Phase 1 Trial of Na-ASP-2 Hookworm Vaccine in Previously Infected Brazilian Adults
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.
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.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Conditions
Hookworm Infection
Intervention
Na-ASP-2 Hookworm Vaccine
Location
Centro de Pesquisas Rene Rachou
Belo Horizonte
Brazil
Status
Active, not recruiting
Source
Albert B. Sabin Vaccine Institute
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00473967
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Haemonchiasis
Infection with nematodes of the genus HAEMONCHUS, characterized by digestive abnormalities and anemia similar to that from hookworm infestation.
Hookworm Infections
Infection of humans or animals with hookworms other than those caused by the genus Ancylostoma or Necator, for which the specific terms ANCYLOSTOMIASIS and NECATORIASIS are available.
Rafoxanide
Veterinary anthelmintic for grazing animals; used to treat fluke, hookworm and other infestations.
Diphtheria-tetanus Vaccine
A combined vaccine used to prevent infection with diphtheria and tetanus toxoid. This is used in place of DTP vaccine (DIPHTHERIA-TETANUS-PERTUSSIS VACCINE) when PERTUSSIS VACCINE is contraindicated.
Ancylostoma
A genus of nematode intestinal parasites that consists of several species. A. duodenale is the common hookworm in humans. A. braziliense, A. ceylonicum, and A. caninum occur primarily in cats and dogs, but all have been known to occur in humans.
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