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

NCT ID: NCT00473967

Last Updated: 2012-07-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2009-03-31

Brief 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.

Conditions

Hookworm Infection

Keywords

Vaccine; Hookworm; Phase 1; Na-ASP-2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

10 mcg Na-ASP-2/Alhydrogel

Na-ASP-2 Hookworm Vaccine

Group Type: EXPERIMENTAL

Na-ASP-2 Hookworm Vaccine

Intervention Type: BIOLOGICAL

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.

Butang hepatitis B vaccine

Hepatitis B Vaccine - comparator vaccine

Group Type: ACTIVE_COMPARATOR

Na-ASP-2 Hookworm Vaccine

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oswaldo Cruz Foundation

OTHER

Sponsor Role: collaborator

George Washington University

OTHER

Sponsor Role: collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role: collaborator

Albert B. Sabin Vaccine Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David J Diemert, MD

Role: PRINCIPAL_INVESTIGATOR

Albert B. Sabin Vaccine Institute

Locations

Centro de Pesquisas Rene Rachou

Belo Horizonte, , Brazil

Countries

Brazil

References

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.

Reference Type: RESULT

PMID: 22633322 (View on PubMed)

Related Links

http://www.sabin.org

Sponsor's Web page

http://www.cpqrr.fiocruz.br

Trial site website

Other Identifiers

SVI-06-02

Identifier Type: -

Identifier Source: org_study_id