Risk of autoimmune diseases and human papilloma virus (HPV) vaccines: six years of case-referent surveillance.
Open accessAbstract
BACKGROUND: Safety of HPV vaccines is still in question due to reports of autoimmune diseases (ADs) following HPV immunization. OBJECTIVES: To assess the risk of ADs associated with HPV vaccination of female adolescents/young adults in France. METHODS: Systematic prospective case-referent study conducted to assess the risks associated with real-life use of HPV vaccines. Cases were female 11-25 years old with incident ADs [central demyelination/multiple sclerosis (CD/MS), connective tissue disease (CTD), Guillain-Barré syndrome (GBS), type-1 diabetes (T1D), autoimmune thyroiditis (AT), and idiopathic thrombocytopenic purpura (ITP)]. Cases were consecutively and prospectively identified at specialized centers across France (2008-2014) and individually matched by age and place of residence to referents recruited in general practice. Risk was computed using multivariate conditional logistic regression models adjusted for family history of ADs, living in France (north/south), co-medications and co-vaccinations. RESULTS: With a total of 478 definite cases matched to 1869 referents, all ADs combined were negatively associated to HPV vaccination with an adjusted odds ratio of 0.58 (95% confidence interval: 0.41-0.83). Similar results were obtained for CD/MS, AT, CT, and T1D, the last two not reaching statistical significance. No association was found for ITP and GBS. Sensitivity analyses combining definite and possible cases with secondary time window showed similar results. CONCLUSION: Exposure to HPV vaccines was not associated with an increased risk of ADs within the time period studied. Results were robust to case definitions and time windows of exposure. Continued active surveillance is needed to confirm this finding for individual ADs.
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A large case-control study in France matching 211 definite cases of autoimmune disease with 875 controls found no association between HPV vaccine and several autoimmune disorders (ITP, GBS, connective tissue disorders, type 1 diabetes, and autoimmune thyroiditis).
“Additionally, a large case control study in France matched 211 definite cases of AI disease with 875 controlls. No association was found between HPV vaccine an several AI disorders (i.e., immune thrombocytopenic purpura [ITP], GBS, connective tissue disorders, DM type 1, and autoimmune thyroiditis) (Grimaldi-Bensouda et al., 2017).”
From Vaccine Safety: Myths and Misinformation (2020) · cites this paper as Grimaldi-Bensouda et al., 2017
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Experimental — accuracy not yet measuredStudies have repeatedly demonstrated that the HPV vaccine is safe and there are strong epidemiologic data refuting claims of an association with autoimmune diseases.
“Studies have repeatedly demonstrated that this is a safe vaccine and there are strong epidemiologic data refuting claims of an association with AI diseases.”
From Vaccine Safety: Myths and Misinformation (2020) · cites this paper as Grimaldi-Bensouda et al., 2017
The Discussion (page unavailable) reports no increased risk for several autoimmune diseases among French female adolescents and young adults, and says the findings add to evidence from other studies. It could not assess Guillain–Barré syndrome, however, and does not establish that HPV vaccines are safe in every respect or for every population. (LLM, conf=0.85)
