H1N1pdm09 adjuvanted vaccination in HIV-infected adults: A randomized trial of two single versus two double doses

PLoS ONE

Volumn 7, Issue 6, 2012, Pages

  Santini Oliveira, Marilia ^a   Camacho, Luiz A B ^b   Souza, Thiago M L ^b   Luz, Paula M ^a   Vasconcellos, Mauricio T L ^a   Giacoia Gripp, Carmem B W ^b   Morgado, Mariza G ^b   Nunes, Estevão P ^a   Lemos, Alberto S ^a   Ferreira, Ana C G ^a   Moreira, Ronaldo I ^a   Veloso, Valdiléa G ^a   Siqueira, Marilda M ^b   Grinsztejn, Beatriz ^a  

^a Funda??o Oswaldo Cruz   (Brazil)

^b INSTITUTO OSWALDO CRUZ   (Brazil)

Author keywords

[No Author keywords available]

Indexed keywords

HEMAGGLUTININ; IMMUNOLOGICAL ADJUVANT;

2009 H1N1 INFLUENZA; ADULT; ANTIBODY DETECTION; ARTICLE; CD4 LYMPHOCYTE COUNT; CONTROLLED STUDY; DOSE RESPONSE; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG SAFETY; FEMALE; HEMAGGLUTINATION INHIBITION TEST; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; IMMUNE RESPONSE; IMMUNOGENICITY; MAJOR CLINICAL STUDY; MALE; PHASE 2 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; SEROCONVERSION; SEX DIFFERENCE; VIRUS LOAD;

ADOLESCENT; ADULT; AGE FACTORS; DRUG ADMINISTRATION SCHEDULE; FEMALE; HEMAGGLUTINATION INHIBITION TESTS; HIV INFECTIONS; HUMANS; INFLUENZA A VIRUS, H1N1 SUBTYPE; INFLUENZA VACCINES; INFLUENZA, HUMAN; MALE; MIDDLE AGED; SEX FACTORS; TREATMENT OUTCOME;

EID: 84862637307     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0039310     Document Type: Article

References (32)

