Cervical CancerPhase 4NCT06536855
Faster Elimination of HPV Infection and Cervical Cancer Using Concomitant HPV Vaccination and HPV Screening: A Demonstration Project in Rwanda
A Phase 4 study testing Gardasil 9 in people with Cervical Cancer, run by Rwanda Biomedical Centre.
Trial summary
Cervical cancer is the fourth most frequently diagnosed cancer and the fourth leading cause of cancer death in women, with an estimated 604,000 new cases and 342,000 deaths worldwide in 2020. Read more about this study
- Who is it for?
- Ages 23 to 29 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Gardasil 9
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 30 Mar 2026
- Phase
- Phase 4
- 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 23 to 29 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Eligible women will include women within the age range of 23-29, who have not opted out of the screening program and who consent to participate in the study
Who cannot join
- Known history of severe allergic reaction or hypersensitivity to any of the components of the HPV vaccine. (For GARDASIL 9: Amorphous aluminium hydroxyphosphate sulphate adjuvant, Sodium chloride, L-histidine, Polysorbate 80, or Sodium borate)
- Known history of immune-related disorders
- Current acute severe febrile illness, except for minor infections such as a cold, mild upper respiratory infection, or low-grade fever.
- Administration of immunoglobulin or blood-derived products within 6 months prior to the scheduled HPV vaccine first dose
- Current pregnancy (reported)
- Women with a total hysterectomy
Trial locations and contacts
No sites are listed yet.
About this study
Cervical cancer is the fourth most frequently diagnosed cancer and the fourth leading cause of cancer death in women, with an estimated 604,000 new cases and 342,000 deaths worldwide in 2020. Rwanda is among countries with a high burden cervical cancer, with an annual incidence of 28.2/100,000 women (1,229 new cases in 2020) and a mortality rate of 20.1/100,000 (829 deaths in 2018) according to WHO (IARC 2020).
Cervical cancer is almost completely preventable because of the highly effective primary (HPV vaccine) and secondary (HPV screening) prevention measures. However, these measures have not been equitably implemented across and within LMICs countries.
Read more
Given the current situation, where the screening coverage is still low due to financial and operational challenges, it will take many years to achieve the elimination targets as included in the global elimination strategy. We are proposing to implement an innovative strategy to accelerate the elimination of cervical cancer in Rwanda consisting of concomitant HPV vaccination and HPV screening for young women aged 23-29 years old.
HPV screening and vaccination are complementary preventive options often implemented as separate public health programs. This project proposal aims to address this disconnect by combining both strategies with the ultimate purpose of accelerating the reduction of cervical cancer incidence and mortality in Rwanda and making the programs both cost-effective and sustainable.
Primary objective
The study aims to evaluate whether organized, concomitant HPV vaccination and HPV screening offered to girls and women aged 23-29 years will result in more rapid elimination of HPV infections in the target districts in Rwanda.
The study design is a before-after study design of the intervention, where the projected incidences and prevalence at the 2-year follow-up visit are modeled using the data from the baseline visit, with evaluation using Observed/expected numbers.
Secondary objectives
The study will evaluate whether concomitant vaccination and cervical screening result in an improved efficiency and/or safety of the cervical cancer screening program. These objectives will be examined among women who participated in the combined screening and vaccination study.
- Protection of Gardasil 9 against HPV infection and against CIN2+ by Gardasil 9 HPV vaccine types in 23 to 29-year-old women from the study districts. This analysis will be performed every 2 years, and the first analysis will determine the effectiveness of one-dose vaccination (incident infections of HPV vaccine types at 2 years), whereas all subsequent analysis will determine the effect of 2-dose vaccinations. The study will be powered to detect a decline in invasive cervical cancer among the study participants, using the cervical cancer incidence in the surrounding districts of Rwanda as the reference. ii) Efficiency will also be measured by the yield of histopathologically confirmed high-grade cervical cancer precursors or cancer (cervical intraepithelial neoplasia grade 2, 3, or cervical cancer) in relation to the consumption of resources and convenience for the women, using the yield at the baseline visit (10% of women tested) as the comparator. The hypothesis is that 2 years after vaccination, there will be only a few incident infections (only some old, persistent infections) resulting in high PPV and high yield of CIN2+ at modest consumption of resources.
