the cellular immune responses to the Na-ASP-2 antigen both before and after immunization
Time frame: For the duration of the study
Results and safety
The study was stopped early (reason given: Occurrence of unacceptable adverse events.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2012.
- Results publication: PubMed 22633322Diemert DJ, Pinto AG, Freire J, Jariwala A, Santiago H, Hamilton RG, Periago MV, Loukas A, Tribolet L, Mulvenna J, Correa-Oliveira R, Hotez PJ, Bethony JM. Generalized urticaria induced by the Na-ASP-2 hookworm vaccine: implications for the development of vaccines against helminths. J Allergy Clin Immunol. 2012 Jul;130(1):169-76.e6. doi: 10.1016/j.jaci.2012.04.027. Epub 2012 May 26.
- Sponsor's Web pageLink provided by the sponsor.
- Trial site websiteLink 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.
David J Diemert, MD principal investigator
Albert B. Sabin Vaccine Institute
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 Hookworm Vaccine in people with Hookworm Infection, run by Albert B. Sabin Vaccine Institute at 1 site in Brazil.
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 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: stopped early, as of the sponsor's last update on 9 Jul 2012. 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 Brazil. 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 was stopped early (reason given: Occurrence of unacceptable adverse events.). Results are not available in the source record.
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?
To determine the frequency of vaccine-related adverse events, graded by severity, for each dose of the Na-ASP-2 Hookworm Vaccine (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 NCT00473967, 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 9 Jul 2012.