{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,7]],"date-time":"2026-01-07T13:05:44Z","timestamp":1767791144710,"version":"3.49.0"},"reference-count":38,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2025,10,15]],"date-time":"2025-10-15T00:00:00Z","timestamp":1760486400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Tropical Med Int Health"],"published-print":{"date-parts":[[2026,1]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Within a randomised controlled trial providing Bacillus Calmette\u2010Gu\u00e9rin, measles vaccine, or placebo to women of fertile age, we aimed to study the risk of adverse events following vaccination. This study addresses the lack of data on adverse reactions in adults, especially women of childbearing age, to inform broader vaccination policies.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The trial included HIV\u2010negative, non\u2010pregnant women aged 15 to 35\u2009years, who had given birth to at least one child, and residing in the Bandim Health Project study area in the capital Bissau of Guinea\u2010Bissau. Excluded were individuals who were frail, had serious illnesses like active tuberculosis, or had no prior births. Participants were randomised 1:1:1 to bacillus calmette\u2010gu\u00e9rin, measles vaccine, or placebo. A subset of participants was enrolled into the adverse events study. Adverse events were registered immediately 15\u2009min post\u2010vaccination and at home visits 7, 14, 28 and 90\u2009days after enrolment to register symptoms that could be related to the trial interventions. We compared symptom distributions by randomisation using chi\u2010squared tests.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Of the total 366 women included in the study, 99% (363) were eligible to follow up for adverse events (Placebo, 121; measles vaccine, 121; Bacillus Calmette\u2010Gu\u00e9rin, 121) and 97% (1414\/1452) of the planned study contacts were successful, 1.3% (18\/1414) of which were mobile phone interviews. The baseline characteristics did not differ between the randomisation groups. There were no immediate reactions within the first 15\u2009min post\u2010vaccination. Seven days after vaccination, there was a tendency for more episodes of headache reported among both the Bacillus Calmette\u2010Gu\u00e9rin and measles vaccine vaccinated participants compared to placebo. We registered 11 medical consultations (placebo: 4, measles vaccine: 5, Bacillus Calmette\u2010Gu\u00e9rin: 2) and no deaths or hospitalisations during 90\u2009days of post\u2010enrolment follow\u2010up.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Bacillus Calmette\u2010Gu\u00e9rin and measles vaccine were safe and tolerable for adult women of childbearing age, with few short\u2010 and medium\u2010term adverse events.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/tmi.70052","type":"journal-article","created":{"date-parts":[[2025,10,16]],"date-time":"2025-10-16T01:43:23Z","timestamp":1760579003000},"page":"91-101","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Adverse Events After Measles and Bacillus Calmette\u2010Gu\u00e9rin Vaccinations of Women of Fertile Age in Guinea\u2010Bissau. A Nested Study Within an Open\u2010Label Placebo\u2010Controlled Randomised Trial"],"prefix":"10.1111","volume":"31","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9371-4253","authenticated-orcid":false,"given":"Isaquel","family":"Silva","sequence":"first","affiliation":[{"name":"Instituto Nacional de Sa\u00fade P\u00fablica da Guin\u00e9\u2010 Bissau (INASA)  Bissau Guinea\u2010Bissau"},{"name":"Bandim Health Project  Bissau Guinea\u2010Bissau"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sebastian","family":"Nielsen","sequence":"additional","affiliation":[{"name":"Bandim Health Project  Bissau Guinea\u2010Bissau"},{"name":"OPEN, Department of Clinical Research University of Southern Denmark  Odense Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter","family":"Aaby","sequence":"additional","affiliation":[{"name":"Bandim Health Project  Bissau Guinea\u2010Bissau"},{"name":"OPEN, Department of Clinical Research University of Southern Denmark  Odense Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christine Stabell","family":"Benn","sequence":"additional","affiliation":[{"name":"Bandim Health Project  Bissau Guinea\u2010Bissau"},{"name":"OPEN, Department of Clinical Research University of Southern Denmark  Odense Denmark"},{"name":"Danish Institute for Advanced Study University of Southern Denmark  Odense Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Frederik","family":"Schaltz\u2010Buchholzer","sequence":"additional","affiliation":[{"name":"Bandim Health Project  Bissau Guinea\u2010Bissau"},{"name":"OPEN, Department of Clinical Research University of Southern Denmark  Odense Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,10,15]]},"reference":[{"key":"e_1_2_7_2_1","unstructured":"WHO \u201cWHO. 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