End of the study
One screening interval (2 years) after the last visit of the last subject, defined as the day the last study subject receives her second vaccination.
The study will be implemented in 4 districts of Rwanda covering 100,000 women aged 23 to 29 years old. We will use Gardasil 9, the HPV the second generation HPV Vaccine manufactured by Merck.
- Conditions
- Cervical Cancer
- Being tested
- Gardasil 9
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gardasil 9Biological
Also called HPV/DNA testing (Gynotyping)
GARDASIL 9 is a vaccine indicated in females 9 through 45 years of age for the prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by human papillomavirus (HPV) Types 16, 18, 31, 33, 45, 52, and 58; cervical, vulvar, vaginal, and anal precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6 and 11.
GARDASIL 9 is indicated in males 9 through 45 years of age for the prevention of anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58; anal precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6 and 11.
| Study group | Role | What they receive |
|---|---|---|
| Gardasil 9 Arm | Experimental | The study is open label with only one arm that will receive the vaccine Receives: Biological: Gardasil 9 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of HPV infections in the study participants
To evaluate whether organised, concomitant HPV vaccination and HPV screening offered to women aged 23-29 will result in faster elimination of HPV infection in the study districts in Rwanda, using before-design modeling the expected numbers after the intervention.
Overall and type-specific prevalence and incidence of HPV will be obtained from the HPV screening at 2 years. Observed numbers will be compared to the predicted (expected numbers).
Measured: 24 months
Secondary outcomes (1)
Prevalence of histopathologically confirmed high-grade cervical cancer precursors or cancer (cervical intraepithelial neoplasia grade 2, 3, or cervical cancer) (CIN2+) by HPV type in the lesion.
The study screenings will determine the prevalence of high-grade cervical cancer precursors or cancer (cervical intraepithelial neoplasia grade 2, 3, or cervical cancer) (CIN2+) by HPV type in the lesion at baseline and at follow-up.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- At the first visit we will administer Gardasil 9 to women aged 23 to 29 years and screening them for HPV to get baseline information, after 24 months at the second visit, provide the second dose and screen again for HPV to be able to compare HPV prevalence at baseline and 24 months after administering the second dose of vaccine.
- Masking
- None (open label)
- Enrolment
- 100,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rwanda Biomedical Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Karolinska Institutet, Center for Family Health Research/Projet San Francisco, ELEKTA Foundation
- Responsible party
- Sponsor
- Investigators
- Francois Uwinkindi, MD, Msc Epi, Principal investigator, Rwanda Biomedical CentreClaude Mambo Muvunyi, MD, PhD, Study chair, Rwanda Biomedical CentreJoachim Dillner, MD, PhD, Study director, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06536855
- Sponsor's protocol ID
- FasterHPV01
- Status last verified
- Jul 2024
- First submitted
- 31 Jul 2024
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We plan to share aggregated results. The IPD will not be shared and this is in line with Rwanda National Ethics Committee and GCP principles
Publications
Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
PubMed 33538338Bosch FX, Lorincz A, Munoz N, Meijer CJ, Shah KV. The causal relation between human papillomavirus and cervical cancer. J Clin Pathol. 2002 Apr;55(4):244-65. doi: 10.1136/jcp.55.4.244.
PubMed 11919208Guan P, Howell-Jones R, Li N, Bruni L, de Sanjose S, Franceschi S, Clifford GM. Human papillomavirus types in 115,789 HPV-positive women: a meta-analysis from cervical infection to cancer. Int J Cancer. 2012 Nov 15;131(10):2349-59. doi: 10.1002/ijc.27485. Epub 2012 Mar 20.
PubMed 22323075Denny L, Adewole I, Anorlu R, Dreyer G, Moodley M, Smith T, Snyman L, Wiredu E, Molijn A, Quint W, Ramakrishnan G, Schmidt J. Human papillomavirus prevalence and type distribution in invasive cervical cancer in sub-Saharan Africa. Int J Cancer. 2014 Mar 15;134(6):1389-98. doi: 10.1002/ijc.28425. Epub 2013 Nov 14.
