Safety & Immunogenicity of 13vPnC in HIV-Infected Subjects Aged 18 or Older Who Were Previously Immunized With 23vPS
Condition: HIV Infections; Pneumococcal Infections
MeSH terms: Infections; Communicable Diseases; Pneumococcal Infections
Intervention: 13-valent pneumococcal conjugate vaccine; Blood draw
Intervention description: Three doses of 13vPnC given 6 months apart.; Six blood draws pre-vaccination and 1 month post-vaccination, doses 1-3.
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 331.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: vaccine; 13-valent pneumococcal conjugate vaccine; human immunodeficiency virus

Summary:

      The study will evaluate the safety, tolerability and immunogenicity of a 13-valent
      pneumococcal conjugate vaccine (13vPnC) in HIV-infected subjects 18 years of age or older who
      have been previously immunized with at least one dose of 23-valent pneumococcal
      polysaccharide vaccine (23vPS). All subjects will receive 3 doses of 13vPnC, with each study
      vaccine dose given approximately 6 months apart.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects aged 18 years or older at the time of enrollment.

          -  All female and male subjects who are biologically capable of having children must
             agree and commit to the use of a reliable method of birth control from the signing of
             the informed consent form (ICF) until 3 months after the last dose of investigational
             product.

          -  Documented vaccination with 1 or more doses of 23vPS at least 6 months before study
             enrollment.

          -  CD4+ T-cell count >= 200 cells/µ, obtained on the most recent 2 occasions within 6
             months before the first investigational product vaccination.

          -  HIV-infected subjects with viral load <50,000 copies/mL, obtained on the most recent 2
             occasions within 6 months before the first investigational product vaccination.

          -  Subject is receiving a stable dose of HAART for at least 6 weeks prior to the first
             investigational product vaccination, or not currently receiving antiretroviral
             therapy.

          -  Subject is expected to be available for the entire study period (approximately 18
             months) and can be contacted by telephone.

          -  Subject must be able to complete an electronic diary (e-diary) and complete all
             relevant study procedures during study participation.

          -  Subject is deemed to be eligible for the study on the basis of medical history,
             physical examination, and clinical judgment. (Note: Subjects with preexisting stable
             disease, defined as disease not requiring significant change in therapy or
             hospitalization for worsening disease 6 weeks before investigational product
             vaccination, are eligible.)

        Exclusion Criteria:

          -  Subjects with active AIDS related illness, including opportunistic infections or
             malignancy.

          -  Evidence of current illicit substance and/or alcohol abuse, that in the investigator's
             opinion, precludes the subject from participating in the study or interferes with the
             evaluation of the study objectives..

          -  Receipt of any licensed or experimental pneumococcal conjugate vaccine prior to
             enrollment.

          -  Contraindication to vaccination with pneumococcal conjugate vaccine.

          -  Previous anaphylactic reaction to any vaccine or vaccine-related component.

          -  History of culture-proven invasive disease caused by Streptococcus pneumoniae within
             the last year.

          -  Current anticoagulant therapy or a history of bleeding diathesis or any condition
             associated with prolonged bleeding time that would contraindicate intramuscular
             injection. (Note: Use of antiplatelet drugs, such as aspirin and clopidogrel, is
             permitted.)

          -  Pregnant or breastfeeding women, as defined by history or positive human chorionic
             gonadotropin (hCG) urine test. All women of childbearing potential must have a urine
             pregnancy test.

          -  History of active hepatitis with elevation in pretreatment aspartate aminotransferase
             (AST) or alanine aminotransferase (ALT) values >5 times the upper limit of normal
             within the last 6 months.

          -  Serious chronic disorder or any other disorder that, in the investigator's opinion,
             precludes the subject from participating in the study or interferes with the
             evaluation of the study objectives. (Note: Serious chronic disorders include
             metastatic malignancy, severe chronic obstructive pulmonary disease requiring
             supplemental oxygen, end-stage renal disease with or without dialysis, and clinically
             unstable cardiac disease).

          -  Any major illness/condition that, in the investigator's judgment, will substantially
             increase the risk associated with the subject's participation in and completion of,
             the study, or could preclude the evaluation of the subject's response.

          -  History of splenectomy.

          -  Receipt of any blood products, including immunoglobulin, within 42 days before
             investigational product vaccination until the last blood draw for the study
             (approximately 13 months after the first investigational product vaccination).

          -  Evidence of dementia or other severe cognitive impairment.

          -  Subject who is, in the opinion of the investigator, unable to receive a vaccination in
             the deltoid muscle of either arm because of insufficient muscle mass.

          -  Participation in another study using investigational product from 28 days before study
             enrollment until the blood draw at visit 6. Between the blood draw at visit 6 and the
             6 month follow-up telephone call (visit 7), use of investigational product must be
             discussed with the Medical Monitor. (Note: Participation in purely observational
             studies is acceptable.)

          -  Residence in a nursing home, long-term care facility, or other institution or
             requirement of semi-skilled nursing care. An ambulatory resident of a retirement home
             or village is eligible for the trial.

          -  Subject who is a direct relative (child, grandchild, parent, or grandparent) of study
             personnel, or who is study personnel.

        Temporary Delay Criteria:

          -  Current febrile illness (oral temperature of =38.0°C [100.4°F]) or other acute illness
             within 48 hours before study vaccine administration.

          -  Currently receiving antibiotic therapy, or has completed a course of antibiotic
             therapy within 10 days before study vaccine administration.

          -  Receipt of novel influenza A (H1N1) vaccine within 14 days before investigational
             product vaccination (seasonal influenza vaccine can be given at any time at the
             discretion of the investigator).