PreHevbrio
hepatitis B vaccine (recombinant), 3-antigen · HBsAg S/pre-S1/pre-S2 VLPsSelection not stated; legacy dose-ranging studies (5 and 10 µg), one with an initial first-in-human part up to 20 µg
Flublok: how was the first human dose set?
influenza vaccine, recombinant hemagglutinin · Influenza HA
First-in-human starting dose
Antigen content of quadrivalent product matched licensed trivalent vaccine plus a second B strain; no separate dose-finding
“The quantity of each HA antigen and excipients of RIV4 was equivalent to that of the US licensed trivalent recombinant influenza vaccine manufactured by PSC with the addition of the second B strain.”
NOAEL / key findings
No NOAEL stated; no systemic toxicity in rats, only transient injection-site microscopic changes
“There were no local reactions and no signs of systemic toxicity including clinical pathology parameters, organ weights and macroscopic findings. The main related findings were transient microscopic changes at the injection sites, which is expected.”
Same question, other vaccines
Arexvy
respiratory syncytial virus vaccine, adjuvanted (AS01E) · RSV preF3; TLR4 (AS01E adjuvant)Not stated for first-in-human; final 120 µg RSVPreF3 + 50 µg AS01E dose selected on clinical data
Cervarix
human papillomavirus bivalent (types 16, 18) vaccine, recombinant, AS04-adjuvanted · HPV 16/18 L1 VLPs; TLR4 (AS04 adjuvant)Not stated in public reviews
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
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
RTS,S/AS01 malaria vaccine · P. falciparum CSP-HBsAg (RTS,S) VLPs; TLR4 (AS01 adjuvant)Not stated in public reviews
Nuvaxovid
COVID-19 vaccine, recombinant spike protein nanoparticle, Matrix-M-adjuvanted · SARS-CoV-2 spike (nanoparticle)Not stated in public reviews
Shingrix
zoster vaccine recombinant, AS01B-adjuvanted · VZV glycoprotein E; TLR4 (AS01B adjuvant)Not stated in public reviews