Clinical trial: Safety of and Immune Response to a DNA HIV Vaccine Boosted With a Modified Vaccinia HIV Vaccine and Protein HIV Vaccine in Healthy Adults (NCT01418235)

Eligibility criteria:
Inclusion Criteria:

          1. Age of 18 to 45 years

          2. Access to a participating HVTN clinical research site and willingness to be followed
             for the planned duration of the study

          3. Ability and willingness to provide informed consent

          4. Assessment of understanding: volunteer demonstrates understanding of this study and
             other relevant study results and completes a questionnaire prior to first vaccination
             with verbal demonstration of understanding of all questionnaire items answered
             incorrectly

          5. Willingness to receive HIV test results

          6. Willingness to discuss HIV infection risks, amenable to HIV risk reduction counseling,
             and committed to maintaining behavior consistent with low risk of HIV exposure through
             the last required protocol clinic visit

          7. Assessed by clinic staff as being at "low risk" for HIV infection on the basis of
             sexual behavior within the 12 months prior to enrollment defined as follows:

               -  Sexually abstinent, or

               -  In a mutually monogamous relationship with a partner with a known HIV-uninfected
                  status, or

               -  Had one partner believed to be HIV-uninfected with whom he/she regularly used
                  condoms for vaginal and anal intercourse

          8. Willing to be contacted annually after completion of scheduled clinic visits for a
             total of 3 years following initial study injection

          9. Agrees not to enroll in another study of an investigational research agent prior to
             completion of last required protocol clinic visit (excludes annual contacts for safety
             surveillance)

         10. Good general health as shown by medical history, physical exam, and screening
             laboratory tests

         11. Hemoglobin = 11.0 g/dL for volunteers who were born female, = 13.0 g/dL for volunteers
             who were born male

         12. White blood cell (WBC) count = 3,300 to 12,000 cells/mm3

         13. Total lymphocyte count = 800 cells/mm3

         14. Platelets = 125,000 to 550,000/mm3

         15. Chemistry panel: Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and
             alkaline phosphatase < 1.25 times the institutional upper limit of normal

         16. Cardiac Troponin T (cTnT) does not exceed the institutional upper limit of normal

         17. Negative HIV-1 and -2 blood test: Sites may use locally available assays that have
             been approved by HVTN Laboratory Operations.

         18. Negative Hepatitis B surface antigen (HBsAg)

         19. Negative anti-Hepatitis C virus antibodies (anti-HCV), or negative HCV polymerase
             chain reaction (PCR) if the anti-HCV is positive

         20. Normal urine:

               -  Negative urine glucose, and

               -  Negative or trace urine protein, and

               -  Negative or trace urine hemoglobin (if trace hemoglobin is present on dipstick, a
                  microscopic urinalysis within institutional normal range).

         21. Volunteers who were born female: negative serum or urine beta human chorionic
             gonadotropin (ß-HCG) pregnancy test performed prior to vaccination on the day of
             initial vaccination

         22. Reproductive status: A volunteer who was born female must:

               -  Agree to consistently use effective contraception, from at least 21 days prior to
                  enrollment through 90 days after the participant's last vaccination, for sexual
                  activity that could lead to pregnancy. Effective contraception for participants
                  in South Africa is defined as using 2 methods, including 1 of the following:

               -  Condoms (male or female) with or without a spermicide,

               -  Diaphragm or cervical cap with spermicide,

             PLUS 1 of the following methods:

               -  Intrauterine device (IUD),

               -  Hormonal contraception, or

               -  Successful vasectomy in the male partner (considered successful if a volunteer
                  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 postvasectomy);

               -  Or not be of reproductive potential, such as having reached menopause (no menses
                  for 1 year) or having undergone hysterectomy, bilateral oophorectomy, or tubal
                  ligation;

               -  Or be sexually abstinent.