PubMed 23929250Carrillo-Garcia A, Ponce-de-Leon-Rosales S, Cantu-de-Leon D, Fragoso-Ontiveros V, Martinez-Ramirez I, Orozco-Colin A, Mohar A, Lizano M. Impact of human papillomavirus coinfections on the risk of high-grade squamous intraepithelial lesion and cervical cancer. Gynecol Oncol. 2014 Sep;134(3):534-9. doi: 10.1016/j.ygyno.2014.06.018. Epub 2014 Jun 27.
PubMed 24979052Cheng L, Wang Y, Du J. Human Papillomavirus Vaccines: An Updated Review. Vaccines (Basel). 2020 Jul 16;8(3):391. doi: 10.3390/vaccines8030391.
PubMed 32708759Ronco G, Dillner J, Elfstrom KM, Tunesi S, Snijders PJ, Arbyn M, Kitchener H, Segnan N, Gilham C, Giorgi-Rossi P, Berkhof J, Peto J, Meijer CJ; International HPV screening working group. Efficacy of HPV-based screening for prevention of invasive cervical cancer: follow-up of four European randomised controlled trials. Lancet. 2014 Feb 8;383(9916):524-32. doi: 10.1016/S0140-6736(13)62218-7. Epub 2013 Nov 3.
PubMed 24192252Knaul FM, Farmer PE, Krakauer EL, De Lima L, Bhadelia A, Jiang Kwete X, Arreola-Ornelas H, Gomez-Dantes O, Rodriguez NM, Alleyne GAO, Connor SR, Hunter DJ, Lohman D, Radbruch L, Del Rocio Saenz Madrigal M, Atun R, Foley KM, Frenk J, Jamison DT, Rajagopal MR; Lancet Commission on Palliative Care and Pain Relief Study Group. Alleviating the access abyss in palliative care and pain relief-an imperative of universal health coverage: the Lancet Commission report. Lancet. 2018 Apr 7;391(10128):1391-1454. doi: 10.1016/S0140-6736(17)32513-8. Epub 2017 Oct 12. No abstract available.
PubMed 29032993Binagwaho A, Wagner CM, Gatera M, Karema C, Nutt CT, Ngabo F. Achieving high coverage in Rwanda's national human papillomavirus vaccination programme. Bull World Health Organ. 2012 Aug 1;90(8):623-8. doi: 10.2471/BLT.11.097253. Epub 2012 May 23.
PubMed 22893746Gatera M, Bhatt S, Ngabo F, Utamuliza M, Sibomana H, Karema C, Mugeni C, Nutt CT, Nsanzimana S, Wagner CM, Binagwaho A. Successive introduction of four new vaccines in Rwanda: High coverage and rapid scale up of Rwanda's expanded immunization program from 2009 to 2013. Vaccine. 2016 Jun 17;34(29):3420-6. doi: 10.1016/j.vaccine.2015.11.076. Epub 2015 Dec 17.
PubMed 26704259Schiller JT, Castellsague X, Garland SM. A review of clinical trials of human papillomavirus prophylactic vaccines. Vaccine. 2012 Nov 20;30 Suppl 5(0 5):F123-38. doi: 10.1016/j.vaccine.2012.04.108.
PubMed 23199956Bogaards JA, Coupe VM, Meijer CJ, Berkhof J. The clinical benefit and cost-effectiveness of human papillomavirus vaccination for adult women in the Netherlands. Vaccine. 2011 Nov 8;29(48):8929-36. doi: 10.1016/j.vaccine.2011.09.055. Epub 2011 Sep 22.
PubMed 21945961Lei J, Ploner A, Elfstrom KM, Wang J, Roth A, Fang F, Sundstrom K, Dillner J, Sparen P. HPV Vaccination and the Risk of Invasive Cervical Cancer. N Engl J Med. 2020 Oct 1;383(14):1340-1348. doi: 10.1056/NEJMoa1917338.
PubMed 32997908Karimi-Zarchi M, Allahqoli L, Nehmati A, Kashi AM, Taghipour-Zahir S, Alkatout I. Can the prophylactic quadrivalent HPV vaccine be used as a therapeutic agent in women with CIN? A randomized trial. BMC Public Health. 2020 Feb 27;20(1):274. doi: 10.1186/s12889-020-8371-z.
