Noah McKittrick, MD; Ian Frank, MD; Jeffrey M. Jacobson, MD; C. Jo White, MD; Deborah Kim, RPh; Rosemarie Kappes, RN, MPH; Carol DiGiorgio, RN; Thomas Kenney, BS; Jean Boyer, PhD; Pablo Tebas, MD; for the Center for AIDS Research
Disclaimer: Sanofi Pasteur was not involved in the study design or the analysis.
Grant Support: In part by grant U01-AI069467 from the National Institute of Allergy and Infectious Diseases and grant P30-AI045008 from the Center for AIDS Research to the University of Pennsylvania.
Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M12-1043.
Reproducible Research Statement: Study protocol, statistical code, and data set: Available from Dr. Tebas (e-mail, email@example.com).
Requests for Single Reprints: Pablo Tebas, MD, University of Pennsylvania, AIDS Clinical Research Unit, 502 Johnson Pavillion, 3610 Hamilton Walk, Philadelphia, PA 19104.
Current Author Addresses: Dr. McKittrick: Jefferson Hospital Ambulatory Practice, 833 Chestnut Street, Suite 220, Philadelphia, PA 19107.
Drs. Frank, White, Boyer, and Tebas; Ms. Kim, Ms. Kappes, Ms. DiGiorgio, and Mr. Kenney: University of Pennsylvania, AIDS Clinical Research Unit, 502 Johnson Pavillion, 3610 Hamilton Walk, Philadelphia, PA 19104.
Dr. Jacobson: Partnership Comprehensive Care Practice, 1427 Vine Street, 3rd Floor, Philadelphia, PA 19102.
Author Contributions: Conception and design: J.M. Jacobson, C.J. White, P. Tebas.
Analysis and interpretation of the data: N. McKittrick, I. Frank, J.M. Jacobson, C.J. White, P. Tebas.
Drafting of the article: N. McKittrick, J. Boyer, P. Tebas.
Critical revision of the article for important intellectual content: N. McKittrick, I. Frank, J.M. Jacobson, C.J. White, P. Tebas.
Final approval of the article: N. McKittrick, I. Frank, J.M. Jacobson, C.J. White, P. Tebas.
Provision of study materials or patients: N. McKittrick, I. Frank, J.M. Jacobson, D. Kim, R. Kappes, C. DiGiorgio, T. Kenney, P. Tebas.
Statistical expertise: P. Tebas.
Obtaining of funding: P. Tebas.
Administrative, technical, or logistic support: N. McKittrick, I. Frank, J.M. Jacobson, C.J. White, D. Kim, R. Kappes, C. DiGiorgio, T. Kenney, P. Tebas.
Collection and assembly of data: N. McKittrick, J.M. Jacobson, C. DiGiorgio, T. Kenney, J. Boyer, P. Tebas.
HIV-infected persons have less robust antibody responses to influenza vaccines.
To compare the immunogenicity of high-dose influenza vaccine with that of standard dosing in HIV-positive participants.
Randomized, double-blind, controlled trial. (ClinicalTrials.gov: NCT01262846)
The MacGregor Clinic of the Hospital of the University of Pennsylvania, Philadelphia, from 27 October 2010 to 27 March 2011.
HIV-infected persons older than 18 years.
Participants were randomly assigned to receive either a standard dose (15 mcg of antigen per strain) or a high dose (60 mcg/strain) of the influenza trivalent vaccine.
The primary end point was the rate of seroprotection, defined as antibody titers of 1:40 or greater on the hemagglutination inhibition assay 21 to 28 days after vaccination. The primary safety end point was frequency and intensity of adverse events. Secondary end points were seroconversion rate (defined as a greater than 4-fold increase in antibody titers) and the geometric mean antibody titer.
195 participants enrolled, and 190 completed the study (93 in the standard-dose group and 97 in the high-dose group). The seroprotection rates after vaccination were higher in the high-dose group for the H1N1 (96% vs. 87%; treatment difference, 9 percentage points [95% CI, 1 to 17 percentage points]; P = 0.029), H3N2 (96% vs. 92%; treatment difference, 3 percentage points [CI, −3 to 10 percentage points]; P = 0.32), and influenza B (91% vs. 80%; treatment difference, 11 percentage points [CI, 1 to 21 percentage points]; P = 0.030) strains. Both vaccines were well-tolerated, with myalgia (19%), malaise (14%), and local pain (10%) the most frequent adverse events.
The effectiveness of the vaccine in preventing clinical influenza was not evaluated. The number of participants with CD4 counts less than 0.200 × 109 cells/L was limited.
HIV-infected persons reach higher levels of influenza seroprotection if vaccinated with the high-dose trivalent vaccine than with the standard-dose.
National Institute of Allergy and Infectious Diseases and Center for AIDS Research of the University of Pennsylvania.
McKittrick N, Frank I, Jacobson JM, White CJ, Kim D, Kappes R, et al. Improved Immunogenicity With High-Dose Seasonal Influenza Vaccine in HIV-Infected Persons: A Single-Center, Parallel, Randomized Trial. Ann Intern Med. 2013;158:19–26. doi: 10.7326/0003-4819-158-1-201301010-00005
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Published: Ann Intern Med. 2013;158(1):19-26.
HIV, Infectious Disease, Influenza, Prevention/Screening, Vaccines/Immunization.
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