1. Beck JM, Rosen MJ, Peavy HH, (2001) Pulmonary complications of HIV infection. Report of the Fourth NHLBI Workshop. Am J Respir Crit Care Med 164: 2120-2126.
2. Bautista E, Chotpitayasunondh T, Gao Z, Harper SA, Shaw M, et al. (2010) Clinical aspects of pandemic 2009 influenza A (H1N1) virus infection. N Engl J Med 362: 1708-1719.
3. Klein MB, Lu Y, DelBalso L, Cote S, Boivin G, (2007) Influenzavirus infection is a primary cause of febrile respiratory illness in HIV-infected adults, despite vaccination. Clin Infect Dis 45: 234-240.
4. CDC (2011) Updated Interim Recommendations- HIV-Infected Adults and Adolescents: Considerations for Clinicians Regarding 2009 H1N1 Influenza. Available: http://www.cdc.gov/h1n1flu/guidance_hiv.htm. Accessed 2011 Oct 21.
5. MS (2010) Nota técnica 67/2010: Pessoas que vivem com HIV/aids serão vacinadas contra o Vírus da Influenza A (H1N1). Departamento de DST, AIDS e Hepatites Virais, Ministério da Saúde. Available: http://www.aids.gov.br/node/40142. Accessed 2011 Dec 27.
6. Bickel M, von Hentig N, Wieters I, Khaykin P, Nisius G, et al. (2011) Immune response after two doses of the novel split virion, adjuvanted pandemic H1N1 influenza A vaccine in HIV-1-infected patients. Clin Infect Dis 52: 122-127.
7. Launay O, Desaint C, Durier C, Loulergue P, Duval X, et al. (2011) Safety and immunogenicity of a monovalent 2009 influenza A/H1N1v vaccine adjuvanted with AS03A or unadjuvanted in HIV-infected adults: a randomized, controlled trial. J Infect Dis 204: 124-134.
8. Dolin R, (2011) Editorial commentary: Perspectives on the role of immunization against influenza in HIV-infected patients. Clin Infect Dis 52: 147-149.
9. Oliveira W, Carmo E, Penna G, Kuchenbecker R, Santos H, et al. (2009) Pandemic H1N1 influenza in Brazil: analysis of the first 34,506 notified cases of influenza-like illness with severe acute respiratory infection (SARI). Euro Surveill 14.
10. Miller E, Hoschler K, Hardelid P, Stanford E, Andrews N, et al. (2010) Incidence of 2009 pandemic influenza A H1N1 infection in England: a cross-sectional serological study. Lancet 375: 1100-1108.
11. Clark TW, Pareek M, Hoschler K, Dillon H, Nicholson KG, et al. (2009) Trial of 2009 influenza A (H1N1) monovalent MF59-adjuvanted vaccine. N Engl J Med 361: 2424-2435.
12. Rowe T, Abernathy RA, Hu-Primmer J, Thompson WW, Lu X, et al. (1999) Detection of antibody to avian influenza A (H5N1) virus in human serum by using a combination of serologic assays. J Clin Microbiol 37: 937-943.
13. Szretter KJ, Balish AL, Katz JM, (2006) Influenza: propagation, quantification, and storage. Curr Protoc Microbiol Chapter 15: Unit 15G 11.
14. WHO (2009) CDC protocol for realtime RTPCR for influenza A (H1N1), World Health Organization. Available: http://www.who.int/csr/resources/publications/swineflu/CDCRealtimeRTPCR_SwineH1Assay-2009_20090430.pdf. Accessed 2009 Apr 30.
15. Fleiss JL, (1981) Statistical methods for rates and proportions. New York: Wiley. xviii, 321 p.
16. SVS (2009) Informe epidemiológico influenza A H1N1: Situação epidemiológica da nova influenza A (H1N1) no Brasil. Secretaria de Vigilancia em Saude. Available: http://portal.saude.gov.br/portal/arquivos/pdf/informe_influenza_se30_03_08_2009.pdf. Accessed 2010 Dec 27.
17. Bickel M, Wieters I, Khaykin P, Nisius G, Haberl A, et al. (2010) Low rate of seroconversion after vaccination with a split virion, adjuvanted pandemic H1N1 influenza vaccine in HIV-1-infected patients. AIDS 24: F31-35.
18. Tebas P, Frank I, Lewis M, Quinn J, Zifchak L, et al. (2010) Poor immunogenicity of the H1N1 2009 vaccine in well controlled HIV-infected individuals. AIDS 24: 2187-2192.
19. Soonawala D, Rimmelzwaan GF, Gelinck LB, Visser LG, Kroon FP, (2011) Response to 2009 pandemic influenza A (H1N1) vaccine in HIV-infected patients and the influence of prior seasonal influenza vaccination. PLoS One 6: e16496.
20. WHO (2011) FluNet. Available: http://www.who.int/influenza/gisrs_laboratory/flunet/en/. Accessed 2011 Nov 18.
21. Crum-Cianflone NF, Iverson E, Defang G, Blair PJ, Eberly LE, et al. (2011) Durability of antibody responses after receipt of the monovalent 2009 pandemic influenza A (H1N1) vaccine among HIV-infected and HIV-uninfected adults. Vaccine 29: 3183-3191.
22. CDC (2011) Inactivated Influenza Vaccine: What you need to know, 2010-2011. Available: http://www.cdc.gov/vaccines/pubs/vis/#flu. Accessed 2011 Nov 14.
23. Couch RB, Kasel JA, (1983) Immunity to influenza in man. Annu Rev Microbiol 37: 529-549.
24. Fiore AE, Uyeki TM, Broder K, Finelli L, Euler GL, et al. (2010) Prevention and control of influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2010. MMWR Recomm Rep 59: 1-62.
25. CDC (2011) Updated CDC Estimates of 2009 H1N1 Influenza Cases, Hospitalizations and Deaths in the United States, April 2009 - April 10, 2010. Available: http://www.cdc.gov/h1n1flu/estimates_2009_h1n1.htm. Accessed 2011 Dec 27.
26. Harris DJ, Douglas PS, (2000) Enrollment of women in cardiovascular clinical trials funded by the National Heart, Lung, and Blood Institute. N Engl J Med 343: 475-480.
27. Jagsi R, Motomura AR, Amarnath S, Jankovic A, Sheets N, et al. (2009) Under-representation of women in high-impact published clinical cancer research. Cancer 115: 3293-3301.
28. Melloni C, Berger JS, Wang TY, Gunes F, Stebbins A, et al. (2010) Representation of women in randomized clinical trials of cardiovascular disease prevention. Circ Cardiovasc Qual Outcomes 3: 135-142.
29. Settembre EC, Dormitzer PR, Rappuoli R, (2010) H1N1: can a pandemic cycle be broken? Sci Transl Med 2: 24ps14.
30. Wei CJ, Boyington JC, Dai K, Houser KV, Pearce MB, et al. (2010) Cross-neutralization of 1918 and 2009 influenza viruses: role of glycans in viral evolution and vaccine design. Sci Transl Med 2: 24ra21.
31. Xu R, Ekiert DC, Krause JC, Hai R, Crowe JE Jr, et al. (2010) Structural basis of preexisting immunity to the 2009 H1N1 pandemic influenza virus. Science 328: 357-360.
32. Crum-Cianflone NF, Eberly LE, Duplessis C, Maguire J, Ganesan A, et al. (2011) Immunogenicity of a monovalent 2009 influenza A (H1N1) vaccine in an immunocompromised population: a prospective study comparing HIV-infected adults with HIV-uninfected adults. Clin Infect Dis 52: 138-146.