Vaccine
-
Meningococcal disease remains an important cause of morbidity and mortality worldwide. The first broadly effective vaccine against group B disease (which causes considerable meningococcal disease in Europe, the Americas and Australasia) was licensed in the EU in January 2013; our objective was to estimate the potential impact of introducing such a vaccine in England. ⋯ New 'MenB' vaccines could substantially reduce disease in England and be cost-effective if competitively priced, particularly if the vaccines can prevent carriage as well as disease. These results are relevant to other countries, with a similar epidemiology to England, considering the introduction of a new 'MenB' vaccine.
-
A National Immunization Technical Advisory Group (NITAG) is an expert advisory committee that provides evidence-based recommendations to the Ministry of Health (MoH) to guide immunization programs and policies. The World Health Organization (WHO), the Initiative for Supporting National Independent Immunization and Vaccine Advisory Committees (SIVAC) at Agence de Médecine Préventive (AMP) and the US Centers for Disease Control and Prevention (US CDC) engaged NITAG stakeholders and technical partners in the development of indicators to assess the effectiveness of NITAGs. A list of 17 process, output and outcome indicators was developed and tested in 14 countries to determine whether they were understandable, feasible to collect, and useful for the countries. Based on the findings, a revised version of the indicators is proposed for self-assessment in the countries, as well as for global monitoring of the NITAGs.
-
Randomized Controlled Trial Multicenter Study
Intradermally-administered influenza virus vaccine is safe and immunogenic in healthy adults 18-64 years of age.
To increase vaccine acceptance, intradermal (ID) influenza vaccine (Fluzone(®) Intradermal, Sanofi Pasteur Inc.) may be an attractive alternative to intramuscular (IM) vaccination due to smaller needle and volume injected. ⋯ The ID vaccine elicited immune responses comparable to IM vaccine except for the seroconversion rate to B virus. With the exception of pain, local injection site reactions were more common with the ID vaccine, but well-tolerated and of short duration.
-
Randomized Controlled Trial
A serum-free, purified vero cell rabies vaccine is safe and as immunogenic as the reference vaccine Verorab for pre-exposure use in healthy adults: results from a randomized controlled phase-II trial.
Verorab was licensed in 1985 for both pre- and post-exposure prophylaxis of rabies. The next generation purified Vero cell rabies vaccine (PVRV-NG) is a highly purified vaccine. We performed a phase II clinical study in adults in France to assess its immunological non-inferiority and clinical safety for pre-exposure prophylaxis. ⋯ PVRV-NG was shown to be at least as immunogenic as Verorab and to present a similar safety profile.
-
Randomized Controlled Trial Comparative Study
Improved CD4⁺ T cell responses to Mycobacterium tuberculosis in PPD-negative adults by M72/AS01 as compared to the M72/AS02 and Mtb72F/AS02 tuberculosis candidate vaccine formulations: a randomized trial.
The Bacille Calmette-Guérin (BCG) tuberculosis (TB) vaccine provides incomplete protection, necessitating development of an effective vaccine against TB disease. The Mtb72F/AS02 candidate vaccine was previously shown to be clinically well tolerated and immunogenic in Purified Protein Derivative (PPD)-negative adults. To improve the stability of Mtb72F, a point mutation was introduced into a putative serine protease site to give the final M72 construct. AS01 is an Adjuvant System that can potentially improve both humoral and cellular immune responses compared to the AS02 Adjuvant System or unadjuvanted vaccine. This study evaluated the safety and immunogenicity in Mtb-naïve adults of vaccines containing 40 μg of the M72 antigen with AS02 or AS01 and compared the results with Mtb72F/AS02 vaccine (40 μg dose), M72 in saline (40 μg dose) and AS01 alone. ⋯ This first clinical study with M72/AS01 and M72/AS02 showed that both vaccines were clinically well tolerated and induced high magnitude and persistent cell-mediated and humoral immune responses. The Mtb72F/AS02 and M72/AS02 vaccines were comparably immunogenic with significantly higher immune responses compared to the M72/saline control. Of the formulations tested, M72/AS01 demonstrated significantly higher vaccine specific Th1 CD4(+) T cell responses supporting its further clinical evaluation.