Safety and tolerability of conserved region vaccines vectored by plasmid DNA, simian adenovirus and modified vaccinia virus ankara administered to human immunodeficiency virus type 1-uninfected adults in a randomized, single-blind phase I trial

Hayton, Emma-Jo, Rose, Annie, Ibrahimsa, Umar, Del Sorbo, Mariarosaria, Capone, Stefania, Crook, Alison, Black, A., Dorrell, Lucy and Hanke, Tomaš 2014. Safety and tolerability of conserved region vaccines vectored by plasmid DNA, simian adenovirus and modified vaccinia virus ankara administered to human immunodeficiency virus type 1-uninfected adults in a randomized, single-blind phase I trial. PLoS ONE. 9 (7). https://doi.org/10.1371/journal.pone.0101591

TitleSafety and tolerability of conserved region vaccines vectored by plasmid DNA, simian adenovirus and modified vaccinia virus ankara administered to human immunodeficiency virus type 1-uninfected adults in a randomized, single-blind phase I trial
TypeJournal article
AuthorsHayton, Emma-Jo, Rose, Annie, Ibrahimsa, Umar, Del Sorbo, Mariarosaria, Capone, Stefania, Crook, Alison, Black, A., Dorrell, Lucy and Hanke, Tomaš
Abstract

Trial Design

HIV-1 vaccine development has advanced slowly due to viral antigenic diversity, poor immunogenicity and recently, safety concerns associated with human adenovirus serotype-5 vectors. To tackle HIV-1 variation, we designed a unique T-cell immunogen HIVconsv from functionally conserved regions of the HIV-1 proteome, which were presented to the immune system using a heterologous prime-boost combination of plasmid DNA, a non-replicating simian (chimpanzee) adenovirus ChAdV-63 and a non-replicating poxvirus, modified vaccinia virus Ankara. A block-randomized, single-blind, placebo-controlled phase I trial HIV-CORE 002 administered for the first time candidate HIV-1- vaccines or placebo to 32 healthy HIV-1/2-uninfected adults in Oxford, UK and elicited high frequencies of HIV-1-specific T cells capable of inhibiting HIV-1 replication in vitro. Here, detail safety and tolerability of these vaccines are reported.

Methods

Local and systemic reactogenicity data were collected using structured interviews and study-specific diary cards. Data on all other adverse events were collected using open questions. Serum neutralizing antibody titres to ChAdV-63 were determined before and after vaccination.

Results

Two volunteers withdrew for vaccine-unrelated reasons. No vaccine-related serious adverse events or reactions occurred during 190 person-months of follow-up. Local and systemic events after vaccination occurred in 27/32 individuals and most were mild (severity grade 1) and predominantly transient (<48 hours). Myalgia and flu-like symptoms were more strongly associated with MVA than ChAdV63 or DNA vectors and more common in vaccine recipients than in placebo. There were no intercurrent HIV-1 infections during follow-up. 2/24 volunteers had low ChAdV-63-neutralizing titres at baseline and 7 increased their titres to over 200 with a median (range) of 633 (231-1533) post-vaccination, which is of no safety concern.

Conclusions

These data demonstrate safety and good tolerability of the pSG2.HIVconsv DNA, ChAdV63.HIVconsv and MVA.HIVconsv vaccines and together with their high immunogenicity support their further development towards efficacy studies.

Trial Registration

ClinicalTrials.gov NCT01151319

JournalPLoS ONE
Journal citation9 (7)
ISSN1932-6203
Year2014
PublisherPLoS
Publisher's version
License
CC BY 4.0
File Access Level
Open (open metadata and files)
Digital Object Identifier (DOI)https://doi.org/10.1371/journal.pone.0101591
Publication dates
Published09 Jul 2014

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A phase I randomized clinical trial of candidate human immunodeficiency virus type 1 vaccine MVA. HIVA administered to Gambian infants
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Immunogenicity of a universal HIV-1 vaccine vectored by DNA, MVA and CHADV-63 in a Phase I/IIA clinical trial
Borthwick, N.J., Ahmed, T., Rose, A., Ebrahimsa, U., Black, A., Hayton, E., Yang, H., Hancock, G., Campion, S., Frahm, N., S Colloca, S., A Nicosia, A., A McMichael, A., L Dorrell, L. and Hanke, T. 2012. Immunogenicity of a universal HIV-1 vaccine vectored by DNA, MVA and CHADV-63 in a Phase I/IIA clinical trial. AIDS Vaccine 2012. Boston, MA, USA 09 - 12 Sep 2012 Springer. https://doi.org/10.1186/1742-4690-9-S2-P118

