Phase I study of a candidate vaccine based on recombinant HIV-1 gp160 (MN/LAI) administered by the mucosal route to HIV-seronegative volunteers: The ANRS VAC14 study

Vaccine

Volumn 26, Issue 21, 2008, Pages 2657-2666

  Pialoux, Gilles ^a   Hocini, Hakim ^b   Pérusat, Sophie ^b,d,e   Silberman, Benjamin ^c   Salmon Ceron, Dominique ^c   Slama, Laurence ^a   Journot, Valérie ^b,d,e   Mathieu, Emmanuelle ^a   Gaillard, Christophe ^a,c   Petitprez, Karine ^c   Launay, Odile ^c   Chêne, Geneviève ^b,d,e  

^a HÔPITAL TENON   (France)

^b INSERM   (France)

^c Hôpital Cochin ^*  (France)

^d UNIVERSITÉ DE BORDEAUX   (France)

^e BORDEAUX UNIVERSITY HOSPITAL   (France)

Author keywords

DC Chol; gp160; HIV; Mucosal vaccination; Vaccine

Indexed keywords

3 BETA [N (N',N' DIMETHYLAMINOETHANE)CARBAMOYL]CHOLESTEROL; GLYCOPROTEIN GP 160; HUMAN IMMUNODEFICIENCY VIRUS ANTIBODY; HUMAN IMMUNODEFICIENCY VIRUS VACCINE; IMMUNOGLOBULIN A ANTIBODY; IMMUNOGLOBULIN G ANTIBODY; IMMUNOGLOBULIN M ANTIBODY; IMMUNOLOGICAL ADJUVANT;

ADULT; ANXIETY; ARTICLE; ASTHENIA; BLOOD TOXICITY; CARDIOTOXICITY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; EAR DISEASE; EYE DISEASE; FEMALE; GASTROINTESTINAL DISEASE; GYNECOLOGIC DISEASE; HEADACHE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; IMMUNOGENICITY; INFECTION; MAJOR CLINICAL STUDY; MALE; MUSCULOSKELETAL DISEASE; NOSE DISEASE; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SKIN MANIFESTATION; THROAT DISEASE; UNSPECIFIED SIDE EFFECT; UTERINE CERVIX CYTOLOGY; VACCINIA VIRUS;

EID: 43049160751     PISSN: 0264410X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.vaccine.2007.11.002     Document Type: Article

References (31)

