Safety and immunogenicity of 13-valent pneumococcal conjugate vaccine formulations with and without aluminum phosphate and comparison of the formulation of choice with 23-valent pneumococcal polysaccharide vaccine in elderly adults: a randomized open-label trial.

This randomized open-label trial was designed to provide preliminary immunogenicity and safety data to support development of the pediatric 13-valent pneumococcal conjugate vaccine (PCV13) for adults. The aims were to: identify an age-appropriate PCV13 formulation, i.e., with (n = 309) or without (n = 304) aluminum phosphate (AlPO 4); compare the selected PCV13 formulation (n = 309) with 23-valent pneumococcal polysaccharide vaccine (PPSV23; n = 301); and, together with an extension study, assess sequential use of pneumococcal vaccines at 1-year intervals in adults aged ≥65 years (n = 105) not pre-vaccinated with PPSV23. Immune responses were measured by ELISA and opsonophagocytic activity assays 1 month postvaccination. Immunoglobulin G responses elicited by PCV13 with AlPO 4 and PCV13 without AlPO 4 were similar for the majority, and noninferior for all PCV13 serotypes. PCV13 with AlPO 4 was generally more reactogenic, with reactions mainly mild or moderate. Thus, PCV13 with AlPO 4 (hereafter PCV13) became the selected formulation. Immune responses to PCV13 were noninferior for all but one serotype and for most PCV13 serotypes superior to PPSV23. Vaccine sequence assessments showed that for PCV13/PPSV23, the initial PCV13 dose generally enhanced responses to a subsequent PPSV23 dose, compared with PPSV23 alone. For PCV13/PCV13, a second dose did not enhance the first dose response when given after 1 year. For PCV13/PPSV23/PCV13, priming with PCV13 (vaccination 1) did not protect against lower responses induced by PPSV23 to subsequent PCV13 (vaccination 3). In conclusion, the pediatric PCV13 formulation with AlPO 4 is well tolerated and immunogenic in adults, is generally more immunogenic than PPSV23, and subsequent vaccination with PPSV23 is possible if required.

Compliance of St Joseph's Hospital Roma, Lesotho with the National Tuberculosis Programme of Lesotho, 2007 and 2008.

BACKGROUND: In 2009 Lesotho had an estimated TB prevalence of 696 cases/100 000 population - the 4th highest in the world. This epidemic was characterised by high rates of death, treatment failure and unknown treatment outcomes. These adverse outcomes were attributable to a high rate of TB and/or HIV co-infection and weaknesses in the implementation of Lesotho's National Tuberculosis Programme (NTP). This study was conducted in St Joseph's Hospital, Roma (SJHR) to assess the implementation of the NTP. METHOD: Records of 993 patients entered into the SJHR TB register between 2007 and 2008 were reviewed. Patients' treatment details were extracted from the register, validated and analysed by STATA 10.0. RESULTS: Of 993 patients registered: 88% were new patients, 37% were diagnosed on sputum smear microscopy alone, 35% were diagnosed on sputum smear microscopy with chest X-ray, whilst 25% were diagnosed on chest X-ray alone. In addition: 33% were sputum smear positive, 45% were sputum smear negative, and 22% had extra-pulmonary TB. As to treatment outcome: 26% were cured, 51% completed treatment, and 51% converted from sputum smear positive to sputum smear negative over six months, whilst 16% died. Regarding HIV, 77% of patients were tested for HIV and 59% had TB and/or HIV co-infection. Of ten NTP targets only the defaulter and treatment failure rate targets were met. CONCLUSION: Whilst only two out of ten NTP targets were met at SJHR in 2007-2008, improvements in TB case management were noted in 2008 which were probably due to the positive effects of audit on staff performance.

Efficacy and safety of a live attenuated influenza vaccine in adults 60 years of age and older.

This randomized, double-blind, placebo-controlled study investigated the efficacy, safety, and immunogenicity of LAIV in community-dwelling ambulatory adults > or =60 years of age in South Africa in 2001. Nose and throat swabs were obtained for influenza virus culture based on the symptoms of influenza-like illness. A total of 3242 subjects were enrolled, with a mean age of 69.5 years. The efficacy of LAIV against influenza viruses antigenically similar to the vaccine was 42.3% (95% CI, 21.6-57.8%). Efficacy against A/H3N2 viruses was 52.5% (95% CI, 32.1-67.2%); vaccine efficacy was not observed against antigenically similar B strains. In post hoc analyses, efficacy in subjects 60 to <70 years of age was 41.8% and -22.7% against A/H3N2 and B, respectively and 65.7% and 9.9%, respectively, for subjects > or =70 years. Reactogenicity events were higher among LAIV than placebo recipients during 11 days postvaccination (P=0.042), including runny nose/nasal congestion, cough, sore throat, headache, muscle aches, tiredness, and decreased appetite. Rates of serious adverse events were similar for LAIV and placebo recipients. This was the first demonstration of statistically significant protection by LAIV against culture-confirmed influenza in adults > or =60 years of age. These results suggest that LAIV may provide an additional public health tool in the prevention of influenza in the elderly. (ClinicalTrials.gov identifier, NCT00217230.).

The Delphi technique in health sciences education research.

The Delphi technique is a method of collecting opinion on a particular research question. It is based on the premise that pooled intelligence enhances individual judgement and captures the collective opinion of a group of experts without being physically assembled. The conventional Delphi uses a series of questionnaires to generate expert opinion in an anonymous fashion and takes place over a series of rounds. The technique is becoming a popular strategy that straddles both quantitative and qualitative realms. Issues that are critical to its validity are the development of the questionnaire; definition of consensus and how to interpret non-consensus; criteria for and selection of the expert panel; sample size; and data analysis. The authors used the Delphi technique to assist with making recommendations regarding education and training for medical practitioners working in district hospitals in South Africa. The objective of this Delphi was to obtain consensus opinion on content and methods relating to the maintenance of competence of these doctors. They believe the experience gained from their work may be useful for other health science education researchers wishing to use the Delphi method.