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)
Shingrix: how long were the pivotal tox studies?
zoster vaccine recombinant, AS01B-adjuvanted · VZV glycoprotein E; TLR4 (AS01B adjuvant)
Longest pivotal study
12 (AS01B alone in rabbit, seven IM doses 14 days apart)
“Group of 10 male and 10 female rabbits were treated with AS01B by intramuscular injection into the muscles of each hind limb on seven occasions 14 days apart. They were given a dose volume of 500 µL of the formulation and thus received 50 µg MPL and 50 µg QS-21 in a liposomal formulation per dose. Five rabbits per sex per group (including control group) were euthanized 3 or 28 days after the last dose.”
Pivotal GLP studies
Two rabbit IM repeat-dose vaccine studies, rat EFD/pre-postnatal and male fertility studies, rabbit local tolerance, rat safety pharmacology
“SHINGRIX has been evaluated in two repeat dose toxicity studies in rabbits, one reproductive-developmental toxicity study in rats, one male fertility study in rats, two local tolerance studies in rabbits, and one safety pharmacology study in rats.”
Route in tox
Intramuscular (clinical route)
“The toxicity studies were usually performed by the IM route of administration since this is the proposed route of administration for clinical use.”
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
PreHevbrio
hepatitis B vaccine (recombinant), 3-antigen · HBsAg S/pre-S1/pre-S2 VLPs8 weeks
HBVaxPro
hepatitis B vaccine (rDNA) · HBsAg VLPsNot stated (rat, 3 injections at monthly intervals)