         23. Volunteers who were born female must also agree not to seek pregnancy through
             alternative methods, such as artificial insemination or in vitro fertilization until
             after the last required protocol clinic visit

        Exclusion Criteria:

          1. Vaccinia (smallpox) vaccination determined by: (1) clinical evidence of vaccinia
             scarification; (2) self-reported history of vaccinia vaccination; or (3) birth year
             1977 or earlier. (Not excluded: a participant born in or before 1977 who self reports
             he/she did not receive vaccinia [smallpox] vaccination and has no evidence of
             scarification.)

          2. Within the 12 months prior to enrollment: excessive daily alcohol use or frequent
             binge drinking or chronic marijuana abuse or any other use of illicit drugs

          3. Within the 12 months prior to enrollment: a history of newly acquired syphilis,
             gonorrhea, non-gonococcal urethritis, herpes simplex virus type 2 (HSV2), Chlamydia,
             pelvic inflammatory disease (PID), trichomonas, mucopurulent cervicitis, epididymitis,
             proctitis, lymphogranuloma venereum, chancroid, or hepatitis B

          4. Untreated or incompletely treated syphilis infection

          5. HIV vaccine(s) received in a prior HIV vaccine trial. For potential participants who
             have received control/placebo in an HIV vaccine trial, the HVTN 086 / SAAVI 103 PSRT
             will determine eligibility on a case-by-case basis.

          6. Non-HIV experimental vaccine(s) received within the last 5 years in a prior vaccine
             trial. Exceptions may be made for vaccines that have subsequently undergone licensure
             by the FDA or MCC. For potential participants who have received control/placebo in an
             experimental vaccine trial, the HVTN 086 / SAAVI 103 PSRT will determine eligibility
             on a case-by-case basis. For potential participants who have received an experimental
             vaccine(s) greater than 5 years ago, eligibility for enrollment will be determined by
             the PSRT on a case-by-case basis.

          7. Immunosuppressive medications received within 168 days before first vaccination. (Not
             excluded: [1] corticosteroid nasal spray for allergic rhinitis; [2] topical
             corticosteroids for mild, uncomplicated dermatitis; or [3] oral/parenteral
             corticosteroids given for non-chronic conditions not expected to recur [length of
             therapy 10 days or less with completion at least 30 days prior to enrollment].)

          8. Blood products received within 120 days before first vaccination

          9. Immunoglobulin received within 60 days before first vaccination

         10. Live attenuated vaccines (not including influenza vaccine) received within 30 days
             before first vaccination or scheduled within 14 days after injection (eg, measles,
             mumps, and rubella [MMR]; oral polio vaccine [OPV]; varicella; yellow fever)

         11. Influenza vaccine or any vaccines that are not live attenuated vaccines and were
             received within 14 days prior to first vaccination (eg, tetanus, pneumococcal,
             Hepatitis A or B)

         12. Investigational research agents received within 30 days before first vaccination or
             scheduled within 14 days after vaccination

         13. Allergy treatment with antigen injections within 30 days before first vaccination or
             that are scheduled within 14 days after first vaccination

         14. Current anti-tuberculosis (TB) prophylaxis or therapy

         15. Clinically significant medical condition, physical examination findings, clinically
             significant abnormal laboratory results, or past medical history with clinically
             significant implications for current health. A clinically significant condition or
             process includes but is not limited to:

               -  A process that would affect the immune response,

               -  A process that would require medication that affects the immune response,

               -  Any contraindication to repeated injections or blood draws,

               -  A condition that requires active medical intervention or monitoring to avert
                  grave danger to the participant's health or well-being during the study period,

               -  A condition or process for which signs or symptoms could be confused with
                  reactions to vaccine, or

               -  Any condition specifically listed among the exclusion criteria below.

         16. Any medical, psychiatric, occupational, or other condition that, in the judgment of
             the investigator, would interfere with, or serve as a contraindication to, protocol
             adherence, assessment of safety or reactogenicity, or a participant's ability to give
             informed consent.

