We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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:
ClinicalTrials.gov Identifier:
NCT00473967
First Posted: May 16, 2007
Last Update Posted: July 9, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Oswaldo Cruz Foundation
George Washington University
London School of Hygiene and Tropical Medicine
Information provided by (Responsible Party):
Albert B. Sabin Vaccine Institute
May 14, 2007
May 16, 2007
July 9, 2012
May 2007
March 2008   (Final data collection date for 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 ]
Same as current
Complete list of historical versions of study NCT00473967 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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
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.
  • 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.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Hookworm Infection
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.
  • Experimental: 10 mcg Na-ASP-2/Alhydrogel
    Na-ASP-2 Hookworm Vaccine
    Intervention: Biological: Na-ASP-2 Hookworm Vaccine
  • Active Comparator: Butang hepatitis B vaccine
    Hepatitis B Vaccine - comparator vaccine
    Intervention: Biological: Na-ASP-2 Hookworm Vaccine
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
9
March 2009
March 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT00473967
SVI-06-02
Yes
Not Provided
Not Provided
Albert B. Sabin Vaccine Institute
Albert B. Sabin Vaccine Institute
  • Oswaldo Cruz Foundation
  • George Washington University
  • London School of Hygiene and Tropical Medicine
Principal Investigator: David J Diemert, MD Albert B. Sabin Vaccine Institute
Albert B. Sabin Vaccine Institute
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP