Arexvy
respiratory syncytial virus vaccine, adjuvanted (AS01E) · RSV preF3; TLR4 (AS01E adjuvant)4 (rabbit, IM doses on days 1, 15 and 29, plus 4-week recovery)
PreHevbrio: how long were the pivotal tox studies?
hepatitis B vaccine (recombinant), 3-antigen · HBsAg S/pre-S1/pre-S2 VLPs
Longest pivotal study
8 weeks
“For the third study, an 8-week repeated dose toxicity study, the testing facility was not GLP certified at the time the study was performed in 2004.”
Pivotal GLP studies
Non-GLP rat IM repeat-dose (doses on days 0, 14, 28; 8-week observation); GLP rat combined EFD and pre/postnatal study
“In this study, three groups of Wistar rats were dosed IM on Days 0, 14 and 28 with 0.5mL of PreHevbri (2 or 10 µg HBsAg per animal), or Al(OH)3 adjuvant alone, and were observed for signs of toxicity for 8 weeks.”
Route in tox
Intramuscular
“In this study, three groups of Wistar rats were dosed IM on Days 0, 14 and 28 with 0.5mL of PreHevbri (2 or 10 µg HBsAg per animal), or Al(OH)3 adjuvant alone, and were observed for signs of toxicity for 8 weeks.”
Same question, other vaccines
Cervarix
human papillomavirus bivalent (types 16, 18) vaccine, recombinant, AS04-adjuvanted · HPV 16/18 L1 VLPs; TLR4 (AS04 adjuvant)8 (rabbit IM, 4 injections days 1-57, plus 13-week recovery)
Cyfendus
anthrax vaccine adsorbed, adjuvanted · B. anthracis PA; TLR9 (CpG 7909 adjuvant)4 (adult rat repeat-dose study, full human dose on SD 1, 15, 29)
Fendrix
hepatitis B vaccine (rDNA), AS04C-adjuvanted · HBsAg VLPs; TLR4 (AS04C adjuvant)2 (14-day IV MPL study in Beagle dog; rabbit vaccine study duration not stated)
Flublok
influenza vaccine, recombinant hemagglutinin · Influenza HA5 weeks
Gardasil
human papillomavirus quadrivalent (types 6, 11, 16, 18) vaccine, recombinant · HPV 6/11/16/18 L1 VLPs10 (BALB/c mouse)
Gardasil 9
human papillomavirus 9-valent vaccine, recombinant · HPV 9-valent L1 VLPs13 (rat, IM, 4 doses every 21 days)
Heplisav-B
hepatitis B vaccine (recombinant), adjuvanted · HBsAg; TLR9 (CpG 1018 adjuvant)8 (rat and cynomolgus monkey, weekly SC CpG 1018 alone)
Mosquirix
RTS,S/AS01 malaria vaccine · P. falciparum CSP-HBsAg (RTS,S) VLPs; TLR4 (AS01 adjuvant)6 (rabbit RTS,S/AS01B, necropsy Day 45; recovery to Day 70)
Nuvaxovid
COVID-19 vaccine, recombinant spike protein nanoparticle, Matrix-M-adjuvanted · SARS-CoV-2 spike (nanoparticle)8 weeks
Shingrix
zoster vaccine recombinant, AS01B-adjuvanted · VZV glycoprotein E; TLR4 (AS01B adjuvant)12 (AS01B alone in rabbit, seven IM doses 14 days apart)
HBVaxPro
hepatitis B vaccine (rDNA) · HBsAg VLPsNot stated (rat, 3 injections at monthly intervals)