1. I.M. Belyakov J.D. Ahlers J.A. Berzofsky Mucosal AIDS vaccines: current status and future directions Expert Rev Vaccines 3 August (Suppl. 4) 2004 S65 S73
2. I.M. Belyakov J.A. Berzofsky Immunobiology of mucosal HIV infection and the basis for development of a new generation of mucosal AIDS vaccines Immunity 20 March (3) 2004 247 253
3. A. Duerr J.N. Wasserheit L. Corey HIV vaccines: new frontiers in vaccine development Clin Infect Dis 43 August (4) 2006 500 511
4. P.A. Kozlowski S. Cu-Uvin M.R. Neutra T.P. Flanigan Mucosal vaccination strategies for women J Infect Dis 179 May (Suppl. 3) 1999 S493 S498
5. M.P. Girard S.K. Osmanov M.P. Kieny A review of vaccine research and development: the human immunodeficiency virus (HIV) Vaccine 24 May (19) 2006 4062 4081
6. L. Stevceva W. Strober Mucosal HIV vaccines: where are we now? Curr HIV Res 2 January (1) 2004 1 10
7. J. Joseph F. Etcheverry J. Alcami G.J. Maria A safe, effective and affordable HIV vaccine—an urgent global need AIDS Rev 7 July–September (3) 2005 131 138
8. G. Pialoux L. Slama HIV vaccines Presse Med 34 November (20 Pt 2) 2005 1592 1596
9. S. Gizurarson Optimal delivery of vaccines: clinical pharmacokinetic considerations Clin Pharmacokinet 30 January (1) 1996 1 15
10. S.W. Wang F.M. Bertley P.A. Kozlowski L. Herrmann K. Manson G. Mazzara An SHIV DNA/MVA rectal vaccination in macaques provides systemic and mucosal virus-specific responses and protection against AIDS AIDS Res Hum Retroviruses 20 August (8) 2004 846 859
11. M. Vajdy M. Singh J. Kazzaz E. Soenawan M. Ugozzoli F. Zhou Mucosal and systemic anti-HIV responses in rhesus macaques following combinations of intranasal and parenteral immunizations AIDS Res Hum Retroviruses 20 November (11) 2004 1269 1281
12. V.R. Gomez-Roman L.J. Patterson D. Venzon D. Liewehr K. Aldrich R. Florese Vaccine-elicited antibodies mediate antibody-dependent cellular cytotoxicity correlated with significantly reduced acute viremia in rhesus macaques challenged with SIVmac251 J Immunol 174 February (4) 2005 2185 2189
13. M.A. Egan S.Y. Chong M. Hagen S. Megati E.B. Schadeck P. Piacente A comparative evaluation of nasal and parenteral vaccine adjuvants to elicit systemic and mucosal HIV-1 peptide-specific humoral immune responses in cynomolgus macaques Vaccine 22 September (27–28) 2004 3774 3788
14. M. Busch K. Abel J. Li M. Piatak Jr. J.D. Lifson C.J. Miller Efficacy of a SHIV 89.6 proviral DNA vaccine against mucosal SIVmac239 challenge Vaccine 23 July (31) 2005 4036 4047
15. R. Kaul D. Trabattoni J.J. Bwayo D. Arienti A. Zagliani F.M. Mwangi HIV-1-specific mucosal IgA in a cohort of HIV-1-resistant Kenyan sex workers AIDS (Lond, England) 13 January (1) 1999 23 29
16. N. Matoba A. Magerus B.C. Geyer Y. Zhang M. Muralidharan A. Alfsen A mucosally targeted subunit vaccine candidate eliciting HIV-1 transcytosis-blocking Abs Proc. Natl. Acad. Sci. U.S.A. 101 September (37) 2004 13584 13589
17. D. Salmon-Ceron J.L. Excler L. Finkielsztejn B. Autran J.C. Gluckman D. Sicard Safety and immunogenicity of a live recombinant canarypox virus expressing HIV type 1 gp120 MN MN tm/gag/protease LAI (ALVAC-HIV, vCP205) followed by a p24E-V3 MN synthetic peptide (CLTB-36) administered in healthy volunteers at low risk for HIV infection. AGIS Group and L’Agence Nationale de Recherches sur Le Sida AIDS Res Hum Retroviruses 15 May (7) 1999 633 645
18. G. Pialoux J.L. Excler Y. Riviere G. Gonzalez-Canali V. Feuillie P. Coulaud A prime-boost approach to HIV preventive vaccine using a recombinant canarypox virus expressing glycoprotein 160 (MN) followed by a recombinant glycoprotein 160 (MN/LAI). The AGIS Group, and l’Agence Nationale de Recherche sur le SIDA AIDS Res Hum Retroviruses 11 March (3) 1995 373 381
19. C. Durier O. Launay V. Meiffredy Y. Saidi D. Salmon Y. Levy Clinical safety of HIV lipopeptides used as vaccines in healthy volunteers and HIV-infected adults. AIDS (Lond, England) 20 April (7) 2006 1039 1049
20. F. Brunel A. Darbouret J. Ronco Cationic lipid DC-Chol induces an improved and balanced immunity able to overcome the unresponsiveness to the hepatitis B vaccine Vaccine 17 April (17) 1999 2192 2203
21. M. Cremel H. Hamzeh-Cognasse C. Genin O. Delezay Female genital tract immunization: evaluation of candidate immunoadjuvants on epithelial cell secretion of CCL20 and dendritic/Langerhans cell maturation Vaccine 24 July (29–30) 2006 5744 5754
22. X. Gao L. Huang A novel cationic liposome reagent for efficient transfection of mammalian cells Biochem Biophys Res Commun 179 August (1) 1991 280 285
23. P.G. Middleton N.J. Caplen X. Gao L. Huang H. Gaya D.M. Geddes Nasal application of the cationic liposome DC-Chol:DOPE does not alter ion transport, lung function or bacterial growth Eur Respir J 7 March (3) 1994 442 445
24. B. Guy N. Pascal A. Francon A. Bonnin S. Gimenez E. Lafay-Vialon Design, characterization and preclinical efficacy of a cationic lipid adjuvant for influenza split vaccine Vaccine 19 February (13–14) 2001 1794 1805
25. G. de Bruyn A.J. Rossini Y.L. Chiu D. Holman M.L. Elizaga S.E. Frey Safety profile of recombinant canarypox HIV vaccines Vaccine 22 January (5–6) 2004 704 713
26. B.S. Graham R.A. Koup M. Roederer R.T. Bailer M.E. Enama Z. Moodie Phase 1 safety and immunogenicity evaluation of a multiclade HIV-1 DNA candidate vaccine J Infect Dis 194 December (12) 2006 1650 1660
27. E. Mills S. Nixon S. Singh S. Dolma A. Nayyar S. Kapoor Enrolling women into HIV preventive vaccine trials: an ethical imperative but a logistical challenge PLoS Med 3 March (3) 2006 e94
28. E.T. Rudy P.A. Newman N. Duan E.M. Kelly K.J. Roberts D.S. Seiden HIV vaccine acceptability among women at risk: perceived barriers and facilitators to future HIV vaccine uptake AIDS Educ Prev 17 June (3) 2005 253 267
29. A.P. de Souza L.H. Haut R. Silva S.I. Ferreira C.R. Zanetti H.C. Ertl Genital CD8+ T cell response to HIV-1 gag in mice immunized by mucosal routes with a recombinant simian adenovirus Vaccine 25 2007 109 116
30. I.M. Belyakov D. Isakov Q. Zhu A. Dzutsev J.A. Berzofsky A novel functional CTL avidity/activity compartmentalization to the site of mucosal immunization contributes to protection of macaques against simian/human immunodeficiency viral depletion of mucosal CD4+ T cells J Immunol 178 June (11) 2007 7211 7221
31. I.M. Belyakov V.A. Kuznetsov B. Kelsall D. Klinman M. Moniuszko M. Lemon Impact of vaccine-induced mucosal high-avidity CD8+ CTLs in delay of AIDS viral dissemination from mucosa Blood 107 April (8) 2006 3258 3264