Data from GTL001, A Therapeutic Vaccine for Women Infected with Human Papillomavirus 16 or 18 and Normal Cervical Cytology: Results of a Phase I Clinical Trial Article Swipe
Pierre Van Damme
,
Myriam Bouillette-Marussig
,
Annick Hens
,
Ilse De Coster
,
Christophe Depuydt
,
Anne Goubier
,
Viggo Van Tendeloo
,
Nathalie Cools
,
Herman Goossens
,
Thierry Hercend
,
Benedikt Timmerman
,
Marie-Christine Bissery
·
YOU?
·
· 2023
· Open Access
·
· DOI: https://doi.org/10.1158/1078-0432.c.6525011.v1
YOU?
·
· 2023
· Open Access
·
· DOI: https://doi.org/10.1158/1078-0432.c.6525011.v1
Purpose: Women infected with human papillomavirus (HPV) with normal cytology to mild abnormalities currently have no treatment options other than watchful waiting or surgery if high-grade cervical lesions or cancer develop. A therapeutic vaccine would offer the possibility of preventing high-grade lesions in HPV-infected women. GTL001 is a therapeutic vaccine composed of recombinant HPV16 and HPV18 E7 proteins fused to catalytically inactive Bordetella pertussis CyaA. This study examined the tolerability and immunogenicity of GTL001 in women infected with HPV16 or HPV18 with normal cytology.Experimental Design: This was a phase I trial (EudraCT No. 2010-018629-21). In an open-label part, subjects received two intradermal vaccinations 6 weeks apart of 100 or 600 μg GTL001 + topical 5% imiquimod cream at the injection site. In a double-blind part, subjects were randomized 2:1:1 to two vaccinations 6 weeks apart of 600 μg GTL001 + imiquimod, 600 μg GTL001 + placebo cream, or placebo + imiquimod.Results: Forty-seven women were included. No dropouts, treatment-related serious adverse events, or dose-limiting toxicities occurred. Local reactions were transient and mostly mild or moderate. HPV16/18 viral load decreased the most in the 600 μg GTL001 + imiquimod group. In post hoc analyses, the 600 μg GTL001 + imiquimod group had the highest rates of initial and sustained HPV16/18 clearance. Imiquimod increased antigen-specific T-cell response rates but not rates of solicited reactions. All subjects seroconverted to CyaA.Conclusions: For women infected with HPV16 or HPV18 with normal cervical cytology, GTL001 was immunogenic and had acceptable safety profile. Clin Cancer Res; 22(13); 3238–48. ©2016 AACR.
Related Topics
Concepts
Metadata
- Type
- preprint
- Language
- en
- Landing Page
- https://doi.org/10.1158/1078-0432.c.6525011.v1
- OA Status
- gold
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4361951875
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4361951875Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.1158/1078-0432.c.6525011.v1Digital Object Identifier
- Title
-
Data from GTL001, A Therapeutic Vaccine for Women Infected with Human Papillomavirus 16 or 18 and Normal Cervical Cytology: Results of a Phase I Clinical TrialWork title
- Type
-
preprintOpenAlex work type
- Language
-
enPrimary language
- Publication year
-
2023Year of publication
- Publication date
-
2023-03-31Full publication date if available
- Authors
-
Pierre Van Damme, Myriam Bouillette-Marussig, Annick Hens, Ilse De Coster, Christophe Depuydt, Anne Goubier, Viggo Van Tendeloo, Nathalie Cools, Herman Goossens, Thierry Hercend, Benedikt Timmerman, Marie-Christine BisseryList of authors in order
- Landing page
-
https://doi.org/10.1158/1078-0432.c.6525011.v1Publisher landing page
- Open access
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YesWhether a free full text is available
- OA status
-
goldOpen access status per OpenAlex
- OA URL
-
https://doi.org/10.1158/1078-0432.c.6525011.v1Direct OA link when available
- Concepts
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Imiquimod, Medicine, Tolerability, Placebo, Cervical cancer, Vaccination, Adverse effect, Internal medicine, Clinical trial, ELISPOT, Gynecology, Gastroenterology, Immunology, Cancer, T cell, Immune system, Pathology, Alternative medicineTop concepts (fields/topics) attached by OpenAlex
- Cited by
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0Total citation count in OpenAlex
- Related works (count)
-
10Other works algorithmically related by OpenAlex
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| abstract_inverted_index.apart | 105, 134 |
| abstract_inverted_index.cream | 116 |
| abstract_inverted_index.fused | 58 |
| abstract_inverted_index.group | 198 |
| abstract_inverted_index.human | 4 |
| abstract_inverted_index.offer | 35 |
| abstract_inverted_index.other | 18 |
| abstract_inverted_index.part, | 97, 124 |
| abstract_inverted_index.phase | 88 |
| abstract_inverted_index.rates | 202, 214, 217 |
| abstract_inverted_index.site. | 120 |
| abstract_inverted_index.study | 66 |
| abstract_inverted_index.trial | 90 |
| abstract_inverted_index.viral | 175 |
| abstract_inverted_index.weeks | 104, 133 |
| abstract_inverted_index.women | 75, 152, 227 |
| abstract_inverted_index.would | 34 |
