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Zika Virus Purified Inactivated Vaccine (ZPIV) Accelerated Vaccination Schedule Study (Z001)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02937233
First Posted: October 18, 2016
Last Update Posted: September 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Walter Reed Army Institute of Research (WRAIR)
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Kathryn Stephenson, Beth Israel Deaconess Medical Center
  Purpose
This is a phase 1 trial of one or more administrations of Zika Virus Purified Inactivated Vaccine (ZPIV). The trial will be conducted under a placebo controlled, double-blind, randomized allocation of study product. There are four groups in the study. Each group is testing a different vaccine schedule.

Condition Intervention Phase
Zika Biological: Zika Virus Purified Inactivated Vaccine Other: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 1, Randomized, Double-Blind Placebo-Controlled Clinical Trial to Evaluate the Safety and Immunogenicity of an Accelerated Vaccination Schedule With a Zika Virus Purified Inactivated Vaccine Plus Alum Adjuvant in Healthy Adults

Resource links provided by NLM:


Further study details as provided by Kathryn Stephenson, Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Incidence, intensity, and relationship to vaccination of solicited local and systemic adverse events [ Time Frame: 7 days following each vaccination ]
  • Incidence, intensity, and relationship to vaccination of unsolicited local and systemic adverse events [ Time Frame: 28 days following each vaccination ]
  • Incidence, intensity, and relationship to vaccination of serious local and systemic adverse events [ Time Frame: 365 days following each vaccination ]

Secondary Outcome Measures:
  • ZIKV microneutralization Log10 MN50 titers [ Time Frame: 28 days following last vaccination, and at 6 months ]
  • Zika Env-specific Log10 endpoint ELISA titers [ Time Frame: 28 days following last vaccination, and at 6 months ]
  • Zika Plaque reduction neutralization test titer [ Time Frame: 28 days following last vaccination, and at 6 months ]
  • IFN-γ ELISPOT responses to prM, Env, Cap, and NS1 peptides [ Time Frame: 28 days following last vaccination, and at 6 months ]

Enrollment: 36
Actual Study Start Date: December 8, 2016
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 4 Week Schedule
Zika Purified Inactivated Vaccine 5 mcg (or placebo) IM at Week 0 and Week 4
Biological: Zika Virus Purified Inactivated Vaccine Other: Placebo
Experimental: 2 Week Schedule
Zika Purified Inactivated Vaccine 5 mcg (or placebo) IM at Week 0 and Week 2
Biological: Zika Virus Purified Inactivated Vaccine Other: Placebo
Experimental: Single Vaccination Schedule
Zika Purified Inactivated Vaccine 5 mcg (or placebo) IM at Week 0 only
Biological: Zika Virus Purified Inactivated Vaccine Other: Placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age 18-50 years old.
  2. Ability and willingness to provide informed consent.
  3. Assessment of understanding: completion of a questionnaire prior to first screening procedure; verbally demonstrate understanding of all questionnaire items answered incorrectly.
  4. Available for the duration of the trial.
  5. Good general health as shown by medical history, physical exam, and screening laboratory tests.
  6. The following laboratory parameters:

    • Hematology

      • Hemoglobin ≥10.5 g/dL for women; ≥11 g/dL for men
      • Absolute Neutrophil Count (ANC): ≥1000/mm3
      • Platelets: 125,000 to 550,000/mm3
    • Chemistry

      • Creatinine: <1.1 x upper limit of normal (ULN)
      • AST: <1.25 x ULN
      • ALT: <1.25 x ULN
    • Normal urinalysis

      • Negative urine glucose.
      • Negative or trace urine protein.
      • Negative or trace urine hemoglobin (if trace hemoglobin is present on dipstick, a microscopic urinalysis within institutional range).
  7. All female participants must be willing to undergo serum or urine beta human chorionic gonadotropin pregnancy tests at time points indicated in the Schedule of Procedures and must test negative prior to vaccination.
  8. All sexually active males (unless anatomically sterile) must be willing to use an effective method of contraception (such as consistent condom use) from the day of first vaccination until Week 12.
  9. If a woman of child-bearing potential, committed to use an effective method of contraception when sexually active with men until Week 12, including:

    • Condoms (male or female) with or without spermicide.
    • Diaphragm or cervical cap with spermicide.
    • Intrauterine device.
    • Hormonal contraception.
    • Successful vasectomy in the male partner (considered successful if a woman reports that a male partner has [1] documentation of azoospermia by microscopy, or [2] a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity post-vasectomy).
    • Not be of reproductive potential, such as having undergone hysterectomy, bilateral oophorectomy, or tubal ligation.

