Vaccine
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Randomized Controlled Trial Multicenter Study
Safety and tolerability of a high-potency zoster vaccine in adults >/= 50 or years of age.
Herpes zoster (HZ) incidence rises with age, especially after 50 years of age, probably due to waning varicella-zoster virus (VZV)-specific immunity. The Shingles Prevention Study [Oxman MN, Levin MJ, Johnson GR, Schmader KE, Straus SE, Gelb LD, et al. A vaccine to prevent herpes zoster and postherpetic neuralgia in older adults, N Engl J Med 2005;352:2271-84], enrolled people >/= 60 or years of age and showed that zoster vaccine prevents HZ and postherpetic neuralgia (PHN), presumably through boosting VZV-specific immunity. This study of people >/= 50 or years of age compared the safety and tolerability of two zoster vaccine potencies. ⋯ Both vaccine potencies were generally well tolerated in this study of people > or years of age. Although rates of some moderate or severe injection-site AEs were greater in the higher potency group, all rates met the prespecified criteria for clinically acceptable tolerability.
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Randomized Controlled Trial Multicenter Study
Immunologic responses following administration of a vaccine targeting human papillomavirus Types 6, 11, 16, and 18.
Human papillomavirus (HPV) infection causes cervical cancer and genital warts. Young women (1106) were randomized to receive one of three formulations of a quadrivalent HPV (Types 6/11/16/18) L1 virus-like particle (VLP) vaccine or one of two placebo formulations. The goal was to assess vaccine safety and immunogenicity in baseline HPV 6/11/16 or 18-naïve and previously infected subjects. ⋯ At Month 2 (postdose 1), among women with vaccine-type antibodies at baseline, vaccine-induced anti-HPV responses were approximately 12- to 26-fold higher than those observed in baseline-naïve women, suggesting an anamnestic response. Following an initial, similar sized decline, anti-HPV responses plateaued and remained stable through end-of-study (3.0 years). No vaccine-related serious adverse experiences were reported.
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
A randomized trial demonstrating successful boosting responses following simultaneous aerosols of measles and rubella (MR) vaccines in school age children.
The reactogenicity and immunogenicity of combined measles and rubella (MR) booster vaccination, via aerosol and subcutaneous routes, was assessed in 562 healthy children. Rates of rubella seroconversion and geometric mean titers (GMT) were similar for both routes. ⋯ This study demonstrates that aerosol vaccine was more immunogenic for measles antibodies, and equally immunogenic for rubella antibodies. Aerosol vaccine was less reactogenic.
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Reactogenicity and immunogenicity of a new combined measles-mumps-rubella vaccine: results of a multicentre trial. The Cooperative Group for the Study of MMR vaccines.
A large single blind, multi-centre study involving 1779 children was performed in Italy. Infants, aged between 12 and 27 months were divided between two groups: group A received a single dose of a new MMR vaccine, 'Priorix'(3), while group B received a widely used MMR vaccine, Triviraten(4). Solicited local and general symptoms were recorded using diary cards and antibody levels were measured, prior to and 60 days post-vaccination, using ELISA assays. ⋯ Significantly higher (p<0.001) post-vaccination GMTs were in group A vs group B for anti-measles (2830 vs 784 IU/ml) and anti-mumps (1640 vs 469 U/ml), however the anti-rubella GMTs were significantly higher (p<0.001) in group B (117.6 IU/ml) compared to group A (92.6 IU/ml). The persistence of antibodies in 35 subjects was assessed 1 year after vaccination and the results showed no appreciable decline in titres with either vaccine. The trial demonstrates 'Priorix' is well tolerated and highly immunogenic.