Loading clinical trials...

Phase 1 Trial of Na-ASP-2 Hookworm Vaccine in Previously Infected Brazilian Adults | Clinical Trials | Clareo Health

TERMINATEDPHASE1

Phase 1 Trial of Na-ASP-2 Hookworm Vaccine in Previously Infected Brazilian Adults

Double-blind, Randomized, Controlled Phase 1 Study of the Safety and Immunogenicity of Na-ASP-2 Hookworm Vaccine in Previously-Infected Brazilian Adults

NCT00473967•Albert B. Sabin Vaccine Institute

View on ClinicalTrials.gov

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. 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.

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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.

Exclusion Criteria

•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.
•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.
+13 more criteria

Locations (1)

Centro de Pesquisas Rene Rachou

Belo Horizonte, Brazil

Key Dates

Start Date

May 1, 2007

Primary Completion Date

March 1, 2008

Completion Date

March 1, 2009

Last Updated

July 9, 2012

Enrollment

ACTUAL participants

Conditions

Hookworm Infection

Interventions

Na-ASP-2 Hookworm Vaccine

BIOLOGICAL

Efficacy and Safety of Emodepside in Participants With Soil-transmitted Helminth Infections

NCT06736691

Trichuris Trichiura; InfectionHookworm Infection+1 more

View study

COMPLETEDPHASE1

Safety and Immunogenicity of a Human Hookworm Candidate Vaccine With Different Doses of a Novel Adjuvant

NCT01385189

Hookworm InfectionHookworm Disease

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 9, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Phase 1 Trial of Na-ASP-2 Hookworm Vaccine in Previously Infected Brazilian Adults

Inclusion Criteria

Exclusion Criteria

Efficacy and Safety of Emodepside in Participants With Soil-transmitted Helminth Infections

Safety and Immunogenicity of a Human Hookworm Candidate Vaccine With Different Doses of a Novel Adjuvant

Efficacy and Safety of Emodepside in Adolescents and Adults Infected With Hookworm

Efficacy and Safety of a New Chewable Versus the Swallowable Tablet of Mebendazole Against Hookworm

Soil-transmitted Helminth Reinfection Rates After Single and Repeated School Hygiene Education

Safety and Immunogenicity of the Na-APR-1 Hookworm Vaccine in Healthy Adults