Vaccine safety in HIV-infected adults within the Vaccine Safety Datalink Project
- PMID: 31064675
- PMCID: PMC6538462
- DOI: 10.1016/j.vaccine.2019.04.080
Vaccine safety in HIV-infected adults within the Vaccine Safety Datalink Project
Abstract
Objectives: We evaluate safety of routine vaccination among adults infected with human immunodeficiency virus (HIV) in five healthcare organizations in the United States.
Methods: We conducted a retrospective cohort study of HIV-infected adults who received inactivated influenza vaccines, hepatitis B vaccines, pneumococcal vaccines, or tetanus, diphtheria, and acellular pertussis vaccines between 2002 and 2013. We conducted self-controlled case series analysis to estimate the relative risk (RR) for 11 pre-specified adverse events (AEs) requiring medical attention.
Results: Among 20,417 HIV-infected adults (90.2% male), a total of 137,674 vaccine doses were administered. Based on ICD-9 codes, we detected an increased risk of cellulitis and infection (RR: 1.18, 95% CI: 1.03-1.35) among all patients, and an increased risk of stroke/cerebrovascular diseases among patients with an HIV viral load >10,000 copies/ml (adjusted RR: 3.94, 95% CI: 1.32-11.72). Further analyses on chart confirmed cases of stroke/cerebrovascular diseases indicated no statistically significant increased risk (adjusted RR: 1.72, 95% CI: 0.41-7.24). There was no evidence of increased risk for other AEs following routine vaccination in HIV-infected adults.
Conclusions: Routinely administered vaccines are generally safe for HIV-infected adults.
Keywords: HIV; Vaccine Safety Datalink; Vaccine safety.
Copyright © 2019 Elsevier Ltd. All rights reserved.
Conflict of interest statement
Conflicts of interest disclosures
Hechter has received research support from Novartis and GSK for unrelated studies. Tartof has received research support from GSK and Merck for unrelated studies. Sy has received research support from Novartis, GlaxoSmithKline, Novavax, and Dynavax. Klein has received research support from Merck, Pfizer, Sanofi Pasteur, Protein Science (now Sanofi Pasteur), GSK, MedImmune, and Dynavax. Mercado and Jacobsen have received research support from Dynavax. Naleway has received research support from Pfizer and Merck for unrelated studies. Qian, McLean, and Weintraub report no conflict of interest.
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References
-
- Tempia S, Walaza S, Moyes J, Cohen AL, von Mollendorf C, McMorrow ML, et al. The effects of the attributable fFraction and the duration of symptoms on burden estimates of influenza-associated respiratory illnesses in a high HIV-prevalence setting, South Africa, 2013–2015. Influenza Other Respir Viruses 2017. - PMC - PubMed
-
- Fine AD, Bridges CB, De Guzman AM, Glover L, Zeller B, Wong SJ, et al. Influenza A among patients with human immunodeficiency virus: an outbreak of infection at a residential facility in New York City. Clin Infect Dis 2001;32 (12):1784–91. - PubMed
-
- Radwan HM, Cheeseman SH, Lai KK, Ellison IR. Influenza in human immunodeficiency virus-infected patients during the 1997–1998 influenza season. Clin Infect Dis 2000;31(2):604–6. - PubMed
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