PubMed 32106837Castellsague X, Munoz N, Pitisuttithum P, Ferris D, Monsonego J, Ault K, Luna J, Myers E, Mallary S, Bautista OM, Bryan J, Vuocolo S, Haupt RM, Saah A. End-of-study safety, immunogenicity, and efficacy of quadrivalent HPV (types 6, 11, 16, 18) recombinant vaccine in adult women 24-45 years of age. Br J Cancer. 2011 Jun 28;105(1):28-37. doi: 10.1038/bjc.2011.185. Epub 2011 May 31.
PubMed 21629249
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Faster Elimination of HPV Infection and Cervical Cancer Using Concomitant HPV Vaccination and HPV Screening: A Demonstration Project in Rwanda
- ClinicalTrials.gov ID
- NCT06536855
- Acronym / sponsor ID
- FasterHPV01
- Conditions
- Cervical Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Rwanda Biomedical CentreUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Karolinska Institutet, Center for Family Health Research/Projet San Francisco, ELEKTA Foundation
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 5 Aug 2024 (actual)
- 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.
Cervical cancer is the fourth most frequently diagnosed cancer and the fourth leading cause of cancer death in women, with an estimated 604,000 new cases and 342,000 deaths worldwide in 2020. Rwanda is among countries with a high burden cervical cancer, with an annual incidence of 28.2/100,000 women (1,229 new cases in 2020) and a mortality rate of 20.1/100,000 (829 deaths in 2018) according to WHO (IARC 2020).
Cervical cancer is almost completely preventable because of the highly effective primary (HPV vaccine) and secondary (HPV screening) prevention measures. However, these measures have not been equitably implemented across and within LMICs countries.
Given the current situation, where the screening coverage is still low due to financial and operational challenges, it will take many years to achieve the elimination targets as included in the global elimination strategy. We are proposing to implement an innovative strategy to accelerate the elimination of cervical cancer in Rwanda consisting of concomitant HPV vaccination and HPV screening for young women aged 23-29 years old.
HPV screening and vaccination are complementary preventive options often implemented as separate public health programs. This project proposal aims to address this disconnect by combining both strategies with the ultimate purpose of accelerating the reduction of cervical cancer incidence and mortality in Rwanda and making the programs both cost-effective and sustainable.
Primary objective
The study aims to evaluate whether organized, concomitant HPV vaccination and HPV screening offered to girls and women aged 23-29 years will result in more rapid elimination of HPV infections in the target districts in Rwanda.
The study design is a before-after study design of the intervention, where the projected incidences and prevalence at the 2-year follow-up visit are modeled using the data from the baseline visit, with evaluation using Observed/expected numbers.
Secondary objectives
The study will evaluate whether concomitant vaccination and cervical screening result in an improved efficiency and/or safety of the cervical cancer screening program. These objectives will be examined among women who participated in the combined screening and vaccination study.
- Protection of Gardasil 9 against HPV infection and against CIN2+ by Gardasil 9 HPV vaccine types in 23 to 29-year-old women from the study districts. This analysis will be performed every 2 years, and the first analysis will determine the effectiveness of one-dose vaccination (incident infections of HPV vaccine types at 2 years), whereas all subsequent analysis will determine the effect of 2-dose vaccinations. The study will be powered to detect a decline in invasive cervical cancer among the study participants, using the cervical cancer incidence in the surrounding districts of Rwanda as the reference. ii) Efficiency will also be measured by the yield of histopathologically confirmed high-grade cervical cancer precursors or cancer (cervical intraepithelial neoplasia grade 2, 3, or cervical cancer) in relation to the consumption of resources and convenience for the women, using the yield at the baseline visit (10% of women tested) as the comparator. The hypothesis is that 2 years after vaccination, there will be only a few incident infections (only some old, persistent infections) resulting in high PPV and high yield of CIN2+ at modest consumption of resources.
End of the study
One screening interval (2 years) after the last visit of the last subject, defined as the day the last study subject receives her second vaccination.
