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

This study has been terminated.
(Occurrence of unacceptable adverse events.)
Sponsor:
Collaborators:
Oswaldo Cruz Foundation
George Washington University
London School of Hygiene and Tropical Medicine
Information provided by (Responsible Party):
Albert B. Sabin Vaccine Institute
ClinicalTrials.gov Identifier:
NCT00473967
First received: May 14, 2007
Last updated: July 6, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Hookworm Infection
Biological: Na-ASP-2 Hookworm Vaccine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Albert B. Sabin Vaccine Institute:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • To assess and compare the duration of antibody response to Na-ASP-2 [ Time Frame: For the duration of the study ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: May 2007
Study Completion Date: March 2009
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 10 mcg Na-ASP-2/Alhydrogel
Na-ASP-2 Hookworm Vaccine
Biological: Na-ASP-2 Hookworm Vaccine
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.
Active Comparator: Butang hepatitis B vaccine
Hepatitis B Vaccine - comparator vaccine
Biological: Na-ASP-2 Hookworm Vaccine
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.

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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00473967

Locations
Brazil
Centro de Pesquisas Rene Rachou
Belo Horizonte, Brazil
Sponsors and Collaborators
Albert B. Sabin Vaccine Institute
Oswaldo Cruz Foundation
George Washington University
London School of Hygiene and Tropical Medicine
Investigators
Principal Investigator: David J Diemert, MD Albert B. Sabin Vaccine Institute
  More Information

Additional Information:
Publications:
Responsible Party: Albert B. Sabin Vaccine Institute
ClinicalTrials.gov Identifier: NCT00473967     History of Changes
Other Study ID Numbers: SVI-06-02
Study First Received: May 14, 2007
Last Updated: July 6, 2012
Health Authority: United States: Food and Drug Administration
Brazil: National Health Surveillance Agency
Brazil: Ministry of Health

Keywords provided by Albert B. Sabin Vaccine Institute:
Vaccine
Hookworm
Phase 1
Na-ASP-2

Additional relevant MeSH terms:
Hookworm Infections
Ancylostomiasis
Strongylida Infections
Secernentea Infections
Nematode Infections
Helminthiasis
Parasitic Diseases

ClinicalTrials.gov processed this record on September 30, 2014