Clinical trial: Zika Virus Purified Inactivated Vaccine (ZPIV) Accelerated Vaccination Schedule Study (NCT02937233)

Eligibility 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
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 50 Years

Patient description (medical language): A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia.  The patient is sexually active with his wife and does not use any contraception methods.  They have been trying to conceive for the past year with no success.  The patient has a past medical history of recurrent pneumonia, shortness of breath, and  persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol.  The patient has no history of other medical conditions including allergies or any kind of surgery.  On physical examination, the digits show clubbing.  An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test.

Patient description (patient's own words): I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test.

Does the patient match the trial criteria? Entailment