Phase I safety and immunogenicity evaluation of MVA-CMDR, a multigenic, recombinant modified vaccinia ankara-HIV-1 vaccine candidate

PLoS ONE

Volumn 5, Issue 11, 2010, Pages

  Currier, Jeffrey R ^a   Ngauy, Viseth ^b   de Souza, Mark S ^b   Ratto Kim, Silvia ^a   Cox, Josephine H ^c   Polonis, Victoria R ^a   Earl, Patricia ^d   Moss, Bernard ^d   Peel, Sheila ^a   Slike, Bonnie ^a   Sriplienchan, Somchai ^b   Thongcharoen, Prasert ^e   Paris, Robert M ^b   Robb, Merlin L ^a   Kim, Jerome ^a   Michael, Nelson L ^a   Marovich, Mary A ^a  

^a US MIlitary HIV Research Program/Henry M Jackson Foundation   (United States)

^b ARMED FORCES RESEARCH INSTITUTE OF MEDICAL SCIENCES   (Thailand)

^c INTERNATIONAL AIDS VACCINE INITIATIVE   (United States)

^d NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES   (United States)

^e MAHIDOL UNIVERSITY   (Thailand)

Author keywords

[No Author keywords available]

Indexed keywords

CHROMIUM 51; GAMMA INTERFERON; GLYCOPROTEIN GP 120; HUMAN IMMUNODEFICIENCY VIRUS VACCINE; MODIFIED VACCINIA ANKARA CHIANG MAI DOUBLE RECOMBINANT VACCINE; PLACEBO; UNCLASSIFIED DRUG; VIRUS ENVELOPE PROTEIN; HUMAN IMMUNODEFICIENCY VIRUS PROTEIN;

ADULT; ARTICLE; CD4+ T LYMPHOCYTE; CELLULAR IMMUNITY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CYTOKINE RELEASE; DOSE RESPONSE; DRUG ADMINISTRATION ROUTE; DRUG EFFICACY; DRUG MEGADOSE; DRUG SAFETY; DRUG TOLERABILITY; ENZYME LINKED IMMUNOSORBENT ASSAY; ENZYME LINKED IMMUNOSPOT ASSAY; FEMALE; HUMAN; HUMAN CELL; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; HUMORAL IMMUNITY; IMMUNOGENICITY; LYMPHOCYTE PROLIFERATION; MALE; NORMAL HUMAN; PHASE 1 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; THAILAND; UNITED STATES; DRUG EFFECT; FATIGUE; FLOW CYTOMETRY; GENE VECTOR; GENETIC RECOMBINATION; GENETICS; HEADACHE; HUMAN IMMUNODEFICIENCY VIRUS 1; IMMUNOLOGY; INTRADERMAL DRUG ADMINISTRATION; INTRAMUSCULAR DRUG ADMINISTRATION; METHODOLOGY; MULTICENTER STUDY; NAUSEA; VACCINATION; VACCINIA VIRUS;

HUMAN IMMUNODEFICIENCY VIRUS 1;

ADULT; AIDS VACCINES; DOSE-RESPONSE RELATIONSHIP, DRUG; ENZYME-LINKED IMMUNOSORBENT ASSAY; FATIGUE; FEMALE; FLOW CYTOMETRY; GENETIC VECTORS; HEADACHE; HIV INFECTIONS; HIV-1; HUMAN IMMUNODEFICIENCY VIRUS PROTEINS; HUMANS; IMMUNITY, CELLULAR; IMMUNITY, HUMORAL; INJECTIONS, INTRADERMAL; INJECTIONS, INTRAMUSCULAR; MALE; NAUSEA; RECOMBINATION, GENETIC; THAILAND; UNITED STATES; VACCINATION; VACCINIA VIRUS;

EID: 78649733251     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0013983     Document Type: Article

References (39)

