Vaccine
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Novel tuberculosis vaccination strategies hinge on BCG priming, yet newborn BCG vaccination may cause BCG disease in HIV-infected infants. Viral-vectored or subunit prime vaccine, followed by delayed BCG boost only for HIV-uninfected infants, may be a safe alternative for all newborns, regardless of maternal HIV infection. This approach should be tested using new tuberculosis vaccine candidates. If safety and immunogenicity of a novel vaccine prime is established in infants of HIV-infected mothers, for whom newborn BCG carries unacceptable risk, this strategy might then be compared to conventional BCG prime and viral-vectored or subunit boost, and BCG alone, in HIV-unexposed infants.
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Randomized Controlled Trial Multicenter Study
Safety, tolerability, and immunogenicity of zoster vaccine in subjects with a history of herpes zoster.
Prior clinical studies of zoster vaccine enrolled subjects without a history of herpes zoster (HZ), so there are limited data on safety and immunogenicity in vaccinees with a prior history of HZ. This study was conducted to evaluate the safety and immunogenicity of zoster vaccine recipients who had a prior episode of HZ. ⋯ In HZ history-positive adults > or = 50 years of age, zoster vaccine: (1) was well tolerated; and (2) significantly boosted the level of VZV antibody from baseline to 4 weeks post-vaccination as measured by GMT and GMFR. These data support the Advisory Committee on Immunization Practices' recommendation for routine zoster vaccination for all immunocompetent persons >/=60 years of age irrespective of HZ history.
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Randomized Controlled Trial Comparative Study
The immunogenicity of intradermal influenza vaccination in COPD patients.
We evaluated the immunogenicity of a reduced-dose intradermal trivalent, inactivated, split-virion seasonal influenza vaccine compared to that of a conventional intramuscular vaccination in chronic obstructive pulmonary disease (COPD) patients. One hundred and fifty-six COPD patients randomly received either 0.2 ml (6 microg hemagglutinin (HA) per strain) split into two-site intradermal (ID) injections or a single 0.5 ml (15 microg HA per strain) intramuscular (IM) injection. Geometric mean titers, seroconversion factors, seroconversion rates and seroprotection rates at 4 weeks post-vaccination in the ID group were less than those in the IM group. ⋯ Nevertheless, each strain of the ID vaccination met all the Committee for Proprietary Medicinal Products (CPMP) criteria. Seroprotection rates were above 60% throughout the year in influenza A (H3N2), for at least 6 months in influenza A (H1N1) and at least 4 weeks in influenza B in both ID and IM groups. The reduced-dose intradermal vaccination may be considered for use in COPD patients in a vaccine shortage situation.
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Thailand has been committed to HIV-Vaccine Research and Development since the launch of its National Plan, in 1993. Series of phase I/II trials, and two phase III clinical trials, have been conducted. ⋯ Both involved similar challenges in terms of infrastructure strengthening, capacity building, implementing the trials into the existing health system, staffing, and commitments. However, there were different issues in recruitment process, follow up, social impact events and community involvement since the target participants were different.
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A complete economic study was carried out to assess the economical impact of two rotavirus vaccine in Colombia. A Markov decision model was built to assess the health outcomes from birth to 24 months of age for three hypothetical cohorts: one unvaccinated, one vaccinated with 2 doses of Rotarix and the third, with 3 doses of Rotateq. Without vaccination, the annual number of medical visits by diarrhea in children under 2 years would be 1,293,159 cases, with 105,378 medical visits and 470 deaths (IC95% 295-560) related to rotavirus. ⋯ Other programmatic aspects such as number of doses to be applied, likelihood of completing vaccination schedule with shorter versus longer schedules, and storage space within the chain cold should be considered to make decisions on which vaccine should be introduced. In conclusion, vaccinating against rotavirus in Colombia with either vaccine would be very cost effective. If cost per vaccinated children falls below USD$3 per dose vaccination would be cost saving.