Abstract
The HPV vaccine has shown sustained efficacy and consistent stabilization of antibody levels, even after a single dose. We defined the HPV16-VLP antibody avidity patterns over 11 years among women who received one- or three doses of the bivalent HPV vaccine in the Costa Rica HPV Vaccine Trial. Absolute HPV16 avidity was lower in women who received one compared to three doses, although the patterns were similar (increased in years 2 and 3 and remained stable over the remaining 8 years). HPV16 avidity among women who were HPV16-seropositive women at HPV vaccination, a marker of natural immune response to HPV16 infection, was significantly lower than those of HPV16-seronegative women, a difference that was more pronounced among one-dose recipients. No differences in HPV16 avidity were observed by HPV18 serostatus at vaccination, confirming the specificity of the findings. Importantly, point estimates for vaccine efficacy against incident, six-month persistent HPV16 infections was similar between women who were HPV16 seronegative and seropositive at the time of initial HPV vaccination for both one-dose and three-dose participants. It is therefore likely that this lower avidity level is still sufficient to enable antibody-mediated protection. It is encouraging for long-term HPV-vaccine protection that HPV16 antibody avidity was maintained for over a decade, even after a single dose.
Original language | English (US) |
---|---|
Article number | 40 |
Journal | npj Vaccines |
Volume | 7 |
Issue number | 1 |
DOIs | |
State | Published - Dec 2022 |
ASJC Scopus subject areas
- Immunology
- Pharmacology
- Infectious Diseases
- Pharmacology (medical)
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HPV16 infection decreases vaccine-induced HPV16 antibody avidity : the CVT trial. / on behalf of the Costa Rica HPV Vaccine Trial Group.
In: npj Vaccines, Vol. 7, No. 1, 40, 12.2022.Research output: Contribution to journal › Article › peer-review
}
TY - JOUR
T1 - HPV16 infection decreases vaccine-induced HPV16 antibody avidity
T2 - the CVT trial
AU - on behalf of the Costa Rica HPV Vaccine Trial Group
AU - Tsang, Sabrina H.
AU - Schiller, John T.
AU - Porras, Carolina
AU - Kemp, Troy J.
AU - Herrero, Rolando
AU - Schussler, John
AU - Sierra, Monica S.
AU - Cortes, Bernal
AU - Hildesheim, Allan
AU - Lowy, Douglas R.
AU - Rodríguez, Ana Cecilia
AU - Romero, Byron
AU - Çuburu, Nicolas
AU - Shing, Jaimie Z.
AU - Pinto, Ligia A.
AU - Sampson, Joshua N.
AU - Kreimer, Aimée R.
AU - Cortés, Bernal
AU - González, Paula
AU - Herrero, Rolando
AU - Jiménez, Silvia E.
AU - Porras, Carolina
AU - Rodríguez, Ana Cecilia
AU - Hildesheim, Allan
AU - Kreimer, Aimée R.
AU - Lowy, Douglas R.
AU - Schiffman, Mark
AU - Schiller, John T.
AU - Sherman, Mark
AU - Wacholder, Sholom
AU - Pinto, Ligia A.
AU - Kemp, Troy J.
AU - Sidawy, Mary K.
AU - Quint, Wim
AU - van Doorn, Leen Jan
AU - Struijk, Linda
AU - Palefsky, Joel M.
AU - Darragh, Teresa M.
AU - Stoler, Mark H.