1. UNAIDS (2009) AIDS: Epidemic Update: November 2009. UNAIDS/09.36E/ JC1700E.
2. Barouch DH, Korber B (2010) HIV-1 vaccine development after STEP. Annu Rev Med 61: 153-167.
3. Korber BT, Letvin NL, Haynes BF (2009) T-cell vaccine strategies for human immunodeficiency virus, the virus with a thousand faces. J Virol 83: 8300-8314.
4. Walker BD, Burton DR (2008) Toward an AIDS vaccine. Science 320: 760-764.
5. Rerks-Ngarm S, Pitisuttithum P, Nitayaphan S, Kaewkungwal J, Chiu J, et al. (2009) Vaccination with ALVAC and AIDSVAX to prevent HIV-1 infection in Thailand. N Engl J Med 361: 2209-2220.
6. Hochstein-Mintzel V, Stickl H, Huber HC (1972) [Oral and nasal immunization with Poxvirus vacciniae. II. New methods of smallpox vaccination]. Zentralbl Bakteriol Orig B 156: 15-29.
7. Mayr A, Stickl H, Muller HK, Danner K, Singer H (1978) [The smallpox vaccination strain MVA: marker, genetic structure, experience gained with the parenteral vaccination and behavior in organisms with a debilitated defence mechanism (author's transl)]. Zentralbl Bakteriol B 167: 375-390.
8. Earl PL, Cotter C, Moss B, VanCott T, Currier J, et al. (2009) Design and evaluation of multi-gene, multi-clade HIV-1 MVA vaccines. Vaccine 27: 5885-5895.
9. Sandstrom E, Nilsson C, Hejdeman B, Brave A, Bratt G, et al. (2008) Broad immunogenicity of a multigene, multiclade HIV-1 DNA vaccine boosted with heterologous HIV-1 recombinant modified vaccinia virus Ankara. J Infect Dis 198: 1482-1490.
10. Carr JK, Salminen MO, Koch C, Gotte D, Artenstein AW, et al. (1996) Fulllength sequence and mosaic structure of a human immunodeficiency virus type 1 isolate from Thailand. J Virol 70: 5935-5943.
11. Frey SE, Newman FK, Yan L, Lottenbach KR, Belshe RB (2003) Response to smallpox vaccine in persons immunized in the distant past. JAMA 289: 3295-3299.
12. Kibuuka H, Kimutai R, Maboko L, Sawe F, Schunk MS, et al. (2010) A phase 1/2 study of a multiclade HIV-1 DNA plasmid prime and recombinant adenovirus serotype 5 boost vaccine in HIV-Uninfected East Africans (RV 172). J Infect Dis 201: 600-607.
13. Rutebemberwa A, Bess JW, Jr., Brown B, Arroyo M, Eller M, et al. (2007) Evaluation of aldrithiol-2-inactivated preparations of HIV type 1 subtypes A, B, and D as reagents to monitor T cell responses. AIDS Res Hum Retroviruses 23: 532-542.
14. Currier JR, Kuta EG, Turk E, Earhart LB, Loomis-Price L, et al. (2002) A panel of MHC class I restricted viral peptides for use as a quality control for vaccine trial ELISPOT assays. J Immunol Methods 260: 157-172.
15. Cox JH, Garner RP, Redfield RR, Aronson NE, Davis C, et al. (1999) Antibodydependent cellular cytotoxicity in HIV type 1-infected patients receiving VaxSyn, a recombinant gp160 envelope vaccine. AIDS Res Hum Retroviruses 15: 847-854.
16. Karnasuta C, Paris RM, Cox JH, Nitayaphan S, Pitisuttithum P, et al. (2005) Antibody-dependent cell-mediated cytotoxic responses in participants enrolled in a phase I/II ALVAC-HIV/AIDSVAX B/E prime-boost HIV-1 vaccine trial in Thailand. Vaccine 23: 2522-2529.
17. Bart PA, Goodall R, Barber T, Harari A, Guimaraes-Walker A, et al. (2008) EV01: a phase I trial in healthy HIV negative volunteers to evaluate a clade C HIV vaccine, NYVAC-C undertaken by the EuroVacc Consortium. Vaccine 26: 3153-3161.
18. Eller MA, Eller LA, Opollo MS, Ouma BJ, Oballah PO, et al. (2007) Induction of HIV-specific functional immune responses by a multiclade HIV-1 DNA vaccine candidate in healthy Ugandans. Vaccine 25: 7737-7742.
19. Graham BS, Koup RA, Roederer M, Bailer RT, Enama ME, et al. (2006) Phase 1 safety and immunogenicity evaluation of a multiclade HIV-1 DNA candidate vaccine. J Infect Dis 194: 1650-1660.
20. McCormack S, Stohr W, Barber T, Bart PA, Harari A, et al. (2008) EV02: a Phase I trial to compare the safety and immunogenicity of HIV DNA-C prime- NYVAC-C boost to NYVAC-C alone. Vaccine 26: 3162-3174.
21. Nitayaphan S, Pitisuttithum P, Karnasuta C, Eamsila C, de Souza M, et al. (2004) Safety and immunogenicity of an HIV subtype B and E prime-boost vaccine combination in HIV-negative Thai adults. J Infect Dis 190: 702-706.
22. Thongcharoen P, Suriyanon V, Paris RM, Khamboonruang C, de Souza MS, et al. (2007) A phase 1/2 comparative vaccine trial of the safety and immunogenicity of a CRF01_AE (subtype E) candidate vaccine: ALVAC-HIV (vCP1521) prime with oligomeric gp160 (92TH023/LAI-DID) or bivalent gp120 (CM235/SF2) boost. J Acquir Immune Defic Syndr 46: 48-55.