Age-stratified seroprevalence of vaccine-preventable infectious disease in Saravan, Southern Lao People’s Democratic Republic
Xaydalasouk, Kinnaly, Sayasinh, Kong, Hübschen, Judith M, Khounvisith, Vilaysone, Keomany, Sommai, Muller, Claude P and Black, A. 2012. Age-stratified seroprevalence of vaccine-preventable infectious disease in Saravan, Southern Lao People’s Democratic Republic. International Journal of Infectious Diseases. 107, pp. 25-30. https://doi.org/10.1016/j.ijid.2021.04.033

Recombinant DNA/MVA/ChAdV-63-elicited T cells specific for conserved regions of the HIV-1 proteome recognize HIV-1 infected cells and suppress HIV-1
Ahmed, T., Borthwick, N., Yang, H., Hancock, G., Yorke, L., Ebrahimsa, U., Rose, A., Black, A., Hayton, E., McMichael, A., Dorrell, L. and Hanke, T. 2012. Recombinant DNA/MVA/ChAdV-63-elicited T cells specific for conserved regions of the HIV-1 proteome recognize HIV-1 infected cells and suppress HIV-1. Retrovirology. 9, p. P259. https://doi.org/10.1186/1742-4690-9-S2-P259

PedVacc001: Safety and Immunogenicity of a Candidate HIV-1 Vaccine, MVA. HIVA, Administered to Healthy Gambian Infants Born to HIV-1/2-Uninfected Mothers
Afolabi, M, Ndure, J, Mueller, J, Thomas, V, Shams-Rony, M, Borthwick, N, Bridgeman, A, Black, A, Reilly, M, Jaoko, W and others 2011. PedVacc001: Safety and Immunogenicity of a Candidate HIV-1 Vaccine, MVA. HIVA, Administered to Healthy Gambian Infants Born to HIV-1/2-Uninfected Mothers. AIDS Vaccine Conference. Bangkok, Thailand 12 - 15 Sep 2011

Characterisation of T cells induced by candidate prophylactic vaccines encoding a HIV-1 conserved immunogen in phase I/IIa trial HIVCORE002
Ahmed, T., Borthwick, N., Yang, H., Hancock, G., Yorke, L., Black, A., Ebrahimsa, U., Rose, A., Dorrell, L. and Hanke, T. 2011. Characterisation of T cells induced by candidate prophylactic vaccines encoding a HIV-1 conserved immunogen in phase I/IIa trial HIVCORE002. Annual Congress of the British Society for Immunology 2011. Liverpool, United Kingdom 05 - 08 Dec 2011

Natural killer cells during primary varicella zoster virus infection
Malavige, Gathsaurie Neelika, Jones, Louise, Kamaladasa, SD, Wijewickrama, Ananda, Seneviratne, Suranjith L, Black, Antony P, Ogg, Graham S and Black, Antony 2010. Natural killer cells during primary varicella zoster virus infection. Journal of Infection. 61 (2), pp. 190-192. https://doi.org/10.1016/j.jinf.2010.05.004

Immune evasion during varicella zoster virus infection of keratinocytes
Black, A.P., Jones, L., Malavige, G.N. and Ogg, G.S. 2009. Immune evasion during varicella zoster virus infection of keratinocytes. Clinical and Experimental Dermatology. 34 (8), pp. e941-e944. https://doi.org/10.1111/j.1365-2230.2009.03350.x

Viral load, clinical disease severity and cellular immune responses in primary varicella zoster virus infection in Sri Lanka
Malavige, Gathsaurie N.eelika, Jones, Louise, Kamaladasa, S.D., Wijewickrama, A., Seneviratne, S.., Black, Antony P. and Ogg, Graham S. 2008. Viral load, clinical disease severity and cellular immune responses in primary varicella zoster virus infection in Sri Lanka. PLoS ONE. 3 (11) e3789. https://doi.org/10.1371/journal.pone.0003789

Varicella zoster virus glycoprotein E-specific CD4+ T cells show evidence of recent activation and effector differentiation, consistent with frequent exposure to replicative cycle antigens in healthy immune donors
Malavige, G.N., Jones, L., Black, A.P. and Ogg, G.S. 2008. Varicella zoster virus glycoprotein E-specific CD4+ T cells show evidence of recent activation and effector differentiation, consistent with frequent exposure to replicative cycle antigens in healthy immune donors. Clinical & Experimental Immunology. 152 (3), pp. 522-531.

