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)
Heplisav-B: how long were the pivotal tox studies?
hepatitis B vaccine (recombinant), adjuvanted · HBsAg; TLR9 (CpG 1018 adjuvant)
Longest pivotal study
8 (rat and cynomolgus monkey, weekly SC CpG 1018 alone)
“rats or cynomolgus monkey received subcutaneously (SC) either 0.5, 1.5, 12.5 mg/kg/week of 1018 ISS adjuvant or PBS weekly for 8 weeks.”
Pivotal GLP studies
Adjuvanted vaccine IM repeat-dose studies in mice (3 doses, days 0, 14, 28) and rats (4 doses, days 0-42)
“The general safety of the 1018 ISS adjuvanted HBsAg vaccine was investigated in two pivotal studies were the vaccine was administrated by the IM injection, the clinical route of administration: a repeated-dose toxicity study in mice (study 00-95) where 3 IM doses were given (at day 0, 14 and 28) and a repeated dose toxicity study in rats (study 12-728) where 4 IM doses were given (at day 0, 14, 28 and 42).”
Route in tox
IM for the adjuvanted vaccine (every second week); SC once weekly for CpG 1018 alone
“Of importance, no kidney or heart findings were observed in monkeys or in the rat study of 1018 ISS adjuvanted HBsAg administered with a dosing regimen (4 IM every second week) more similar to the clinical dosing regimen of 2 IM doses 1 month apart than in the rat study of 1018 ISS alone (8 SC doses every week).”
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)
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
PreHevbrio
hepatitis B vaccine (recombinant), 3-antigen · HBsAg S/pre-S1/pre-S2 VLPs8 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)