         17. Serious adverse reactions to vaccines including anaphylaxis and related symptoms such
             as hives, respiratory difficulty, angioedema, and/or abdominal pain. (Not excluded: a
             participant who had a nonanaphylactic adverse reaction to pertussis vaccine as a
             child.)

         18. Hypersensitivity to eggs or egg products

         19. ECG with clinically significant findings, or features that would interfere with the
             assessment of myo/pericarditis, as determined by a contract ECG laboratory or
             cardiologist, including any of the following: (1) conduction disturbance (complete
             left or complete right bundle branch block or nonspecific intraventricular conduction
             disturbance with QRS =120ms, AV block of any degree, or QTc prolongation (> 440ms);
             (2) repolarization (ST segment or T wave) abnormality; (3) significant atrial or
             ventricular arrhythmia; (4) frequent atrial or ventricular ectopy (eg, frequent
             premature atrial contractions, 2 premature ventricular contractions in a row); (5) ST
             elevation consistent with ischemia; (6) evidence of past or evolving myocardial
             infarction.

         20. Cardiac risk factors, including 2 or more of the following: (1) participant report of
             history of elevated blood cholesterol defined as fasting low density lipoprotein (LDL)
             > 160 mg/dL; (2) first degree relative (eg, mother, father, brother, or sister) who
             had coronary artery disease before the age of 50 years; (3) current smoker; or (4) BMI
             = 35.

         21. History of, or known active cardiac disease including: (1) previous myocardial
             infarction (heart attack); (2) angina pectoris; (3) congestive heart failure; (4)
             valvular heart disease including mitral valve prolapse; (5) cardiomyopathy; (6)
             pericarditis; (7) stroke or transient ischemic attack; (8) chest pain or shortness of
             breath with activity (such as walking up stairs); (9) dysrhythmia/episodic
             palpitations (Not excluded: sinus arrhythmia); or (10) other heart conditions under
             the care of a doctor.

         22. Autoimmune disease

         23. Immunodeficiency

         24. Asthma other than mild, well-controlled asthma. Exclude a participant who:

               -  Generally uses a bronchodilator (beta2 agonist) daily, or

               -  In the past year, has (any of the following):

               -  Had > 1 exacerbation of symptoms treated with oral steroids (Note:
                  oral/parenteral steroid use for asthma is exclusionary within 168 days before
                  first vaccination.);

               -  Routinely used moderate to high dose inhaled corticosteroids (eg, more than the
                  equivalent of 250 µg fluticasone; 400 µg budesonide; 500 µg beclomethasone; or
                  1000 µg triamcinolone/flunisolide, as a daily dose) or theophylline for asthma;
                  or

               -  Needed emergency care, urgent care, hospitalization, or intubation for asthma.

         25. Diabetes mellitus type 1 or type 2, including cases controlled with diet alone. (Not
             excluded: history of isolated gestational diabetes.)

         26. Thyroidectomy, or thyroid disease requiring medication during the last 12 months

         27. Angioedema within the last 3 years if episodes are considered serious or have required
             medication within the last 2 years

         28. Hypertension:

               -  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 Hg systolic and = 100 mm Hg
                  diastolic. For these participants, blood pressure must be = 140 mm Hg systolic
                  and = 90 mm Hg diastolic at enrollment.

               -  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 = 100 mm Hg at enrollment.

         29. Body mass index (BMI) = 40

         30. Bleeding disorder diagnosed by a doctor (eg, factor deficiency, coagulopathy, or
             platelet disorder requiring special precautions)

         31. 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 period of the study.)

         32. Seizure disorder (Not excluded: a participant with a history of seizures who has not
             required medications or had a seizure within the past 3 years.)

         33. Asplenia: any condition resulting in the absence of a functional spleen

         34. Psychiatric condition that precludes compliance with the protocol. Specifically
             excluded are persons with psychoses within the past 3 years, ongoing risk for suicide,
             or history of suicide attempt or gesture within the past 3 years.

         35. Pregnant or breastfeeding
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 45 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