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Precedia/Protein and VLP vaccines/Arexvy/Study length

Arexvy: how long were the pivotal tox studies?

respiratory syncytial virus vaccine, adjuvanted (AS01E) · RSV preF3; TLR4 (AS01E adjuvant)
Check my plan vs. these
Longest pivotal study
4 (rabbit, IM doses on days 1, 15 and 29, plus 4-week recovery)
“Two GLP-compliant repeated dose toxicity studies (and) were conducted in New Zealand White rabbits (10/sex/group), which received three intramuscular injections (Day 1, Day 15 and Day 29, followed by a 4- week recovery period.)”
✓ VerifiedEMA assessment report, p. 32Source ↗
Pivotal GLP studies
Two GLP rabbit IM studies of RSVPreF3 alone or with AS01B, three injections two weeks apart, with 4-week recovery
“Two GLP-compliant repeated dose toxicity studies (and) were conducted in New Zealand White rabbits (10/sex/group), which received three intramuscular injections (Day 1, Day 15 and Day 29, followed by a 4- week recovery period.)”
✓ VerifiedEMA assessment report, p. 32Source ↗
Route in tox
Intramuscular
“Two GLP-compliant repeated dose toxicity studies (and) were conducted in New Zealand White rabbits (10/sex/group), which received three intramuscular injections (Day 1, Day 15 and Day 29, followed by a 4- week recovery period.)”
✓ VerifiedEMA assessment report, p. 32Source ↗

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 HA
5 weeks

Gardasil

human papillomavirus quadrivalent (types 6, 11, 16, 18) vaccine, recombinant · HPV 6/11/16/18 L1 VLPs
10 (BALB/c mouse)

Gardasil 9

human papillomavirus 9-valent vaccine, recombinant · HPV 9-valent L1 VLPs
13 (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 VLPs
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 VLPs
Not stated (rat, 3 injections at monthly intervals)

Summary across all 13 vaccines →