Cervical NeoplasiaNCT01086709
Crossover Vaccination of Women Previously Randomized Into Protocol 04-C-N191
An observational study of Cervical Neoplasia and HPV Infections, run by National Cancer Institute (NCI) at 1 site in Costa Rica.
Trial summary
Background: National Cancer Institute Protocol 04-C-N191, also known as the Costa Rica Vaccine Trial, was a double-blind controlled study of the effectiveness of an experimental human papillomavirus (HPV) vaccine in preventing cervical cancer in young women in Costa Rica. Read more about this study
- Who is it for?
- Ages 21 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Neoplasia, HPV Infections
- How many people
- 5,444 participants
- Where
- 1 siteCosta Rica
- Study dates
- 27 Jan 2010to 17 Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- To be eligible to receive crossover vaccination, participants must fulfill all of the following inclusion criteria:
- Participation Status: Women previously randomized into the HPV-16/18 vaccine trial 04-C-N191, also known as the Costa Rica Vaccine Trial.
- Planned Residence: Residents of Guanacaste or Puntarenas Province or willingness to visit one of the study clinics for participation.
- Consent: Written informed consent obtained prior to enrollment into the crossover protocol.
Who cannot join
- The following criteria will be checked for all potential participants at the time of enrollment. If any apply, the participant will not be included in the study.
- History of (a) allergic reaction (e.g., difficulty breathing) after receipt of any vaccine, (b) hypersensitivity to latex.
- History of vaccine related adverse events during the vaccination phase that, at the discretion of the investigators, preclude vaccination during the crossover phase.
- Are receiving vaccination with Cervarix , are sexually experienced and of childbearing potential (i.e., not surgically sterilized), and are unwilling to use an effective method of birth control for 30 days before vaccination until 60 days after the last Cervarix vaccination (approximately 9 months). Acceptable forms of birth control include abstinence, surgical sterilization, hormonal contraceptives (e.g., oral, injectable, implant, and patch), intrauterine devices, and diaphragm or condom.
- History of chronic condition that per attending doctor opinion precludes her from receiving vaccination (e.g., no proper treatment available or participant is unwilling to stay under proper treatment).
- The participant has a diagnosed autoimmune illness (per the specific requirement of the INCIENSA IRB).
- The vaccine or vaccines the participant is interested in receiving are contraindicated in her case.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Crossover Vaccination of Women Previously Randomized Into Protocol 04-C-N191(NCI)/IC-200403(INCIENSA)
Background:
- National Cancer Institute Protocol 04-C-N191, also known as the Costa Rica Vaccine Trial, was a double-blind controlled study of the effectiveness of an experimental human papillomavirus (HPV) vaccine in preventing cervical cancer in young women in Costa Rica. Costa Rica was part of the first large study to show the association between HPV and cervical cancer, and the study contributed greatly to the understanding of this association. The women who have participated in the vaccine trial in Costa Rica are reaching the end of the follow-up period offered in the vaccine trial protocol, and as a result they are being offered the chance to have complementary vaccinations against HPV, hepatitis A, and hepatitis B.
Read more
Objectives:
- To offer participants in the Costa Rica Vaccine Trial the vaccine that they did not receive during the masked portion of the trial (HPV vaccine or hepatitis A vaccine) and hepatitis B vaccination.
- To collect information about exposure to known and suspected risk factors for HPV infection and cervical cancer from women who are receiving vaccination against HPV at crossover.
Eligibility:
- Women who participated in National Cancer Institute Protocol 04-C-N191.
Design:
- All participants will be offered vaccination against hepatitis B.
- Women who received the hepatitis A vaccine during the trial will be offered vaccination against HPV.
- Women who received the HPV vaccine during the trial will be offered vaccination against hepatitis A.
- Appropriate vaccinations (including a combined hepatitis A and hepatitis B vaccine) will be available to reduce the number of injections that participants will be asked to receive.
- All vaccines will be given according to the manufacturer's specifications for appropriate length of time between vaccine doses.
