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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
80
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, 52 and 58). It was authorized for marketing in the EU on June 9th, 201
Kambia Research Centre
Freetown, Sierra Leone
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®).
To analyse the differences in the HPV neutralization capacity of HPV 16, 18, 31, 33, 45, 52, 58 vaccine-induced antibodies in serum and cervical samples at month 6 between HPV-positive unvaccinated women and HPV-positive women who receive one dose of the HPV L1 nonavalent vaccine (Gardasil9®).
Time frame: 7 months
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
To analyse the differences in the HPV neutralization capacity of HPV 16, 18, 31, 33, 45, 52, 58 vaccine-induced antibodies in serum and cervical samples at month 6 between HPV-positive unvaccinated women and HPV-positive women who receive one dose of the HPV L1 nonavalent vaccine (Gardasil9®).
Time frame: 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®).
To analyse the differences in the HPV viral load in cervical samples at 6 months between HPV-positive unvaccinated women and HPV-positive women who receive one dose of the HPV L1 nonavalent vaccine (Gardasil9®).
Time frame: 7 months
Neutralising antibodies infective capacity of HPV virions and HPV viral load in urine samples
To analyse urine samples at month 6 to detect neutralizing antibodies to HPV 16, 18, 31, 33, 45, 52, 58, and the infective capacity of HPV 16, 18, 31, 33, 45, 52, 58 virions and to measure HPV 16, 18, 31, 33, 45, 52, 58 viral load
Time frame: 7 months
The difference in infectivity reduction and vaccine induced antibodies among different HPV types.
To analyse differences in infectivity reduction and vaccine induced antibodies among different HPV types included in the 9-valent vaccine.
Time frame: 7 months
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