Flublok
influenza vaccine, recombinant hemagglutinin · Influenza HAAntigen content of quadrivalent product matched licensed trivalent vaccine plus a second B strain; no separate dose-finding
PreHevbrio: how was the first human dose set?
hepatitis B vaccine (recombinant), 3-antigen · HBsAg S/pre-S1/pre-S2 VLPs
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.”
NOAEL / key findings
No NOAEL stated; injection-site reactions and expected lymphoid hyperplasia only, no other systemic effects
“Based on the limited data submitted, the vaccine caused typical location reactions at the injection sites but did not cause any systemic effects other than the expected lymphoid hyperplasia.”
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