Read the detailed description
Since the mid 1980 s, the Division of Cancer Epidemiology and Genetics of the National Cancer Institute in collaboration with investigators in Costa Rica has conducted studies regarding cervical cancer and HPV infection. The first effort was a case control study where Costa Rica was one of the Latin American countries included, and it was the first large epidemiological study to show the association between HPV and cervical cancer. The second study, consisting of a 10,049 women population-based cohort, the Guanacaste cohort, was carried out from 1993 until 2004, and has greatly contributed to the understanding of the natural history of HPV infection and its relationship with precancerous cervical lesions.
The profound knowledge of the natural history of HPV infection and cervical neoplasia in Guanacaste, Costa Rica together with the promising results of the different HPV vaccine trials led the National Cancer Institute, in collaboration with investigators in Costa Rica, to launch a community-based randomized phase III clinical trial to evaluate the efficacy of a virus-like particle HPV vaccine (henceforth referred to as the Costa Rica Vaccine Trial (CVT)).
The main objectives of the Costa Rica Vaccine Trial were to evaluate the efficacy of the candidate vaccine to prevent persisting HPV-16/18 infections and related histopathologically confirmed CIN2+ lesions among the according to protocol subcohort and the overall population enrolled in the study. In contrast, the objectives of this protocol are aimed at offering beneficial complementary vaccination to women enrolled in the trial with an additional objective to collect biological specimens from women receiving the HPV-16/18 vaccine to complement the information obtained during the masked phase of the trial. As an additional objective, we propose to collect information regarding exposure to known and suspected risk factors for HPV infection and cervical cancer and biological specimens during this crossover phase that will complement those collected during the masked phase of the Costa Rica Vaccine Trial.
Collection of risk factor information and biological specimens during this crossover phase will be restricted to women receiving vaccination against HPV 16/18 at crossover. These samples will permit a more complete and comprehensive evaluation of the vaccine immunogenicity. Also, those specimens will allow for ancillary analyses and studies (e.g., natural history of HPV infection acquisition/clearance) and to assist ongoing efforts to evaluate the longer-term impact of HPV-16/18 vaccination.
- Conditions
- Cervical Neoplasia, HPV Infections
- Keywords
- Human Papillomavirus, Vaccine, Crossover, Hepatitis A, Hepatitis B
- Medical subject headings
- Papillomavirus Infections, Hepatitis A, Hepatitis B
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2010 (estimated)
- Study start27 Jan 2010
- Study completion17 Mar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cervical NeoplasiaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 5,444 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Allan Hildesheim, Ph.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01086709
- Sponsor's protocol ID
- 999910059
- Other IDs
- 10-C-N059
- Status last verified
- 17 Mar 2015
- First submitted
- 12 Mar 2010
- Last updated
- 5 Apr 2018
- Results posted
- No
Publications
Reeves WC, Brinton LA, Garcia M, Brenes MM, Herrero R, Gaitan E, Tenorio F, de Britton RC, Rawls WE. Human papillomavirus infection and cervical cancer in Latin America. N Engl J Med. 1989 Jun 1;320(22):1437-41. doi: 10.1056/NEJM198906013202201.
PubMed 2541336Herrero R, Brinton LA, Reeves WC, Brenes MM, Tenorio F, de Britton RC, Gaitan E, Garcia M, Rawls WE. Invasive cervical cancer and smoking in Latin America. J Natl Cancer Inst. 1989 Feb 1;81(3):205-11. doi: 10.1093/jnci/81.3.205.
PubMed 2536087Herrero R, Schiffman MH, Bratti C, Hildesheim A, Balmaceda I, Sherman ME, Greenberg M, Cardenas F, Gomez V, Helgesen K, Morales J, Hutchinson M, Mango L, Alfaro M, Potischman NW, Wacholder S, Swanson C, Brinton LA. Design and methods of a population-based natural history study of cervical neoplasia in a rural province of Costa Rica: the Guanacaste Project. Rev Panam Salud Publica. 1997 May;1(5):362-75. doi: 10.1590/s1020-49891997000500005.
