Duration of Vi antibodies in participants vaccinated with Typhim Vi (Typhoid Vi polysaccharide vaccine) in an area not endemic for typhoid fever.

After a single injection of Typhim Vi (typhoid Vi polysaccharide vaccine), serum antibody concentrations were monitored for 3 years in 37 adults who resided where typhoid fever was not endemic. Anti-Vi antibody concentrations declined progressively during the study, to levels that support the current US recommendation for revaccination every 2 years.

Prospective assessment of the effect of needle length and injection site on the risk of local reactions to the fifth diphtheria-tetanus-acellular pertussis vaccination.

OBJECTIVE: Local reactions are relatively common after the fifth diphtheria-tetanus-acellular pertussis vaccination, but factors associated with an increased risk of those reactions are not well defined. The objective of this study was to assess the relationship between needle length and injection site on the risk of local reactions to the fifth diphtheria-tetanus-acellular pertussis vaccination administered in the context of usual clinical care. METHODS: In this prospective assessment, parents reported signs and symptoms of adverse events for 7 days after vaccination. The relative risk of adverse events in relation to needle length (16 or 25 mm) and injection site (arm or thigh) was estimated in multivariate analyses that adjusted for age, gender, and BMI. RESULTS; Of the 1315 study participants, 89% were vaccinated in the arm, and 67% were vaccinated with a 25-mm needle. Among children vaccinated in the arm, use of the shorter 16-mm needle was associated with a significantly higher risk of any redness, > or = 5 cm of redness, persistent redness on day 2, and pain compared with vaccination with a 25-mm needle. Similar trends among the smaller group of children vaccinated in the thigh were also suggested but were not statistically significant. In analyses that were restricted to children vaccinated with a 25-mm needle, vaccination in the thigh versus arm was associated with a substantially lower risk of > or = 5 cm of redness and a significantly lower risk of swelling and any itching but not with any difference in the risk of pain, irritability, or change in activity. CONCLUSIONS: These findings suggest that a 25-mm needle should be used for the fifth diphtheria-tetanus-acellular pertussis vaccination regardless of injection site and that vaccination in the thigh is an option that may be considered by parents and providers who would like to decrease the risk of local reactions characterized by redness and swelling.

Safety of Typhim Vi vaccine in a postmarketing observational study.

BACKGROUND: Typhoid fever is endemic in many parts of the world. In the United States, nearly three quarters of all cases are contracted by persons who traveled to regions with endemic disease. Typhim Vi, a vaccine containing the purified cell surface Vi polysaccharide of the Salmonella enterica serovar Typhi, was developed to provide protection against typhoid fever. We present the results of the largest safety study of this Vi vaccine to date. METHODS: This open-label, descriptive study assessed safety and reactogenicity following the Vi vaccine administration. Coadministration of other vaccines (at separate sites) was permitted, consistent with clinical practice. Participants aged 2 years or older with no known sensitivities to any vaccine component, who received the Vi vaccine, according to label directions, at a participating travel clinic, were eligible to participate. Information was collected on concurrent medications and medical conditions. The occurrence of solicited injection site reactions and systemic reactions was recorded on diary cards for 7 days following vaccination, along with any unsolicited medical events. Serious adverse events were reported for 30 days postimmunization. RESULTS: A total of 1,204 participants (mean age: 37.2 y, range: 2-82 y, 55% female) were enrolled into the study, and 1,111 completed the 7-day follow-up. The most common solicited reactions were injection site pain [850 of 1,111 (76.5%)], tenderness [838 of 1,111 (75.4%)], and muscle aches [434 of 1,111 (39.1%)]. Fever was reported in 18 (1.6%) of 1,111 participants. Coadministration of other common travel vaccines did not affect reactogenicity profiles, except for an increase in the Vi vaccine injection site redness when two vaccines were administered in the same limb. CONCLUSIONS: The Vi vaccine was well tolerated in an unselected population, aged 2 to 82 years, presenting to a travel clinic for vaccination.

Immediate hypersensitivity reactions after use of tuberculin skin testing.

This report describes the frequency and characteristics of serious or life-threatening hypersensitivity reactions to the tuberculin skin test over an 11-year period through November 2000. There were 24 reports and no deaths, indicating that such reactions are rare (0.08 reported reactions per million doses of tuberculin).