N1 - Funding Information: We dedicate this work to the memory of our beloved colleague and friend Paula Gonzalez, the principal investigator of the Costa Rica Vaccine Trial long-term follow-up study. We extend a special thanks to the women of Guanacaste and Puntarenas, Costa Rica, who gave of themselves in participating in this effort. In Costa Rica, we acknowledge the tremendous effort and dedication of the staff involved in this project; we would like to specifically acknowledge the meaningful contributions by Carlos Avila, Loretto Carvajal, Rebeca Ocampo, Cristian Montero, Diego Guillen, Jorge Morales, and Mario Alfaro. In the United States, we extend our appreciation to the team from Information Management Services (IMS) responsible for the development and maintenance of the data system used in the trial and who serve as the data management center for this effort, especially Jean Cyr, Julie Buckland, John Schussler, and Brian Befano. We thank Dr. Diane Solomon (CVT: medical monitor & QC pathologist) for her invaluable contributions in the design and conduct of the trial and Nora Macklin and Kate Torres for the expertise in coordinating the study. We thank the members of the Data and Safety Monitoring Board charged with protecting the safety and interest of participants during the randomized, blinded phase of our study (Steve Self, Chair, Adriana Benavides, Luis Diego Calzada, Ruth Karron, Ritu Nayar, and Nancy Roach) and members of the external Scientific HPV Working Group who have contributed to the success of our efforts over the years (Henriette Raventós, Chair, Joanna Cain, Diane Davey, Gypsyamber D’Souza, Elizabeth Fontham, Anne Gershon, Elizabeth Holly, Silvia Lara, Wasima Rida, Richard Roden, Maria del Rocío Sáenz Madrigal, and Margaret Stanley). We thank Dr. Susan Pierce at the US NCI for her insights into the interpretation of the data. The Costa Rica HPV Vaccine Trial is a long-standing collaboration between investigators in Costa Rica and the NCI. The trial is sponsored and funded by the NCI (contract N01-CP-11005), with funding support from the National Institutes of Health Office of Research on Women’s Health. GlaxoSmithKline Biologicals (GSK) provided vaccine and support for aspects of the trial associated with regulatory submission needs of the company under a Clinical Trials Agreement (FDA BB-IND 7920) during the four-year, randomized blinded phase of our study. The NCI and Costa Rica investigators are responsible for the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation of the manuscript. Where authors are identified as personnel of the International Agency for Research on Cancer / World Health Organization, the authors alone are responsible for the views expressed in this article and they do not necessarily represent the decisions, policy or views of the International Agency for Research on Cancer / World Health Organization. Registered with Clinicaltrials.gov NCT00128661. Funding Information: Open Access funding provided by the National Institutes of Health (NIH). Funding Information: We dedicate this work to the memory of our beloved colleague and friend Paula Gonzalez, the principal investigator of the Costa Rica Vaccine Trial long-term follow-up study. We extend a special thanks to the women of Guanacaste and Puntarenas, Costa Rica, who gave of themselves in participating in this effort. In Costa Rica, we acknowledge the tremendous effort and dedication of the staff involved in this project; we would like to specifically acknowledge the meaningful contributions by Carlos Avila, Loretto Carvajal, Rebeca Ocampo, Cristian Montero, Diego Guillen, Jorge Morales, and Mario Alfaro. In the United States, we extend our appreciation to the team from Information Management Services (IMS) responsible for the development and maintenance of the data system used in the trial and who serve as the data management center for this effort, especially Jean Cyr, Julie Buckland, John Schussler, and Brian Befano. We thank Dr. Diane Solomon (CVT: medical monitor & QC pathologist) for her invaluable contributions in the design and conduct of the trial and Nora Macklin and Kate Torres for the expertise in coordinating the study. We thank the members of the Data and Safety Monitoring Board charged with protecting the safety and interest of participants during the randomized, blinded phase of our study (Steve Self, Chair, Adriana Benavides, Luis Diego Calzada, Ruth Karron, Ritu Nayar, and Nancy Roach) and members of the external Scientific HPV Working Group who have contributed to the success of our efforts over the years (Henriette Ravent?s, Chair, Joanna Cain, Diane Davey, Gypsyamber D?Souza, Elizabeth Fontham, Anne Gershon, Elizabeth Holly, Silvia Lara, Wasima Rida, Richard Roden, Maria del Roc?o S?enz Madrigal, and Margaret Stanley). We thank Dr. Susan Pierce at the US NCI for her insights into the interpretation of the data. The Costa Rica HPV Vaccine Trial is a long-standing collaboration between investigators in Costa Rica and the NCI. The trial is sponsored and funded by the NCI (contract N01-CP-11005), with funding support from the National Institutes of Health Office of Research on Women?s Health. GlaxoSmithKline Biologicals (GSK) provided vaccine and support for aspects of the trial associated with regulatory submission needs of the company under a Clinical Trials Agreement (FDA BB-IND 7920) during the four-year, randomized blinded phase of our study. The NCI and Costa Rica investigators are responsible for the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation of the manuscript. Where authors are identified as personnel of the International Agency for Research on Cancer / World Health Organization, the authors alone are responsible for the views expressed in this article and they do not necessarily represent the decisions, policy or views of the International Agency for Research on Cancer / World Health Organization. Registered with Clinicaltrials.gov NCT00128661. Publisher Copyright: © 2022, This is a U.S. government work and not under copyright protection in the U.S.; foreign copyright protection may apply.
