A randomized clinical trial of the impact of melatonin on influenza vaccine: Outcomes from the melatonin and vaccine response immunity and chronobiology study (MAVRICS)

Vaccine immunogenicity is affected by a variety of factors. Melatonin has been reported to affect immune responses to vaccines and infection. This was a randomized open-label trial – in which adults scheduled to receive the influenza vaccine were randomized to 5 mg melatonin or control to evaluate t...

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Main Authors: Rachel U. Lee, Nora L. Watson, Gena L. Glickman, Lindsey White, Sandra D. Isidean, Chad K. Porter, Monique Hollis-Perry, Samuel R. Walther, Santina Maiolatesi, Martha Sedegah, Harini Ganeshan, Jun Huang, David A. Boulifard, Daniel Ewing, Appavu K. Sundaram, Elizabeth M. Harrison, Katherine DeTizio, Maria Belmonte, Arnel Belmonte, Sandra Inoue, Alexandra Easterling, Elizabeth S. Cooper, Janine Danko
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Language:English
Published: Taylor & Francis Group 2024-12-01
Series:Human Vaccines & Immunotherapeutics
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Online Access:https://www.tandfonline.com/doi/10.1080/21645515.2024.2419742
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author Rachel U. Lee
Nora L. Watson
Gena L. Glickman
Lindsey White
Sandra D. Isidean
Chad K. Porter
Monique Hollis-Perry
Samuel R. Walther
Santina Maiolatesi
Martha Sedegah
Harini Ganeshan
Jun Huang
David A. Boulifard
Daniel Ewing
Appavu K. Sundaram
Elizabeth M. Harrison
Katherine DeTizio
Maria Belmonte
Arnel Belmonte
Sandra Inoue
Alexandra Easterling
Elizabeth S. Cooper
Janine Danko
author_facet Rachel U. Lee
Nora L. Watson
Gena L. Glickman
Lindsey White
Sandra D. Isidean
Chad K. Porter
Monique Hollis-Perry
Samuel R. Walther
Santina Maiolatesi
Martha Sedegah
Harini Ganeshan
Jun Huang
David A. Boulifard
Daniel Ewing
Appavu K. Sundaram
Elizabeth M. Harrison
Katherine DeTizio
Maria Belmonte
Arnel Belmonte
Sandra Inoue
Alexandra Easterling
Elizabeth S. Cooper
Janine Danko
author_sort Rachel U. Lee
collection DOAJ
description Vaccine immunogenicity is affected by a variety of factors. Melatonin has been reported to affect immune responses to vaccines and infection. This was a randomized open-label trial – in which adults scheduled to receive the influenza vaccine were randomized to 5 mg melatonin or control to evaluate the effect of post-vaccination melatonin on humoral (hemagglutination-inhibition assays, HAI) and cellular (FluoroSpot) vaccine-specific cytokine responses 14–21 days post-vaccination. A total of 108 participants (melatonin treatment group: 53; control group: 55) completed the study. The groups were similar in baseline characteristics, including sleep as measured by the Pittsburgh Sleep Quality Index. Seroconversion rates or geometric mean fold rises (GMFR) in HAI titers did not vary by treatment group. There were also no statistically significant differences between pre- and post-vaccination levels of interferon gamma (IFN-γ) or granzyme B (GzB) by treatment; however, there was a significantly higher fold rise in the double secretor (IFN-γ + GzB) peripheral blood mononuclear cells for influenza vaccine in subjects taking daily melatonin (GMFR 1.7; 95% CI 1.3, 2.3) compared to those who did not (GMFR 0.9; 95% CI 0.7, 1.1) (p < .001). Daily melatonin for 14 days post-influenza vaccination significantly increased the cellular co-expression of IFN-γ + GzB; however, there were no other differences in the cellular or humoral responses. Future studies of the potential utility of melatonin for enhancing vaccine response with larger sample sizes may help elucidate candidate mechanisms for these limited effects, including any interactions with the circadian system.
