Human vaccines & immunotherapeutics
-
Hum Vaccin Immunother · Jan 2015
Randomized Controlled TrialPrevention of adult pneumococcal pneumonia with the 13-valent pneumococcal conjugate vaccine: CAPiTA, the community-acquired pneumonia immunization trial in adults.
The aging of the world population is expected to be accompanied by increased pneumococcal pneumonia in older adults. To address this, the Community-Acquired Pneumonia immunization Trial in Adults (CAPiTA), a large, randomized, placebo-controlled trial conducted to assess the 13-valent pneumococcal conjugate vaccine (PCV13) in adults ≥ 65 years, found statistically significant vaccine efficacy for first episodes of vaccine-type community-acquired pneumonia (VT-CAP; 46%), nonbacteremic/noninvasive VT-CAP (45%), and VT invasive pneumococcal disease (75%), along with an acceptable safety profile. Study results were presented to the US Advisory Committee on Immunization Practices in June 2014, which subsequently recommended sequential PCV13 and 23-valent pneumococcal polysaccharide vaccination for adults ≥ 65 years. Thus, appropriate protection of adults at risk for pneumococcal CAP will include vaccination with PCV13.
-
Hum Vaccin Immunother · Jan 2015
Randomized Controlled TrialSafety and persistence of the humoral and cellular immune responses induced by 2 doses of an AS03-adjuvanted A(H1N1)pdm09 pandemic influenza vaccine administered to infants, children and adolescents: Two open, uncontrolled studies.
In children, 2 AS03-adjuvanted A(H1N1)pdm09 vaccine doses given 21 days apart were previously shown to induce a high humoral immune response and to have an acceptable safety profile up to 42 days following the first vaccination. Here, we analyzed the persistence data from 2 open-label studies, which assessed the safety, and humoral and cell-mediated immune responses induced by 2 doses of this vaccine. The first study was a phase II, randomized trial conducted in 104 children aged 6-35 months vaccinated with the A(H1N1)pdm09 vaccine containing 1.9 µg haemagglutinin antigen (HA) and AS03B (5.93 mg tocopherol) and the second study, a phase III, non-randomized trial conducted in 210 children and adolescents aged 3-17 years vaccinated with the A(H1N1)pdm09 vaccine containing 3.75 µg HA and AS03A (11.86 mg tocopherol). ⋯ The vaccine did not raise any safety concern, though these trials were not designed to detect rare events. In conclusion, 2 doses of the AS03-adjuvanted A(H1N1)pdm09 vaccine at 2 different dosages had a clinically acceptable safety profile, and induced high and persistent humoral and cell-mediated immune responses in children aged 6-35 months and 3-17 years. These studies have been registered at www.clinicaltrials.gov NCT00971321 and NCT00964158.
-
Hum Vaccin Immunother · Jan 2015
Randomized Controlled Trial Comparative StudyInfluenza vaccination in children primed with MF59-adjuvanted or non-adjuvanted seasonal influenza vaccine.
Routine annual influenza immunization is increasingly recommended in young children. We compared the safety and immunogenicity of vaccination with trivalent inactivated influenza vaccine (TIV) versus MF59-adjuvanted TIV (aTIV) in children who received 2 half or full doses of aTIV or TIV, or non-influenza control vaccine, in an efficacy trial conducted 2 years earlier. 197 healthy children aged 30-96 months were randomized to receive vaccination with aTIV or TIV in 2010. To evaluate responses to the first follow-up seasonal vaccination after priming we excluded children who received influenza vaccine(s) in the 2009 pandemic year leaving 40 children vaccinated with aTIV, 26 children with TIV and 10 children with aTIV after a control vaccine in the parent study. ⋯ The response to the B/Victoria lineage antigen in the second year's vaccine (the first vaccine contained a B/Yamagata lineage antigen) demonstrated that aTIV primed for an adequate response after a single dose on Day 22 (GMTs 160, 95 to antigens in the 2 lineages, respectively), whereas TIV did not (GMTs 38, 20). Vaccination with aTIV produced slightly higher but acceptable local and systemic reactogenicity compared to TIV-TIV and TIV-aTIV mixed regimens. Within the limitations of a small study, the strong immune responses support the use of aTIV for vaccination in young children.
-
Hum Vaccin Immunother · Jan 2015
Cost-effectiveness of quadrivalent influenza vaccine in Hong Kong - A decision analysis.
Trivalent influenza vaccine (TIV) selects one of the 2 co-circulating influenza B lineages whereas quadrivalent influenza vaccine (QIV) includes both lineages. We examined potential cost-effectiveness of QIV versus TIV from perspectives of healthcare provider and society of Hong Kong. A decision tree was designed to simulate the outcomes of QIV vs. ⋯ From perspectives of healthcare provider and society, QIV was the preferred option in 52.77% and 66.94% of 10,000 Monte Carlo simulations, respectively. QIV appears to be cost-effective in Hong Kong population, except for age group 15-64 years, from societal perspective. From healthcare provider's perspective, QIV seems to be cost-effective in very young (6 months-9 years) and older (≥80 years) age groups.
-
Hum Vaccin Immunother · Jan 2015
LetterThe future of immunization policies in Italy and in the European Union: The Declaration of Erice.
On December 2014 the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) of the European Union adopted the Council Conclusions on "Vaccinations as an effective tool in public health," a crucial step to strengthen EU action supporting Member States (MS) to implement effective immunization policies and programs. As a contribution to the ongoing pan-European discussion and to the Italian commitment to stay at the forefront of promoting vaccination policies, the Erice Declaration was drafted by Italy's best experts in the field of immunization to transpose to the national level the goals set by the EPSCO Conclusions. The aim of the current letter is to present to the broader international audience the Italian perspective as a case study to assess different immunization policy models, challenges and priorities.