Varicella-zoster virus vaccine is able to evade the T-cell response during the replicative phase of the viral life cycle
Black, A., Jones, L., Malavige, G. and Ogg, G. 2008. Varicella-zoster virus vaccine is able to evade the T-cell response during the replicative phase of the viral life cycle. Annual Meeting of the British Society for Investigative Dermatology 2008. Oxford, England 07 - 09 Apr 2008 Oxford University Press. https://doi.org/10.1111/j.1365-2133.2008.08486.x

Viral loads in primary varicella zoster virus infection
Malavige, Gathsaurie, Jones, Lousie, Black, Antony, Wijewickrama, Ananda, Seneviratne, Suranjith, Kamaladasa, Satheeka and Ogg, Graham 2008. Viral loads in primary varicella zoster virus infection. Journal of Infection. 56 (4) P307.

Anti-lymphocyte function associated antigen-1 inhibits T-helper 2 function of human allergen-specific CD4+ T cells
Ardern-Jones, MR, Black, A. and Ogg, GS 2008. Anti-lymphocyte function associated antigen-1 inhibits T-helper 2 function of human allergen-specific CD4+ T cells. British Journal of Dermatology. 158 (3), p. 456–462. https://doi.org/10.1111/j.1365-2133.2007.08393.x

Phenotypic analysis of human cd4+ t cells specific for ie63 protein of vzv
Jones, Louise, Black, Antony, Malavige, Gathsaurie and Ogg, Graham 2008. Phenotypic analysis of human cd4+ t cells specific for ie63 protein of vzv. Journal of Infection. 56 (4), p. 300. https://doi.org/10.1016/j.jinf.2008.01.020

Interleukin-4 promotes human CD8+ T cell expression of CCR7
Seneviratne, Suranjith L., Black, Antony P., Jones, Louise, Di Gleria, Kati, Bailey, Abigail S. and Ogg, Graham S. 2007. Interleukin-4 promotes human CD8+ T cell expression of CCR7. Immunology. 120 (1), pp. 66-72. https://doi.org/10.1111/j.1365-2567.2006.02478.x

The role of skin-homing T cells in extrinsic atopic dermatitis
Seneviratne, S.L., Black, A.P., Jones, L., Bailey, A.S. and Ogg, G.S. 2007. The role of skin-homing T cells in extrinsic atopic dermatitis. QJM: An International Journal of Medicine. 100 (1), pp. 19-27. https://doi.org/10.1093/qjmed/hcl132

The role of human keratinocytes in T-cell activation
Black, A., Ardern-Jones, M., Jones, L. and Ogg, G. 2007. The role of human keratinocytes in T-cell activation. British Society for Investigative Dermatology Annual Meeting 2007. Birmingham ICC 10 - 13 Jul 2007 Oxford University Press. https://doi.org/10.1111/j.1365-2133.2007.07822.x

Keratinocyte apoptosis induced by allergen-specific T cells
Ardern-Jones, M.R., Black, A. and Ogg, G. 2007. Keratinocyte apoptosis induced by allergen-specific T cells. British Society for Investigative Dermatology Annual Meeting 2007. Birmingham ICC 10 - 13 Jul 2007 Oxford University Press. https://doi.org/10.1111/j.1365-2133.2007.07822.x

Human keratinocyte induction of rapid effector function in antigen-specific memory CD4+ and CD8+ T cells
Black, Antony P.B., Ardern-Jones, Michael R., Kasprowicz, Victoria, Bowness, Paul, Jones, Louise, Bailey, Abigail S. and Ogg, Graham S. 2007. Human keratinocyte induction of rapid effector function in antigen-specific memory CD4+ and CD8+ T cells. European Journal of Immunology. 37 (6), pp. 1485-1493. https://doi.org/10.1002/eji.200636915

Bacterial superantigen facilitates epithelial presentation of allergen to T helper 2 cells
Ardern-Jones, Michael R., Black, Antony P., Bateman, Elizabeth A. and Ogg, Graham S. 2007. Bacterial superantigen facilitates epithelial presentation of allergen to T helper 2 cells. Proceedings of the National Academy of Sciences. 104 (13), pp. 5557-5562. https://doi.org/10.1073/pnas.0700733104

Rapid effector function of varicella-zoster virus glycoprotein I-specific CD4+ T cells many decades after primary infection
Malavige, Gathsaurie Neelika, Jones, Louise, Black, Antony Paul and Ogg, Graham Stuart 2007. Rapid effector function of varicella-zoster virus glycoprotein I-specific CD4+ T cells many decades after primary infection. The Journal of Infectious Diseases. 195 (5), pp. 660-664. https://doi.org/10.1086/511274

