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)
Mosquirix: how long were the pivotal tox studies?
RTS,S/AS01 malaria vaccine · P. falciparum CSP-HBsAg (RTS,S) VLPs; TLR4 (AS01 adjuvant)
Longest pivotal study
6 (rabbit RTS,S/AS01B, necropsy Day 45; recovery to Day 70)
“Five males and five females from each group were killed on Day 45 (3 days after the last injection) and the remainder on Day 70 of study (28 days after the last injection) in order to study recovery.”
Pivotal GLP studies
GLP rabbit IM RTS,S/AS01B, 4 doses at 2-week intervals (Days 0-42); AS01B, QS-21 and MPL component studies
“Two groups of 20 New Zealand White rabbits (10 males + 10 females) were administered 4 intramuscular (IM) injections at 2 weeks interval (Day 0, 14, 28 and 42) of the candidate vaccine.”
Route in tox
Intramuscular
“Two groups of 20 New Zealand White rabbits (10 males + 10 females) were administered 4 intramuscular (IM) injections at 2 weeks interval (Day 0, 14, 28 and 42) of the candidate vaccine.”
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)
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)