Univariate and Multivariable Poisson Regression for Incident Infections, 12-Month Persistent Infections, and ASC-US+ Cervical Cytology Associated with HPV-16: TVC-E Control Arm, 15–25 Years Old at Enrollment Among Participants Reporting Ever had Sexual Intercourse
| . | . | . | . | . | Univariate Analysis . | Multivariable Analysis . | ||
|---|---|---|---|---|---|---|---|---|
| Exposure Variable . | Categories . | No. of Subjects . | No. of Events . | Incidence per 100/per Year . | Relative Rate (95% CI) . | P Value . | Relative Rate (95% CI) . | P Value . |
| Endpoint: HPV-16 incident infection | ||||||||
| (N = 10447) | (N = 1534) | (N = 10447) | (N = 10046) | |||||
| HPV-16 serostatus | Negative | 8564 | 1338 | 4.37 | 1.00 | … | 1.00 | … |
| Positive(≥8 EU/mL) | 1883 | 196 | 2.81 | 0.64 (0.55–0.75) | <.0001 | 0.63 (0.53–0.73) | <.0001 | |
| HPV-16 titers | Negative (<8 EU/mL) | 8564 | 1338 | 4.37 | 1.00 | … | 1.00 | … |
| Q1a (8–13 EU/mL) | 530 | 63 | 3.28 | 0.75 (0.58–0.97) | .03 | 0.76 (0.59–0.99) | .04 | |
| Q2 (13–24 EU/mL) | 428 | 61 | 3.88 | 0.89 (0.69–1.15) | .37 | 0.86 (0.66–1.12) | .27 | |
| Q3 (24–64 EU/mL) | 467 | 44 | 2.56 | 0.59 (0.43–0.79) | .0005 | 0.58 (0.43–0.8) | .0007 | |
| Q4 (64–3202 EU/mL) | 458 | 28 | 1.59 | 0.36 (0.25–0.53) | <.0001 | 0.32 (0.22–0.48) | <.0001 | |
| P trend <.0001 | ||||||||
| Endpoint: 12-month persistent infection | ||||||||
| (N = 10082) | (N = 517) | (N = 10082) | (N = 9344) | |||||
| HPV-16 serostatus | Negative | 8268 | 448 | 1.41 | 1.00 | … | 1.00 | … |
| Positive(≥8 EU/mL) | 1814 | 69 | 0.97 | 0.68 (0.53–0.88) | .003 | 0.70 (0.54–0.92) | .01 | |
| HPV-16 titers | Negative (<8 EU/mL) | 8268 | 448 | 1.41 | 1.00 | … | 1.00 | … |
| Q1a (8–13 EU/mL) | 510 | 26 | 1.31 | 0.93 (0.63–1.38) | .72 | 0.97 (0.64–1.47) | .89 | |
| Q2 (13–24 EU/mL) | 414 | 16 | 0.98 | 0.70 (0.42–1.15) | .16 | 0.74 (0.45–1.22) | .24 | |
| Q3 (24–64 EU/mL) | 443 | 19 | 1.08 | 0.77 (0.48–1.21) | .25 | 0.81 (0.5–1.3) | .38 | |
| Q4 (64–3202 EU/mL) | 447 | 8 | 0.45 | 0.32 (0.16–0.64) | .001 | 0.29 (0.14–0.61) | .001 | |
| P trend 0.0002 | ||||||||
| Endpoint: HPV-16 ASC-US+ | ||||||||
| (N = 10288) | (N = 719) | (N = 10288) | (N = 9516) | |||||
| HPV-16 serostatus | Negative | 8426 | 632 | 1.98 | 1.00 | … | 1.00 | … |
| Positive (≥8 EU/mL) | 1862 | 87 | 1.21 | 0.61 (0.49–0.77) | <.0001 | 0.57 (0.45–0.73) | <.0001 | |
| HPV-16 titers | Negative (<8 EU/mL) | 8426 | 632 | 1.98 | 1.00 | … | 1.00 | … |
| Q1a (8–13 EU/mL) | 526 | 30 | 1.50 | 0.76 (0.53–1.09) | .14 | 0.78 (0.54–1.13) | .19 | |