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Vaccine Safety: Myths and Misinformation
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- Authors
- Grimaldi-Bensouda, L., Rossignol, M., Koné-Paut, I., Krivitzky, A., Lebrun-Frenay, C., Clet, J., Brassat, D., Papeix, C., Nicolino, M., Benhamou, P.-Y., Fain, O., Costedoat-Chalumeau, N., Courcoux, M.-F., Viallard, J.-F., Godeau, B., Papo, T., Vermersch, P., Bourgault-Villada, I., Breart, G., Abenhaim, L., Abbas, F., Abdelmoumni, A., Hilliquin, P., Requeda, E., Adoue, D., Brassat, D., Agard, C., Masseau, A., Aladjidi, N., Clet, J., Fernandes, H., Lemasson, G., Perel, Y., Raymond, I., Richer, O., Vital, A., Allain-Launay, E., Bru, M., Nicolino, M., Thomas, C., Altman, J.-J., Amsallem, D., Aras, N., Boukari, L., Dubrel, M., Fain, O., Letellier, E., Lucidarme, N., Mekinian, A., Morin, A.-S., Stirnemann, J., Atlan, C., Audry, D., Augustin, J., Bakir, R., Bartolucci, P., Chevalier, X., Godeau, B., Guillaud, C., Khellaf, M., Limal, N., Lousteau, V., Mahevas, M., Méliksetyan, G., Michel, M., Roumier, M., Bayart, S., Bonnet, F., Decaux, O., Bekherraz, A., Brihaye, B., Dachez, R., Daugas, E., Hayem, G., Meyer, O., Papo, T., Pasqualoni, E., Sacre, K., Travert, F., Bellon, H., Beltrand, J., Lefrere, F., Simon, A., Benhamou, P.-Y., Benveniste, O., Bolgert, F., Costedoat-Chalumeau, N., De Paz, R., Demeret, S., Fautrel, B., Jacqueminet, S., Louapre, C., Maillart, E., Morel, N., Papeix, C., Rigabert, J., Bensaid, P., Berger, C., Berquin, P., Le Moing, A.-G., Berroir, S., Besson, G., Boutte, C., Casez, O., Bonnotte, B., Audia, S., Bossu-Estour, C., Bourgarit, A., Dupuy, A., Keshmandt, H., Bourre, B., Brac, A., Perrin, A., Pondarré, C., Villar-Fimbel, S., Bruckert, I., Cosson, A., Magy-Bertrand, N., Tisserand, G., Camu, W., Carlander, B., Morales, R. J., Cances, C., Pasquet, M., Castilla Lievre, M. A., Chabroux, S., Charif, M., Chatelus, E., Sibilia, J., Chevrant-Breton, J., Clavel, S., Bille-Turc, F., Cohen, J., Courcoux, M. F., Leverger, G., Machet, L., Cuisset, J.-M., Cony-Makhoul, P., Darsy, P., Favre, S., Giraud, P., Leitenschenck, L., Monteiro, I., Morati, C., DeSeze, J., Dinulescu, M., Dhaoui, T., Dommange-Romero, F., Drevard, E., Dupuis, C., Dumuis, M.-L., Durand, J.-M., Farad, S., Lecomte, P., Pierre, P., Fouyssac, F., Gaudin, P., Gautier, A., Gellen-Dautremer, J., Jarrin, I., Richette, P., Georget, E., Gras, P., Moreau, T., Giraud, E., Hacini, M., Mayer, A., Guillaumat, C., Guillaume, S., Guitton, C., Kone-Paut, I., Marsaud, C., Rossi, L., Guyot, M.-H., Hassler, P., Heimfert, C., Heinzlef, O., Hillion, B., Hocquelet, C., Husson, H., Ichai, P., Jeziorski, E., Deslandre, C. J., Le Guern, V., Kamenov, K., Kerlan, V., Lemoine, P., Misery, L., Pan-Petesch, B., Krivitzky, A., Labauge, P., Rodier, M., Lacade, C., Razafimahefa, B., Lachgar, K., Larmarau, M.-P., Leblanc, T., Lebrun-Frenay, C., Lefèbvre, P., Lejoyeux, P., Leske, C., Ly, K., Magy, L., Mansuy, S., Marechaud, R., Martin Negrier, M.-L., Sole, G., Maupetit, J., Mazingue, F., Mochon, S., Moktar, B., Morcamp, D., Morlet-Barla, N., Nicolas, G., Pautot, V., Pellier, I., Verret, J.-L., Outteryck, O., Vermersch, P., Pallot-Prades, B., Paquet, J. M., Puechal, X., Sortais, A., Pelletier, J., Rico, A., Pez, D., Stankoff, B., Quittet, P., Rémy, C., Roba, E., Rosario, H., Roudaut, N., Sonnet, E., Ruel, M., Sebban, S., Schaepelynck, P., Simonin, M.-J., Vial, C., Viallard, J.-F., Ladedan, I., & Zenone, T.
