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- Bergfors, Elisabet, 1945
(författare)
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Aspects of pertussis, pertussis vaccination and adverse events associated with aluminum adsorbed vaccines
- 2006
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- The thesis originates in a clinical study of one of the new acellular pertussis vaccines performed in Göteborg in the 1990s. The monocomponent vaccine, pertussis toxoid adsorbed to aluminium hydroxide, had previously been shown to have an efficacy of 71%. The first aim of the study was to see if the vaccine could induce herd immunity, with protection also of unvaccinated individuals, by mass vaccination of infants and children. A second aim was to study epdemiologic, clinical and immunologic characteristics of parapertussis, a disease related to pertussis. Further aims were to descibe the incidence, clinical picture and prognosis of two rare vaccine-related side effects, persistent pruritic nodules and delayed hypersensitivity to aluminium, in participants in the vaccine trials and in recipients of other aluminium adsorbed diphtheria-tetanus-pertussis vaccines. METHODS. All children in the Göteborg area born during the 1990s were offered three doses of pertussis vaccine. The incidence of pertussis was followed by the number of positive pertussis cultures and hospitalisations due to pertussis before and during the mass vaccination. Parapertussis cases were identified in a previous vaccine efficacy trial and in clinical routine. Children with persistent itching nodules were found through passive reporting and active search for cases. Aluminium allergy was tested with an epicutaneous test. Symptoms were evaluated by examination of afflicted children, yearly structured questionnaires and/or telephone interviews. RESULTS More than 60,000 children were vaccinated with the pertussis vaccine. Numbers of positive cultures decreased drastically during the mass vaccination, both in vaccinated children and in unvaccinated infants and individuals ≥15 years. - 81 patients with parapertussis were identified. The duration of their disease was shorter and their symptoms milder than seen in patients with pertussis. Antibody levels against FHA and pertactin were similar after both diseases while pertussis toxin antibodies only increased in pertussis patients. - Persistent itching nodules at the injection site were found in 645 children (almost 1 % of all vaccinees). The itching was often severe and long lasting (about 4 years) in children followed until recovery. Contact allergy to aluminium was demonstrated in 352 of 455 children tested (77 %) with pruritic nodules and in 17 of 211 (8 %) of asymptomatic siblings, who had received the same vaccine. - 19 cases of itching nodules in recipients of currently used aluminium adsorbed vaccines were described. 15 were tested for aluminium allergy, all with positive results. CONCLUSIONS A monocomponent pertussis toxoid vaccine induced a high degree of herd immunity against pertussis with indirect protection of unvaccinated individuals. Parapertussis is an uncommon disease causing similar, but usually milder, symptoms as pertussis. Antibodies against FHA and pertactin, but not pertussis toxin, were induced. Aluminium adsorbed vaccines from three different producers can cause long-lasting, intensely itching nodules and hypersensitivity to aluminium.
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| 3. |
- Bergfors, Elisabet, 1945, et al.
(författare)
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Nineteen cases of persistent pruritic nodules and contact allergy to aluminium after injection of commonly used aluminium-adsorbed vaccines.
- 2005
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Ingår i: European journal of pediatrics. - : Springer Science and Business Media LLC. - 0340-6199 .- 1432-1076. ; 164:11, s. 691-7
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Tidskriftsartikel (refereegranskat)abstract
- Rare cases of persistent pruritic nodules, sometimes associated with aluminium (Al) allergy, have been reported after the use of several Al adsorbed vaccines. During vaccine trials in the 1990s a high incidence of pruritic nodules (645 cases/76,000 recipients), in 77% associated with Al allergy, was observed after the administration of diphtheria-tetanus / acellular pertussis (DT/aP) vaccines from a single producer. In the present report 19 children with pruritic nodules after vaccination with Al hydroxide-adsorbed DTaP/polio+Hib (Infanrix, Pentavac) are described. The children had intensely itching nodules at the injection site, often aggravated during upper respiratory tract infections, and local skin alterations. So far, the symptoms have persisted for up to 7 years. The median time between vaccination and onset of symptoms was 1 month. 16 children were epicutaneously tested for Al, all with positive reactions indicating delayed hypersensitivity to Al. The condition is not commonly known but is important to recognise, as the child and the family may suffer considerably. Future vaccinations with Al-adsorbed vaccines may cause aggravation of the symptoms and the Al allergy. Al-containing skin products, such as antiperspirants, may cause contact dermatitis. Nodules may be mistaken for tumours. Even though the incidence of itching nodules and Al allergy after administration of Infanrix, Pentavac and other Al-adsorbed vaccines is probably low, research to replace Al adjuvants seems appropriate. We conclude that intensely itching subcutaneous nodules, lasting for many years, and hypersensitivity to aluminium may occur after DTaP/polio+Hib vaccination of infants.
