NCT00120081

Brief Summary

The primary objective of this clinical trial is to determine the safety and tolerability of the Na-ASP-2 Hookworm Vaccine in healthy subjects following the administration of 3 intramuscular (IM) injections of the vaccine over 16 weeks using 3 different doses. The secondary objective is to make a preliminary evaluation of the immunogenicity of each of the 3 doses of the vaccine in healthy volunteers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 15, 2005

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

May 31, 2017

Status Verified

May 1, 2017

Enrollment Period

1.4 years

First QC Date

July 7, 2005

Last Update Submit

May 30, 2017

Conditions

Hookworm Infection

Keywords

VaccineHookwormPhase 1Human Hookworm InfectionNa-ASP-2

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability of three different doses of the Na-ASP-2 hookworm vaccine in healthy volunteers

    For the duration of the study

Secondary Outcomes (1)

  • To determine the immunogenicity, both humoral and cellular, of the vaccine at specified time points following vaccination

    2, 8, 10, 16, 18, 24, and 48 weeks after the first injection

Study Arms (4)

Low dose

EXPERIMENTAL

10 mcg Na-ASP-2/Alhydrogel

Biological: Na-ASP-2/Alhydrogel Hookworm Vaccine

Medium dose

EXPERIMENTAL

50 mcg Na-ASP-2/Alhydrogel

Biological: Na-ASP-2/Alhydrogel Hookworm Vaccine

High dose

EXPERIMENTAL

100 mcg Na-ASP-2/Alhydrogel

Biological: Na-ASP-2/Alhydrogel Hookworm Vaccine

Saline placebo

PLACEBO COMPARATOR

Saline placebo

Biological: Saline placebo

Interventions

Na-ASP-2/Alhydrogel Hookworm VaccineBIOLOGICAL

The recombinant hookworm protein Na-ASP-2 formulated on aluminum hydroxide adjuvant (Alhydrogel), in one of three dose concentrations, compared to a saline placebo control.

High doseLow doseMedium dose
Saline placeboBIOLOGICAL

Inactive saline placebo control

Saline placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adults 18 to 45 years of age.
  • Signed informed consent.
  • History, physical exam, and laboratory tests indicating good general health obtained prior to the first injection.
  • All females must have a negative pregnancy test (FDA-approved test for β human chorionic gonadotropin \[β-HCG\]) on the day of the first injection.
  • Serologic tests for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) are negative at screening.
  • All subjects must agree to use an acceptable method of birth control from the start of screening until 2 weeks after the third injection. Acceptable methods for female subjects include hormonal contraceptives, intrauterine device (IUD), diaphragm with spermicide, condoms, abstinence, surgically sterile (hysterectomy), and surgically sterile partner. Acceptable methods for male subjects include surgical sterilization, condoms, partner who uses an acceptable method of birth control, and abstinence.

You may not qualify if:

  • Any history of anaphylaxis or allergy to vaccine components or allergy to insect stings, including bee stings.
  • A past or current history of hookworm infection.
  • BMI \< 18.0 or \> 30.0.
  • Recent (\< 72 hours) history of febrile illness at the time of vaccination (temperature \> 99.6°F or equivalent).
  • Received any immune globulin or blood product 3 months prior to injection or scheduled within 4 weeks thereafter.
  • Had vaccination with a live virus vaccine within 4 weeks before receipt of the vaccine or scheduled within 4 weeks thereafter.
  • Had vaccination with a killed vaccine, or allergy treatment with antigen injections within 14 days of initial study injection.
  • Received an investigational agent within 4 weeks of initial study injection.
  • Known or suspected impairment of immunologic function including, but not limited to clinically significant liver disease, diabetes mellitus, moderate to severe kidney impairment (creatinine \> 1.5), any history of malignancy (except squamous cell or basal cell skin cancer), HIV infection or autoimmune diseases, or concomitant immunosuppressive medication such as glucocorticosteroids.
  • A history of essential hypertension, gastrointestinal abnormalities such as peptic ulcer disease, cardiac (ECG abnormalities), pulmonary, hepatic, renal, pancreatic, or neurologic disease.
  • Taken prescription medications with the exception of subjects on a stable regimen (\> 30 days) of: (1) hormone replacement therapy, (2) use of nasal steroids, (3) topical therapy, (4) certain classes of antidepressants (i.e., selective serotonin re-uptake inhibitors), (5) oral contraceptives, (6) nonsteroidal anti-inflammatory agents, or (7) antihistamines or decongestants for seasonal allergies taken as needed.
  • Contraindication to IM injection such as anti-coagulant therapy or thrombocytopenia.
  • Pregnant, nursing, or expecting to conceive during the study.
  • Any history of chronic alcohol or drug abuse or current treatment with any known prescribed or over-the-counter supplements that may be hepatotoxins.
  • Any subject who, in the Investigator's opinion, will be unable to adhere to protocol requirements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

George Washington University Medical Center

Washington D.C., District of Columbia, 20037, United States

Location

Related Publications (1)

  • Bethony JM, Simon G, Diemert DJ, Parenti D, Desrosiers A, Schuck S, Fujiwara R, Santiago H, Hotez PJ. Randomized, placebo-controlled, double-blind trial of the Na-ASP-2 hookworm vaccine in unexposed adults. Vaccine. 2008 May 2;26(19):2408-17. doi: 10.1016/j.vaccine.2008.02.049. Epub 2008 Mar 11.

    PMID: 18396361RESULT

Related Links

MeSH Terms

Conditions

Hookworm InfectionsAncylostomiasis

Condition Hierarchy (Ancestors)

Strongylida InfectionsSecernentea InfectionsNematode InfectionsHelminthiasisParasitic DiseasesInfections

Study Officials

  • Gary Simon, M.D., Ph.D

    George Washington University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 7, 2005

First Posted

July 15, 2005

Study Start

April 1, 2005

Primary Completion

September 1, 2006

Study Completion

September 1, 2006

Last Updated

May 31, 2017

Record last verified: 2017-05

Locations

US(1)