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

Albert B. Sabin Vaccine Institute

Status and phase

Terminated

Phase 1

Conditions

Hookworm Infection

Treatments

Biological: Na-ASP-2 Hookworm Vaccine

Study type

Interventional

Funder types

Other

Identifiers

NCT00473967

SVI-06-02

Details and patient eligibility

About

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.

Full 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.

Enrollment

9 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.