23. Catanzaro AT, Koup RA, Roederer M, Bailer RT, Enama ME, et al. (2006) Phase 1 safety and immunogenicity evaluation of a multiclade HIV-1 candidate vaccine delivered by a replication-defective recombinant adenovirus vector. J Infect Dis 194: 1638-1649.
24. Koup RA, Roederer M, Lamoreaux L, Fischer J, Novik L, et al. (2010) Priming immunization with DNA augments immunogenicity of recombinant adenoviral vectors for both HIV-1 specific antibody and T-cell responses. PLoS One 5: e9015.
25. Betts MR, Nason MC, West SM, De Rosa SC, Migueles SA, et al. (2006) HIV nonprogressors preferentially maintain highly functional HIV-specific CD8+ T cells. Blood 107: 4781-4789.
26. Frahm N, Korber BT, Adams CM, Szinger JJ, Draenert R, et al. (2004) Consistent cytotoxic-T-lymphocyte targeting of immunodominant regions in human immunodeficiency virus across multiple ethnicities. J Virol 78: 2187-2200.
27. Geldmacher C, Currier JR, Herrmann E, Haule A, Kuta E, et al. (2007) CD8 Tcell recognition of multiple epitopes within specific Gag regions is associated with maintenance of a low steady-state viremia in human immunodeficiency virus type 1-seropositive patients. J Virol 81: 2440-2448.
28. Kiepiela P, Ngumbela K, Thobakgale C, Ramduth D, Honeyborne I, et al. (2007) CD8+ T-cell responses to different HIV proteins have discordant associations with viral load. Nat Med 13: 46-53.
29. Buchbinder SP, Mehrotra DV, Duerr A, Fitzgerald DW, Mogg R, et al. (2008) Efficacy assessment of a cell-mediated immunity HIV-1 vaccine (the Step Study): a double-blind, randomised, placebo-controlled, test-of-concept trial. Lancet 372: 1881-1893.
30. McElrath MJ, De Rosa SC, Moodie Z, Dubey S, Kierstead L, et al. (2008) HIV- 1 vaccine-induced immunity in the test-of-concept Step Study: a case-cohort analysis. Lancet 372: 1894-1905.
31. Vasan S, Schlesinger SJ, Chen Z, Hurley A, Lombardo A, et al. (2010) Phase 1 safety and immunogenicity evaluation of ADMVA, a multigenic, modified vaccinia Ankara-HIV-1 B9/C candidate vaccine. PLoS One 5: e8816.
32. Ramanathan VD, Kumar M, Mahalingam J, Sathyamoorthy P, Narayanan PR, et al. (2009) A Phase 1 study to evaluate the safety and immunogenicity of a recombinant HIV type 1 subtype C-modified vaccinia Ankara virus vaccine candidate in Indian volunteers. AIDS Res Hum Retroviruses 25: 1107-1116.
33. Jaoko W, Nakwagala FN, Anzala O, Manyonyi GO, Birungi J, et al. (2008) Safety and immunogenicity of recombinant low-dosage HIV-1 A vaccine candidates vectored by plasmid pTHr DNA or modified vaccinia virus Ankara (MVA) in humans in East Africa. Vaccine 26: 2788-2795.
34. Guimaraes-Walker A, Mackie N, McCormack S, Hanke T, Schmidt C, et al. (2008) Lessons from IAVI-006, a phase I clinical trial to evaluate the safety and immunogenicity of the pTHr.HIVA DNA and MVA.HIVA vaccines in a primeboost strategy to induce HIV-1 specific T-cell responses in healthy volunteers. Vaccine 26: 6671-6677.
35. Harari A, Bart PA, Stohr W, Tapia G, Garcia M, et al. (2008) An HIV-1 clade C DNA prime, NYVAC boost vaccine regimen induces reliable, polyfunctional, and long-lasting T cell responses. J Exp Med 205: 63-77.
36. Harro C, Sun X, Stek JE, Leavitt RY, Mehrotra DV, et al. (2009) Safety and immunogenicity of the Merck adenovirus serotype 5 (MRKAd5) and MRKAd6 human immunodeficiency virus type 1 trigene vaccines alone and in combination in healthy adults. Clin Vaccine Immunol 16: 1285-1292.
37. Aboud S, Nilsson C, Karlen K, Marovich M, Wahren B, et al. (2010) Strong HIV-Specific CD4+ and CD8+ T lymphocyte proliferative responses in healthy individuals immunized with a HIV-1 DNA vaccine and boosted with HIV-1 recombinant Modified Vaccinia virus Ankara (MVA). Clin Vaccine Immunol.
38. Burgers WA, Chege GK, Muller TL, van Harmelen JH, Khoury G, et al. (2009) Broad, high-magnitude and multifunctional CD4+ and CD8+ T-cell responses elicited by a DNA and modified vaccinia Ankara vaccine containing human immunodeficiency virus type 1 subtype C genes in baboons. J Gen Virol 90: 468-480.
39. Gudmundsdotter L, Nilsson C, Brave A, Hejdeman B, Earl P, et al. (2009) Recombinant Modified Vaccinia Ankara (MVA) effectively boosts DNA-primed HIV-specific immune responses in humans despite pre-existing vaccinia immunity. Vaccine 27: 4468-4474