The study will be implemented in 4 districts of Rwanda covering 100,000 women aged 23 to 29 years old. We will use Gardasil 9, the HPV the second generation HPV Vaccine manufactured by Merck.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- At the first visit we will administer Gardasil 9 to women aged 23 to 29 years and screening them for HPV to get baseline information, after 24 months at the second visit, provide the second dose and screen again for HPV to be able to compare HPV prevalence at baseline and 24 months after administering the second dose of vaccine.
| Arm | Type | Receives |
|---|---|---|
| Gardasil 9 Arm | Experimental | Biological: Gardasil 9The study is open label with only one arm that will receive the vaccine |
Who may qualify
- Ages
- 23 to 29 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Eligible women will include women within the age range of 23-29, who have not opted out of the screening program and who consent to participate in the study
Key exclusion criteria (6 listed)
- Known history of severe allergic reaction or hypersensitivity to any of the components of the HPV vaccine. (For GARDASIL 9: Amorphous aluminium hydroxyphosphate sulphate adjuvant, Sodium chloride, L-histidine, Polysorbate 80, or Sodium borate)
- Known history of immune-related disorders
- Current acute severe febrile illness, except for minor infections such as a cold, mild upper respiratory infection, or low-grade fever.
- Administration of immunoglobulin or blood-derived products within 6 months prior to the scheduled HPV vaccine first dose
- Current pregnancy (reported)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gardasil 9Also: HPV/DNA testing (Gynotyping)GARDASIL 9 is a vaccine indicated in females 9 through 45 years of age for the prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by human papillomavirus (HPV) Types 16, 18, 31, 33, 45, 52, and 58; cervical, vulvar, vaginal, and anal precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6 and 11. GARDASIL 9 is indicated in males 9 through 45 years of age for the prevention of anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58; anal precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6 and 11. | Biological | Gardasil 9 Arm |
Primary outcome
Prevalence of HPV infections in the study participants
Time frame: 24 months
To evaluate whether organised, concomitant HPV vaccination and HPV screening offered to women aged 23-29 will result in faster elimination of HPV infection in the study districts in Rwanda, using before-design modeling the expected numbers after the intervention. Overall and type-specific prevalence and incidence of HPV will be obtained from the HPV screening at 2 years. Observed numbers will be compared to the predicted (expected numbers).
1 secondary outcome
Prevalence of histopathologically confirmed high-grade cervical cancer precursors or cancer (cervical intraepithelial neoplasia grade 2, 3, or cervical cancer) (CIN2+) by HPV type in the lesion.
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- Results publication: PubMed 33538338Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
- Results publication: PubMed 11919208Bosch FX, Lorincz A, Munoz N, Meijer CJ, Shah KV. The causal relation between human papillomavirus and cervical cancer. J Clin Pathol. 2002 Apr;55(4):244-65. doi: 10.1136/jcp.55.4.244.
- Results publication: PubMed 22323075Guan P, Howell-Jones R, Li N, Bruni L, de Sanjose S, Franceschi S, Clifford GM. Human papillomavirus types in 115,789 HPV-positive women: a meta-analysis from cervical infection to cancer. Int J Cancer. 2012 Nov 15;131(10):2349-59. doi: 10.1002/ijc.27485. Epub 2012 Mar 20.
- Results publication: PubMed 23929250Denny L, Adewole I, Anorlu R, Dreyer G, Moodley M, Smith T, Snyman L, Wiredu E, Molijn A, Quint W, Ramakrishnan G, Schmidt J. Human papillomavirus prevalence and type distribution in invasive cervical cancer in sub-Saharan Africa. Int J Cancer. 2014 Mar 15;134(6):1389-98. doi: 10.1002/ijc.28425. Epub 2013 Nov 14.
- Results publication: PubMed 24979052Carrillo-Garcia A, Ponce-de-Leon-Rosales S, Cantu-de-Leon D, Fragoso-Ontiveros V, Martinez-Ramirez I, Orozco-Colin A, Mohar A, Lizano M. Impact of human papillomavirus coinfections on the risk of high-grade squamous intraepithelial lesion and cervical cancer. Gynecol Oncol. 2014 Sep;134(3):534-9. doi: 10.1016/j.ygyno.2014.06.018. Epub 2014 Jun 27.
- Results publication: PubMed 32708759Cheng L, Wang Y, Du J. Human Papillomavirus Vaccines: An Updated Review. Vaccines (Basel). 2020 Jul 16;8(3):391. doi: 10.3390/vaccines8030391.
