Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase I Study to Evaluate the Safety and Immunogenicity of ALVAC-HIV vCP1521 in Infants Born to HIV-1 Infected Women in Uganda
Brief Summary: The purpose of this study is to test the safety of and immune response to an HIV-1 vaccine, ALVAC-HIV vCP1521, given to infants born to HIV-1 infected mothers in Uganda.


Options:
A: Inclusion Criteria:

Age Eligible for Study: 18 years - NA, Genders Eligible for Study: Both

Criteria

Inclusion criteria:

* HIV infection
* T CD4 count cell level above 200 per mm3
* Serology Hepatitis B negative (AgHBs, AbHBs and AbHBc negative)
* unchanged ARV for the last 3 months for patients who are receiving ARV at the screening visit
* Undetectable for the last 6 months with ARV for any patient with T CD4 level below 350 per mm3
* Pregnancy test negative at the screening and inclusion visits

Exclusion Criteria:

* Any injection of the vaccine against Hepatitis B in the medical history
* Acute cytolysis in the last 3 months with transaminases equal or above 5 times the upper normal range for HIV-HCV coinfected patients, or transaminases equal or above 2 times the upper normal for non coinfected patients
* Any vaccine received one month before the inclusion
* History of intolerance to any component of GenHevac-B
* Evolutive opportunistic infection treated the month before the screening visit
* Severe and acute pyretic infection or unexplained fever the week before inclusion
* Evolutive hemopathy or solid-organ cancer
* Prothrombin factor equal or below 50 percent and/or platelets equal or below 50 000 per mm3
* Immunosuppressive treatment or general corticotherapy (equal or above 0,5 mg per kg per day during above 7 days) in the last 6 months before the screening visit
* Previous Immunomodulating treatment (interferon, interleukin-2,etc) or plan in the next 6 months
* Splenectomy
* Decompensated cirrhosis (Child Pugh B or C)
* Kidney deficient function (creatinine clearance below 50 ml per mn)
* Other immunocompromised condition not related to HIV infection (solid-organ transplantation, chemotherapy in the last 6 months)
* Any participation to another clinical trial plan until Week 28
B: Inclusion Criteria:

* HIV negative youth age 12-17 years (No serologic evidence of HIV infection).
* Negative hepatitis B serology. (No serologic evidence of hepatitis B surface antigen (HBSAg), hepatitis B surface antibody (HBsAb or anti-HBs) and hepatitis B core antibody (HBcAb or anti-HBc)).
* Either no prior hepatitis B immunizations or unknown or incomplete hepatitis B immunization status.
* Willing to participate in HIV risk-reduction counseling and computer assisted measurement of behaviors.
* Parent or legal guardian willing to provide written permission
* Females of childbearing potential must have a negative pregnancy test at screening and should agree to avoid pregnancy through the end of the vaccine phase of the study. Females who are engaging in sexual intercourse must be willing to practice a reliable method of birth control through the end of the vaccine-phase of the study (approximately 6 months). The decision of what is "reliable" is at the discretion of the site investigator.

Exclusion Criteria:

* Presence of any serious illness requiring treatment with systemic medications, excluding treatment for asthma.
* Previous allergic reaction to any vaccines or to constituents of these vaccines (yeast, thimerosal or aluminum)
* Pregnancy
* Current immunomodulator therapy
* Receipt of immunosuppressor therapy (more than 10 mg/day of prednisone or equivalent for \>1 week) in the 6 months preceding entry or anticipated long-term corticosteroid therapy in the above dose and duration. Short term (\< 7 days) steroid use for the treatment of asthma is not an exclusion.
* Receipt of any vaccine within 2 weeks preceding study entry.
C: Inclusion Criteria

Patients may be eligible for this study if they:

* Are 2 to 18 years of age.
* Are HIV-infected.
* Have a viral load (amount of HIV in the blood) under 60,000 copies/ml within 30 days of study entry.
* Have been on their current anti-HIV drugs for at least 3 months.
* Have received 4 or more doses of a pertussis vaccine.
* Have received 1 or more doses of measles vaccine unless a CD4 percent or CD4 number ruled out taking the vaccine. (This reflects a change in the CD4 requirement.)
* Expect to be able to complete all study injections and follow-up.
* Have a negative pregnancy test if able to have children and use effective methods of birth control.
* Have parent or guardian's consent if under 18 years of age.
* Have received an approved hepatitis B vaccine series. Not required for study entry, but children who have received this vaccine will be studied.
* (This study was changed to allow patients who became HIV infected after birth, have a viral load between 30,000 and 60,000 copies/ml, and who have been on their current anti-HIV drugs for 3 to 6 months.)

Exclusion Criteria

Patients will not be eligible for this study if they:

* Had a certain CD4 level before beginning anti-HIV drugs and at screening.
* Have received any killed vaccine within 4 weeks, or any live vaccine within 6 weeks, of entering the study.
* Have received pneumococcal vaccines or had a reaction to PPV.
* Have had an allergic reaction to any measles or hepatitis B vaccines, or to other routine childhood immunizations if 13 years of age or less.
* Have any other condition that would make receiving study vaccines inadvisable.
* Are currently on medications that affect the immune system, except for G-CSF and erythropoietin. This includes the equivalent to more than 1 mg/kg/day of prednisone in the 2 weeks preceding study screening. Nonsteroidal anti-inflammatory agents and inhaled corticosteroids are not excluded.
* Have received certain blood products within the previous 6 months.
* Have other diseases of the immune system.
* Have had cancer within 3 months of study screening or are being treated or have been treated for cancer within 3 months of study entry.
* Are pregnant.
* Have any other disease or previous surgery that would interfere with study treatment.
* Are likely to have bleeding disorders.
* Show certain side effects to vaccines at screening.
D: Inclusion Criteria for HIV Infected Women:

* HIV infected
* In third trimester of pregnancy
* CD4 count of more than 500 cells/mm3 at screening
* Intends to give birth at Mulago Hospital, Uganda
* Willing to be taken home by a home visitor after delivery to document locator information and willing to be visited at home later

Inclusion Criteria for Infants Born to HIV Infected Women:

* 3 or fewer days of age
* Born to an HIV infected woman eligible for the study
* Weight at birth at least 2000 g (4.4 lbs)

Exclusion Criteria for HIV Infected Women:

* Prior participation in an HIV-1 vaccine trial
* Investigational agents, blood products, immunoglobulin, or immunotherapy any time during this pregnancy
* Documented or suspected serious medical illness or life-threatening condition that may interfere with the study
* Multiple birth predicted in current pregnancy

Exclusion Criteria for Infants Born to HIV Infected Women:

* Mother left study prior to infant enrollment and randomization
* Mother or infant received any active or passive HIV immunotherapy or investigational product other than the study vaccine. Mothers and infants who have taken nevirapine prior to study entry are not excluded.
* Blood products, immunoglobulin, or immunosuppressive therapy during labor and delivery or prior to study enrollment
* Abnormal vital signs prior to vaccination or clinical symptoms that may interfere with vaccine reaction assessment
* Part of a multiple birth

Answer: D