Staci L Sudenga1, B Nelson Torres1, Matthys H Botha2, Michele Zeier3, Martha E Abrahamsen1, Richard H Glashoff4, Susan Engelbrecht4, Maarten F Schim Van der Loeff5, Louvina E Van der Laan2, Siegfried Kipping2, Douglas Taylor6, Anna R Giuliano7. 1. Center for Infection Research in Cancer, Moffitt Cancer Center, Tampa, FL, USA. 2. Department of Obstetrics and Gynaecology and Unit for Gynaecological Oncology, Tygerberg Hospital, Stellenbosch University, Cape Town, South Africa. 3. Department of Medicine and Centre for Infectious Diseases, Stellenbosch University, Cape Town, South Africa. 4. Division of Medical Virology, Stellenbosch University and NHLS Tygerberg, Cape Town, South Africa. 5. Department of Infectious Diseases, Public Health Service of Amsterdam, Amsterdam, The Netherlands; Center for Infection and Immunity Amsterdam (CINIMA), Department of Internal Medicine, Academic Medical Center, Amsterdam, The Netherlands. 6. FHI 360, Durham, NC, USA. 7. Center for Infection Research in Cancer, Moffitt Cancer Center, Tampa, FL, USA. Electronic address: Anna.Giuliano@moffitt.org.
Abstract
OBJECTIVE: The objective of this analysis was to assess human papillomavirus (HPV) infection persistence and incidence 7-months post-enrollment by HPV vaccine study arm (vaccine or placebo). METHODS:HIV-negative, sexually active women aged 16-24 years in the Western Cape, South Africa, were enrolled in the EVRI Trial and were randomized to receive 4-valent HPV vaccine or placebo. Cervical specimens were collected at enrollment and at the 7-month visit and were genotyped for HPV. HPV prevalence, persistence, and incidence were calculated. Prevalence ratios and odds ratios were calculated to assess factors associated with a prevalent and incident HPV infection. RESULTS:HPV incidence rates were marginally higher for the placebo group (n = 163) compared to the vaccine group (n = 169). A large proportion of the prevalent high-risk (HR-HPV) HPV types (49%) persisted over the 7-month period in both arms. Prevalent HR-HPV infection was significantly associated with a prevalent gonorrhea infection and detection of Herpes simplex type 2 antibodies. Incident HR-HPV infection was significantly associated with abnormal cervical cytology at enrollment and younger age. CONCLUSIONS:Women living in geographic areas, such as southern Africa, at high-risk for HPV need to receiveHPV vaccination at a very young age to maximally prevent infection and subsequent disease.
RCT Entities:
OBJECTIVE: The objective of this analysis was to assess humanpapillomavirus (HPV) infection persistence and incidence 7-months post-enrollment by HPV vaccine study arm (vaccine or placebo). METHODS:HIV-negative, sexually active women aged 16-24 years in the Western Cape, South Africa, were enrolled in the EVRI Trial and were randomized to receive 4-valent HPV vaccine or placebo. Cervical specimens were collected at enrollment and at the 7-month visit and were genotyped for HPV. HPV prevalence, persistence, and incidence were calculated. Prevalence ratios and odds ratios were calculated to assess factors associated with a prevalent and incident HPV infection. RESULTS:HPV incidence rates were marginally higher for the placebo group (n = 163) compared to the vaccine group (n = 169). A large proportion of the prevalent high-risk (HR-HPV) HPV types (49%) persisted over the 7-month period in both arms. Prevalent HR-HPV infection was significantly associated with a prevalent gonorrhea infection and detection of Herpes simplex type 2 antibodies. Incident HR-HPV infection was significantly associated with abnormal cervical cytology at enrollment and younger age. CONCLUSIONS:Women living in geographic areas, such as southern Africa, at high-risk for HPV need to receive HPV vaccination at a very young age to maximally prevent infection and subsequent disease.
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