| Q2 (13–24 EU/mL) | 422 | 24 | 1.49 | 0.75 (0.5–1.13) | .17 | 0.73 (0.48–1.1) | .13 | |
| Q3 (24–64 EU/mL) | 458 | 23 | 1.30 | 0.66 (0.43–0.99) | .05 | 0.60 (0.38–0.93) | .02 | |
| Q4 (64–3202 EU/mL) | 456 | 10 | 0.56 | 0.28 (0.15–0.52) | <.0001 | 0.21 (0.1–0.42) | <.0001 | |
| P trend <.0001 | ||||||||
| . | . | . | . | . | Univariate Analysis . | Multivariable Analysis . | ||
|---|---|---|---|---|---|---|---|---|
| Exposure Variable . | Categories . | No. of Subjects . | No. of Events . | Incidence per 100/per Year . | Relative Rate (95% CI) . | P Value . | Relative Rate (95% CI) . | P Value . |
| Endpoint: HPV-16 incident infection | ||||||||
| (N = 10447) | (N = 1534) | (N = 10447) | (N = 10046) | |||||
| HPV-16 serostatus | Negative | 8564 | 1338 | 4.37 | 1.00 | … | 1.00 | … |
| Positive(≥8 EU/mL) | 1883 | 196 | 2.81 | 0.64 (0.55–0.75) | <.0001 | 0.63 (0.53–0.73) | <.0001 | |
| HPV-16 titers | Negative (<8 EU/mL) | 8564 | 1338 | 4.37 | 1.00 | … | 1.00 | … |
| Q1a (8–13 EU/mL) | 530 | 63 | 3.28 | 0.75 (0.58–0.97) | .03 | 0.76 (0.59–0.99) | .04 | |
| Q2 (13–24 EU/mL) | 428 | 61 | 3.88 | 0.89 (0.69–1.15) | .37 | 0.86 (0.66–1.12) | .27 | |
| Q3 (24–64 EU/mL) | 467 | 44 | 2.56 | 0.59 (0.43–0.79) | .0005 | 0.58 (0.43–0.8) | .0007 | |
| Q4 (64–3202 EU/mL) | 458 | 28 | 1.59 | 0.36 (0.25–0.53) | <.0001 | 0.32 (0.22–0.48) | <.0001 | |
| P trend <.0001 | ||||||||
| Endpoint: 12-month persistent infection | ||||||||
| (N = 10082) | (N = 517) | (N = 10082) | (N = 9344) | |||||
| HPV-16 serostatus | Negative | 8268 | 448 | 1.41 | 1.00 | … | 1.00 | … |
| Positive(≥8 EU/mL) | 1814 | 69 | 0.97 | 0.68 (0.53–0.88) | .003 | 0.70 (0.54–0.92) | .01 | |
| HPV-16 titers | Negative (<8 EU/mL) | 8268 | 448 | 1.41 | 1.00 | … | 1.00 | … |
| Q1a (8–13 EU/mL) | 510 | 26 | 1.31 | 0.93 (0.63–1.38) | .72 | 0.97 (0.64–1.47) | .89 | |
| Q2 (13–24 EU/mL) | 414 | 16 | 0.98 | 0.70 (0.42–1.15) | .16 | 0.74 (0.45–1.22) | .24 | |
| Q3 (24–64 EU/mL) | 443 | 19 | 1.08 | 0.77 (0.48–1.21) | .25 | 0.81 (0.5–1.3) | .38 | |
| Q4 (64–3202 EU/mL) | 447 | 8 | 0.45 | 0.32 (0.16–0.64) | .001 | 0.29 (0.14–0.61) | .001 | |
| P trend 0.0002 | ||||||||
| Endpoint: HPV-16 ASC-US+ | ||||||||
| (N = 10288) | (N = 719) | (N = 10288) | (N = 9516) | |||||
| HPV-16 serostatus | Negative | 8426 | 632 | 1.98 | 1.00 | … | 1.00 | … |
| Positive (≥8 EU/mL) | 1862 | 87 | 1.21 | 0.61 (0.49–0.77) | <.0001 | 0.57 (0.45–0.73) | <.0001 | |
| HPV-16 titers | Negative (<8 EU/mL) | 8426 | 632 | 1.98 | 1.00 | … | 1.00 | … |
