Table 4.
Incident-Persistent Infection in the Study Population
| Per-Protocol Naive to Specified HPV Typeb | Per-Protocol Previously Exposed to Specified HPV Typeb | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Endpoint: Persistent Infectiona | No. Included in Analyses | No. of Affected Participants | Person-Years at Risk | Events per 100 Person-Years at Risk | No. Included in Analyses | No. of Affected Participants | Person-Years at Risk | Events per 100 Person-Years at Risk | P c |
| HPV6 | 29 | 1 | 55.5 | 1.8 | 15 | 0 | 29.0 | 0.0 | .671 |
| HPV11 | 55 | 0 | 108.6 | 0.0 | 33 | 0 | 64.9 | 0.0 | >.999 |
| HPV16 | 54 | 3 | 102.9 | 2.9 | 23 | 0 | 46.0 | 0.0 | .386 |
| HPV18 | 74 | 1 | 142.9 | 0.7 | 23 | 0 | 46.1 | 0.0 | .622 |
No. = number of participants with ≥2 follow-up visits. Abbreviation: HPV, human papillomavirus.
aMust have had a positive HPV test at 2 consecutive visits after month 7 (months 12, 18, and 24) at any site (swab DNA anal/perianal, penile/scrotal, oral) and persistent at same site (anal/perianal, penile/scrotal, oral).
bBased on serum at baseline and DNA from baseline and month 7 from any anatomical site. By definition, the previously exposed category included only those who were seropositive, DNA-negative for the specific HPV type. Participants could be in >1 exposure category.
cNaive and previously exposed group comparison of event rates were based on exact Poisson calculations (2-sided test).