A Phase 3, Randomized, Controlled, Open Label Study to Evaluate the Immunogenicity, Safety, and Tolerability of MF59-Adjuvanted Versus Non-Adjuvanted Vaccines Against Novel H1N1 Virus in Patients With Human Immunodeficiency Virus Type 1 (HIV-1) Infection
Sponsor study identifier
interventional
154
1 country
2
Study Start
April 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2011
Actual (reported)Study Completion
July 2012
Actual (reported)This is a phase III, randomized, controlled, open label study with two vaccine regimens. The study will assess the relative safety and immunogenicity of vaccine regimens comparing adjuvanted versus non-adjuvanted formulations of A(H1N1) inactivated influenza virus vaccine in subjects with Human Immunodeficiency Virus Type 1 (HIV-1) Infection and to compare safety and immunogenicity data with a contemporaneously enrolled control group of age-comparable, healthy subjects. Because certain individuals may be hypo-responsive to influenza vaccination, additional studies with high-risk groups are warranted in order to determine the optimal vaccine formulation and dosing schedule for prevention of novel H1N1 virus infection.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 14, 2009
Actual (reported)December 15, 2009
Actual (reported)April 2010
Date type not reportedThis date has not been verified as actual or estimated.
September 2011
Actual (reported)July 2012
Actual (reported)Geometric Mean HI Titer by Visit
Geometric mean hemagglutination inhibition (HI) titer = GMT
13 months after vaccination (Day 1, Day 22, Day 43, Day 133, Day 223 and Day 403)
Percentage of Subjects Who Reached Seroprotection by Visit
The primary objective of this study is to determine the optimal influenza vaccination strategy in patients with HIV infection. The percentage of subjects that reached seroprotection in comparison to the pre-vaccination result are presented by visit. Seroprotection was defined as HI titer ≥40.
13 Months after vaccination (Day 22, Day 43, Day 133, Day 223 and Day 403)
Difference in the Seroconversion Rates or Significant Increase by Visit (Vaccine With Adjuvant - Vaccine Without Adjuvant)
Each subject received two doses of vaccine with adjuvant (Focetria®), the first on Study Day 1, and the second on Study Day 22
Each subject received two doses of vaccine without adjuvant (Begrivac®), the first on Study Day 1, and the second on Study Day 22
7.5 ug of HA antigen; adjuvanted; monovalent
15 ug of HA antigen; non-adjuvanted; trivalent
Centro Médico São Francisco
Curitiba, Paraná, Brazil
ICG - Instituto Centro de Genomas
São Paulo, São Paulo, Brazil
Clark TW, Pareek M, Hoschler K, Dillon H, Nicholson KG, Groth N, Stephenson I. Trial of 2009 influenza A (H1N1) monovalent MF59-adjuvanted vaccine. N Engl J Med. 2009 Dec 17;361(25):2424-35. doi: 10.1056/NEJMoa0907650. Epub 2009 Sep 10.
Novel Swine-Origin Influenza A (H1N1) Virus Investigation Team; Dawood FS, Jain S, Finelli L, Shaw MW, Lindstrom S, Garten RJ, Gubareva LV, Xu X, Bridges CB, Uyeki TM. Emergence of a novel swine-origin influenza A (H1N1) virus in humans. N Engl J Med. 2009 Jun 18;360(25):2605-15. doi: 10.1056/NEJMoa0903810. Epub 2009 May 7.
154 participants (actual enrollment reported by the registry).
First Submitted
December 14, 2009
First Posted
December 15, 2009
Study Start
April 2010
Date type not reportedThis date has not been verified as actual or estimated.
The primary objective of this study was to help determine the ideal strategy of vaccination against pandemic H1N1 influenza in subjects with invasive solid tumors/hematologic neoplasms. Comparisons were made by vaccine group using differences in the percentage of subjects with seroconversion/significant increase and were presented with 95% confidence intervals.
13 Months after vaccination (Day 22, Day 43, Day 133, Day 223 and Day 403)
Geometric Mean Ratio by Visit
13 months after vaccination (Day 22/Day1, Day 43/Day 1, Day 43/Day 22, Day 133/Day 43, Day 223/Day 43 and Day 403/Day 223)
Ratio of Immunogenicity Data by Visit (Vaccine with Adjuvant:Vaccine Without Adjuvant)
13 months after vaccination (Day 1, Day 22, Day 22/Day1, Day 43, Day 43/Day 1, Day 43/Day 22, Day 133, Day 133/Day 43, Day 223, Day 223/Day 43 and Day 403, Day 403/Day 223)
Percentage of Subjects Who Seroconverted or Had a Significant Increase in GMT by Visit
13 Months after vaccination (Day 22, Day 43, Day 133, Day 223 and Day 403)
Difference in Seroprotection Rates by Visit (Vaccine with Adjuvant - Vaccine without Adjuvant)
13 months after vaccination (Day 22, Day 43, Day 133, Day 223, Day 403)
Each subject received two doses of vaccine with adjuvant (Focetria®), the first on Study Day 1, and the second on Study Day 22
Each subject received two doses of vaccine without adjuvant (Begrivac®), the first on Study Day 1, and the second on Study Day 22
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Evison J, Farese S, Seitz M, Uehlinger DE, Furrer H, Muhlemann K. Randomized, double-blind comparative trial of subunit and virosomal influenza vaccines for immunocompromised patients. Clin Infect Dis. 2009 May 15;48(10):1402-12. doi: 10.1086/598193.
Fine AD, Bridges CB, De Guzman AM, Glover L, Zeller B, Wong SJ, Baker I, Regnery H, Fukuda K. Influenza A among patients with human immunodeficiency virus: an outbreak of infection at a residential facility in New York City. Clin Infect Dis. 2001 Jun 15;32(12):1784-91. doi: 10.1086/320747. Epub 2001 May 16.
Kunisaki KM, Janoff EN. Influenza in immunosuppressed populations: a review of infection frequency, morbidity, mortality, and vaccine responses. Lancet Infect Dis. 2009 Aug;9(8):493-504. doi: 10.1016/S1473-3099(09)70175-6.
Ranieri R, Veronelli A, Santambrogio C, Pontiroli AE. Impact of influenza vaccine on response to vaccination with pneumococcal vaccine in HIV patients. AIDS Res Hum Retroviruses. 2005 May;21(5):407-9. doi: 10.1089/aid.2005.21.407.
Sullivan PS, Hanson DL, Dworkin MS, Jones JL, Ward JW; Adult and Adolescent Spectrum of HIV Disease Investigators. Effect of influenza vaccination on disease progression among HIV-infected persons. AIDS. 2000 Dec 1;14(17):2781-5. doi: 10.1097/00002030-200012010-00018.
Tasker SA, Treanor JJ, Paxton WB, Wallace MR. Efficacy of influenza vaccination in HIV-infected persons. A randomized, double-blind, placebo-controlled trial. Ann Intern Med. 1999 Sep 21;131(6):430-3. doi: 10.7326/0003-4819-131-6-199909210-00006.
Yamanaka H, Teruya K, Tanaka M, Kikuchi Y, Takahashi T, Kimura S, Oka S; HIV/Influenza Vaccine Study Team. Efficacy and immunologic responses to influenza vaccine in HIV-1-infected patients. J Acquir Immune Defic Syndr. 2005 Jun 1;39(2):167-73.
Primary Completion
September 2011
Actual (reported)Study Completion
July 2012
Actual (reported)Last Updated
June 5, 2013
Record last verified: 2013-06
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