Phenotypic analysis of human CD4+ T cells specific for immediate early 63 protein of varicella-zoster virus
Jones, Louise, Black, A., Malavige, Gathsaurie N and Ogg, Graham S 2007. Phenotypic analysis of human CD4+ T cells specific for immediate early 63 protein of varicella-zoster virus. European journal of immunology. 37 (12), pp. 3393-3403. https://doi.org/10.1002/eji.200737648

A novel fluorescent sensitive assay for detection of differential T cell mediated lysis of multiple adherent target cells
Black, Antony P., Jones, Louise, Ardern-Jones, Michael and Ogg, Graham S. 2006. A novel fluorescent sensitive assay for detection of differential T cell mediated lysis of multiple adherent target cells. Journal of Immunological Methods. 316 (1-2), pp. 153-157. https://doi.org/10.1016/j.jim.2006.07.022

Role of T cells in the pathogenesis of mucous membrane pemphigoid
Black, Antony P., Wojnarowska, Fenella and Ogg, Graham S. 2006. Role of T cells in the pathogenesis of mucous membrane pemphigoid. Expert Review of Dermatology. 1 (1), pp. 25-30. https://doi.org/10.1586/17469872.1.1.25

Persistent high frequencies of varicella-zoster virus ORF4 protein-specific CD4+ T cells after primary infection
Jones, Louise, Black, Antony P., Malavige, Gathsaurie N. and Ogg, Graham S. 2006. Persistent high frequencies of varicella-zoster virus ORF4 protein-specific CD4+ T cells after primary infection. Journal of Virology. 80 (19). https://doi.org/10.1128/jvi.00564-06

Superantigen-attergen synergy: a novel mechanism of cutaneous atopic disease
Ardern-Jones, M.R., Black, A.P., Bateman, E.A. and Ogg, G.S. 2006. Superantigen-attergen synergy: a novel mechanism of cutaneous atopic disease. British Association of Dermatologists Annual Meeting, 2006. Manchester 04 - 07 Jul 2006 Wiley.

Severe atopic dermatitis is associated with a reduced frequency of IL-10 producing allergen-specific CD4+ T cells
Seneviratne, SL, Jones, L, Bailey, AS, Black, AP, Ogg, G S and Black, A. 2006. Severe atopic dermatitis is associated with a reduced frequency of IL-10 producing allergen-specific CD4+ T cells. Clinical and Experimental Dermatology. 31, p. 689–694. https://doi.org/10.1111/j.1365-2230.2006.02172.x

Phenotypic analysis of Der P 1-peptide specific T cells in individuals with severe atopic dermatitis
Ardern-Jones, M.R., Bateman, E., Black, A., Bailey, A. and Ogg, G. 2005. Phenotypic analysis of Der P 1-peptide specific T cells in individuals with severe atopic dermatitis. Immunology. 116 (s1), p. 91.

Interleukin-4 induced down-regulation of skin homing receptor expression by human viral-specific CD8+ T cells may contribute to atopic risk of cutaneous infection
Seneviratne, S.L., Jones, L., Bailey, A.S., Samuel, R.V., Black, A.P. and Ogg, G.S. 2005. Interleukin-4 induced down-regulation of skin homing receptor expression by human viral-specific CD8+ T cells may contribute to atopic risk of cutaneous infection. Clinical & Experimental Immunology. 141 (1), pp. 107-115. https://doi.org/10.1111/j.1365-2249.2005.02823.x

p53-specific CD8+ T-cell responses in individuals with cutaneous squamous cell carcinoma
Black, A.P., Bailey, A., Jones, L., Turner, R.J., Hollowood, K. and Ogg, G.S. 2005. p53-specific CD8+ T-cell responses in individuals with cutaneous squamous cell carcinoma. British Journal of Dermatology. 153 (5), pp. 987-991. https://doi.org/10.1111/j.1365-2133.2005.06878.x

Combined Oligonucleotide and Protein Microarray Temporal Analysis of p53-mediated Apoptosis
Black A.P., Wee E., Lambe T., Bailey A., Jones L. and Ogg G.S. 2005. Combined Oligonucleotide and Protein Microarray Temporal Analysis of p53-mediated Apoptosis. Cancer Genomics & Proteomics. 2 (2), pp. 61-69.

