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

NCT00473967 | Terminated Phase 1 DMC

• 1 other identifier: SVI-06-02
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Hookworm Infection

Keywords

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

Outcome Measures

Primary Outcomes (1)

• To determine the frequency of vaccine-related adverse events, graded by severity, for each dose of the Na-ASP-2 Hookworm Vaccine

  For the duration of the study

Secondary Outcomes (3)

• To determine the dose of Na-ASP-2 that generates the highest antibody response as determined by an indirect enzyme-linked immunosorbent assay (ELISA)

  2 weeks after the third injection

• To assess and compare the duration of antibody response to Na-ASP-2

  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

  For the duration of the study

Study Arms (2)

10 mcg Na-ASP-2/Alhydrogel

EXPERIMENTAL

Na-ASP-2 Hookworm Vaccine

Biological: Na-ASP-2 Hookworm Vaccine

Butang hepatitis B vaccine

ACTIVE COMPARATOR

Hepatitis B Vaccine - comparator vaccine

Biological: Na-ASP-2 Hookworm Vaccine

Interventions

Na-ASP-2 Hookworm Vaccine 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.

10 mcg Na-ASP-2/Alhydrogel; Butang hepatitis B vaccine

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Albert B. Sabin Vaccine Institute: lead
• Oswaldo Cruz Foundation: collaborator
• George Washington University: collaborator
• London School of Hygiene and Tropical Medicine: collaborator

Study Sites (1)

Centro de Pesquisas Rene Rachou

Belo Horizonte, Brazil

Location

Related Publications (1)

• 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.

  PMID: 22633322 RESULT

Related Links

• Sponsor's Web page
• Trial site website

MeSH Terms

Conditions

Hookworm Infections; Ancylostomiasis

Condition Hierarchy (Ancestors)

Strongylida Infections; Secernentea Infections; Nematode Infections; Helminthiasis; Parasitic Diseases; Infections

Study Officials

• David J Diemert, MD

  Albert B. Sabin Vaccine Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2007
• First Posted: May 16, 2007
• Study Start: May 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2009
• Last Updated: July 9, 2012

Record last verified: 2012-07

Locations

BR (1)