exams. Diseases and unexplained symptoms occurred at a rate that would be expected in a comparable group (Claypool, 1999).
Fort Bragg Booster Study. Pittman and colleagues (1997) studied the frequency of possible vaccine-related adverse outcomes during an open-label study of DoD personnel who received anthrax and/or botulinum toxoid vaccines during Operation Desert Shield/Desert Storm in 1990–1991. The objectives of the study were to assess the persistence of antibodies to the vaccines, determine the serological response 30 days after receiving a booster dose, and evaluate the reactogenicity of the vaccines. All of the 486 subjects were male volunteers who had documented records of receiving one or more doses of the anthrax or botulinum vaccine during the Gulf War. Subjects received booster shots (in different arms) of either the anthrax or the botulinum toxoid vaccine, or both, depending on what they had received in 1990–1991. The report states that there was daily monitoring for systemic and local reactions but does not state the total duration of follow-up.
Approximately 20–25 percent of subjects complained of erythema, induration, or swelling at the site of the anthrax vaccine injection; about 3 percent described the reaction as severe. Fever (defined as an oral temperature of 100.5°F or greater) occurred in 2.8 percent of subjects. Systemic symptoms within the first 7 days after receiving the vaccine(s) occurred in 44 percent of study subjects. Symptoms included muscle aches (30 percent), headache (16.5 percent), feeling ill (16 percent), and rash (16 percent). Other symptoms included loss of appetite, difficulty breathing, joint aches, and nausea. The study reports that most of the symptoms were mild; however, 20 volunteers had severe symptoms (the authors did not define “severity”).
Canadian Armed Forces Study. A study monitored 547 individuals in the Canadian Armed Forces who received the anthrax vaccine in 1998 (Claypool, 1999; Friedlander et al., 1999). Mild local reactions occurred with 10.1 percent of doses, moderate local reactions occurred with 0.5 percent of doses, and there were no reports of severe local reactions. Systemic reactions occurred with 1.5 percent of doses (five individuals had fever, two had heartburn, one experienced a “transient nerve disorder”) (Claypool, 1999). Reactions were transient except for one individual who reported persistent nodules. The type of monitoring for adverse health effects was not described.
USAMRIID Reduced Dose and Route Change Study. A pilot study at USAMRIID compared the safety of three doses of anthrax vaccine delivered by subcutaneous injection at 0, 2, and 4 weeks (the current primary schedule and route) with two doses given subcutaneously, and with two intramuscular deltoid injections (Claypool, 1999); 173 people were studied. The incidence of systemic effects did not differ between the three groups: headache (14 percent), malaise (9 percent), loss of appetite (3 percent), nausea or vomiting (3 percent), muscle ache (3 percent), itchiness (3 percent), and low-grade fever (3 percent). Local reactions