| Q1a (8–13 EU/mL) | 526 | 30 | 1.50 | 0.76 (0.53–1.09) | .14 | 0.78 (0.54–1.13) | .19 | |
| Q2 (13–24 EU/mL) | 422 | 24 | 1.49 | 0.75 (0.5–1.13) | .17 | 0.73 (0.48–1.1) | .13 | |
| Q3 (24–64 EU/mL) | 458 | 23 | 1.30 | 0.66 (0.43–0.99) | .05 | 0.60 (0.38–0.93) | .02 | |
| Q4 (64–3202 EU/mL) | 456 | 10 | 0.56 | 0.28 (0.15–0.52) | <.0001 | 0.21 (0.1–0.42) | <.0001 | |
| P trend <.0001 | ||||||||
Relative rates are presented for the multivariable model including serostatus as binary and separately for models that include serostatus as categorical variables.
Full models including titers are available in Supplemental Table 2. Models coadjusted for: study (CVT and PATRICIA), study region, marital status, age at first sexual intercourse, pack-years smoked (0–0.5 vs 0.5+), lifetime sexual partners, previous pregnancy, Chlamydia test results.
Abbreviations: ASC-US+, atypical squamous cells of undetermined significance or greater; CI, confidence interval; CVT, Costa Rica vaccine trial; HPV, human papillomavirus; N, number of subjects with available data; PATRICIA, Papilloma Trial Against Cancer in Young Adults; TVC-E, total vaccinated cohort for efficacy.
aQ1–Q4: quartiles 1 to 4.
Univariate and Multivariable Poisson Regression for Incident Infections, 12-Month Persistent Infections, and ASC-US+ Cervical Cytology Associated with HPV-16: TVC-E Control Arm, 15–25 Years Old at Enrollment Among Participants Reporting Ever had Sexual Intercourse
| . | . | . | . | . | Univariate Analysis . | Multivariable Analysis . | ||
|---|---|---|---|---|---|---|---|---|
| Exposure Variable . | Categories . | No. of Subjects . | No. of Events . | Incidence per 100/per Year . | Relative Rate (95% CI) . | P Value . | Relative Rate (95% CI) . | P Value . |
| Endpoint: HPV-16 incident infection | ||||||||
| (N = 10447) | (N = 1534) | (N = 10447) | (N = 10046) | |||||
| HPV-16 serostatus | Negative | 8564 | 1338 | 4.37 | 1.00 | … | 1.00 | … |
| Positive(≥8 EU/mL) | 1883 | 196 | 2.81 | 0.64 (0.55–0.75) | <.0001 | 0.63 (0.53–0.73) | <.0001 | |
| HPV-16 titers | Negative (<8 EU/mL) | 8564 | 1338 | 4.37 | 1.00 | … | 1.00 | … |
| Q1a (8–13 EU/mL) | 530 | 63 | 3.28 | 0.75 (0.58–0.97) | .03 | 0.76 (0.59–0.99) | .04 | |
| Q2 (13–24 EU/mL) | 428 | 61 | 3.88 | 0.89 (0.69–1.15) | .37 | 0.86 (0.66–1.12) | .27 | |
| Q3 (24–64 EU/mL) | 467 | 44 | 2.56 | 0.59 (0.43–0.79) | .0005 | 0.58 (0.43–0.8) | .0007 | |
| Q4 (64–3202 EU/mL) | 458 | 28 | 1.59 | 0.36 (0.25–0.53) | <.0001 | 0.32 (0.22–0.48) | <.0001 | |
| P trend <.0001 | ||||||||
| Endpoint: 12-month persistent infection | ||||||||
| (N = 10082) | (N = 517) | (N = 10082) | (N = 9344) | |||||
| HPV-16 serostatus | Negative | 8268 | 448 | 1.41 | 1.00 | … | 1.00 | … |
| Positive(≥8 EU/mL) | 1814 | 69 | 0.97 | 0.68 (0.53–0.88) | .003 | 0.70 (0.54–0.92) | .01 | |
| HPV-16 titers | Negative (<8 EU/mL) | 8268 | 448 | 1.41 | 1.00 | … | 1.00 | … |
| Q1a (8–13 EU/mL) | 510 | 26 | 1.31 | 0.93 (0.63–1.38) | .72 | 0.97 (0.64–1.47) | .89 | |
| Q2 (13–24 EU/mL) | 414 | 16 | 0.98 | 0.70 (0.42–1.15) | .16 | 0.74 (0.45–1.22) | .24 | |
| Q3 (24–64 EU/mL) | 443 | 19 | 1.08 | 0.77 (0.48–1.21) | .25 | 0.81 (0.5–1.3) | .38 | |
| Q4 (64–3202 EU/mL) | 447 | 8 | 0.45 | 0.32 (0.16–0.64) | .001 | 0.29 (0.14–0.61) | .001 | |
| P trend 0.0002 | ||||||||
| Endpoint: HPV-16 ASC-US+ | ||||||||
| (N = 10288) | (N = 719) | (N = 10288) | (N = 9516) | |||||
| HPV-16 serostatus | Negative | 8426 | 632 | 1.98 | 1.00 | … | 1.00 | … |
| Positive (≥8 EU/mL) | 1862 | 87 | 1.21 | 0.61 (0.49–0.77) | <.0001 | 0.57 (0.45–0.73) | <.0001 | |
| HPV-16 titers | Negative (<8 EU/mL) | 8426 | 632 | 1.98 | 1.00 | … | 1.00 | … |
| Q1a (8–13 EU/mL) | 526 | 30 | 1.50 | 0.76 (0.53–1.09) | .14 | 0.78 (0.54–1.13) | .19 | |
| Q2 (13–24 EU/mL) | 422 | 24 | 1.49 | 0.75 (0.5–1.13) | .17 | 0.73 (0.48–1.1) | .13 | |
| Q3 (24–64 EU/mL) | 458 | 23 | 1.30 | 0.66 (0.43–0.99) | .05 | 0.60 (0.38–0.93) | .02 | |
| Q4 (64–3202 EU/mL) | 456 | 10 | 0.56 | 0.28 (0.15–0.52) | <.0001 | 0.21 (0.1–0.42) | <.0001 | |
| P trend <.0001 | ||||||||
| . | . | . | . | . | Univariate Analysis . | Multivariable Analysis . | ||
|---|---|---|---|---|---|---|---|---|
| Exposure Variable . | Categories . | No. of Subjects . | No. of Events . | Incidence per 100/per Year . | Relative Rate (95% CI) . | P Value . | Relative Rate (95% CI) . | P Value . |
| Endpoint: HPV-16 incident infection | ||||||||
| (N = 10447) | (N = 1534) | (N = 10447) | (N = 10046) | |||||
| HPV-16 serostatus | Negative | 8564 | 1338 | 4.37 | 1.00 | … | 1.00 | … |
| Positive(≥8 EU/mL) | 1883 | 196 | 2.81 | 0.64 (0.55–0.75) | <.0001 | 0.63 (0.53–0.73) | <.0001 | |
| HPV-16 titers | Negative (<8 EU/mL) | 8564 | 1338 | 4.37 | 1.00 | … | 1.00 | … |
| Q1a (8–13 EU/mL) | 530 | 63 | 3.28 | 0.75 (0.58–0.97) | .03 | 0.76 (0.59–0.99) | .04 | |
| Q2 (13–24 EU/mL) | 428 | 61 | 3.88 | 0.89 (0.69–1.15) | .37 | 0.86 (0.66–1.12) | .27 | |
| Q3 (24–64 EU/mL) | 467 | 44 | 2.56 | 0.59 (0.43–0.79) | .0005 | 0.58 (0.43–0.8) | .0007 | |
| Q4 (64–3202 EU/mL) | 458 | 28 | 1.59 | 0.36 (0.25–0.53) | <.0001 | 0.32 (0.22–0.48) | <.0001 | |