PubMed 9180057Panagiotou OA, Befano BL, Gonzalez P, Rodriguez AC, Herrero R, Schiller JT, Kreimer AR, Schiffman M, Hildesheim A, Wilcox AJ, Wacholder S; Costa Rica HPV Vaccine Trial (CVT) Group (see end of manuscript for full list of investigators). Effect of bivalent human papillomavirus vaccination on pregnancy outcomes: long term observational follow-up in the Costa Rica HPV Vaccine Trial. BMJ. 2015 Sep 7;351:h4358. doi: 10.1136/bmj.h4358.
PubMed 26346155
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Crossover Vaccination of Women Previously Randomized Into Protocol 04-C-N191(NCI)/IC-200403(INCIENSA)
- ClinicalTrials.gov ID
- NCT01086709
- Acronym / sponsor ID
- 999910059
- Conditions
- Cervical Neoplasia, HPV Infections
- Keywords
- Human Papillomavirus, Vaccine, Crossover, Hepatitis A, Hepatitis B
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,444 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 27 Jan 2010
- Study completion
- 17 Mar 2015
- First posted
- 15 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- National Cancer Institute Protocol 04-C-N191, also known as the Costa Rica Vaccine Trial, was a double-blind controlled study of the effectiveness of an experimental human papillomavirus (HPV) vaccine in preventing cervical cancer in young women in Costa Rica. Costa Rica was part of the first large study to show the association between HPV and cervical cancer, and the study contributed greatly to the understanding of this association. The women who have participated in the vaccine trial in Costa Rica are reaching the end of the follow-up period offered in the vaccine trial protocol, and as a result they are being offered the chance to have complementary vaccinations against HPV, hepatitis A, and hepatitis B.
Objectives:
- To offer participants in the Costa Rica Vaccine Trial the vaccine that they did not receive during the masked portion of the trial (HPV vaccine or hepatitis A vaccine) and hepatitis B vaccination.
- To collect information about exposure to known and suspected risk factors for HPV infection and cervical cancer from women who are receiving vaccination against HPV at crossover.
Eligibility:
- Women who participated in National Cancer Institute Protocol 04-C-N191.
Design:
- All participants will be offered vaccination against hepatitis B.
- Women who received the hepatitis A vaccine during the trial will be offered vaccination against HPV.
- Women who received the HPV vaccine during the trial will be offered vaccination against hepatitis A.
- Appropriate vaccinations (including a combined hepatitis A and hepatitis B vaccine) will be available to reduce the number of injections that participants will be asked to receive.
- All vaccines will be given according to the manufacturer's specifications for appropriate length of time between vaccine doses.
Detailed description
Since the mid 1980 s, the Division of Cancer Epidemiology and Genetics of the National Cancer Institute in collaboration with investigators in Costa Rica has conducted studies regarding cervical cancer and HPV infection. The first effort was a case control study where Costa Rica was one of the Latin American countries included, and it was the first large epidemiological study to show the association between HPV and cervical cancer. The second study, consisting of a 10,049 women population-based cohort, the Guanacaste cohort, was carried out from 1993 until 2004, and has greatly contributed to the understanding of the natural history of HPV infection and its relationship with precancerous cervical lesions.
The profound knowledge of the natural history of HPV infection and cervical neoplasia in Guanacaste, Costa Rica together with the promising results of the different HPV vaccine trials led the National Cancer Institute, in collaboration with investigators in Costa Rica, to launch a community-based randomized phase III clinical trial to evaluate the efficacy of a virus-like particle HPV vaccine (henceforth referred to as the Costa Rica Vaccine Trial (CVT)).
The main objectives of the Costa Rica Vaccine Trial were to evaluate the efficacy of the candidate vaccine to prevent persisting HPV-16/18 infections and related histopathologically confirmed CIN2+ lesions among the according to protocol subcohort and the overall population enrolled in the study. In contrast, the objectives of this protocol are aimed at offering beneficial complementary vaccination to women enrolled in the trial with an additional objective to collect biological specimens from women receiving the HPV-16/18 vaccine to complement the information obtained during the masked phase of the trial. As an additional objective, we propose to collect information regarding exposure to known and suspected risk factors for HPV infection and cervical cancer and biological specimens during this crossover phase that will complement those collected during the masked phase of the Costa Rica Vaccine Trial.