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| 4. |
- Bergfors, Elisabet, 1945, et al.
(författare)
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Patch testing children with aluminium chloride hexahydrate in petrolatum: A review and a recommendation
- 2019
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Ingår i: Contact Dermatitis. - : WILEY. - 0105-1873 .- 1600-0536. ; 81:2, s. 81-88
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Forskningsöversikt (refereegranskat)abstract
- Background: According to studies on adults, patch testing with aluminium chloride hexahydrate 2% pet. is insufficient to detect aluminium allergy, and a 10% preparation is recommended. Other studies suggest that a 2% preparation is sufficient for testing children. Objectives: To review three previously published Swedish studies on patch testing children with aluminium chloride hexahydrate 2% pet. Patients/Methods: Altogether, 601 children with persistent itching subcutaneous nodules (granulomas) induced by aluminium-adsorbed vaccines were patch tested with aluminium chloride hexahydrate 2% pet. and metallic aluminium in (a) a pertussis vaccine trial, (b) clinical practice, and (ca) prospective study. Results: Overall, 459 children had positive reactions to the 2% pet. preparation. Another 10 reacted positively only to metallic aluminium. An extreme positive reaction (+++) was seen in 65% of children aged 1 to 2 years as compared with 22% of children aged 7 years. From 8 years onwards, extreme positive reactions were scarce. Conclusions: Aluminium chloride hexahydrate 2% pet. is sufficient to trace aluminium allergy in children. Small children are at risk of extreme reactions. We thus suggest that aluminium chloride hexahydrate 10% pet. should not be used routinely in children before the age of 7 to 8 years.
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| 5. |
- Bergfors, Elisabet, 1945, et al.
(författare)
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Unexpectedly high incidence of persistent itching nodules and delayed hypersensitivity to aluminium in children after the use of adsorbed vaccines from a single manufacturer
- 2003
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Ingår i: Vaccine. - 0264-410X .- 0264-410X. ; 22:1, s. 64-9
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Tidskriftsartikel (refereegranskat)abstract
- During trials of aluminium adsorbed diphtheria-tetanus/acellular pertussis vaccines from a single producer, persistent itching nodules at the vaccination site were observed in an unexpectedly high frequency. The afflicted children were followed in a longitudinal observational study, and the presence of aluminium sensitization was investigated in the children with itching nodules and their symptomless siblings by patch tests. Itching nodules were found in 645 children out of about 76,000 vaccinees (0.8%) after both subcutaneous (s.c.) and intramuscular (i.m.) injection. The itching was intense and long-lasting. So far, 75% still have symptoms after a median duration of 4 years. Contact hypersensitivity to aluminium was demonstrated in 77% of the children with itching nodules and in 8% of the symptomless siblings who had received the same vaccines (P<0.001). Children with persistent itching nodules and/or aluminium sensitization should be warned about aluminium containing products (e.g. vaccines and antiperspirants). The reason for the high incidence of itching nodules after SSI vaccines is unknown and should be further investigated.
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| 6. |
- Gente-Lidholm, Anette, et al.
(författare)
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Comparison of reactivity to a metallic disc and 2% aluminium salt in 366 children, and reproducibility over time for 241 young adults with childhood vaccine-related aluminium contact allergy
- 2018
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Ingår i: Contact Dermatitis. - : Wiley. - 0105-1873. ; 79:1, s. 26-30
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Tidskriftsartikel (refereegranskat)abstract
- Background: An aluminium hydroxide-adsorbed pertussis toxoid vaccine was studied in 76 000 children in the 1990s in Gothenburg, Sweden. Long-lasting itchy subcutaneous nodules at the vaccination site were seen in 745 participants. Of 495 children with itchy nodules who were patch tested for aluminium allergy, 377 were positive. In 2007-2008, 241 of the positive children were retested. Only in one third were earlier positive results reproduced. Objectives: To further describe patch test reactions to different aluminium compounds in children with vaccine-induced aluminium allergy. Patients/Methods: Positive patch test results for metallic aluminium (empty Finn Chamber) and aluminium chloride hexahydrate 2% petrolatum (pet.) were analysed in 366 children with vaccine-induced persistent itching nodules tested in 1998-2002. Of those, 241 were tested a second time (2007-2008), and the patch test results of the two aluminium preparations were analysed. Results: Patch testing with aluminium chloride hexahydrate 2% pet. is a more sensitive way to diagnose aluminium contact allergy than patch testing with metallic aluminium. A general decrease in the strength of reactions to both aluminium preparations in 241 children tested twice was observed. Conclusions: Aluminium contact allergy can be diagnosed by patch testing without using metallic aluminium.
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| 7. |
- Gente-Lidholm, Anette, et al.