| abstract_inverted_index.Cancer | 246 |
| abstract_inverted_index.GTL001 | 45, 73, 111, 138, 143, 184, 195, 237 |
| abstract_inverted_index.T-cell | 212 |
| abstract_inverted_index.cancer | 29 |
| abstract_inverted_index.cream, | 146 |
| abstract_inverted_index.group. | 187 |
| abstract_inverted_index.mostly | 170 |
| abstract_inverted_index.normal | 8, 82, 234 |
| abstract_inverted_index.safety | 243 |
| abstract_inverted_index.women. | 44 |
| abstract_inverted_index.©2016 | 250 |
| abstract_inverted_index.22(13); | 248 |
| abstract_inverted_index.adverse | 159 |
| abstract_inverted_index.events, | 160 |
| abstract_inverted_index.highest | 201 |
| abstract_inverted_index.initial | 204 |
| abstract_inverted_index.lesions | 27, 41 |
| abstract_inverted_index.options | 17 |
| abstract_inverted_index.placebo | 145, 148 |
| abstract_inverted_index.serious | 158 |
| abstract_inverted_index.surgery | 23 |
| abstract_inverted_index.topical | 113 |
| abstract_inverted_index.vaccine | 33, 49 |
| abstract_inverted_index.waiting | 21 |
| abstract_inverted_index.(EudraCT | 91 |
| abstract_inverted_index.HPV16/18 | 174, 207 |
| abstract_inverted_index.cervical | 26, 235 |
| abstract_inverted_index.composed | 50 |
| abstract_inverted_index.cytology | 9 |
| abstract_inverted_index.develop. | 30 |
| abstract_inverted_index.examined | 67 |
| abstract_inverted_index.inactive | 61 |
| abstract_inverted_index.infected | 2, 76, 228 |
| abstract_inverted_index.profile. | 244 |
| abstract_inverted_index.proteins | 57 |
| abstract_inverted_index.received | 99 |
| abstract_inverted_index.response | 213 |
| abstract_inverted_index.subjects | 98, 125, 222 |
| abstract_inverted_index.watchful | 20 |
| abstract_inverted_index.Imiquimod | 209 |
| abstract_inverted_index.analyses, | 191 |
| abstract_inverted_index.currently | 13 |
| abstract_inverted_index.cytology, | 236 |
| abstract_inverted_index.decreased | 177 |
| abstract_inverted_index.dropouts, | 156 |
| abstract_inverted_index.imiquimod | 115, 186, 197 |
| abstract_inverted_index.included. | 154 |
| abstract_inverted_index.increased | 210 |
| abstract_inverted_index.injection | 119 |
| abstract_inverted_index.moderate. | 173 |
| abstract_inverted_index.occurred. | 164 |
| abstract_inverted_index.reactions | 166 |
| abstract_inverted_index.solicited | 219 |
| abstract_inverted_index.sustained | 206 |
| abstract_inverted_index.transient | 168 |
| abstract_inverted_index.treatment | 16 |
| abstract_inverted_index.3238–48. | 249 |
| abstract_inverted_index.acceptable | 242 |
| abstract_inverted_index.clearance. | 208 |
| abstract_inverted_index.high-grade | 25, 40 |
| abstract_inverted_index.imiquimod, | 140 |
| abstract_inverted_index.open-label | 96 |
| abstract_inverted_index.preventing | 39 |
| abstract_inverted_index.randomized | 127 |
| abstract_inverted_index.reactions. | 220 |
| abstract_inverted_index.toxicities | 163 |
| abstract_inverted_index.Forty-seven | 151 |
| abstract_inverted_index.immunogenic | 239 |
| abstract_inverted_index.intradermal | 101 |
| abstract_inverted_index.possibility | 37 |
| abstract_inverted_index.recombinant | 52 |
| abstract_inverted_index.therapeutic | 32, 48 |
| abstract_inverted_index.HPV-infected | 43 |
| abstract_inverted_index.double-blind | 123 |
| abstract_inverted_index.tolerability | 69 |
| abstract_inverted_index.vaccinations | 102, 131 |
| abstract_inverted_index.<i>Clin | 245 |
| abstract_inverted_index.<i>post | 189 |
| abstract_inverted_index.abnormalities | 12 |
| abstract_inverted_index.catalytically | 60 |
| abstract_inverted_index.dose-limiting | 162 |
| abstract_inverted_index.hoc</i> | 190 |
| abstract_inverted_index.seroconverted | 223 |
| abstract_inverted_index.immunogenicity | 71 |
| abstract_inverted_index.papillomavirus | 5 |
| abstract_inverted_index.2010-018629-21). | 93 |
| abstract_inverted_index.antigen-specific | 211 |
| abstract_inverted_index.Design:</b> | 84 |
| abstract_inverted_index.treatment-related | 157 |
| abstract_inverted_index.<i>Bordetella | 62 |
| abstract_inverted_index.pertussis</i> | 63 |
| abstract_inverted_index.AACR</i>.</p></div> | 251 |
| abstract_inverted_index.cytology.</p><p><b>Experimental | 83 |
| abstract_inverted_index.<div>Abstract<p><b>Purpose:</b> | 0 |
| abstract_inverted_index.CyaA.</p><p><b>Conclusions:</b> | 225 |
| abstract_inverted_index.imiquimod.</p><p><b>Results:</b> | 150 |
| cited_by_percentile_year | |
| countries_distinct_count | 0 |
| institutions_distinct_count | 12 |
| sustainable_development_goals[0].id | https://metadata.un.org/sdg/3 |
| sustainable_development_goals[0].score | 0.8299999833106995 |
| sustainable_development_goals[0].display_name | Good health and well-being |
| citation_normalized_percentile.value | 0.07685643 |
| citation_normalized_percentile.is_in_top_1_percent | False |
| citation_normalized_percentile.is_in_top_10_percent | False |