Evaluation of the effect of quaternary HPV vaccine in the treatment of women with cervical intraepithelial neoplasia cin1

Determining the effect of quadrivalent HPV vaccine in the treatment of women with cin1 cervical intraepithelial neoplasia

Clinical trial with control group, single-blind, on 300 patients, block randomization

intervention in the obstetrics and gynecology clinic of Fatemieh Hospital, Hamedan University of Medical Sciences, in the scope of the study to investigate the effect of quadrivalent HPV vaccine Gardasil (Papilogard) in the treatment of women with cervical intraepithelial neoplasia cin1. The specialist who evaluates the patients is not aware of the treatment group or whether the person is placebo and the design will be done in a blinded manner.

Inclusion: age 21 to 45 years, not currently pregnant, not having had more than one sexual partner during their period, women with histologically confirmed CIN 1, undergoing conservative treatment. Exclusion: pregnancy, sensitivity to the vaccine, non-cooperation, those who have been cin 1 for more than 24 mont

Intervention group: will receive conservative treatment according to ASCCP algorithm along with quadrivalent HPV vaccination (Gardasil). The vaccine will be administered as a series of intramuscular injections of 0.5 ml on day 1, month 2, and month 6. During 2 years, patients will be followed up. The efficacy of the HPV vaccine in the treatment of CIN 1 will be defined as a primary outcome. To measure this criterion, women are visited three times (12th, 18th , 24th ) and undergo gynecological examination, pap smear test, colposcopy and annual biopsy. Control: Women in the control group will receive no HPV vaccination and placebo (vitamin B complex) according to the ASCCP algorithm.

Histological biopsy status of CIN 1 lesions in two control and intervention groups

Patients will be counseled upon entering the hospital and informed consent will be obtained from the patient. After entering the room, they are examined and then they are randomly assigned to one of the two groups. Randomization is done by writing the letters A and B on two sheets and putting them in a box, and one of these sheets is taken out by the researcher for each patient. After finishing, the sheets are removed again for the next two patients with this random method until we reach the desired sample size.

The specialist who evaluates the patients is not aware of the treatment group or the person's placebo, and the design will be done in a blinded manner.