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To determine the safety of 2 candidate vaccines against human immunodeficiency virus type 1 (HIV-1), a randomized, placebo-controlled, multicenter trial compared low, medium, and high doses of the vaccines or an adjuvant among infants born to HIV-infected women. No local or systemic reactions of grade 2 or greater were reported 48 h after the subjects underwent immunization. Grade 3 or 4 chemistry toxicities occurred in 5 (3%) and grade 3 or 4 hematologic toxicities in 17 (11%) of 154 vaccinated subjects (not significantly different from 29 adjuvant recipients). CD4(+) cell percentages of < or = 20% occurred at least once in 9 vaccinated subjects and 1 control subject. Sustained CD4(+) cell percentages of < or = 20% occurred in 4 HIV-infected children. Fourteen infants (8%) were confirmed to be HIV-infected; median CD4(+) cell counts among these children were 2074, 1674, 1584, and 821 cells/mm(3) at birth and weeks 24, 52, and 104, respectively. Thus, both vaccines were safe and well tolerated in neonates, and there was no evidence of accelerated immunologic decline in HIV-infected infants.

Cross-protection between Venezuelan, Eastern, and Western equine encephalomyelitis (VEE, EEE, WEE) viruses was studied in the hamster by using challenge responses and neutralizing antibody titers as indexes of protection. Formalin-inactivated vaccines induced only homologous protection regardless of the sequence of vaccination or the combination of vaccines employed. Use of attenuated VEE vaccine, singly, produced absolute homologous protection as well as 37 and 59% protection against WEE and EEE challenges, respectively. Neither deleterious nor enhancing interaction occurred when attenuated VEE and inactivated WEE and EEE vaccines were employed in various sequences of immunization and all possible combinations. The most rapid and simple immunization scheme eliciting excellent homologous protection consisted of a single dose of combined attenuated VEE and inactivated WEE and EEE vaccines. Studies with attenuated strains of VEE, EEE, and WEE viruses showed that all elicited excellent homologous protection when administered singly. However, use of these live strains in many combinations and sequences resulted in a significant ( P < 0.05 to <0.001) decrease in the protective efficacy of the WEE or EEE strains. These results are discussed in relation to serum neutralization test data obtained on sera drawn pre- and postchallenge.