Clinical trial: Pivotal Phase 2b/3 ALVAC/Bivalent gp120/MF59 HIV Vaccine Prevention Safety and Efficacy Study in South Africa (NCT02968849)

Eligibility criteria:
Inclusion Criteria

          -  Age of 18 to 35 years

          -  Sexually active, defined as having had sexual intercourse at least twice in the past
             30 days prior to screening, and is considered by the site staff to be at risk for HIV
             infection.

          -  Access to a participating HVTN CRS and willingness to be followed for the planned
             duration of the study

          -  Ability and willingness to provide informed consent

          -  Assessment of understanding: volunteer demonstrates understanding of this study prior
             to first vaccination with verbal demonstration of understanding of all questions.

          -  Agrees not to enroll in another study of an investigational research agent until the
             participant is unblinded or their study participation ends, whichever occurs last

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

          -  Willingness to receive HIV test results

          -  Willingness to discuss HIV infection risks and willing to receive HIV risk reduction
             counseling.

          -  Alanine aminotransferase (ALT) < 2.5 times the institutional upper limit of normal

          -  Negative HIV-1 and -2 blood test within 30 days prior to enrollment: Sites may use
             locally available assays that have been approved by HVTN Laboratory Operations.

          -  Volunteers who were born female: negative serum or urine beta human chorionic
             gonadotropin (β-HCG) pregnancy test performed prior to vaccination on the day of
             initial vaccination. Persons who are NOT of reproductive potential due to having
             undergone total hysterectomy or bilateral oophorectomy (verified by medical records),
             are not required to undergo pregnancy testing.

          -  Reproductive status: A volunteer who was born female must:

               -  Agree to consistently use effective contraception (Appendix B and Appendix C) for
                  sexual activity that could lead to pregnancy from at least 21 days prior to
                  enrollment through 3 months after the last vaccination. Effective contraception
                  is defined as using 2 methods of birth control. These include 1 of the following
                  methods:

                    -  Condoms (male or female)

                    -  Diaphragm or cervical cap

        PLUS 1 of the following methods:

          -  Intrauterine device (IUD),

          -  Hormonal contraception (in accordance with applicable national contraception
             guidelines), 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

          -  Any other contraceptive method approved by the protocol safety review team;

               -  Or not be of reproductive potential, such as having been diagnosed with premature
                  menopause (with no menses for 1 year) or having undergone hysterectomy, bilateral
                  oophorectomy, or tubal ligation.

                    -  Volunteers who were born female must also agree not to seek pregnancy
                       through alternative methods, such as artificial insemination or in vitro
                       fertilization until 3 months after the last vaccination

        Exclusion Criteria

          -  Blood products received within 90 days before first vaccination

          -  Investigational research agents received within 30 days before first vaccination

          -  Intent to participate in another study of an investigational research agent or any
             other study that requires non-HVTN HIV antibody testing during the planned duration of
             the study

          -  Pregnant or breastfeeding

          -  HIV vaccine(s) received in a prior HIV vaccine trial. For volunteers who have received
             control/placebo in an HIV vaccine trial, the HVTN 702 PSRT will determine eligibility
             on a case-by-case basis.

          -  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.
             For volunteers who have received control/placebo in an experimental vaccine trial, the
             protocol safety review team will determine eligibility on a case-by-case basis. For
             volunteers who have received an experimental vaccine(s) greater than 5 years ago,
             eligibility for enrollment will be determined by the protocol safety review team on a
             case-by-case basis.

          -  Live attenuated vaccines other than 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)

          -  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)

          -  Immunosuppressive medications received within 168 days before first vaccination. (Not
             exclusionary: [1] corticosteroid nasal spray; [2] inhaled corticosteroids; [3] topical
             corticosteroids for mild, uncomplicated dermatitis; or [4] a single course of
             oral/parenteral corticosteroids at doses < 2 mg/kg/day and length of therapy < 11 days
             with completion at least 30 days prior to enrollment.)

          -  Serious adverse reactions to vaccines or to vaccine components such as eggs, egg
             products, or neomycin including history of anaphylaxis and related symptoms such as
             hives, respiratory difficulty, angioedema, and/or abdominal pain. (Not excluded from
             participation: a volunteer who had a non-anaphylactic adverse reaction to pertussis
             vaccine as a child.)

          -  Immunoglobulin received within 60 days before first vaccination

          -  Immunodeficiency

          -  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 volunteer'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.

          -  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 volunteer's ability to give
             informed consent

          -  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.

          -  Active tuberculosis (TB) disease

          -  Uncontrolled hypertension: systolic blood pressure (SBP) ≥ 160 mm Hg or diastolic
             blood pressure (DBP) ≥ 100 mm Hg

          -  Bleeding disorder (diagnosed by a doctor) contraindicating IM injection and/or blood
             draws, based on investigator's judgment

          -  Malignancy (Not excluded from participation: Volunteer who has had malignancy excised
             surgically and who, in the investigator's estimation, has a reasonable assurance of
             sustained cure or who is unlikely to experience recurrence of malignancy during the
             period of the study)

          -  History of hereditary angioedema, acquired angioedema, or idiopathic angioedema
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 35 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