- Affiliations
- McGill University (CA)
- London School of Hygiene & Tropical Medicine (GB)
- Hôpital Cochin (FR)
- Centre Hospitalier Universitaire de Bordeaux (FR)
- Centre Hospitalier Universitaire de Caen Normandie (FR)
- Hôpital Femme Mère Enfant (FR)
- Centre Hospitalier Universitaire Henri-Mondor (FR)
- Assistance Publique – Hôpitaux de Paris (FR)
- Centre Hospitalier Universitaire de Grenoble (FR)
- Hôpital Avicenne (FR)
- Université de Versailles Saint-Quentin-en-Yvelines (FR)
- Centre de Référence des Maladies Autoinflammatoires et des Amyloses (FR)
- Centre Hospitalier Universitaire de Nice (FR)
- Lille Inflammation Research International Center (FR)
- Corresponding author
- Rossignol, Michel
- ORCID
- Bourgault-Villada, Isabelle
- Abenhaim, Lucien
- Agard, Christian
- Aladjidi, Nathalie
- Fernandes, Helder
- Richer, Olivier
- Thomas, Caroline
- Altman, Jean-Jacques
- Mekinian, Arsène
- Stirnemann, Jérôme
- Bartolucci, Pablo
- Chevalier, Xavier
- Khellaf, Mehdi
- Michel, Marc
- Bayart, Sophie
- Bonnet, Fabrice
- Decaux, Olivier
- Brihaye, Benoit
- Hayem, Gilles
- Beltrand, Jacques
- Demeret, Sophie
- Fautrel, Bruno
- Jacqueminet, Sophie
- Louapre, Céline
- Berger, Claire
- Berquin, Patrick
- Besson, Gérard
- Casez, Olivier
- Bonnotte, Bernard
- Audia, Sylvain
- Bourgarit, Anne
- Dupuy, Alain
- Bourre, Bertrand
- Pondarré, Corinne
- Magy-Bertrand, Nadine
- Camu, William
- Morales, Raul Juntas
- Chatelus, Emmanuel
- Sibilia, Jean
- Cohen, Jacques
- Leverger, Guy
- Machet, Laurent
- Dinulescu, Monica
- Durand, Jean-Marc
- Gaudin, Philippe
- Richette, Pascal
- Moreau, Thibault
- Guitton, Corinne
- Heinzlef, Olivier
- Hillion, Brigitte
- Kerlan, Véronique
- Misery, Laurent
- Labauge, Pierre
- Leblanc, Thierry
- Lefèbvre, Patrick
- Ly, Kim
- Magy, Laurent
- Nicolas, Guillaume
- Pellier, Isabelle
- Outteryck, Olivier
- Pelletier, Jean
- Rico, Audrey
- Stankoff, Bruno
- Quittet, Philippe
- Roudaut, Nathalie
- Schaepelynck, Pauline
- Venue
- Journal of Autoimmunity
- Publisher
- Elsevier BV
- Published
- 2017-05
- Volume
- 79
- Pages
- 84-90
- ISSN
- 0896-8411 (ISSN-L)
- OpenAlex
- W2586708682
- Cited by
- 84
- References
- 24
- Citations by year
- 2026: 1 · 2025: 7 · 2024: 7 · 2023: 3 · 2022: 12 · 2021: 7 · 2020: 11 · 2019: 12 · 2018: 13 · 2017: 10
- FWCI
- 9.85
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Journal of Autoimmunity (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- HAL (submittedVersion, cc-by-nc-nd)
- Topics
- Health Sciences › Medicine › Epidemiology › Cervical Cancer and HPV Research
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Health Sciences › Medicine › Emergency Medicine › Intramuscular injections and effects
- Keywords
- HPV vaccine, vaccine safety, autoimmune disease, multiple sclerosis, connective tissue diseases, Guillain-Barré syndrome, type 1 diabetes, autoimmune thyroiditis, idiopathic thrombocytopenic purpura, central nervous system demyelination, young women, vaccine adverse events
- MeSH terms
- Adolescent, Adult, Autoimmune Diseases, Child, Female, Follow-Up Studies, Humans, Male, Population Surveillance, Risk, Odds Ratio, Papillomavirus Infections, Papillomavirus Vaccines, Young Adult
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