Exclusion Criteria:

  1. History of known flavivirus infection or previous receipt of flavivirus vaccine.
  2. Positive serology for HIV-1, Hepatitis B surface antigen, or anti-hepatitis C virus antibodies prior to enrollment.
  3. Planned travel to areas with active Zika virus transmission during the study period.
  4. Recent (within 3 weeks) travel to an area with active Zika virus transmission.
  5. Current or planned participation in another clinical trial of an experimental agent during the study period.
  6. Pregnant or lactating.
  7. Any condition, including any clinically significant acute or chronic medical condition, for which, in the opinion of the investigator, participation would not be in the best interest of the subject (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
  8. Use of anticancer, antituberculosis or other medications considered significant by the investigator within the previous 6 months.
  9. Receipt of live-attenuated vaccine within the previous 60 days or planned receipt within 60 days after vaccination with Investigational Product (within 14 days for live attenuated influenza vaccine [LAIV]); or receipt of other vaccine (e.g., influenza, pneumococcal), allergy treatment with antigen injections or tuberculin skin test within the previous 14 days or planned receipt within 14 days after vaccination with Investigational Product
  10. Receipt of blood transfusion or blood-derived products within the previous 3 months.
  11. Previous severe local or systemic reactions to vaccination.
  12. History of splenectomy
  13. History of seizure in the last 3 years (participants with a history of seizures who have neither required medications nor had a seizure for 3 years are not excluded)
  14. Known autoimmune disease
  15. Asthma other than mild, well-controlled asthma. Exclude participants who:

    1. Use a bronchodilator (beta 2 agonist) daily, or
    2. In the past year have (any of the following):

    i. Had > 1 exacerbation of symptoms treated with oral steroids ii. Routinely used moderate to high dose inhaled corticosteroids (e.g., more than the equivalent of 250 mcg fluticasone; 400 mcg budesonide; 500 mcg beclomethasone; or 1000 mcg triamcinolone/flunisolide, as a daily dose) or theophylline iii. Needed emergency care, urgent care, hospitalization, or intubation for asthma c. Prophylactic bronchodilator use prior to exercise is not exclusionary

  16. Diabetes mellitus type 1 or type 2, including cases controlled with diet alone. (Not excluded: history of isolated gestational diabetes.)
  17. Thyroidectomy, or thyroid disease requiring medication during the last 12 months
  18. Angioedema within the last 3 years if episodes are considered serious or have required medication within the last 2 years
  19. Uncontrolled Hypertension:

    1. If a person has been diagnosed with hypertension during screening or previously, exclude for hypertension that is not well controlled. Well- controlled hypertension is defined as blood pressure consistently ≤ 140 mm Hg systolic and ≤ 90 mm Hg diastolic, with or without medication, with only isolated, brief instances of higher readings, which must be ≤ 150 mm
    2. If a person has NOT been diagnosed with hypertension during screening or previously, exclude for systolic blood pressure ≥ 150 mm Hg at enrollment or diastolic blood pressure ≥ 90 mm Hg at enrolment
  20. Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions)
  21. Malignancy (Not excluded: a participant with a surgical excision and subsequent observation period that in the investigator's estimation has a reasonable assurance of sustained cure or is unlikely to recur during the study period)
  22. Psychiatric condition that compromises safety of the participant or precludes compliance with the protocol, specifically excluding persons with psychoses within the past 3 years, ongoing risk for suicide, or history of suicide attempt or gesture within the past 3 years
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02937233


Locations
United States, Massachusetts
Center for Virology and Vaccine Research Clinical Trials Unit, Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Kathryn Stephenson
Walter Reed Army Institute of Research (WRAIR)
National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

Responsible Party: Kathryn Stephenson, Assistant Professor of Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT02937233     History of Changes
Other Study ID Numbers: 2016P000268
First Submitted: October 12, 2016
First Posted: October 18, 2016
Last Update Posted: September 29, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Kathryn Stephenson, Beth Israel Deaconess Medical Center:
Zika
Vaccine
ZPIV

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs