Study Assessing Reduced HPV Infectivity and Transmission in HPV-Positive Women Following Vaccination With 9vHPV

Официальное название

HPV Vaccination and Infectivity Reduction in HPV-positive Women

Обзор

This is a randomized, open-label trial, to assess whether a single dose of HPV nonavalent vaccine, administered to HIV uninfected, unvaccinated women with high risk HPV16/18/31/33/45/52 or 58 can decrease the infectivity of shed HPV viruses. Our hypothesis is that vaccination will have little or no impact on HPV sample positivity by DNA PCR since the viral particles will continue to be produced and released, but that particles will be neutralized by vaccine-induced antibodies, thereby reducing their infective capacity. Cervical samples will be collected at randomisation and at 6 months, to compare infectivity of shed HPV viruses.

Вмешательства

• Биопрепарат Nonavalent HPV vaccine (9vHPV)
  Nonavalent HPV vaccine (9vHPV/ Gardasil-9™). Sterile suspension, 0.5 ml dose, intramuscular, prepared from the highly purified viruslike particles (VLPs) of the major capsid L1 protein from 9 HPV types: 6/11/16/18/31/33/45/52/58. 9vHPV is currently indicated in the EU in individuals from 9 years of age for the prevention of diseases caused by vaccine's 9 HPV types: genital warts (HPV6 and 11) and premalignant lesions and cancers affecting the cervix, vulva, vagina and anus (HPV16, 18, 31, 22, 45

Первичные конечные точки

• The difference in infective capacity of cervical HPV virions at 6 months, between HPV-positive unvaccinated women and HPV-positive women who receive one dose of the HPV L1 nonavalent vaccine (Gardasil9®). [Срок оценки: 7 months]

Вторичные конечные точки (4)

• The difference in the HPV neutralization capacity of vaccine-induced antibodies in serum and cervical samples at 6 months, between HPV-positive unvaccinated women with HPV-positive women who receive one dose of the HPV L1 nonavalent vaccine [Срок оценки: 7 months]
• The difference in HPV viral load in cervical samples at 6 months, between HPV-positive unvaccinated women with HPV-positive women who receive one dose of the HPV L1 nonavalent vaccine (Gardasil9®). [Срок оценки: 7 months]
• Neutralising antibodies infective capacity of HPV virions and HPV viral load in urine samples [Срок оценки: 7 months]
• The difference in infectivity reduction and vaccine induced antibodies among different HPV types. [Срок оценки: 7 months]

Критерии участия

Критерии включения

• Born female
• Aged between 18-29 years old;
• Living in Kambia district (or neighbouring district if included) without plans to move away in the next 12 months;
• Willing to participate in the study and have signed the informed consent form;
• In good health as determined by a medical history (a physical examination will be conducted if necessary according to the clinician's judgement);
• Willing to be tested for HIV;
• Are HIV negative at the screening visit;
• Not pregnant;
• Able to pass a Test of Understanding (TOU);
• Willing to provide cervical, urine and blood samples;
• Agree to be vaccinated with a single dose of Gardasil9® if randomised to the vaccine arm at Day 0;
• Have no visible suspicious cervical lesions on examination.
• Agree to a pregnancy test at screening and before any HPV vaccination.

Критерии исключения

• They have been previously vaccinated against HPV;
• They have a chronic condition, such as autoimmune conditions, degenerative diseases, neurologic or genetic diseases among others;
• They are HIV positive or immunocompromised;
• They are pregnant or planning to get pregnant in the next 12 months;
• They are less than three months post-partum or currently breastfeeding;
• They are allergic to one of the vaccine components or to latex;
• They are sexually active and are not using, or are not willing to use, an effective birth control method from D-14 until 60 days after the last vaccine dose
• The nurse or clinician determining the eligibility, in agreement with principal investigator, considers that there is a reason that precludes participation.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Sierra Leone · 1 центр

• Kambia Research Centre — Freetown

Публикации

• Hooper R, Forbes A, Hemming K, Takeda A, Beresford L. Analysis of cluster randomised trials with an assessment of outcome at baseline. BMJ. 2018 Mar 20;360:k1121. doi: 10.1136/bmj.k1121. No abstract available. PMID 29559436
• Houlihan CF, Baisley K, Bravo IG, Kapiga S, de Sanjose S, Changalucha J, Ross DA, Hayes RJ, Watson-Jones D. Rapid acquisition of HPV around the time of sexual debut in adolescent girls in Tanzania. Int J Epidemiol. 2016 Jun;45(3):762-73. doi: 10.1093/ije/dyv367. Epub 2016 Mar 4. PMID 26944311
• Centers for Disease Control and Prevention. (2025, 6 de marzo). Human Papillomavirus (HPV) Vaccine Safety. https://www.cdc.gov/vaccine-safety/vaccines/hpv.html
• Watson-Jones D, Baisley K, Brown J, Kavishe B, Andreasen A, Changalucha J, Mayaud P, Kapiga S, Gumodoka B, Hayes RJ, de Sanjose S. High prevalence and incidence of human papillomavirus in a cohort of healthy young African female subjects. Sex Transm Infect. 2013 Aug;89(5):358-65. doi: 10.1136/sextrans-2012-050685. Epub 2013 Mar 13. PMID 23486859
• Centers for Disease Control and Prevention. (2024, 9 de julio). HPV Vaccine Safety and Effectiveness Data. https://www.cdc.gov/hpv/hcp/vaccination-considerations/safety-and-effectiveness-data.html
• Chow EP, Read TR, Wigan R, Donovan B, Chen MY, Bradshaw CS, Fairley CK. Ongoing decline in genital warts among young heterosexuals 7 years after the Australian human papillomavirus (HPV) vaccination programme. Sex Transm Infect. 2015 May;91(3):214-9. doi: 10.1136/sextrans-2014-051813. Epub 2014 Oct 10. PMID 25305210
• Whitworth HS, Mounier-Jack S, Choi EM, Gallagher KE, Howard N, Kelly H, Mbwanji G, Kreimer AR, Basu P, Barnabas R, Drolet M, Brisson M, Watson-Jones D. Efficacy and immunogenicity of a single dose of human papillomavirus vaccine compared to multidose vaccination regimens or no vaccination: An updated systematic review of evidence from clinical trials. Vaccine X. 2024 Apr 16;19:100486. doi: 10.1016 PMID 38873638
• Kamolratanakul S, Pitisuttithum P. Human Papillomavirus Vaccine Efficacy and Effectiveness against Cancer. Vaccines (Basel). 2021 Nov 30;9(12):1413. doi: 10.3390/vaccines9121413. PMID 34960159

Идентификаторы

NCT: NCT07303751 · INV-074218

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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