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Table 1 Included studies

From: HPV vaccine in the treatment of usual type vulval and vaginal intraepithelial neoplasia: a systematic review

Author Study Design Participants N Average Disease Duration Intervention Follow up Results
Baldwin 2003 [20] Case series Aged 42–54 (mean age 46) HG HPV positive VIN/VAIN 12 3–14 months TA-HPV, a live recombinant vaccinia virus, expressing modified versions of the E6 and E7 open reading frames from HPV-16 and HPV-18. 6 months Enhanced vaccine T-cell specific response (60%) Symptom relief (25%) Lesion response (reduction in size; 83%) Regression to normal histology (8%) HPV negative post intervention (8%) No disease progression over the 6 months follow up period
Daayana 2010 [21] Case series Aged 18–70 (mean 46) Biopsy proven VIN2/3 20 7 years Weeks 1–8 Imiquimod then three intramuscular doses of TA-CIN - E6 and E7 L2 fusion protein - (1 ml of 128 mg/ml) at weeks 10, 14 and 18. 1 year Lymphoproliferative response (84%) Symptom relief (68.4%) Lesion response (79%) Regression on Histology (63%) HPV negative (74.3%) 1 progression to invasive cancer after the trial period
Davidson 2003 [22] Case series HPV16 positive HG VIN 18 6.4 years (6 months – 17 years) Vaccination with TA-HPV E6/E7 (2.5 × 105 plaque-forming units) by a single dermal scarification to the deltoid region of the upper arm. 6 months Immune response (94%) Symptom relief (50%) Lesion response (44%) Regression on histology (5.5%) HPV negative (11%)
Fiander 2006 [23] Case series Aged 18–65 (median 40) Biopsy proven HG non-cervical ano-genital intraepithelial neoplasia 29 2–120 months Three prime vaccinations of TA-CIN (533 μg) were given intramuscularly into the deltoid region days 0, 28, and 56 followed by TA-HPV administered by dermal scarification of the deltoid (2.5 × 105 plaque-forming units) on day 72. 6 months Symptom relief (56%) Lesion response - CR (disappearance of lesion) seen in 1/29 (3%), partial (> 50%) in 5 (17%), stable disease in 18 (62%), progression in 5 patients (17%) Regression on histology (17%) HPV negative (14%) Nil developed invasive lesions Trend for older women to respond Prime boost strategy does not demonstrate additional efficacy compared to the recombinant vaccine (TA-HPV) alone
Kenter 2009 [19] Case series Aged 23–61 (mean 29) Histologically confirmed HPV16 positive VIN3 22 3–185 months Vaccine containing nine HPV-16 E6 and four HPV-16 E7 synthetic peptides, the vaccine was administered subcutaneously at 3-week intervals 1 year Immune response − 85% had circulating T cells post vaccine Symptom relief (63%) Lesion response (79%) Regression on histology (45%) HPV status – 4/20 (20%) negative at 3 months
Muderspach 2000 [24] Case series Median age 29 CIN2/3 or VIN 2/3 16 Vaccination HPV-16 E7 12–20 peptide, 3 groups varied dose LEEP as standard in CIN patients 1 month Immune response 10/16 (63%) Lesion response 9/17 (53%) HPV status 12/18 negative (67%) Symptom relief and histology not reported
Samuels 2017 [25] Case series Median age 50 Biopsy proven HPV16 positive uVIN 12 TTFC-E7SH, E. coli derived plasmid backbone, fusion protein of tetanus toxin, and shuffled version of HPV16 E7 oncoprotein. Patients vaccinated with a fixed dose on days 0,3, and 6 then received booster at week 4. Administration using novel intradermal application (tattooing). Cohort 1–0.2 mg injection, cohort 2 – 2 mg. 3 months Symptoms – no response after 3 months Lesions – no response after 3 months Histological features – no response after 3 months Vaccine induced T cell responses found in 4/12 patients