Two of these infants died, one in each study group, and are included in the mortality analysis below. For safety analyses, these infants were classified according to their enrolment status: 5/6 (3 vaccine and 2 placebo) and 1/6 (placebo) who converted at 9 months were exposed and negative at enrolment, respectively; at 12 months, 1 of those who seroconverted was exposed and 1 was negative (both were in the vaccine group) at enrolment. Including the extended follow-up of 300 participants through
September 30, 2009, 72 participants died at any time after receiving the first dose of PRV/placebo. These deaths occurred among 38/649 (5.9%) vaccine recipients and 34/643 (5.3%) placebo recipients (p = 0.66). For all participants, the two most frequent causes of death were gastroenteritis (13 among vaccine recipients and 11 among placebo recipients) and pneumonia (10 among vaccine recipients and 9 among selleckchem placebo recipients). 3-MA ic50 The overall mortality observed for the vaccine recipients was 60.7/1000 person-years and for the placebo recipients, 53.8/1000 person-years (p = 0.61). No significant differences were observed between the vaccine and placebo groups. Among the 38 infants HIV-infected at enrolment, 12 deaths occurred: 8 (38%) of those receiving vaccine and 4 (23.5%) of those receiving placebo (RR = 1.6; 95% CI = 0.59–4.5); p = 0.49) ( Table 5C).
Two deaths (10.5%) among the HIV-infected vaccine recipients
Mephenoxalone and 1 death (10%) among the HIV-infected placebo recipients occurred before completing the 14-day response period following each dose. Overall, among the 21 HIV-infected infants in the vaccine group, 2 of 8 deaths were gastroenteritis-related, one of which was among a child classified as malnourished; 4 other HIV-infected vaccine recipients who died were classified as malnourished. Among the 17 HIV-infected infants in the placebo group, 3 of 4 deaths were gastroenteritis-related; 2 of these deaths were among children classified as malnourished ( Table 5C). Among the 177 infants HIV-exposed at enrolment, 12 deaths occurred: 6/88 (6.8%) of those receiving vaccine and 6/89 (6.7%) of those receiving placebo (Table 5D). Two of 6 deaths (33.3%) among the HIV-exposed vaccine recipients and 1 of 6 deaths (16.7%) among the HIV-exposed placebo recipients were gastroenteritis-related; one of the deaths in the vaccine group was in a child classified as malnourished. Among the 6 deaths in the HIV-exposed vaccine group, 1 participant seroconverted to HIV-infected prior to death (Table 5D). The median age at death for all vaccine recipients was 282 days (9.4 months), and for all placebo recipients, 223 days [7.4 months (p = 0.75)]. The median time to death after enrollment among vaccine recipients was 241 days; among placebo recipients it was 173.5 days (p = 0.47).