Vaccine
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Randomized Controlled Trial Multicenter Study Comparative Study
Demonstration of safety and enhanced seroprotection against hepatitis B with investigational HBsAg-1018 ISS vaccine compared to a licensed hepatitis B vaccine.
Adults 40 years of age and older have been shown to be hypo-responsive immunologically to the currently available hepatitis B virus (HBV) vaccines. Three intramuscular doses of a Toll-like receptor 9 agonist, 1018 immunostimulatory sequence (1018 ISS) adjuvant, combined with recombinant hepatitis B surface antigen (HBsAg) demonstrated faster, superior, and more durable seroprotection than three doses of a licensed comparator HBV vaccine (Engerix-B(®)). This investigational vaccine, HBsAg-1018 ISS, was well tolerated with a safety profile similar to the comparator vaccine. These results suggest that HBsAg-1018 may be more effective in this hypo-responsive population.
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HPV vaccine coverage for females has increased in the U.S., although challenges to achieving high coverage remain. HPV vaccine coverage continues to lag behind that of other routinely recommended adolescent vaccines and these gaps in coverage are widening. To inform strategies to improve uptake, we explore correlates of vaccine intention and describe reasons for refusing HPV vaccination among unvaccinated females in a nationally representative sample of adolescents and young adults during early stages of HPV vaccine availability. ⋯ In the first years immediately post-licensure of an HPV vaccine, the majority of unvaccinated women indicated that they were unlikely to seek vaccination. Intent to receive the HPV vaccine is tied to sexual experience and most women who do not intend to get vaccinated and have never had sex believe they are not at risk of HPV or do not need an HPV vaccine. These findings highlight the need to better communicate information regarding lifetime risk for HPV and the importance of receiving HPV vaccine prior to sexual initiation. These findings should inform strategies to increase vaccine uptake.
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Comparison of safety and immunogenicity of two doses of investigational hepatitis B virus surface antigen co-administered with an immunostimulatory phosphorothioate oligodeoxyribonucleotide and three doses of a licensed hepatitis B vaccine in healthy adults 18-55 years of age.
The currently licensed aluminum-hydroxide-adjuvanted hepatitis B vaccines require three doses over a 6-month period to achieve high rates of protection in adults. We compared tolerability and immunogenicity of two doses of an investigational hepatitis B vaccine using hepatitis B surface antigen adjuvanted with an immunostimulatory phosphorothioate oligodeoxyribonucleotide (HBV-ISS) to three doses of a licensed alum-adjuvanted vaccine (HBV-Eng). ⋯ A short, two-dose regimen of HBV-ISS induced a superior antibody response than a three-dose regimen of a licensed hepatitis B vaccine and was well tolerated.
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Globally, rotavirus gastroenteritis is the most common identifiable cause of severe diarrhea in children under 5. Recently introduced rotavirus vaccines from Merck & Co. and GlaxoSmithKline have the potential to save hundreds of thousands of lives. Efficacy results in Ghana suggest Merck & Co.'s live oral pentavalent rotavirus vaccine (RotaTeq(®)) prevents 65.0% of severe gastroenteritis due to rotavirus infection in children under 5. The announcement by Merck and GSK to make their rotavirus vaccines available for developing nations at reduced prices provides Ghana with the opportunity to introduce rotavirus vaccines into the national immunization program after investigation of the medical, economic and political implications. ⋯ RotaTeq vaccination for children under five in Ghana would be a highly cost-effective public health intervention. Ghanaian health officials should seek GAVI funding and evaluate how to maximize RotaTeq access.
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Patients with chronic kidney disease typically show an impaired immune response to hepatitis B virus vaccine compared with healthy individuals. A variety of inherited or acquired factors have been implicated in this diminished response. Some authors suggested a benefit with adjuvantation to improve the immunogenicity of existing HBV vaccines. ⋯ Our meta-analysis showed that adjuvanted hepatitis B vaccine did not significantly improve the seroprotection rate in patients with renal insufficiency. These results do not support adjuvantation as an approach to increase the immunogenicity of existing recombinant vaccines towards HBV in this high-risk population.