IMMUNOLOGIC RESPONSIVENESS AND SAFETY ASSOCIATED WITH THE COCCIDIOIDES IMMITIS SPHERULE VACCINE IN VOLUNTEERS OF WHITE, BLACK, AND FILIPINO ANCESTRY

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Abstract
A trial of the killed Coccidioides immitis spherule vaccine was undertaken with 151 healthy skin test negative adult volunteers and controls to evaluate the safety of selected regimens, the induction of humoral and cell-mediated immune responses, and to determine if there were immunogenetic differences in these responses. The vaccine was given as three intra-deltoid doses over 8 weeks. No severe systemic symptoms were noted, although 3% of 3.5 mg doses (but no 1.75 mg doses) were associated with severe local reactions. Half the vaccinees had skin test conversions, which generally persisted ≥6 months, two-thirds showed boosting of lymphocyte transformation in vitro, and 16% given three 3.5 mg doses developed antibody. There was an association between degree of local adverse vaccine reaction and immunostimulation, and a trend to immune response in persons of O blood type and with some HLA phenotypes. There was no evidence of deficient response to vaccination in subpopulatlons known to respond to coccidioidal infection poorly. A regimen of three 1.75 mg doses appears to be safe and without reduced Immunogenicity, and there is no evidence dosage modification for certain subpopulatlons would be necessary in efficacy studies.

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