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)
Gardasil 9: how long were the pivotal tox studies?
human papillomavirus 9-valent vaccine, recombinant · HPV 9-valent L1 VLPs
Longest pivotal study
13 (rat, IM, 4 doses every 21 days)
“A recovery group consisting of 10 males and 10 females rats per group were sacrificed 21 days after the interim necropsy (day 67). Study duration was 13 weeks.”
Pivotal GLP studies
13-week IM rat repeat-dose (with local tolerance); rat fertility/embryo-foetal study; rat postnatal developmental study
“Toxicology studies supporting the safety of the 9vHPV vaccine included 3 GLP-compliant studies in rats consisting of: i) a repeat-dose toxicity study (with local tolerance and non-GLP immunogenicity assessments), ii) an intramuscular developmental toxicity and immunogenicity study with female fertility and embryo-foetal evaluation and iii) an intramuscular developmental toxicity and immunogenicity study with postnatal evaluation.”
Route in tox
Intramuscular (quadriceps)
“Route and site of administration: Intramuscular (into each quadriceps) administration.”
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)
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
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)