Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-01-10 @ 5:15 PM
Study NCT ID:
NCT00473967
Status:
TERMINATED
Last Update Posted:
2012-07-09
First Post:
2007-05-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1 Trial of Na-ASP-2 Hookworm Vaccine in Previously Infected Brazilian Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006725', 'term': 'Hookworm Infections'}, {'id': 'D000724', 'term': 'Ancylostomiasis'}], 'ancestors': [{'id': 'D017206', 'term': 'Strongylida Infections'}, {'id': 'D017190', 'term': 'Secernentea Infections'}, {'id': 'D009349', 'term': 'Nematode Infections'}, {'id': 'D006373', 'term': 'Helminthiasis'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'whyStopped': 'Occurrence of unacceptable adverse events.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-06', 'studyFirstSubmitDate': '2007-05-14', 'studyFirstSubmitQcDate': '2007-05-14', 'lastUpdatePostDateStruct': {'date': '2012-07-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-05-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the frequency of vaccine-related adverse events, graded by severity, for each dose of the Na-ASP-2 Hookworm Vaccine', 'timeFrame': 'For the duration of the study'}], 'secondaryOutcomes': [{'measure': 'To determine the dose of Na-ASP-2 that generates the highest antibody response as determined by an indirect enzyme-linked immunosorbent assay (ELISA)', 'timeFrame': '2 weeks after the third injection'}, {'measure': 'To assess and compare the duration of antibody response to Na-ASP-2', 'timeFrame': 'For the duration of the study'}, {'measure': 'To perform exploratory studies of the cellular immune responses to the Na-ASP-2 antigen both before and after immunization', 'timeFrame': 'For the duration of the study'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Vaccine', 'Hookworm', 'Phase 1', 'Na-ASP-2'], 'conditions': ['Hookworm Infection']}, 'referencesModule': {'references': [{'pmid': '22633322', 'type': 'RESULT', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://www.sabin.org', 'label': "Sponsor's Web page"}, {'url': 'http://www.cpqrr.fiocruz.br', 'label': 'Trial site website'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '* Double-blind, randomized, controlled Phase 1 clinical trial.\n* Study site: Americaninhas, Minas Gerais, Brazil.\n* 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).\n* Study duration: 48 weeks; each participant will be followed for a total of 42 weeks.\n* Immunization schedule: Study days 0, 56 and 112.\n* Route: IM in the deltoid muscle.\n* Dose of Na-ASP-2: 10, 50 and 100 µg for the first, second and third dose cohort, respectively.\n* Dose of Alhydrogel®: 800 µg for each dose of Na-ASP-2.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or females between 18 and 45 years, inclusive.\n* Known residents of the Municipality of Novo Oriente de Minas, Minas Gerais, Brazil.\n* Good general health as determined by means of the screening procedure.\n* Completed a 3-dose albendazole treatment for documented hookworm infection during the previous 3 months.\n* Available for the duration of the trial (42 weeks).\n* Willingness to participate in the study as evidenced by signing the informed consent document.\n\nExclusion Criteria:\n\n* Pregnancy as determined by a positive urine β-hCG (if female).\n* Participant unwilling to use reliable contraception methods up until one month following the third immunization (if female).\n* Currently lactating and breast-feeding (if female).\n* Inability to correctly answer all questions on the informed consent comprehension questionnaire.\n* Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies.\n* 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.\n* Laboratory evidence of liver disease (alanine aminotransferase \\[ALT\\] greater than 64 U/l \\[females\\] or greater than 58 U/l \\[males\\]).\n* 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).\n* 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).\n* 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.\n* Participation in another investigational vaccine or drug trial within 30 days of starting this study.\n* Volunteer has had medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months.\n* History of a severe allergic reaction or anaphylaxis.\n* Severe asthma as defined by the need for regular use of inhalers or emergency clinic visit or hospitalization within the last 6 months.\n* Positive ELISA for HCV.\n* Positive ELISA for HBsAg.\n* Known immunodeficiency syndrome.\n* Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 30 days of starting this study.\n* Receipt of a live vaccine within past 4 weeks or a killed vaccine within past 2 weeks prior to entry into the study.\n* History of a surgical splenectomy.\n* Receipt of blood products within the past 6 months.\n* Previous receipt of a primary series of any hepatitis B vaccine.\n* History of allergy to yeast.'}, 'identificationModule': {'nctId': 'NCT00473967', 'briefTitle': 'Phase 1 Trial of Na-ASP-2 Hookworm Vaccine in Previously Infected Brazilian Adults', 'organization': {'class': 'OTHER', 'fullName': 'Albert B. Sabin Vaccine Institute'}, 'officialTitle': 'Double-blind, Randomized, Controlled Phase 1 Study of the Safety and Immunogenicity of Na-ASP-2 Hookworm Vaccine in Previously-Infected Brazilian Adults', 'orgStudyIdInfo': {'id': 'SVI-06-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '10 mcg Na-ASP-2/Alhydrogel', 'description': 'Na-ASP-2 Hookworm Vaccine', 'interventionNames': ['Biological: Na-ASP-2 Hookworm Vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Butang hepatitis B vaccine', 'description': 'Hepatitis B Vaccine - comparator vaccine', 'interventionNames': ['Biological: Na-ASP-2 Hookworm Vaccine']}], 'interventions': [{'name': 'Na-ASP-2 Hookworm Vaccine', 'type': 'BIOLOGICAL', 'description': '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.', 'armGroupLabels': ['10 mcg Na-ASP-2/Alhydrogel', 'Butang hepatitis B vaccine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Belo Horizonte', 'country': 'Brazil', 'facility': 'Centro de Pesquisas Rene Rachou', 'geoPoint': {'lat': -19.92083, 'lon': -43.93778}}], 'overallOfficials': [{'name': 'David J Diemert, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Albert B. Sabin Vaccine Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Albert B. Sabin Vaccine Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Oswaldo Cruz Foundation', 'class': 'OTHER'}, {'name': 'George Washington University', 'class': 'OTHER'}, {'name': 'London School of Hygiene and Tropical Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}