Modulation of chemokine receptor expression on CLA+ T cells in atopic dermatitis
Seneviratne, S.L., Black, A., Jones, L., Chakraborthy, R., King, A., Powell, S., McMichael, A.J. and Ogg, G.S. 2004. Modulation of chemokine receptor expression on CLA+ T cells in atopic dermatitis. AAAAI 60th Annual Meeting. San Francisco, California, USA 19 - 23 Mar 2004 Elsevier. https://doi.org/10.1016/j.jaci.2003.12.164

Rapid effector function of circulating NC16A-specific T cells in individuals with mucous membrane pemphigoid
Black, A., Seneviratne, SL, Jones, L, King, AS, Winsey, S, Arsecularatne, G, Wojnarowska, F and Ogg, GS 2004. Rapid effector function of circulating NC16A-specific T cells in individuals with mucous membrane pemphigoid. British Journal of Dermatology. 151 (6), p. 1160–1164. https://doi.org/10.1111/j.1365-2133.2004.06219.x

Low IL-10 production by der p 1-specific T cells in severe atopic dermatitis
Seneviratne, S.L., Jones, L., Black, A., King, A., Powell, S., McMichael, A.J. and Ogg, G.S. 2003. Low IL-10 production by der p 1-specific T cells in severe atopic dermatitis. AAAAI 60th Anniversary Meeting. Denver, Colorado 07 - 12 Mar 2003 Elsevier. https://doi.org/10.1016/S0091-6749(03)80610-3

Protein microarray analysis of p53-mediated apoptosis; identification of potential tumour associated antigens
Black, A., Jones, L., Wee, E., Kollnberger, S., Seneviratne, S. and Ogg, G. 2003. Protein microarray analysis of p53-mediated apoptosis; identification of potential tumour associated antigens. British Society for Investigative Dermatology Annual Meeting 2003. University of Southampton 07 - 09 Apr 2003 Wiley. https://doi.org/10.1046/j.1365-2133.2003.04529.x

The role of p53 in the immunobiology of cutaneous squamous cell carcinoma
Black, A.P.B. and Ogg, G.S. 2003. The role of p53 in the immunobiology of cutaneous squamous cell carcinoma. Clinical & Experimental Immunology. 132 (3), pp. 379-384. https://doi.org/10.1046/j.1365-2249.2003.02159.x

An association between the acute phase response and patterns of antigen induced T cell proliferation in juvenile idiopathic arthritis
Black, A., Bhayani, Hansha, Ryder, Clive AJ, Pugh, Mark T, Gardner-Medwin, Janet MM and Southwood, Taunton R 2003. An association between the acute phase response and patterns of antigen induced T cell proliferation in juvenile idiopathic arthritis. Arthritis Research & Therapy. 5. https://doi.org/10.1186/ar791

T-cell activation without proliferation in juvenile idiopathic arthritis
Black, Antony P.B., Bhayani, Hansha, Ryder, Clive A.J., Gardner-Medwin, Janet M.M. and Southwood, Taunton R. 2002. T-cell activation without proliferation in juvenile idiopathic arthritis. Arthritis Research & Therapy. 4, pp. 177-183. https://doi.org/10.1186/ar403

Identification and characterisation of DerP1-specific CD8+ T cells in the peripheral blood of atopic individuals
Seneviratne, Suranjith, Jones, Louis, King, Abigail, Black, Antony, Powell, Shiela, McMichael, Andrew and Ogg, GS 2002. Identification and characterisation of DerP1-specific CD8+ T cells in the peripheral blood of atopic individuals. Clinical Science. 103 (s47), p. 2P. https://doi.org/10.1042/cs103002Pa

Allergen-specific CD8+ T cells and atopic disease
Seneviratne, Suranjith L, Jones, Louise, King, Abigail S, Black, Antony, Powell, Sheila, McMichael, Andrew J, Ogg, Graham S and Black, Antony 2002. Allergen-specific CD8+ T cells and atopic disease. The Journal of clinical investigation. 110 (9), pp. 1283-1291. https://doi.org/10.1172/JCI15753

T cell phenotype and function in juvenile idiopathic arthritis
Black, Antony P.B. 2000. T cell phenotype and function in juvenile idiopathic arthritis. PhD thesis University of Birmingham

Influence of the acute phase response on T cell phenotype and proliferation in juvenile idiopathic arthritis. Evidence for two distinct patterns
Black, A.P.B., Bhayani, H., Gardner-Medwin, J.M., Ryder, C.A.J. and Southwood, T.R. 1999. Influence of the acute phase response on T cell phenotype and proliferation in juvenile idiopathic arthritis. Evidence for two distinct patterns. Arthritis and Rheumatism. 42 (S9), p. S180.

γδ+ T Cells Preferentially Respond to Live Rather than Killed Malaria Parasites
Waterfall, Martin, Black, Antony and Riley, Eleanor 1998. γδ+ T Cells Preferentially Respond to Live Rather than Killed Malaria Parasites. Infection and Immunity. 66 (5), pp. 2393-2398. https://doi.org/10.1128/iai.66.5.2393-2398.1998

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