Nuvaxovid
COVID-19 vaccine, recombinant spike protein nanoparticle, Matrix-M-adjuvanted · SARS-CoV-2 spike (nanoparticle)Australia: Study 2019nCoV-101 Part 1, started May 2020
PreHevbrio: what was done before first-in-human, and what came after?
hepatitis B vaccine (recombinant), 3-antigen · HBsAg S/pre-S1/pre-S2 VLPs
Before first-in-human
First-in-human: where
Israel, Thailand and Singapore: legacy dose-ranging studies, one with a first-in-human part up to 20 µg
“The studies were conducted inIsrael, Thailand, and Singapore. They were open-label, comprising two dose regimens, 5 and 10 µg. One had a preliminary phase 1 FIH part with a dosage up to 20 µg.”
Repeat-dose tox before first-in-human
Not stated in public reviews
Not reported in the public reviews. Reviewers summarise selectively, so this usually means it wasn't discussed publicly, not that it wasn't studied.
First-in-human starting dose
Selection not stated; legacy dose-ranging studies (5 and 10 µg), one with an initial first-in-human part up to 20 µg
“The studies were conducted inIsrael, Thailand, and Singapore. They were open-label, comprising two dose regimens, 5 and 10 µg. One had a preliminary phase 1 FIH part with a dosage up to 20 µg.”
Longest repeat-dose systemic studies
Longest repeat-dose study and recovery
Non-GLP rat IM study: necropsy 2 days after last dose (week 4) or at 8 weeks after recovery
“Animals were sacrificed 2 days after the last dose (= 4-week time point) or at 8 weeks following recovery.”
Pivotal GLP studies
Non-GLP rat IM repeat-dose (doses on days 0, 14, 28; 8-week observation); GLP rat combined EFD and pre/postnatal study
“In this study, three groups of Wistar rats were dosed IM on Days 0, 14 and 28 with 0.5mL of PreHevbri (2 or 10 µg HBsAg per animal), or Al(OH)3 adjuvant alone, and were observed for signs of toxicity for 8 weeks.”
DART package
Species: DART
Rat (combined embryo-fetal and pre/postnatal development, female)
“A GLP-compliant embryo-fetal and pre/post-natal reproductive toxicity study was conducted with the current vaccine formulation of PreHevbri in female Sprague-Dawley rats.”
Reproductive & developmental
GLP rat embryo-fetal and pre/postnatal study: no female reproductive, embryo-fetal or postnatal effects
“There were no female reproductive effects and no effects on fetal/embryonal development and postnatal development up to day 23.”
PPND / ePPND: when
Combined embryo-fetal and pre/postnatal study in rat (GLP) completed before the marketing application
“A GLP-compliant embryo-fetal and pre/post-natal reproductive toxicity study was conducted with the current vaccine formulation of PreHevbri in female Sprague-Dawley rats.”
Carcinogenicity
Species: carcinogenicity
Not conducted (in line with applicable guidelines)
“There were no studies on genotoxicity and carcinogenicity, which is in line with applicable guidelines.”
Carcinogenicity model
Not conducted (in line with applicable guidelines)
“There were no studies on genotoxicity and carcinogenicity, which is in line with applicable guidelines.”
Carcinogenicity timing
Not required (in line with applicable guidelines)
“There were no studies on genotoxicity and carcinogenicity, which is in line with applicable guidelines.”
Same question, other vaccines
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Cyfendus
anthrax vaccine adsorbed, adjuvanted · B. anthracis PA; TLR9 (CpG 7909 adjuvant)Not stated in public reviews
Fendrix
hepatitis B vaccine (rDNA), AS04C-adjuvanted · HBsAg VLPs; TLR4 (AS04C adjuvant)Not stated in public reviews
Flublok
influenza vaccine, recombinant hemagglutinin · Influenza HANot stated in public reviews
Gardasil
human papillomavirus quadrivalent (types 6, 11, 16, 18) vaccine, recombinant · HPV 6/11/16/18 L1 VLPsNot stated in public reviews
Gardasil 9
human papillomavirus 9-valent vaccine, recombinant · HPV 9-valent L1 VLPsNot stated in public reviews
HBVaxPro
hepatitis B vaccine (rDNA) · HBsAg VLPsNot stated in public reviews
Heplisav-B
hepatitis B vaccine (recombinant), adjuvanted · HBsAg; TLR9 (CpG 1018 adjuvant)Not stated in public reviews
Mosquirix
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Shingrix
zoster vaccine recombinant, AS01B-adjuvanted · VZV glycoprotein E; TLR4 (AS01B adjuvant)Not stated in public reviews