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Vaccines
Volume 13
Issue 9
10.3390/vaccines13090922
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Article

A Novel Carbohydrate Fatty-Acid Monosulphate Ester, Squalane-in-Water Adjuvant Is Safe and Enhances Inactivated Influenza Vaccine Immunogenicity in Older Adults

by
Valentino D’Onofrio
1,
Bart Jacobs
1,
Azhar Alhatemi
1,
Simon De Gussem
1,
Marjolein Verstraete
1,
Sharon Porrez
1,
Anthony Willems
1,
Fien De Boever
1,
Gwenn Waerlop
1,
Geert Leroux-Roels
1,
Els Michels
2,
Francesca Vanni
3,
Alessandro Manenti
3,
Peter Paul Platenburg
4,
Luuk Hilgers
4 and
Isabel Leroux-Roels
1,*
1
Center for Vaccinology (CEVAC), Ghent University and Ghent University Hospital, 9000 Ghent, Belgium
2
Harmony Clinical Research BV, 9090 Melle, Belgium
3
VisMederi S.r.l., 53035 Monteriggioni, Italy
4
LiteVax, 4061 BJ Ophemert, The Netherlands
*
Author to whom correspondence should be addressed.
Vaccines 2025, 13(9), 922; https://doi.org/10.3390/vaccines13090922
Submission received: 28 July 2025 / Revised: 26 August 2025 / Accepted: 28 August 2025 / Published: 29 August 2025
(This article belongs to the Special Issue Advances in Vaccine Adjuvants)
Review Reports Versions Notes

Abstract

Influenza vaccines are the primary strategy to prevent severe influenza disease; however, their efficacy is often suboptimal, particularly in older adults (OAs). LiteVax Adjuvant (LVA), a novel adjuvant containing carbohydrate fatty-acid monosulphate ester (CMS) as the active ingredient, has demonstrated a favourable safety profile and enhanced immunogenicity when combined with a low-dose seasonal influenza vaccine in adults aged 18 to 50 years in a first-in-human phase 1 study. The present study investigates the reactogenicity and immunogenicity of CMS-based adjuvanted seasonal influenza vaccine in OAs, with a comparison to responses in younger adults (YAs). In this phase 1b, double-blind, active-controlled clinical trial, 36 YAs (18–50 years) and 48 OAs (≥60 years) were randomized (1:1:1) to receive either 0.5 mg or 1 mg LVA combined with VaxigripTetra, or VaxigripTetra alone. Solicited adverse events (AEs) were recorded using an electronic diary for 7 days following vaccination. Hemagglutination inhibition (HI) titers against four influenza strains were measured at baseline (pre-vaccination) and at 7-, 28-, and 180-days post-vaccination. All 24 YAs and 31 out of 32 OAs receiving CMS-based adjuvanted vaccines reported pain post-vaccination, compared to 8/12 YAs and 4/16 OAs receiving VaxigripTetra. Systemic AEs were more frequently reported among YAs receiving CMS-based adjuvanted vaccines (22/24) compared to those receiving VaxigripTetra (8/12). In OAs, the number of systemic AEs was similar regardless of CMS-based adjuvant administration. Most AEs were mild to moderate and resolved within 3 days. Both CMS-based adjuvanted formulations elicited increased HI titers at Day 7, peaking at Day 28, with a decline thereafter that remained above baseline at Day 180. In YAs, HI titers were comparable between the CMS-based adjuvanted and non-adjuvanted vaccines across all strains and timepoints. In contrast, CMS-based adjuvanted vaccination in OAs induced higher HI titers at Days 28 and 180 for all influenza strains tested. LVA shows an acceptable safety profile in both age cohorts and enhances humoral immune responses in older adults. The 1 mg dose of LVA was more immunogenic, highlighting its potential utility in this target population. Future research will focus on elucidating the mechanisms underlying the immunostimulatory effect of the CMS-based adjuvant.
Keywords: adjuvant; influenza vaccine; immunogenicity; safety; reactogenicity; older adults adjuvant; influenza vaccine; immunogenicity; safety; reactogenicity; older adults

Share and Cite

MDPI and ACS Style

D’Onofrio, V.; Jacobs, B.; Alhatemi, A.; De Gussem, S.; Verstraete, M.; Porrez, S.; Willems, A.; De Boever, F.; Waerlop, G.; Leroux-Roels, G.; et al. A Novel Carbohydrate Fatty-Acid Monosulphate Ester, Squalane-in-Water Adjuvant Is Safe and Enhances Inactivated Influenza Vaccine Immunogenicity in Older Adults. Vaccines 2025, 13, 922. https://doi.org/10.3390/vaccines13090922

AMA Style

D’Onofrio V, Jacobs B, Alhatemi A, De Gussem S, Verstraete M, Porrez S, Willems A, De Boever F, Waerlop G, Leroux-Roels G, et al. A Novel Carbohydrate Fatty-Acid Monosulphate Ester, Squalane-in-Water Adjuvant Is Safe and Enhances Inactivated Influenza Vaccine Immunogenicity in Older Adults. Vaccines. 2025; 13(9):922. https://doi.org/10.3390/vaccines13090922

Chicago/Turabian Style

D’Onofrio, Valentino, Bart Jacobs, Azhar Alhatemi, Simon De Gussem, Marjolein Verstraete, Sharon Porrez, Anthony Willems, Fien De Boever, Gwenn Waerlop, Geert Leroux-Roels, and et al. 2025. "A Novel Carbohydrate Fatty-Acid Monosulphate Ester, Squalane-in-Water Adjuvant Is Safe and Enhances Inactivated Influenza Vaccine Immunogenicity in Older Adults" Vaccines 13, no. 9: 922. https://doi.org/10.3390/vaccines13090922

APA Style

D’Onofrio, V., Jacobs, B., Alhatemi, A., De Gussem, S., Verstraete, M., Porrez, S., Willems, A., De Boever, F., Waerlop, G., Leroux-Roels, G., Michels, E., Vanni, F., Manenti, A., Platenburg, P. P., Hilgers, L., & Leroux-Roels, I. (2025). A Novel Carbohydrate Fatty-Acid Monosulphate Ester, Squalane-in-Water Adjuvant Is Safe and Enhances Inactivated Influenza Vaccine Immunogenicity in Older Adults. Vaccines, 13(9), 922. https://doi.org/10.3390/vaccines13090922

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