Immunogenicity, safety and lot consistency in adults of a chromatographically purified Vero-cell rabies vaccine: a randomized, double-blind trial with human diploid cell rabies vaccine

A randomized, placebo-controlled phase I study assessing the safety and immunogenicity of aPseudomonas aeruginosahybrid outer membrane protein OprF/I vaccine (IC43) in healthy volunteers

“…32 The number and percentage of subjects reaching a 2-fold increase in OPA titer from day 0 to day 14 were calculated and analyzed descriptively for each group, including two-sided 95% CIs. 33 A similar analysis of OPA titers, from day 0 to day 7 and day 0 to day 180, was performed for a subset of responders (subjects with OPA titer increase from day 0 to day 14 ≥ 2-fold). For all subjects, the OPA ratio (OPA titer day 14/OPA titer day 0) was compared between each treatment group using a Wilcoxon test for unpaired observations.…”

Use and interpretation of diagnostic vaccination in primary immunodeficiency: A working group report of the Basic and Clinical Immunology Interest Section of the American Academy of Allergy, Asthma & Immunology

“…Importantly, the vaccines commonly used for diagnostic purposes have particular immunogenic characteristics, as described throughout this document (examples are shown in Table III). [5][6][7][8][9][10][11][12][13][14][15][16] Summary Statement 2: The diagnosis and treatment of common variable immunodeficiency (CVID) has traditionally included assessment of vaccine responses. (IIa B)…”

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“…Previously published studies with larger sample sizes have consistently shown a lower frequency of local and systemic reactions with CPRV in relation to HDCV. 14,17 This trial showed comparable frequencies of local reactions and slightly higher frequencies for systemic reactions occurring within 3 days of CPRV administration. The occurrence of mild myalgia after dose 1 was higher in the CPRV group (56%) than in the HDCV group (40%).…”

“…Previously published studies 14,17 have tended to show lower GMTs with CPRV than with HDCV. However, this is thought to be clinically irrelevant, as both groups were well above the minimally acceptable seroconversion titer of Ն 0.5 IU/mL.Despite this,the GMTs reported after dose 3 in this study were similar (Table 4).…”

“…[14][15][16][17] These include a preexposure study in Thai children, 14 a preexposure study in European adults in comparison to PVRV, 15 a postexposure trial in the Phillipines, 16 a lot consistency study using a postexposure regimen, and a postexposure study in comparison to HDCV. 17 Here we report the immunogenicity and safety of CPRV in comparison to HDCV when administered as a typical preexposure schedule in healthy adults, i.e., the most commonly used regimen of the rabies vaccine in the US, in comparison to the most commonly used standard of care in the US. The primary objective of this trial was to show that all subjects receiving a three-dose standard preexposure schedule of CPRV achieved a level of virus neutralizing antibody greater than or equal to 0.5 IU/mL, the internationally accepted level of seroconversion.…”