(författare)
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Long-term clinical course and prognosis of vaccine-related persistent itching nodules (1997-2019): An observational study
- 2022
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Ingår i: Vaccine: X. - : Elsevier BV. - 2590-1362. ; 11
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Tidskriftsartikel (refereegranskat)abstract
- Background: Vaccines adsorbed to aluminium can induce long-lasting intensely itching subcutaneous nodules (granulomas) at the injection site as well as contact allergy to aluminium. In clinical trials of a new acellular pertussis vaccine performed in the 1990s (Gothenburg, Sweden) with 76 000 participants, itching nodules were reported in 745 children. A positive patch test to aluminium was verified in 77% of the tested children with itchy nodules. Aim: To describe the long-term clinical course and prognosis of vaccine-related itching nodules caused by aluminium-containing pediatric vaccines and to estimate the risk for new symptoms after future vaccination with aluminium-containing vaccines. Methods: 745 children with vaccine-related itching nodules were followed by regular interviews/questionnaires for more than 20 years. 723 of them received a booster dose of diphtheria/tetanus vaccine either with or without aluminium adjuvant during the follow-up time. Results: Most study participants (86%) reported a full recovery from their itching nodules after a median duration of 6.6 years. Only a few of the diphtheria/tetanus-booster-vaccinated children (3%) reported mild transient itching and swelling at the new injection site. Conclusion: Vaccine-induced itching granulomas caused by an aluminium-adsorbed acellular pertussis toxoid vaccine seem to disappear over time. Future vaccinations with aluminium-adsorbed vaccines can be performed with little risk for new itching nodules later in life. (c) 2022 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY license (http:// creativecommons.org/licenses/by/4.0/).
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| 8. |
- Gente-Lidholm, Anette, et al.
(författare)
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Long-term prognosis of vaccine-induced contact allergy to aluminium: Third patch-test with additional test preparations
- 2023
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Ingår i: Contact Dermatitis. - 0105-1873. ; 89:5, s. 359-367
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Tidskriftsartikel (refereegranskat)abstract
- Background A high incidence of local itching subcutaneous nodules and aluminium allergy was observed in clinical trials of a new aluminium adsorbed pertussis vaccine in Gothenburg, Sweden, in the 1990s. A total of 495 children with itching nodules were patch tested with aluminium chloride hexahydrate 2% and an empty Finn Chamber (R), 377 (76%) with positive reactions. When 241 of them were re-tested some years later 186 (3 out of 4) had unexpectedly lost their patch test reactivity.Aim To investigate the long-term prognosis of vaccine-induced contact allergy to aluminium by a third patch test about 20 years after Patch test I.Methods Twenty individuals with positive and 11 with negative results in Patch test II were tested a third time with the same sensitisers as in in the first two tests. Three additional aluminium preparations were also tested.Results A total 15 out of 20 persons with positive results in the second test had lost their patch test reactivity. Two of 11 with negative tests had turned positive again. The addition of the preparations gave no conclusive results.Conclusion Contact allergy to aluminium caused by vaccination with aluminium-adsorbed vaccines in childhood seems to fade away with time as measured by loss of patch test reactivity.
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| 9. |
- Gente-Lidholm, Anette, et al.
(författare)
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Loss of patch-test reaction to aluminium years after vaccination with aluminium adjuvants in a population of 76.000 children.
- 2010
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Ingår i: Contact Dermatitis. - 0105-1873 .- 1600-0536.
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Konferensbidrag (refereegranskat)abstract
- During trials of aluminium adsorbed diphtheria–rntetanus/acellular pertussis vaccines from a single producer,rnpersistent intensely itching nodules at the vaccination site werernobserved in an unexpectedly high frequency (about 1%) in thernstudy area around Gothenburg, Sweden. All afflicted childrenrnwere offered patch testing for aluminium. Among the childrenrnsensitisation to aluminium was demonstrated in a highrnfrequency (77%). The children demonstrated positive patchrntests for aluminium were offered to repeat the test 5 years later.rnObjectives: To study the clinical course of itching nodules andrncontact allergy to aluminium.rnMethods: Two hundred and fifty children with itching nodulesrnat the injection site after vaccination with aluminium adsorbedrndiphtheria–tetanus/acellular pertussis vaccines that earlier hadrnshown a positive patch test reaction to aluminium, wherernrepeated the patch test more than 5 years later. Thernchildren were patch tested in the same way as beforernwith aluminiumchloridehexahydrate 2% in petrolatumrn(Chemotechnique Diagnostics, Sweden) in plastic chambersrnfrom the same manufacturer, and also with an empty FinnrnChamber (Epitest, Finland). The tests were read on day threernusing the ICDRG’s criteria.rnResults: Among the 250 children tested, approximately 75% hadrnno remaining positive patch test to aluminium. Only a few of thernchildren presented still itching nodules.rnConclusion: Three out of four children with earlier shownrncontact allergy to aluminium had lost their patch testrnreactivity 5 years later.
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