Human vaccines & immunotherapeutics
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Hum Vaccin Immunother · Jan 2014
Randomized Controlled TrialAssessment of bivalent and tetravalent dengue vaccine formulations in flavivirus-naïve adults in Mexico.
Several ChimeriVax-Dengue (CYD)-based vaccination strategies were investigated as potential alternatives to vaccination with tetravalent CYD vaccine (CYD-TDV) in this phase IIa trial conducted in 2008-9 in 150 healthy adults. Participants were randomized and vaccinated on D0 and D105 (± 15 days). One group received bivalent CYD vaccine against serotypes 1 and 3 (CYD-1;3) on day 0 and CYD-2;4 on day 105 (± 15 days). Two groups received an injection at each timepoint of a tetravalent blend of CYD-1;3;4 and a VERO cell derived, live attenuated vaccine against serotype 2 (VDV-2), or the reference CYD-TDV. A fourth group received Japanese encephalitis (JE) vaccine on days -14, -7 and 0, followed by CYD-TDV on day 105. Viraemia was infrequent in all groups. CYD-4 viraemia was most frequent after tetravalent vaccination, while CYD-3 viraemia was most frequent after the first bivalent vaccination. Immunogenicity as assessed by 50% plaque reduction neutralisation test on D28 was comparable after the first injection of either tetravalent vaccine, and increased after the second injection, particularly with the blended CYD-1;3;4/ VDV-2 vaccine. In the bivalent vaccine group, immune response against serotype 3 was highest and the second injection elicited a low immune response against CYD 2 and 4. Immune responses after the first injection of CYD-TDV in the JE-primed group were in general higher than after the first injection in the other groups. All tested regimens were well tolerated without marked differences between groups. Bivalent vaccination showed no advantage in terms of immunogenicity. ⋯ NCT00740155.
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Hum Vaccin Immunother · Jan 2014
Clinical TrialEfficacy of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine against cervical intraepithelial neoplasia and cervical infection in young Japanese women.
In this open, extended follow-up study (NCT00929526, Clinicaltrials.gov), we evaluated the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine efficacy, immunogenicity and safety up to 4 years after first vaccination in Japanese women aged 20-25 years. In the initial randomized, double-blind study (NCT00316693), 1040 women received the study vaccine or hepatitis A control vaccine; 752 women were included in the follow-up study. ⋯ During the 4-year period, protection against CIN1+ and CIN2+, irrespective of the HPV type, was 56.7% (32.8-72.6) and 54.9% (20.5-75.3) in women receiving ≥1 vaccine dose, regardless of baseline serostatus (total vaccinated cohort [TVC]) and 61.0% (11.8-84.2) and 73.9% (1.1-95.3) in women naïve to HPV infection at baseline (TVC-naïve), respectively. The high VE observed in Japanese women, accompanied by a sustained immune response and a clinically acceptable safety profile, support findings of large, international trials.
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Hum Vaccin Immunother · Jan 2014
ReviewThe evolution of the EGFRvIII (rindopepimut) immunotherapy for glioblastoma multiforme patients.
Glioblastoma Multiforme (GBM) is the most common type of brain tumor and it is uniformly fatal. The community standard of treatment for this disease is gross or subtotal resection of the tumor, followed by radiation and temozolomide. At recurrence bevacizumab can be added for increased progression free survival. ⋯ Therefore in the past few years attention was turned to immunological means for the treatment of this devastating disease. EGFRvIII targeting has proven a good way to attack glioblastoma cells by using the immune system. Although in still in development, this approach holds the promise as a great first step toward immune-tailored drugs for the treatment of brain cancers.
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Hum Vaccin Immunother · Jan 2014
Immunogenicity assessment of HPV16/18 vaccine using the glutathione S-transferase L1 multiplex serology assay.
The glutathione S-transferase (GST)-L1 multiplex serology assay has favorable properties for use in clinical trials and epidemiologic studies, including low cost, high throughput capacity, and low serum volume requirement. Therefore, we evaluated the GST-L1 assay as a measure of HPV16/18 vaccine immunogenicity. Our study population included 65 women selected from the Costa Rica Vaccine Trial who received the bivalent HPV16/18 virus-like particle (VLP) vaccine at the recommended 0/1/6-month schedule. ⋯ GST-L1 correlated best after 3 doses with VLP-ELISA (HPV16 and HPV18 each ρ = 0.72) and SEAP-NA (HPV16 ρ = 0.65, HPV18 ρ = 0.71) (all P < 0.001); correlation was lower with cLIA. The GST-L1 is suitable for evaluating HPV16/18 vaccine immunogenicity after 3 vaccine doses, although in contrast to other assays it may classify some samples as HPV16/18 seronegative. The assay's utility is limited for lower antibody levels such as after receipt of 1 dose.
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Hum Vaccin Immunother · Jan 2014
Attitude toward immunization and risk perception of measles, rubella, mumps, varicella, and pertussis in health care workers working in 6 hospitals of Florence, Italy 2011.
Health care workers (HCWs) are at risk of infection and transmission of vaccine-preventable infectious diseases. In recent years cases of measles or varicella in health care workers were observed with increasing frequency. The aim of our study was to investigate attitude toward immunization and risk perception of measles, rubella, mumps, varicella, and pertussis in HCWs working in 6 hospitals of Florence (Italy). ⋯ Attitudes toward immunization observed in this study are generally positive for preventing some infectious diseases (i.e., measles and rubella), but relatively poor for others (i.e., varicella). More information should be made available to HCWs on the benefits of vaccination and efforts to encourage vaccination uptake should be performed. Educational program on the risk of being infected working in a hospital should be implemented in order to increase the risk perception toward infectious diseases among HCWs.