Arexvy
respiratory syncytial virus vaccine, adjuvanted (AS01E) · RSV preF3; TLR4 (AS01E adjuvant)Immunogenicity of RSVPreF3 with or without AS01 in naive mice (neutralising antibodies, CD4+/CD8+ T cells); no challenge model
Heplisav-B: animal efficacy model or human cells?
hepatitis B vaccine (recombinant), adjuvanted · HBsAg; TLR9 (CpG 1018 adjuvant)
Efficacy evidence
Anti-HBsAg immunogenicity of the adjuvanted vaccine in mice, rats and baboons
“The immunogenicity of HBsAg adjuvanted with 1018 ISS has been evaluated in mice, rat and baboons.”
Why that model
Animal anti-HBV responses read against the human seroprotection threshold (>=10 mIU/ml); response depended on CpG adjuvant dose
“The immunogenicity studies also demonstrated that the anti-HBV antibody response and more importantly the frequency of animals responding with antibody levels ≥10 mIU/ml (the defined threshold for seroprotection in humans) is depending on the 1018 ISS dose.”
Reviewer's view of the efficacy data
CpG adjuvant judged potent: far higher anti-HBV responses than HBsAg alone or alum-adjuvanted comparator
“The anti-HBV antibody response after two administrations of the vaccine candidate was much higher in magnitude in comparison to injections with an equal dose of HBsAg alone or a licensed comparator (HBsAg antigen plus aluminium). This indicates that the 1018 ISS is a potent adjuvant.”
Same question, other vaccines
Cervarix
human papillomavirus bivalent (types 16, 18) vaccine, recombinant, AS04-adjuvanted · HPV 16/18 L1 VLPs; TLR4 (AS04 adjuvant)Immunogenicity in mice and rhesus monkeys (AS04 superior to aluminium alone); no protection model
Cyfendus
anthrax vaccine adsorbed, adjuvanted · B. anthracis PA; TLR9 (CpG 7909 adjuvant)Guinea pig and cynomolgus macaque lethal aerosolized B. anthracis spore challenge after two IM vaccinations
Fendrix
hepatitis B vaccine (rDNA), AS04C-adjuvanted · HBsAg VLPs; TLR4 (AS04C adjuvant)Immunogenicity in mice: HBsAg with AS04C more immunogenic than with alum
Flublok
influenza vaccine, recombinant hemagglutinin · Influenza HAMouse immunogenicity (HAI and neutralizing antibodies) with monovalent rH3 and trivalent RIV3; no challenge studies
Gardasil
human papillomavirus quadrivalent (types 6, 11, 16, 18) vaccine, recombinant · HPV 6/11/16/18 L1 VLPsImmunogenicity in rhesus macaques, chimpanzees and African green monkeys; neutralising antibodies; no HPV challenge model
Gardasil 9
human papillomavirus 9-valent vaccine, recombinant · HPV 9-valent L1 VLPsImmunogenicity in rhesus macaques (non-GLP): antibodies to all 9 HPV types; no protection model
HBVaxPro
hepatitis B vaccine (rDNA) · HBsAg VLPsC3H mouse potency (ED50) testing versus the licensed thiomersal-containing vaccine
Mosquirix
RTS,S/AS01 malaria vaccine · P. falciparum CSP-HBsAg (RTS,S) VLPs; TLR4 (AS01 adjuvant)Immunogenicity in mice and monkeys (3 IM doses, days 0, 14, 28)
Nuvaxovid
COVID-19 vaccine, recombinant spike protein nanoparticle, Matrix-M-adjuvanted · SARS-CoV-2 spike (nanoparticle)SARS-CoV-2 live-virus challenge in mice, hamsters, cynomolgus and rhesus macaques
PreHevbrio
hepatitis B vaccine (recombinant), 3-antigen · HBsAg S/pre-S1/pre-S2 VLPsImmunogenicity in mice and rats; no challenge model
Shingrix
zoster vaccine recombinant, AS01B-adjuvanted · VZV glycoprotein E; TLR4 (AS01B adjuvant)Immunogenicity (cellular and humoral anti-gE) in mice