Fifteen-year Immunologic Follow-up of Women Who Received One, Two and Three Doses of the Bivalent HPV Vaccine in the Costa Rica HPV-16/18 Vaccine Trial (CVT): Generating Durability Data: The ESCUDDO-CVT Study
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|ClinicalTrials.gov Identifier: NCT03309033|
Recruitment Status : Terminated (NIH is not engaged in human subjects research)
First Posted : October 13, 2017
Last Update Posted : May 15, 2020
HPV is the human papillomavirus. Women who get infected with it can get cervical cancer. The Costa Rica vaccine trial (CVT) studied an HPV vaccine for young women. A Long Term Follow Up (LTFU) study was done 10 years later. Researchers want to follow up with the women in these studies for 5 more years. This will help them learn more about the risks and benefits of the HPV vaccine.
To study anti-HPV-16/18 antibodies over the long term in women who got an HPV vaccinate. To study how antibody levels have changed depending on the dose and type of vaccine.
Women in the original CVT LTFU study
Staff will contact participants from the CVT LTFU study. This will be done by phone or in person at home. Participants will be asked about participating in a new study.
Participants who agree will have their first study visit and sign the informed consent document.
Participants will answer questions about sexual behavior, smoking, contraceptives, and reproductive history.
Participants will have blood collected.
Study visits will be conducted either in a clinic or at home.
|Condition or disease|
|Human Papillomavirus Cervical Cancer|
Human papillomavirus (HPV) infection is necessary for the development of cervical cancer. Worldwide, infection with HPV types 16 and 18 account for approximately 70% of cervical cancer cases. Currently available data suggest that prophylactic vaccination against HPV types-16 and 18 is nearly 100% effective in preventing persistent cervical infections and resultant disease from these types for at least five years following vaccination. The U.S. National Cancer Institute (NCI) and the ACIB (formerly PEG) conducted a community-based, randomized clinical trial (RCT) in Costa Rica (called the Costa Rica Vaccine Trial, CVT) pre-licensure to evaluate the VLP-based, bivalent HPV vaccine. One of the more unexpected and novel discoveries showed that, in a post-hoc analysis, protection over four years against HPV16/18 infections among women initially uninfected with these types was uniformly high for recipients of one, two, or three doses after four years of follow-up in the blinded phase of the CVT. Among women who received a single dose, HPV16 and HPV18 antibody titers (assessed by ELISA) were substantially higher than those among unvaccinated women previously exposed to HPV16/18; titers remained stably elevated from 6-to-48 months post-vaccination, albeit at lower levels than for two or three doses. These and other data have motivated a new undertaking to directly evaluate the protection afforded by single-dose regimens of the HPV vaccines in a formal RCT. Complementary to the non-inferiority data that will be generated over 4 years in this new RCT, it is imperative that we continue to evaluate long-term stability of antibody responses. To do so, the current proposal aims to extend the follow-up time of women in the original CVT who received one or two doses and a subset who received three doses of the HPV vaccine from 10 to 15 years (two additional visits from ~1000 women at years 13 and 15, respectively) to describe, by dose, the long-term positivity and stability of the antibody response to HPV vaccination. There are two main objectives to this work:
- Estimate the change in antibody levels between years 10 and 15 after vaccination.
- Estimate the proportion of individuals who become seronegative (i.e.: serorevert) between years 10 and 15 after vaccination.
This research will provide invaluable data that will allow for the continued investigation into the risks and benefits of the prophylactic HPV vaccine; also, new serologic testing of banked samples from the original phases of this research will be conducted to merge data from years 1 and 10 with years 13 and 15 to provide a complete assessment of antibody changes over time. Additional immunologic assays will be conducted, including assessment of antibody avidity, between years 10 and 15.
The CVT EXTEND study will be conducted by the ACIB team, which has extensive experience in conducting epidemiological and clinical studies with high ethical and scientific standards. These studies have high rates of recruitment and retention.
|Study Type :||Observational|
|Actual Enrollment :||869 participants|
|Official Title:||Fifteen-year Immunologic Follow-up of Women Who Received One, Two and Three Doses of the Bivalent HPV Vaccine in the Costa Rica HPV-16/18 Vaccine Trial (CVT): Generating Durability Data: The ESCUDDO-CVT Study|
|Actual Study Start Date :||July 18, 2018|
|Actual Primary Completion Date :||May 13, 2020|
|Actual Study Completion Date :||May 13, 2020|
-Women aged 30-38 who participated in the CVT LTFU study
- Estimate the change in antibody levels between years 10 and 15 foreach dose regimen (i.e. 1-dose, 2-doses, 3-doses) and each HPV type (i.e. 16, 18). [ Time Frame: Year 5 of EXTEND (Year 15 of CVT follow-up). ]Estimate the change in antibody levels between years 10 and 15 for each dose regimen (i.e. 1-dose, 2-doses, 3-doses) and each HPV type (i.e. 16, 18).
- Estimate the proportion of individuals who become seronegative (i.e.: serorevert) between years 10 and 15 for each dose regimen (i.e. 1-dose, 2-doses, 3-doses) and each HPV type (i.e. 16, 18). [ Time Frame: Year 5 of EXTEND (Year 15 of CVT follow-up) ]Estimate the proportion of individuals who become seronegative (i.e.: serorevert) between years 10 and 15 for each dose regimen (i.e. 1-dose, 2-doses, 3-doses) and each HPV type (i.e. 16, 18).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03309033
|Agencia Costarricen se de Investigacio nes Biom(SqrRoot)(Copyright)dicas (ACIB)|
|Liberia, Costa Rica|
|Principal Investigator:||Aimee R. Kreimer, Ph.D.||National Cancer Institute (NCI)|