- Results publication: PubMed 24192252Ronco G, Dillner J, Elfstrom KM, Tunesi S, Snijders PJ, Arbyn M, Kitchener H, Segnan N, Gilham C, Giorgi-Rossi P, Berkhof J, Peto J, Meijer CJ; International HPV screening working group. Efficacy of HPV-based screening for prevention of invasive cervical cancer: follow-up of four European randomised controlled trials. Lancet. 2014 Feb 8;383(9916):524-32. doi: 10.1016/S0140-6736(13)62218-7. Epub 2013 Nov 3.
- Results publication: PubMed 29032993Knaul FM, Farmer PE, Krakauer EL, De Lima L, Bhadelia A, Jiang Kwete X, Arreola-Ornelas H, Gomez-Dantes O, Rodriguez NM, Alleyne GAO, Connor SR, Hunter DJ, Lohman D, Radbruch L, Del Rocio Saenz Madrigal M, Atun R, Foley KM, Frenk J, Jamison DT, Rajagopal MR; Lancet Commission on Palliative Care and Pain Relief Study Group. Alleviating the access abyss in palliative care and pain relief-an imperative of universal health coverage: the Lancet Commission report. Lancet. 2018 Apr 7;391(10128):1391-1454. doi: 10.1016/S0140-6736(17)32513-8. Epub 2017 Oct 12. No abstract available.
- Results publication: PubMed 22893746Binagwaho A, Wagner CM, Gatera M, Karema C, Nutt CT, Ngabo F. Achieving high coverage in Rwanda's national human papillomavirus vaccination programme. Bull World Health Organ. 2012 Aug 1;90(8):623-8. doi: 10.2471/BLT.11.097253. Epub 2012 May 23.
- Results publication: PubMed 26704259Gatera M, Bhatt S, Ngabo F, Utamuliza M, Sibomana H, Karema C, Mugeni C, Nutt CT, Nsanzimana S, Wagner CM, Binagwaho A. Successive introduction of four new vaccines in Rwanda: High coverage and rapid scale up of Rwanda's expanded immunization program from 2009 to 2013. Vaccine. 2016 Jun 17;34(29):3420-6. doi: 10.1016/j.vaccine.2015.11.076. Epub 2015 Dec 17.
- Results publication: PubMed 23199956Schiller JT, Castellsague X, Garland SM. A review of clinical trials of human papillomavirus prophylactic vaccines. Vaccine. 2012 Nov 20;30 Suppl 5(0 5):F123-38. doi: 10.1016/j.vaccine.2012.04.108.
- Results publication: PubMed 21945961Bogaards JA, Coupe VM, Meijer CJ, Berkhof J. The clinical benefit and cost-effectiveness of human papillomavirus vaccination for adult women in the Netherlands. Vaccine. 2011 Nov 8;29(48):8929-36. doi: 10.1016/j.vaccine.2011.09.055. Epub 2011 Sep 22.
- Globocan estimate, Rwanda 2020Link provided by the sponsor.
- IARC Monographs on the Evaluation of Carcinogenic Risks to Humans Volume 90Link provided by the sponsor.
- WHO guideline for screening and treatment of cervical precancer lesions for cervical cancer preventionLink provided by the sponsor.
- Global strategy to accelerate the elimination of cervical cancer as a public health problemLink provided by the sponsor.
- Human papillomavirus vaccines: WHO position paper (2022 update)Link provided by the sponsor.
- Individual participant dataSharing planned: No. We plan to share aggregated results. The IPD will not be shared and this is in line with Rwanda National Ethics Committee and GCP principles
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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.
Francois Uwinkindi, MD, Msc Epi principal investigator
Rwanda Biomedical Centre
Claude Mambo Muvunyi, MD, PhD study chair
Rwanda Biomedical Centre
Joachim Dillner, MD, PhD study director
Karolinska Institutet
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gardasil 9 in people with Cervical Cancer, run by Rwanda Biomedical Centre.
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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francois Uwinkindi, MD, Msc Epi (+250788854473, francois.uwinkindi@rbc.gov.rw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of HPV infections in the study participants (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06536855, which also lists 19 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 Aug 2024.