This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Research article
Jing Xu
National Vaccine and Serum Institute (NVSI), China National Biotech Group (CNBG), Beijing, China
Corresponding Author
ORCiD: https://orcid.org/0000-0003-2929-1326
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background
New recombinant protein vaccines with high purity, clear ingredients and good safety are gradually replacing attenuated and inactivated vaccines in clinical practice. However, one of the main issues with use of these new vaccines is the need for adjuvants to enhance their immune effect. Aluminium salts (hydroxide and phosphate) were the first approved adjuvants used in human vaccines, but these salts have some limitations, such as their induction of primarily humoural immunity with weaker induction of cell-mediated immunity and the failure to clear intracellular viral infections. Therefore, there is a growing need for novel adjuvants. Combined adjuvants or adjuvant systems are increasingly being used to meet the need for adjuvant development for vaccines. Different pathogen antigens also need specific adjuvants to enhance the immune response and protection.
Methods
The present study evaluated the synergistic immunological effect of a combined nano emulsion (NE) with Ginsenoside Rg1, i.e. NE+Rg1, for the hepatitis B surface antigen (HBsAg) or H1N1 haemagglutinin (HA) of an inactivated influenza vaccine (split virion) in mice and the vaccine stability and safety. Non-parametric tests (Mann-Whitney test) and one-way analysis of variance (ANOVA) were used for statistical analyses. Tests were considered significant when P < 0.05.
Results
The combined adjuvant NE+Rg1 showed high stability, a mean diameter of 168.1 nm, and a zeta potential of -22.8 mV. When combined with HBsAg, it produced a similar or higher anti-HB and IgG1/IgG2a titre and elevated IL-2 and IFN-γ expression in spot forming cells (SFCs) compared with NE alone and higher IFN-γ and IL-2 expression in CD8+ T cells than aluminium hydroxide. However, when combined with HA, HA+NE+Rg1 resulted in a comparable haemagglutination inhibition (HAI) titre as HA+NE compared to that in mice immunized with HA alone or HA+Rg1 and an even lower protection rate than HA+NE after PR/8/34 virus strain challenge in mice.
Conclusions
This research demonstrated that the same combined adjuvant NE+Rg1 had different immune effects on different antigens and suggests that the research and development of adjuvants must consider specific pathogens and should be studied on a case-by-case basis.
Keywords
Nano emulsion, Ginsenoside Rg1, Combined adjuvant, hepatitis B surface antigen, haemagglutinin
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This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Research article
Jing Xu
National Vaccine and Serum Institute (NVSI), China National Biotech Group (CNBG), Beijing, China
Corresponding Author
ORCiD: https://orcid.org/0000-0003-2929-1326
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
History
CURRENT STATUS: Posted
Version 1
Posted 29 Mar, 2021
No community comments so far
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Immunology
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background
New recombinant protein vaccines with high purity, clear ingredients and good safety are gradually replacing attenuated and inactivated vaccines in clinical practice. However, one of the main issues with use of these new vaccines is the need for adjuvants to enhance their immune effect. Aluminium salts (hydroxide and phosphate) were the first approved adjuvants used in human vaccines, but these salts have some limitations, such as their induction of primarily humoural immunity with weaker induction of cell-mediated immunity and the failure to clear intracellular viral infections. Therefore, there is a growing need for novel adjuvants. Combined adjuvants or adjuvant systems are increasingly being used to meet the need for adjuvant development for vaccines. Different pathogen antigens also need specific adjuvants to enhance the immune response and protection.
Methods
The present study evaluated the synergistic immunological effect of a combined nano emulsion (NE) with Ginsenoside Rg1, i.e. NE+Rg1, for the hepatitis B surface antigen (HBsAg) or H1N1 haemagglutinin (HA) of an inactivated influenza vaccine (split virion) in mice and the vaccine stability and safety. Non-parametric tests (Mann-Whitney test) and one-way analysis of variance (ANOVA) were used for statistical analyses. Tests were considered significant when P < 0.05.
Results
The combined adjuvant NE+Rg1 showed high stability, a mean diameter of 168.1 nm, and a zeta potential of -22.8 mV. When combined with HBsAg, it produced a similar or higher anti-HB and IgG1/IgG2a titre and elevated IL-2 and IFN-γ expression in spot forming cells (SFCs) compared with NE alone and higher IFN-γ and IL-2 expression in CD8+ T cells than aluminium hydroxide. However, when combined with HA, HA+NE+Rg1 resulted in a comparable haemagglutination inhibition (HAI) titre as HA+NE compared to that in mice immunized with HA alone or HA+Rg1 and an even lower protection rate than HA+NE after PR/8/34 virus strain challenge in mice.
Conclusions
This research demonstrated that the same combined adjuvant NE+Rg1 had different immune effects on different antigens and suggests that the research and development of adjuvants must consider specific pathogens and should be studied on a case-by-case basis.
Figure 1
Figure 2
Figure 3
Figure 4
Figure 5
Figure 6
This is a list of supplementary files associated with this preprint. Click to download.
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