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Improved immunogenicity with high-dose seasonal influenza vaccine in HIV-infected persons: a single-center, parallel, randomized trial.
Ann Intern Med. 2013 Jan 01; 158(1):19-26.AIM

Abstract

BACKGROUND

HIV-infected persons have less robust antibody responses to influenza vaccines.

OBJECTIVE

To compare the immunogenicity of high-dose influenza vaccine with that of standard dosing in HIV-positive participants.

DESIGN

Randomized, double-blind, controlled trial. (ClinicalTrials.gov: NCT01262846)

SETTING

The MacGregor Clinic of the Hospital of the University of Pennsylvania, Philadelphia, from 27 October 2010 to 27 March 2011.

PARTICIPANTS

HIV-infected persons older than 18 years.

INTERVENTION

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.

MEASUREMENTS

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.

RESULTS

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.

LIMITATIONS

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.

CONCLUSION

HIV-infected persons reach higher levels of influenza seroprotection if vaccinated with the high-dose trivalent vaccine than with the standard-dose.

PRIMARY FUNDING SOURCE

National Institute of Allergy and Infectious Diseases and Center for AIDS Research of the University of Pennsylvania.

Authors+Show Affiliations

University of Pennsylvania, Philadelphia, PA 19104, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

23277897

Citation

McKittrick, Noah, et al. "Improved Immunogenicity With High-dose Seasonal Influenza Vaccine in HIV-infected Persons: a Single-center, Parallel, Randomized Trial." Annals of Internal Medicine, vol. 158, no. 1, 2013, pp. 19-26.
McKittrick N, Frank I, Jacobson JM, 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(1):19-26.
McKittrick, N., Frank, I., Jacobson, J. M., White, C. J., Kim, D., Kappes, R., DiGiorgio, C., Kenney, T., Boyer, J., & Tebas, P. (2013). Improved immunogenicity with high-dose seasonal influenza vaccine in HIV-infected persons: a single-center, parallel, randomized trial. Annals of Internal Medicine, 158(1), 19-26. https://doi.org/10.7326/0003-4819-158-1-201301010-00005
McKittrick N, et al. Improved Immunogenicity With High-dose Seasonal Influenza Vaccine in HIV-infected Persons: a Single-center, Parallel, Randomized Trial. Ann Intern Med. 2013 Jan 1;158(1):19-26. PubMed PMID: 23277897.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Improved immunogenicity with high-dose seasonal influenza vaccine in HIV-infected persons: a single-center, parallel, randomized trial. AU - McKittrick,Noah, AU - Frank,Ian, AU - Jacobson,Jeffrey M, AU - White,C Jo, AU - Kim,Deborah, AU - Kappes,Rosemarie, AU - DiGiorgio,Carol, AU - Kenney,Thomas, AU - Boyer,Jean, AU - Tebas,Pablo, PY - 2013/1/2/entrez PY - 2013/1/2/pubmed PY - 2013/3/5/medline SP - 19 EP - 26 JF - Annals of internal medicine JO - Ann. Intern. Med. VL - 158 IS - 1 N2 - BACKGROUND: HIV-infected persons have less robust antibody responses to influenza vaccines. OBJECTIVE: To compare the immunogenicity of high-dose influenza vaccine with that of standard dosing in HIV-positive participants. DESIGN: Randomized, double-blind, controlled trial. (ClinicalTrials.gov: NCT01262846) SETTING: The MacGregor Clinic of the Hospital of the University of Pennsylvania, Philadelphia, from 27 October 2010 to 27 March 2011. PARTICIPANTS: HIV-infected persons older than 18 years. INTERVENTION: 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. MEASUREMENTS: 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. RESULTS: 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. LIMITATIONS: 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. CONCLUSION: HIV-infected persons reach higher levels of influenza seroprotection if vaccinated with the high-dose trivalent vaccine than with the standard-dose. PRIMARY FUNDING SOURCE: National Institute of Allergy and Infectious Diseases and Center for AIDS Research of the University of Pennsylvania. SN - 1539-3704 UR - https://www.unboundmedicine.com/medline/citation/23277897/Improved_immunogenicity_with_high_dose_seasonal_influenza_vaccine_in_HIV_infected_persons:_a_single_center_parallel_randomized_trial_ L2 - https://www.annals.org/aim/fullarticle/doi/10.7326/0003-4819-158-1-201301010-00005 DB - PRIME DP - Unbound Medicine ER -