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spelling doaj-art-c7ccef5edbf947ac99105d9dffc42fec2025-08-20T02:16:49ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2024-12-0120110.1080/21645515.2024.2419742A randomized clinical trial of the impact of melatonin on influenza vaccine: Outcomes from the melatonin and vaccine response immunity and chronobiology study (MAVRICS)Rachel U. Lee0Nora L. Watson1Gena L. Glickman2Lindsey White3Sandra D. Isidean4Chad K. Porter5Monique Hollis-Perry6Samuel R. Walther7Santina Maiolatesi8Martha Sedegah9Harini Ganeshan10Jun Huang11David A. Boulifard12Daniel Ewing13Appavu K. Sundaram14Elizabeth M. Harrison15Katherine DeTizio16Maria Belmonte17Arnel Belmonte18Sandra Inoue19Alexandra Easterling20Elizabeth S. Cooper21Janine Danko22Department of Medicine, Walter Reed National Military Medical Center, Bethesda, MD, USADepartment of Medicine, Walter Reed National Military Medical Center, Bethesda, MD, USADepartment of Psychiatry and Neuroscience, Uniformed Services University of the Health Sciences, Bethesda, MD, USAHenry M. Jackson Foundation for the Advancement of Military Medicine, Inc., Bethesda, MD, USAHenry M. Jackson Foundation for the Advancement of Military Medicine, Inc., Bethesda, MD, USADepartment of Translational and Clinical Research, Naval Medical Research Command, Silver Spring, MD, USADepartment of Psychiatry and Neuroscience, Uniformed Services University of the Health Sciences, Bethesda, MD, USADepartment of Translational and Clinical Research, Naval Medical Research Command, Silver Spring, MD, USAHenry M. Jackson Foundation for the Advancement of Military Medicine, Inc., Bethesda, MD, USADepartment of Translational and Clinical Research, Naval Medical Research Command, Silver Spring, MD, USAHenry M. Jackson Foundation for the Advancement of Military Medicine, Inc., Bethesda, MD, USAHenry M. Jackson Foundation for the Advancement of Military Medicine, Inc., Bethesda, MD, USAHenry M. Jackson Foundation for the Advancement of Military Medicine, Inc., Bethesda, MD, USADepartment of Translational and Clinical Research, Naval Medical Research Command, Silver Spring, MD, USADepartment of Translational and Clinical Research, Naval Medical Research Command, Silver Spring, MD, USADepartment of Psychiatry and Neuroscience, Uniformed Services University of the Health Sciences, Bethesda, MD, USAHenry M. Jackson Foundation for the Advancement of Military Medicine, Inc., Bethesda, MD, USAHenry M. Jackson Foundation for the Advancement of Military Medicine, Inc., Bethesda, MD, USADepartment of Translational and Clinical Research, Naval Medical Research Command, Silver Spring, MD, USADepartment of Translational and Clinical Research, Naval Medical Research Command, Silver Spring, MD, USAHenry M. Jackson Foundation for the Advancement of Military Medicine, Inc., Bethesda, MD, USADepartment of Translational and Clinical Research, Naval Medical Research Command, Silver Spring, MD, USADepartment of Translational and Clinical Research, Naval Medical Research Command, Silver Spring, MD, USAVaccine immunogenicity is affected by a variety of factors. Melatonin has been reported to affect immune responses to vaccines and infection. This was a randomized open-label trial – in which adults scheduled to receive the influenza vaccine were randomized to 5 mg melatonin or control to evaluate the effect of post-vaccination melatonin on humoral (hemagglutination-inhibition assays, HAI) and cellular (FluoroSpot) vaccine-specific cytokine responses 14–21 days post-vaccination. A total of 108 participants (melatonin treatment group: 53; control group: 55) completed the study. The groups were similar in baseline characteristics, including sleep as measured by the Pittsburgh Sleep Quality Index. Seroconversion rates or geometric mean fold rises (GMFR) in HAI titers did not vary by treatment group. There were also no statistically significant differences between pre- and post-vaccination levels of interferon gamma (IFN-γ) or granzyme B (GzB) by treatment; however, there was a significantly higher fold rise in the double secretor (IFN-γ + GzB) peripheral blood mononuclear cells for influenza vaccine in subjects taking daily melatonin (GMFR 1.7; 95% CI 1.3, 2.3) compared to those who did not (GMFR 0.9; 95% CI 0.7, 1.1) (p < .001). Daily melatonin for 14 days post-influenza vaccination significantly increased the cellular co-expression of IFN-γ + GzB; however, there were no other differences in the cellular or humoral responses. Future studies of the potential utility of melatonin for enhancing vaccine response with larger sample sizes may help elucidate candidate mechanisms for these limited effects, including any interactions with the circadian system.https://www.tandfonline.com/doi/10.1080/21645515.2024.2419742Vaccine immunogenicityinfluenza vaccinemelatoninvaccine adjuvanthumoral immunitycellular immunity
spellingShingle Rachel U. Lee
Nora L. Watson
Gena L. Glickman
Lindsey White
Sandra D. Isidean
Chad K. Porter
Monique Hollis-Perry
Samuel R. Walther
Santina Maiolatesi
Martha Sedegah
Harini Ganeshan
Jun Huang
David A. Boulifard
Daniel Ewing
Appavu K. Sundaram
Elizabeth M. Harrison
Katherine DeTizio
Maria Belmonte
Arnel Belmonte
Sandra Inoue
Alexandra Easterling
Elizabeth S. Cooper
Janine Danko
A randomized clinical trial of the impact of melatonin on influenza vaccine: Outcomes from the melatonin and vaccine response immunity and chronobiology study (MAVRICS)
Human Vaccines & Immunotherapeutics
Vaccine immunogenicity
influenza vaccine
melatonin
vaccine adjuvant
humoral immunity
cellular immunity
title A randomized clinical trial of the impact of melatonin on influenza vaccine: Outcomes from the melatonin and vaccine response immunity and chronobiology study (MAVRICS)
title_full A randomized clinical trial of the impact of melatonin on influenza vaccine: Outcomes from the melatonin and vaccine response immunity and chronobiology study (MAVRICS)
title_fullStr A randomized clinical trial of the impact of melatonin on influenza vaccine: Outcomes from the melatonin and vaccine response immunity and chronobiology study (MAVRICS)
title_full_unstemmed A randomized clinical trial of the impact of melatonin on influenza vaccine: Outcomes from the melatonin and vaccine response immunity and chronobiology study (MAVRICS)
title_short A randomized clinical trial of the impact of melatonin on influenza vaccine: Outcomes from the melatonin and vaccine response immunity and chronobiology study (MAVRICS)
title_sort randomized clinical trial of the impact of melatonin on influenza vaccine outcomes from the melatonin and vaccine response immunity and chronobiology study mavrics
topic Vaccine immunogenicity
influenza vaccine
melatonin
vaccine adjuvant
humoral immunity
cellular immunity
url https://www.tandfonline.com/doi/10.1080/21645515.2024.2419742
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