PY - 2022/12
Y1 - 2022/12
N2 - The HPV vaccine has shown sustained efficacy and consistent stabilization of antibody levels, even after a single dose. We defined the HPV16-VLP antibody avidity patterns over 11 years among women who received one- or three doses of the bivalent HPV vaccine in the Costa Rica HPV Vaccine Trial. Absolute HPV16 avidity was lower in women who received one compared to three doses, although the patterns were similar (increased in years 2 and 3 and remained stable over the remaining 8 years). HPV16 avidity among women who were HPV16-seropositive women at HPV vaccination, a marker of natural immune response to HPV16 infection, was significantly lower than those of HPV16-seronegative women, a difference that was more pronounced among one-dose recipients. No differences in HPV16 avidity were observed by HPV18 serostatus at vaccination, confirming the specificity of the findings. Importantly, point estimates for vaccine efficacy against incident, six-month persistent HPV16 infections was similar between women who were HPV16 seronegative and seropositive at the time of initial HPV vaccination for both one-dose and three-dose participants. It is therefore likely that this lower avidity level is still sufficient to enable antibody-mediated protection. It is encouraging for long-term HPV-vaccine protection that HPV16 antibody avidity was maintained for over a decade, even after a single dose.
AB - The HPV vaccine has shown sustained efficacy and consistent stabilization of antibody levels, even after a single dose. We defined the HPV16-VLP antibody avidity patterns over 11 years among women who received one- or three doses of the bivalent HPV vaccine in the Costa Rica HPV Vaccine Trial. Absolute HPV16 avidity was lower in women who received one compared to three doses, although the patterns were similar (increased in years 2 and 3 and remained stable over the remaining 8 years). HPV16 avidity among women who were HPV16-seropositive women at HPV vaccination, a marker of natural immune response to HPV16 infection, was significantly lower than those of HPV16-seronegative women, a difference that was more pronounced among one-dose recipients. No differences in HPV16 avidity were observed by HPV18 serostatus at vaccination, confirming the specificity of the findings. Importantly, point estimates for vaccine efficacy against incident, six-month persistent HPV16 infections was similar between women who were HPV16 seronegative and seropositive at the time of initial HPV vaccination for both one-dose and three-dose participants. It is therefore likely that this lower avidity level is still sufficient to enable antibody-mediated protection. It is encouraging for long-term HPV-vaccine protection that HPV16 antibody avidity was maintained for over a decade, even after a single dose.
UR - http://www.scopus.com/inward/record.url?scp=85127384459&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85127384459&partnerID=8YFLogxK
U2 - 10.1038/s41541-022-00431-x
DO - 10.1038/s41541-022-00431-x
M3 - Article
AN - SCOPUS:85127384459
VL - 7
JO - npj Vaccines
JF - npj Vaccines
SN - 2059-0105
IS - 1
M1 - 40
ER -