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

May 14, 2007
July 6, 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 ] [ Designated as safety issue: Yes ]
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 ]
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 ] [ 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 ]
  • 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 ]
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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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.
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00473967
SVI-06-02
Yes
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