ABSTRACT
BACKGROUND: Quadrivalent human papillomavirus vaccine (QHPV) is > 95% effective in preventing infection with vaccine-type human papillomavirus. The safety and immunogenicity of QHPV are unknown in HIV-infected children. METHODS: HIV-infected children (N = 126)-age > 7 to < 12 years, with a CD4% ≥ 15-and on stable antiretroviral therapy if CD4% was < 25-were blindly assigned to receive a dose of QHPV or placebo (3:1 ratio) at 0, 8, and 24 weeks. Adverse events were evaluated after each dose. Serum antibody against QHPV antigens was measured by a competitive Luminex immunoassay 1 month after the third QHPV dose. RESULTS: The safety profile of QHPV was similar in the 2 study arms and to that previously reported for QHPV recipients. QHPV did not alter the CD4% or plasma HIV RNA. Seroconversion to all 4 antigens occurred in > 96% of QHPV recipients and in no placebo recipients. Geometric mean titer was > 27 to 262 times greater than the seropositivity cutoff value, depending on the antigen, but was 30%-50% lower against types 6 and 18 than those of age-similar historical controls. CONCLUSIONS: QHPV was safe and immunogenic in this cohort of HIV-infected children. Efficacy trials are warranted.
Subject(s)
HIV Infections/immunology , Papillomavirus Vaccines/immunology , Antibodies, Viral/immunology , CD4 Lymphocyte Count , Child , Double-Blind Method , Female , Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 , Humans , Linear Models , Male , Papillomaviridae/immunology , Papillomavirus Vaccines/adverse effects , Viral LoadABSTRACT
Adolescents and young adults are at high risk for human papillomavirus (HPV) and hepatitis B virus (HBV) infections, which are preventable by currently available, safe and effective, prophylactic vaccines. However, development of a combined immunization strategy may lead to better compliance for these vaccines, thereby contributing to the overall goal of protection against these diseases. This study assessed the safety and immunogenicity of co-administered quadrivalent HPV-6/11/16/18 L1 VLP and HBV vaccines in women (n=1877) aged 16-23 years. Co-administration of HPV and HBV vaccines induced robust anti-HPV-6, HPV-11, HPV-16, HPV-18 geometric mean titers (GMTs) and > or =99% seroconversion rates (Month 7) that were both non-inferior (p<0.001) to those induced by HPV vaccine alone. High Month 7 anti-HBs GMTs were also observed following concomitant vaccination. These GMTs were lower compared to those induced by the HBV vaccine itself; however, >96% of subjects achieved an anti-HBs seroprotection level of > or =10 mIU/mL that was non-inferior (p<0.001) to that of HBV vaccine alone. Overall, co-administered and individual vaccines were generally well-tolerated and did not interfere with the immune response of either vaccine (ClinicalTrials.gov number, NCT00092521).
Subject(s)
Antibodies, Viral/blood , Hepatitis B Antibodies/blood , Hepatitis B Vaccines/immunology , Hepatitis B virus/immunology , Hepatitis B/immunology , Papillomaviridae/immunology , Papillomavirus Infections/immunology , Papillomavirus Vaccines/immunology , Vaccination , Adolescent , Adult , Female , Fever/chemically induced , Headache/chemically induced , Hepatitis B Vaccines/administration & dosage , Hepatitis B Vaccines/adverse effects , Humans , Injections, Intramuscular , Papillomavirus Vaccines/administration & dosage , Papillomavirus Vaccines/adverse effects , United States , Vaccines, Combined/administration & dosage , Vaccines, Combined/adverse effects , Vaccines, Combined/immunology , Vaccines, Synthetic/administration & dosage , Vaccines, Synthetic/adverse effects , Vaccines, Synthetic/immunologyABSTRACT
CONTEXT: Community-acquired, methicillin-resistant (CA-MRSA) infections in children are increasing in frequency for unknown reasons. OBJECTIVES: To compare the presence of risk factors for methicillin resistance between patients with CA-MRSA and community-acquired methicillin-susceptible (CA-MSSA) infection and to compare the presence of risk factors among household contacts of the patients from both groups. To compare the demographic and clinical characteristics between children with CA-MRSA and CA-MSSA infection. DESIGN: Prospective observational study conducted between February 2, 2000 and November 14, 2000, excluding the month of May and the period between September 2 and October 15. SETTING AND PATIENTS: Texas Children's Hospital, Houston, TX; inpatients and outpatients with community-acquired infection. MAIN OUTCOME MEASURES: Proportion of MRSA among all community-acquired infections. The presence of risk factors associated with methicillin resistance among patients, and their household contacts, with CA-MRSA and CA-MSSA. RESULTS: The monthly rates of methicillin resistance of varied between 35 and 51%. CA-MSSA isolates were associated with deep-seated infections significantly more often (30%) than CA-MRSA isolates (11%; P= 0.01). CA-MRSA isolates were generally susceptible to clindamycin and trimethoprim-sulfamethoxazole and resistant to erythromycin. There were no significant differences in the exposure to risk factors between children with CA-MRSA and CA-MSSA infection. No significant risk factors for CA-MRSA were identified among household contacts. CONCLUSIONS: MRSA is an established, community-acquired pathogen in our area. This necessitates a change in empiric therapy of infections suspected to be caused by.