Adjuvants and GSK’s Adjuvants
What is an adjuvant?
Adjuvant is the Latin ‘adjuvare’ meaning ‘to help’
Adjuvants are designed to enhance and modulate immune responses to vaccine antigens
Aluminum was the first vaccine adjuvant to be used in human vaccines2
Why are Adjuvants Included in Vaccines?
- To help enhance the immune response to poorly immunogenic antigens2,1
- Acceptable safety profile2
- To help stimulate the types of immune response required to induce immunity to a given pathogen2,3
Key expected benefits of adjuvants
A faster, stronger, broader and longer-lasting immune response2 (benefits may not all be present at the same time)
Enhanced immune responses in low-responding populations2 (Older adults & Immunocompromised)
Use of smaller amounts of vaccine antigen (antigen sparing)2
How do adjuvants work?
They are a diverse group of substances with different modes of action.3 Some mimic natural pathogen ‘triggers’ to activate the immune response4,5
GSK’s Adjuvant Systems (AS)
Adjuvant systems were developed in the 90s and combine two or more adjuvants selected to provide a more 'tailored' immune response.2,7
AS01 contains a carrier* and two immunostimulants**2,9 +**MPL+**QS-21 (icon of liposomes above)
Adjuvant System 01 (AS01), for example, is used in GSK’s shingles vaccine8
Safety
- The safety profile of aluminum-based vaccines has been established over a period of 90 years with billions of doses administered to individuals across a large age range2
- More than 13 years post-licensure experience with Adjuvant Systems12
- The safety profile of GSK’s Adjuvant Systems is based on a large body of clinical trial and post-licensure safety data10
- More than 78.2 million RZV/AS01 doses distributed until Q2/202213
- Clinically acceptable safety profiles2
- Frequent increase in reactogenicity, especially at injection site2. Symptoms mostly mild to moderate in intensity and of short duration2.
Abbreviations
MPL, monophosphoryl lipid A; QS-21, a saponin purified from the bark of the tree Quillaja saponaria. RZV/AS01. Recombinant Zoster Vaccine adjuvanted with AS01.
References
- Bonanni P, Santos JI. Vaccine evolution. In: Garçon N, Stern PL, Cunningham AL & Stanberry LR, (editors). Understanding modern vaccines: Perspectives in vaccinology. Elsevier. 2011; 1-24
- Gaçon N, Leroux-Roels G, Cheng W-F. Vaccine adjuvants. In: garçon N, Stern PL, Cunningham AL & Stanberry LR (editors). Understanding modern vaccines: Perspectives in vaccinology. Elsevier. 2011;89-113
- Di Pasquale A. Preiss S, Silva FT, Garçon N. Vaccine Adjuvants: from 1920 to 2015 and Beyond. Vaccines (Basel) 2015; 3:320-343.
- Dougan G, Hormaeche C. How bacteria and their products provide clues to vaccine and adjuvant development. Vaccine 2006; 24 Suppl 2:S2-S9.
- O’Hagan DT, Valiante NM. Recent advances in the discovery to vaccine adjuvants. Nat Rev Drug Discov 2003; 2:727-735.
- Garçon N, Di Pasquale A. From discovery to licensure, the Adjuvant System story. Hum Vaccin Immunother 2017; 13:19-33.
- Garçon N. Adjuvant systems in vaccines. Expert Rev Vaccines 2007; 6:723-739.
- FDA. Shingrix VRBPAC briefing document. Available at: https://www.fda.gov/media/107553/download. 2017
- Garçon N, Van Mechelen M. Recent clinical experience with vaccines using MPL- and QS 21- containing adjuvant systems. Experts Rev Vaccines 2011; 10:471-486.
- Da Silva FT, Di Pasquale A, Yarzabal JP, Garçon N. Safety assessment of adjuvanted vaccines: Methodological considerations. Hum Vaccin Immunother 2015; 11:1814-1824.
- Tavares-Da-Silva F, Co MM, Dessart C, Hervé C, Lopez-Fauqued M, Mahaud O, Van Holle L, Stegmann JU, Review of the initial prost-marketing safety surveillance for the recombinant zostervaccine, Vaccine? 2020;38;3489-3500
- Laupeze B. Adjuvant Systems for vaccines: 13 years of post-licensure experience in diverse populations have progressed the way adjuvanted vaccine safety is investigated and understood. Vaccine. 2019;37;5670-5680
- GSK Data on file REF-166625
Material supplied by the above-country business unit to LOCs for localisation must be subject to local Medical and/or Regulatory review and approval prior to use and/or external distribution.
LOCs to insert local adverse events reporting procedure.
© 2022 GSK group of companies or its licensor. GlaxoSmithKline Biologicals SA. Rixensart, Belgium.
NX-GBL-GVX-WCNT-220015 | July 2023