Flublok
influenza vaccine, recombinant hemagglutinin · Influenza HAAntigen content of quadrivalent product matched licensed trivalent vaccine plus a second B strain; no separate dose-finding
Arexvy: how was the first human dose set?
respiratory syncytial virus vaccine, adjuvanted (AS01E) · RSV preF3; TLR4 (AS01E adjuvant)
First-in-human starting dose
Not stated for first-in-human; final 120 µg RSVPreF3 + 50 µg AS01E dose selected on clinical data
“The final formulation, antigen and adjuvant doses (120 µg RSVPreF3 with 50 µg AS01E) was selected based on clinical data.”
NOAEL / key findings
No NOAEL set; immune-stimulation findings in rabbits: WBC/neutrophil changes, lower albumin, larger iliac/popliteal lymph nodes, raised CRP and fibrinogen
“The vaccine resulted in effects on clinical pathology parameters and histopathology that are consistent with immune stimulation following administration of a vaccine, amongst others changes in white blood cell and absolute neutrophil counts, minimally to mildly decreased albumin, increased lymph node weights (ileac and popliteal), CRP and fibrinogen.”
Same question, other vaccines
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
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