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Precedia/Protein and VLP vaccines/HBVaxPro/Efficacy evidence

HBVaxPro: animal efficacy model or human cells?

hepatitis B vaccine (rDNA) · HBsAg VLPs
Check my plan vs. these
Efficacy evidence
C3H mouse potency (ED50) testing versus the licensed thiomersal-containing vaccine
“In-vivo potency testing in C3H mice showed the thiomersal-free vaccine to be highly potent and comparable to that of the thiomersal-containing formulation.”
✓ VerifiedEMA assessment report, p. 4Source ↗
Why that model
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.
Reviewer's view of the efficacy data
Mouse immunogenicity at least equivalent, but extrapolation to humans is controversial
“The comparative mouse immunogenicity test performed with the hepatitis B vaccine with and without thiomersal indicates that there is at least equivalent immunogenicity of both products. However, it is controversial to what extent these data can be extrapolated to humans.”
✓ VerifiedEMA assessment report, p. 4Source ↗

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Efficacy evidence for HBVaxPro, each with the regulator's own words, the page and a link. Ready to paste into a briefing document or send to your team.

Same question, other vaccines

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

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 HA
Mouse 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 VLPs
Immunogenicity 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 VLPs
Immunogenicity in rhesus macaques (non-GLP): antibodies to all 9 HPV types; no protection model

Heplisav-B

hepatitis B vaccine (recombinant), adjuvanted · HBsAg; TLR9 (CpG 1018 adjuvant)
Anti-HBsAg immunogenicity of the adjuvanted vaccine in mice, rats and baboons

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 VLPs
Immunogenicity 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

Summary across all 13 vaccines →