Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2021 May;20(5):497-517.
doi: 10.1080/14760584.2021.1902314. Epub 2021 Jun 26.

Development of thermostable vaccine adjuvants

Yizhi Qi  1 , Christopher B Fox  1   2
Affiliations
Review

Development of thermostable vaccine adjuvants

Yizhi Qi et al. Expert Rev Vaccines. 2021 May.

Abstract

Introduction: The importance of vaccine thermostability has been discussed in the literature. Nevertheless, the challenge of developing thermostable vaccine adjuvants has sometimes not received appropriate emphasis. Adjuvants comprise an expansive range of particulate and molecular compositions, requiring innovative thermostable formulation and process development approaches.

Areas covered: Reports on efforts to develop thermostable adjuvant-containing vaccines have increased in recent years, and substantial progress has been made in enhancing the stability of the major classes of adjuvants. This narrative review summarizes the current status of thermostable vaccine adjuvant development and looks forward to the next potential developments in the field.

Expert opinion: As adjuvant-containing vaccines become more widely used, the unique challenges associated with developing thermostable adjuvant formulations merit increased attention. In particular, more focused efforts are needed to translate promising proof-of-concept technologies and formulations into clinical products.

Keywords: Thermostable; aluminum salts; emulsions; liposomes; lyophilization; nanoparticles; spray drying; vaccine adjuvant.

PubMed Disclaimer

Conflict of interest statement

Declaration of interest

Y Qi and C Fox are employees of the Infectious Disease Research Institute, which has product assets related to thermostable vaccine adjuvant formulations including patents and patent applications. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Figures

Figure 1.
Figure 1.
Thermostable Adjuvanted Vaccine Product Development Flow Chart. Thermostable product design should be considered early in development to maximize efficiency and chance for success. Vials are represented in the figure but other containers or delivery devices may be employed (e.g. pre-filled syringe, nasal powder delivery device, microneedle patch). The thermostability profile categories are adapted from references 1 and 19. Artwork by Yizhi Qi.
See this image and copyright information in PMC

References

    1. Karp CL, Lans D, Esparza J et al. Evaluating the value proposition for improving vaccine thermostability to increase vaccine impact in low and middle-income countries. Vaccine, 33(30), 3471–3479 (2015).

      •• A critical assessment of the potential real-world impact of thermostable vaccines

    1. Lee BY, Wedlock PT, Haidari LA et al. Economic impact of thermostable vaccines. Vaccine, 35(23), 3135–3142 (2017). - PMC - PubMed
    1. Kristensen DD, Lorenson T, Bartholomew K, Villadiego S. Can thermostable vaccines help address cold-chain challenges? Results from stakeholder interviews in six low- and middle-income countries. Vaccine, 34(7), 899–904 (2016). - PMC - PubMed
    1. Kristensen D, Chen D. Stabilization of vaccines: Lessons learned. Human Vaccines, 6(3), 227–231 (2010). - PubMed
    1. Kumru OS, Joshi SB, Smith DE, Middaugh CR, Prusik T, Volkin DB. Vaccine instability in the cold chain: Mechanisms, analysis and formulation strategies. Biologicals, 42(5), 237–259 (2014). - PubMed

Publication types