Exclusion criteria included documented pregnancy or lactation, chronic active viral hepatitis, splenectomy, current temperature of 38C, poor performance status (inability to ambulate 1000 meters), contraindications to an intramuscular injection, ongoing illicit drug use or alcohol abuse, current use of immunosuppressive or cancer chemotherapeutic agents, AIDS-related wasting, and a current plasma HIV RNA level of 50,000 copies/ml

Exclusion criteria included documented pregnancy or lactation, chronic active viral hepatitis, splenectomy, current temperature of 38C, poor performance status (inability to ambulate 1000 meters), contraindications to an intramuscular injection, ongoing illicit drug use or alcohol abuse, current use of immunosuppressive or cancer chemotherapeutic agents, AIDS-related wasting, and a current plasma HIV RNA level of 50,000 copies/ml. Study and Laboratory Procedures Pneumococcal vaccines were administered intramuscularly (0.5 ml) in the deltoid muscle using a 23-gauge, 1-inch needle. adults. Conclusions Among persons with HIV infection, revaccination with PCV was only transiently more immunogenic than PPV, and responses were inferior to those in HIV-uninfected subjects with primary vaccination. Pneumococcal vaccines with more robust and sustained immunogenicity are needed for HIV-infected adults. Introduction infections are a common cause of morbidity and mortality among persons infected with human immunodeficiency virus (HIV) [1C5]. Highly active antiretroviral therapy (HAART) has reduced the incidence of pneumococcal disease among HIV-infected persons by half. However, the incidence remains significantly greater than that of the general population [2, 6]. Despite administration of the 23-valent pneumococcal polysaccharide vaccine (PPV) to HIV-infected adults [7], their risk for infections persists [2, 5]. The 7-valent pneumococcal conjugate vaccine (PCV), which contained 70C80% of pediatric serotypes that cause invasive pneumococcal infections in North America at the time of its release [8], effectively prevents invasive pneumococcal disease in HIV-uninfected infants and children [9C12]. Compared with PPV, PCV elicits increased antibody responses among those with immature or compromised immune systems, including transplant recipients [13C16] and HIV-infected children [17, 18]. Studies among HIV-infected adults have mainly focused on comparing strategies for primary vaccination using varying sequences of two doses of PCV and PPV, which have shown variable results [19C21]. Most persons diagnosed with HIV infection receive primary PPV vaccination based on current guidelines [7]. A critical issue is to determine the most effective strategy for revaccination among this prevaccinated group. Earlier results revealed that the immunogenicity Polaprezinc of PPV revaccination five or more years after the initial dose was very limited [22]. Therefore, we performed a prospective, randomized study to determine whether the immunogenicity of revaccination with PCV exceeded that of PPV to guide recommendations on revaccination of HIV-infected adults. Methods Study Population HIV-infected adults previously vaccinated with PPV 3C8 years earlier were randomized 2:1 to be revaccinated with PCV (Prevnar; Wyeth Pharmaceuticals) or PPV (Pneumovax, Merck & Co., Inc.). A block randomization strategy coordinated at a central location was utilized to attain an overall 2:1 vaccine ratio for the PCV and PPV randomization arms. A group of HIV-uninfected subjects (n=25) without prior pneumococcal vaccination were enrolled and received a single injection of PCV. DCHS1 Study participants were enrolled at five sites: Naval Medical Center San Diego, National Naval Medical Center, Naval Medical Center Portsmouth, Brooke Army Medical Center, and Walter Reed Army Medical Center. All subjects provided written informed consent, the study was approved by both central and local military institutional review boards (IRB) and the University of Colorado Multi-institutional IRB, and was registered with the Clinical Trials network (registration ID# “type”:”clinical-trial”,”attrs”:”text”:”NCT00622843″,”term_id”:”NCT00622843″NCT00622843). All study participants were 18C60 years old. Participants with HIV infection had documented evidence of HIV infection (positive ELISA and Western Blot tests). Subjects without HIV infection had a negative HIV ELISA result at or within one year of enrollment. Exclusion criteria included documented pregnancy or lactation, chronic active viral hepatitis, splenectomy, current temperature Polaprezinc of 38C, poor performance status (inability to ambulate 1000 meters), contraindications to an intramuscular injection, ongoing illicit drug use or alcohol abuse, current use of immunosuppressive or cancer chemotherapeutic agents, AIDS-related wasting, and a current plasma Polaprezinc HIV RNA level of 50,000 copies/ml. Study and Laboratory Procedures Pneumococcal vaccines were administered intramuscularly (0.5 ml) in the deltoid muscle using a 23-gauge, 1-inch needle. Vaccines were stored in temperature-controlled and monitored refrigerators, and transportation was in accordance with manufacturers guidelines. Adverse events (AE) temporally related (within seven days) to revaccination were graded based on their impact on participants daily activities [23]. Serious reactions, possibly related to vaccination resulting in hospitalization, disability, or death, were reported to the Vaccine Adverse Event Reporting System. Serum samples for pneumococcal capsule-specific IgG responses were collected at baseline (1C21 days ahead of revaccination) and times 14, 60 and 180 after revaccination. Compact disc4+ T cell matters (movement cytometry) and plasma HIV RNA amounts (Roche Amplicor) had been established locally at every time stage. We assessed IgG reactive with each of four pneumococcal serotypes (4, 9V, 14, and 19F) by ELISA, as referred to [22]. The four serotypes examined had been chosen because they had been common to both PPV and PCV and stand for a variety of.

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