Fig 1.
Plain language summary.
Fig 2.
Study design and participant flowchart.
*Twelve participants who received a PCEC rabies vaccine booster dose after the completion of the parent study [12] and before entering this extension study were included in the post-booster immunogenicity analysis. For these participants, the rabies virus neutralizing antibody concentrations were not tested before the administration of the booster dose. FAS-2 includes all participants who provided immunogenicity data and PPS-2 includes all participants in FAS-2 who had no major protocol deviations leading to exclusion. FAS-1 includes all participants who received at least one booster dose during the trial and provided immunogenicity data and PPS-1 includes all participants in the FAS-1 who had no major protocol deviations leading to exclusion. Rabies+JE-Accelerated, participants who received rabies vaccine concomitantly with Japanese encephalitis vaccine according to the accelerated one-week schedule; Rabies+JE-Conventional, participants who received rabies vaccine concomitantly with Japanese encephalitis vaccine according to the conventional four-week schedule; Rabies-Conventional, participants who received rabies vaccine alone according to the conventional four-week schedule; Y, year; IU, international units; PCEC, purified chick embryo cell; N, number of participants; FAS, full analysis set; PPS, per-protocol set.
Table 1.
Characteristics of the participants at baseline (i.e., at year 3 after primary vaccination; enrolled set).
Fig 3.
Kaplan-Meier estimation of the survival function of RVNAs (full analysis set 2).
RVNA, rabies virus neutralizing antibody; IU, international units; Rabies+JE-Accelerated, participants who received rabies vaccine concomitantly with Japanese encephalitis vaccine according to the accelerated one-week schedule; Rabies+JE-Conventional, participants who received rabies vaccine concomitantly with Japanese encephalitis vaccine according to the conventional four-week schedule; Rabies-Conventional, participants who received rabies vaccine alone according to the conventional four-week schedule.
Fig 4.
Adjusted hazard ratio for time to first RVNA concentration below 0.5 IU/mL (full analysis set 2).
RVNA, rabies virus neutralizing antibody; IU, international units; Rabies+JE-Accelerated, participants who received rabies vaccine concomitantly with Japanese encephalitis vaccine according to the accelerated one-week schedule; Rabies+JE-Conventional, participants who received rabies vaccine concomitantly with Japanese encephalitis vaccine according to the conventional four-week schedule; Rabies-Conventional, participants who received rabies vaccine alone according to the conventional four-week schedule; NA, not applicable; 95% CI, 95% confidence interval.
Fig 5.
Probability of long-term RVNA persistence (full analysis set 2).
RVNA, rabies virus neutralizing antibody; IU, international units; Rabies+JE-Accelerated, participants who received rabies vaccine concomitantly with Japanese encephalitis vaccine according to the accelerated one-week schedule; Rabies+JE-Conventional, participants who received rabies vaccine concomitantly with Japanese encephalitis vaccine according to the conventional four-week schedule; Rabies-Conventional, participants who received rabies vaccine alone according to the conventional four-week schedule; D, day; Y, year. Note: Error bars represent 95% confidence intervals.
Table 2.
Long-term RVNA persistence using repeated measures (full analysis set 2).
Fig 6.
Overall (Y3–Y10) boostability of the PCEC rabies vaccine (full analysis set 1).
Y, year; PCEC, purified chick embryo cell; RVNA, rabies virus neutralizing antibody; IU, international units; GMC, geometric mean concentration; GMR, geometric mean ratio; Rabies+JE-Accelerated, participants who received rabies vaccine concomitantly with Japanese encephalitis vaccine according to the accelerated one-week schedule; Rabies+JE-Conventional, participants who received rabies vaccine concomitantly with Japanese encephalitis vaccine according to the conventional four-week schedule; Rabies-Conventional, participants who received rabies vaccine alone according to the conventional four-week schedule. Note: Error bars represent 95% confidence intervals.