Collection of risk factor information and biological specimens during this crossover phase will be restricted to women receiving vaccination against HPV 16/18 at crossover. These samples will permit a more complete and comprehensive evaluation of the vaccine immunogenicity. Also, those specimens will allow for ancillary analyses and studies (e.g., natural history of HPV infection acquisition/clearance) and to assist ongoing efforts to evaluate the longer-term impact of HPV-16/18 vaccination.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- To be eligible to receive crossover vaccination, participants must fulfill all of the following inclusion criteria:
- Participation Status: Women previously randomized into the HPV-16/18 vaccine trial 04-C-N191, also known as the Costa Rica Vaccine Trial.
- Planned Residence: Residents of Guanacaste or Puntarenas Province or willingness to visit one of the study clinics for participation.
- Consent: Written informed consent obtained prior to enrollment into the crossover protocol.
Key exclusion criteria (7 listed)
- The following criteria will be checked for all potential participants at the time of enrollment. If any apply, the participant will not be included in the study.
- History of (a) allergic reaction (e.g., difficulty breathing) after receipt of any vaccine, (b) hypersensitivity to latex.
- History of vaccine related adverse events during the vaccination phase that, at the discretion of the investigators, preclude vaccination during the crossover phase.
- Are receiving vaccination with Cervarix , are sexually experienced and of childbearing potential (i.e., not surgically sterilized), and are unwilling to use an effective method of birth control for 30 days before vaccination until 60 days after the last Cervarix vaccination (approximately 9 months). Acceptable forms of birth control include abstinence, surgical sterilization, hormonal contraceptives (e.g., oral, injectable, implant, and patch), intrauterine devices, and diaphragm or condom.
- History of chronic condition that per attending doctor opinion precludes her from receiving vaccination (e.g., no proper treatment available or participant is unwilling to stay under proper treatment).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Background: PubMed 2541336Reeves WC, Brinton LA, Garcia M, Brenes MM, Herrero R, Gaitan E, Tenorio F, de Britton RC, Rawls WE. Human papillomavirus infection and cervical cancer in Latin America. N Engl J Med. 1989 Jun 1;320(22):1437-41. doi: 10.1056/NEJM198906013202201.
- Background: PubMed 2536087Herrero R, Brinton LA, Reeves WC, Brenes MM, Tenorio F, de Britton RC, Gaitan E, Garcia M, Rawls WE. Invasive cervical cancer and smoking in Latin America. J Natl Cancer Inst. 1989 Feb 1;81(3):205-11. doi: 10.1093/jnci/81.3.205.
- Background: PubMed 9180057Herrero R, Schiffman MH, Bratti C, Hildesheim A, Balmaceda I, Sherman ME, Greenberg M, Cardenas F, Gomez V, Helgesen K, Morales J, Hutchinson M, Mango L, Alfaro M, Potischman NW, Wacholder S, Swanson C, Brinton LA. Design and methods of a population-based natural history study of cervical neoplasia in a rural province of Costa Rica: the Guanacaste Project. Rev Panam Salud Publica. 1997 May;1(5):362-75. doi: 10.1590/s1020-49891997000500005.
- Derived from this study: PubMed 26346155Panagiotou OA, Befano BL, Gonzalez P, Rodriguez AC, Herrero R, Schiller JT, Kreimer AR, Schiffman M, Hildesheim A, Wilcox AJ, Wacholder S; Costa Rica HPV Vaccine Trial (CVT) Group (see end of manuscript for full list of investigators). Effect of bivalent human papillomavirus vaccination on pregnancy outcomes: long term observational follow-up in the Costa Rica HPV Vaccine Trial. BMJ. 2015 Sep 7;351:h4358. doi: 10.1136/bmj.h4358.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allan Hildesheim, Ph.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Neoplasia and HPV Infections, run by National Cancer Institute (NCI) at 1 site in Costa Rica.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Costa Rica. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01086709, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018; AzTrials last refreshed its copy on 6 Nov 2026.