Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026
Immunogenicity and Safety of 2 Versus 3 Doses of 9-Valent Vaccine Against Human Papillomavirus in Women With Human Immunodeficiency Virus: The Papillon Randomized Trial.
СтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Konopnicki Deborah, Gilles Christine, Manigart Yannick, Barlow Patricia, Reschner Anca, Necsoi Coca, Delforge Marc, Vanden Broeck Davy, Dauby Nicolas, De Wit Stéphane
Аннотация
BACKGROUND: The World Health Organization recommends 2 doses of human papillomavirus (HPV) vaccine for adults without human immunodeficiency virus (HIV) but 3 doses in persons with HIV. There are no immunogenicity data on the 2-dose schedule in women with HIV (WWH).
METHODS: This was a prospective study comparing 2 doses (months 0 and 6) versus 3 (months 0, 2, and 6) doses of 9-valent vaccine (Gardasil 9, Merck Sharp & Dohme) in WWH (15-40 years), on antiretrovirals with HIV RNA <400 copies/mL, enrolled during 2018-2021. After an open-label phase assessing safety (n = 45 receiving 3 doses), participants were randomized between 2 or 3 doses. Primary outcome was noninferiority of 2 doses compared to 3 doses for seroconversion against all vaccine genotypes. Due to the COVID-19 pandemic, 100 WWH, instead of initially planned 120, were randomized. The trial was further amended to give 2 doses to all participants enrolled thereafter (n = 22). Results were analyzed in modified intention-to-treat (mITT) on the randomized cohort (n = 100) and per protocol on the whole cohort (n = 167).
RESULTS: Participants' median age was 35 years, median CD4 count was 649 cells/µL, and 16 missed the month 7 visit. In mITT, seroconversion was 97.7% for 2 doses and 97.9% for 3 doses, meeting the predefined noninferiority criteria. At month 7, antibodies titers against all vaccine genotypes were high in both groups (increase by 1.2-2.4 log10). There were no serious adverse events; participants with 3 doses experienced local reactions more frequently (82% vs 60% for 2 doses, P = .027) with more symptoms and longer duration.
CONCLUSIONS: In women with well-controlled HIV, 2 doses of 9-valent HPV vaccine is noninferior to 3 doses in terms of seroconversion and is associated with less reactogenicity.
CLINICAL TRIALS REGISTRATION: NCT03391921; EUDRACT 2018-000228-33; CTIS-EMA 2024-520419-42-00.
METHODS: This was a prospective study comparing 2 doses (months 0 and 6) versus 3 (months 0, 2, and 6) doses of 9-valent vaccine (Gardasil 9, Merck Sharp & Dohme) in WWH (15-40 years), on antiretrovirals with HIV RNA <400 copies/mL, enrolled during 2018-2021. After an open-label phase assessing safety (n = 45 receiving 3 doses), participants were randomized between 2 or 3 doses. Primary outcome was noninferiority of 2 doses compared to 3 doses for seroconversion against all vaccine genotypes. Due to the COVID-19 pandemic, 100 WWH, instead of initially planned 120, were randomized. The trial was further amended to give 2 doses to all participants enrolled thereafter (n = 22). Results were analyzed in modified intention-to-treat (mITT) on the randomized cohort (n = 100) and per protocol on the whole cohort (n = 167).
RESULTS: Participants' median age was 35 years, median CD4 count was 649 cells/µL, and 16 missed the month 7 visit. In mITT, seroconversion was 97.7% for 2 doses and 97.9% for 3 doses, meeting the predefined noninferiority criteria. At month 7, antibodies titers against all vaccine genotypes were high in both groups (increase by 1.2-2.4 log10). There were no serious adverse events; participants with 3 doses experienced local reactions more frequently (82% vs 60% for 2 doses, P = .027) with more symptoms and longer duration.
CONCLUSIONS: In women with well-controlled HIV, 2 doses of 9-valent HPV vaccine is noninferior to 3 doses in terms of seroconversion and is associated with less reactogenicity.
CLINICAL TRIALS REGISTRATION: NCT03391921; EUDRACT 2018-000228-33; CTIS-EMA 2024-520419-42-00.
Предметные рубрики MeSH
HumansFemaleAdultHIV InfectionsPapillomavirus InfectionsProspective StudiesYoung AdultImmunogenicity, VaccineImmunization ScheduleAdolescentPapillomavirus VaccinesAntibodies, ViralHuman Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18COVID-19SeroconversionHuman Papillomavirus Viruses