Multiple modes of hepatitis A virus transmission among methamphetamine users.

Methamphetamine users are at increased risk of hepatitis A, but modes of transmission are unclear. The authors conducted a case-control study among methamphetamine users during an outbreak in Iowa in 1997. Twenty-eight reported, laboratory-confirmed, hepatitis A cases did not differ from 18 susceptible controls with respect to age, sex, or number of doses used. When compared with controls in multivariate analysis, case-patients were more likely to have injected methamphetamine (odds ratio (OR) = 5.5, 95% confidence interval (CI): 1.1, 27), to have used methamphetamine with another case-patient (OR = 6.2, 95% CI: 0.95, 41), and to have used brown methamphetamine (OR = 5.5, 95% CI: 0.51, 59). Receptive needle sharing was reported by 10 of the 20 case-patients who injected. Methamphetamine use with another case-patient was also associated with hepatitis A in an analysis restricted to noninjectors (OR = 17, 95% CI: 1.0, 630). During this outbreak, hepatitis A may have been transmitted from person to person among methamphetamine users through the fecal-oral and the percutaneous routes. Methamphetamine users should be vaccinated against hepatitis A and should be given immune globulin if they used methamphetamine with a case-patient in the last 2 weeks. Persons who intend to continue using methamphetamine should be advised about safer practices.

Lessons learned from a review of the development of selected vaccines. National Vaccine Advisory Committee.

BACKGROUND: Although the vaccine research and development network in the United States remains vibrant, its continued success requires maintaining harmonious interaction among its many components. Changing one component is likely to affect the system overall. An examination of case studies of the development of selected vaccines would allow an examination of the network as a whole. This article presents conclusions drawn from the case study review undertaken. OBJECTIVE: Successful development of vaccines is a time-intensive process requiring years of commitment from a network of scientists and a continuum of regulatory and manufacturing entities. We undertook this work to shed light on how well the vaccine development system in the United States performs. METHOD: The National Vaccine Advisory Committee examined the research and development pathways of several vaccines that reached licensure expeditiously (hepatitis B vaccine, Haemophilus influenzae type b conjugate vaccines); some that became licensed only after considerable delay (oral typhoid Ty21a vaccine, varicella vaccine); some that are at the point of imminent or recent licensure (reassortant Rhesus rotavirus vaccine, which was licensed by the Food and Drug Administration on August 30, 1998) or near submission for licensure (intranasal cold adapted influenza vaccine); and one for which clinical development is slow because of hurdles that must be overcome (respiratory syncytial virus vaccines). RESULTS: Some common themes emerged from the reviews of these vaccine "case histories": the expediting influence of a strong scientific base and rationale; the need for firm quantitation of disease burden and clear identification of target populations; the critical role played by individuals or teams who act as "champions" to overcome the inevitable obstacles; availability of relevant animal models, high-quality reagents and standardized assays to measure immune response; the absolute requirement for well designed, meticulously executed clinical trials of vaccine safety, immunogenicity, and efficacy; postlicensure measurements of the public health impact of the vaccine and a track record of the vaccine's safety and acceptance with large-scale use; and the critical need for international collaborations to evaluate vaccines against diseases of global importance that are rare in the United States (eg, typhoid fever). It was clear that the critical step-up from bench scale to pilot lots and then to large-scale production, which depends on a small group of highly trained individuals, is often a particularly vulnerable point in the development process. CONCLUSIONS: One fundamental lesson learned is that within the varied and comprehensive US vaccine development infrastructure, multiple and rather distinct paths can be followed to reach vaccine licensure. The National Vaccine Advisory Committee review process should be conducted periodically in the future to ascertain that the US vaccine development network, which has been enormously productive heretofore and has played a leadership role globally, is adapting appropriately to ensure that new, safe, and efficacious vaccines become available in a timely manner.

Identifying target groups for a potential vaccination program during a hepatitis A communitywide outbreak.

OBJECTIVES: This study sought to identify groups for targeted vaccination during a communitywide hepatitis A outbreak in 1996. METHODS: Residents of the Sioux City, Iowa, metropolitan area reported with hepatitis A between September 1995 and August 1996 were sampled and compared with population-based controls. RESULTS: In comparison with 51 controls, the 40 case patients were more likely to inject methamphetamine, to attend emergency rooms more often than other health care facilities, and to have a family member who used the Special Supplemental Nutrition Program for Women, Infants, and Children. CONCLUSIONS: Groups at increased risk of hepatitis A can be identified that might be [corrected] accessed for vaccination during communitywide outbreaks.