| P trend <.0001 | ||||||||
| Endpoint: 12-month persistent infection | ||||||||
| (N = 10082) | (N = 517) | (N = 10082) | (N = 9344) | |||||
| HPV-16 serostatus | Negative | 8268 | 448 | 1.41 | 1.00 | … | 1.00 | … |
| Positive(≥8 EU/mL) | 1814 | 69 | 0.97 | 0.68 (0.53–0.88) | .003 | 0.70 (0.54–0.92) | .01 | |
| HPV-16 titers | Negative (<8 EU/mL) | 8268 | 448 | 1.41 | 1.00 | … | 1.00 | … |
| Q1a (8–13 EU/mL) | 510 | 26 | 1.31 | 0.93 (0.63–1.38) | .72 | 0.97 (0.64–1.47) | .89 | |
| Q2 (13–24 EU/mL) | 414 | 16 | 0.98 | 0.70 (0.42–1.15) | .16 | 0.74 (0.45–1.22) | .24 | |
| Q3 (24–64 EU/mL) | 443 | 19 | 1.08 | 0.77 (0.48–1.21) | .25 | 0.81 (0.5–1.3) | .38 | |
| Q4 (64–3202 EU/mL) | 447 | 8 | 0.45 | 0.32 (0.16–0.64) | .001 | 0.29 (0.14–0.61) | .001 | |
| P trend 0.0002 | ||||||||
| Endpoint: HPV-16 ASC-US+ | ||||||||
| (N = 10288) | (N = 719) | (N = 10288) | (N = 9516) | |||||
| HPV-16 serostatus | Negative | 8426 | 632 | 1.98 | 1.00 | … | 1.00 | … |
| Positive (≥8 EU/mL) | 1862 | 87 | 1.21 | 0.61 (0.49–0.77) | <.0001 | 0.57 (0.45–0.73) | <.0001 | |
| HPV-16 titers | Negative (<8 EU/mL) | 8426 | 632 | 1.98 | 1.00 | … | 1.00 | … |
| Q1a (8–13 EU/mL) | 526 | 30 | 1.50 | 0.76 (0.53–1.09) | .14 | 0.78 (0.54–1.13) | .19 | |
| Q2 (13–24 EU/mL) | 422 | 24 | 1.49 | 0.75 (0.5–1.13) | .17 | 0.73 (0.48–1.1) | .13 | |
| Q3 (24–64 EU/mL) | 458 | 23 | 1.30 | 0.66 (0.43–0.99) | .05 | 0.60 (0.38–0.93) | .02 | |
| Q4 (64–3202 EU/mL) | 456 | 10 | 0.56 | 0.28 (0.15–0.52) | <.0001 | 0.21 (0.1–0.42) | <.0001 | |
| P trend <.0001 | ||||||||
Relative rates are presented for the multivariable model including serostatus as binary and separately for models that include serostatus as categorical variables.
Full models including titers are available in Supplemental Table 2. Models coadjusted for: study (CVT and PATRICIA), study region, marital status, age at first sexual intercourse, pack-years smoked (0–0.5 vs 0.5+), lifetime sexual partners, previous pregnancy, Chlamydia test results.
Abbreviations: ASC-US+, atypical squamous cells of undetermined significance or greater; CI, confidence interval; CVT, Costa Rica vaccine trial; HPV, human papillomavirus; N, number of subjects with available data; PATRICIA, Papilloma Trial Against Cancer in Young Adults; TVC-E, total vaccinated cohort for efficacy.
aQ1–Q4: quartiles 1 to 4.
This PDF is available to Subscribers Only
View Article Abstract & Purchase OptionsFor full access to this pdf, sign in to an existing account, or purchase an annual subscription.
