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result sql = Rationale and design of a community-based double-blind randomized clinical trial of an HPV 16 and 18 vaccine in Guanacaste, Costa Rica.
Rationale and design of a community-based double-blind randomized clinical trial of an HPV 16 and 18 vaccine in Guanacaste, Costa Rica.
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char = e;code = 101
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char = s;code = 115
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char = m;code = 109
char = m;code = 109
char = u;code = 117
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char = ;code = 32
char = c;code = 99
char = e;code = 101
char = l;code = 108
char = l;code = 108
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char = ;code = 32
char = f;code = 102
char = o;code = 111
char = r;code = 114
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char = P;code = 80
char = V;code = 86
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char = ;code = 32
char = C;code = 67
char = h;code = 104
char = l;code = 108
char = a;code = 97
char = m;code = 109
char = y;code = 121
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char = i;code = 105
char = a;code = 97
char = ;code = 32
char = t;code = 116
char = r;code = 114
char = a;code = 97
char = c;code = 99
char = h;code = 104
char = o;code = 111
char = m;code = 109
char = a;code = 97
char = t;code = 116
char = i;code = 105
char = s;code = 115
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char = a;code = 97
char = n;code = 110
char = d;code = 100
char = ;code = 32
char = g;code = 103
char = o;code = 111
char = n;code = 110
char = o;code = 111
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char = r;code = 114
char = h;code = 104
char = e;code = 101
char = a;code = 97
char = ;code = 32
char = t;code = 116
char = e;code = 101
char = s;code = 115
char = t;code = 116
char = i;code = 105
char = n;code = 110
char = g;code = 103
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char = ;code = 32
char = E;code = 69
char = i;code = 105
char = g;code = 103
char = h;code = 104
char = t;code = 116
char = y;code = 121
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char = e;code = 101
char = r;code = 114
char = c;code = 99
char = e;code = 101
char = n;code = 110
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char = o;code = 111
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char = ;code = 32
char = t;code = 116
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char = e;code = 101
char = ;code = 32
char = w;code = 119
char = o;code = 111
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char = e;code = 101
char = n;code = 110
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char = r;code = 114
char = e;code = 101
char = c;code = 99
char = e;code = 101
char = i;code = 105
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char = e;code = 101
char = d;code = 100
char = ;code = 32
char = t;code = 116
char = h;code = 104
char = r;code = 114
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char = e;code = 101
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char = d;code = 100
char = o;code = 111
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char = e;code = 101
char = s;code = 115
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char = ;code = 32
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char = ;code = 32
char = 7;code = 55
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char = ;code = 32
char = d;code = 100
char = o;code = 111
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char = A;code = 65
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char = ;code = 32
char = v;code = 118
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char = s;code = 115
char = i;code = 105
char = t;code = 116
char = s;code = 115
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char = p;code = 112
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char = a;code = 97
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char = c;code = 99
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char = w;code = 119
char = i;code = 105
char = t;code = 116
char = h;code = 104
char = ;code = 32
char = d;code = 100
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char = t;code = 116
char = a;code = 97
char = ;code = 32
char = a;code = 97
char = n;code = 110
char = d;code = 100
char = ;code = 32
char = s;code = 115
char = p;code = 112
char = e;code = 101
char = c;code = 99
char = i;code = 105
char = m;code = 109
char = e;code = 101
char = n;code = 110
char = ;code = 32
char = c;code = 99
char = o;code = 111
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char = l;code = 108
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char = c;code = 99
char = t;code = 116
char = i;code = 105
char = o;code = 111
char = n;code = 110
char = ;code = 32
char = w;code = 119
char = a;code = 97
char = s;code = 115
char = ;code = 32
char = c;code = 99
char = l;code = 108
char = o;code = 111
char = s;code = 115
char = e;code = 101
char = ;code = 32
char = t;code = 116
char = o;code = 111
char = ;code = 32
char = 1;code = 49
char = 0;code = 48
char = 0;code = 48
char = %;code = 37
char = .;code = 46
char = ;code = 32
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char = e;code = 101
char = l;code = 108
char = i;code = 105
char = n;code = 110
char = e;code = 101
char = ;code = 32
char = c;code = 99
char = h;code = 104
char = a;code = 97
char = r;code = 114
char = a;code = 97
char = c;code = 99
char = t;code = 116
char = e;code = 101
char = r;code = 114
char = i;code = 105
char = s;code = 115
char = t;code = 116
char = i;code = 105
char = c;code = 99
char = s;code = 115
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char = a;code = 97
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char = d;code = 100
char = ;code = 32
char = a;code = 97
char = g;code = 103
char = e;code = 101
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char = s;code = 115
char = p;code = 112
char = e;code = 101
char = c;code = 99
char = i;code = 105
char = f;code = 102
char = i;code = 105
char = c;code = 99
char = ;code = 32
char = p;code = 112
char = r;code = 114
char = e;code = 101
char = v;code = 118
char = a;code = 97
char = l;code = 108
char = e;code = 101
char = n;code = 110
char = c;code = 99
char = e;code = 101
char = ;code = 32
char = o;code = 111
char = f;code = 102
char = ;code = 32
char = H;code = 72
char = P;code = 80
char = V;code = 86
char = ;code = 32
char = a;code = 97
char = n;code = 110
char = d;code = 100
char = ;code = 32
char = c;code = 99
char = e;code = 101
char = r;code = 114
char = v;code = 118
char = i;code = 105
char = c;code = 99
char = a;code = 97
char = l;code = 108
char = ;code = 32
char = n;code = 110
char = e;code = 101
char = o;code = 111
char = p;code = 112
char = l;code = 108
char = a;code = 97
char = s;code = 115
char = i;code = 105
char = a;code = 97
char = ;code = 32
char = a;code = 97
char = r;code = 114
char = e;code = 101
char = ;code = 32
char = r;code = 114
char = e;code = 101
char = p;code = 112
char = o;code = 111
char = r;code = 114
char = t;code = 116
char = e;code = 101
char = d;code = 100
char = .;code = 46
char = ;code = 32
char = O;code = 79
char = v;code = 118
char = e;code = 101
char = r;code = 114
char = a;code = 97
char = l;code = 108
char = l;code = 108
char = ;code = 32
char = p;code = 112
char = r;code = 114
char = e;code = 101
char = v;code = 118
char = a;code = 97
char = l;code = 108
char = e;code = 101
char = n;code = 110
char = c;code = 99
char = e;code = 101
char = ;code = 32
char = o;code = 111
char = f;code = 102
char = ;code = 32
char = H;code = 72
char = P;code = 80
char = V;code = 86
char = ;code = 32
char = w;code = 119
char = a;code = 97
char = s;code = 115
char = ;code = 32
char = h;code = 104
char = i;code = 105
char = g;code = 103
char = h;code = 104
char = ;code = 32
char = (;code = 40
char = 5;code = 53
char = 0;code = 48
char = %;code = 37
char = );code = 41
char = ,;code = 44
char = ;code = 32
char = w;code = 119
char = i;code = 105
char = t;code = 116
char = h;code = 104
char = ;code = 32
char = 8;code = 56
char = .;code = 46
char = 3;code = 51
char = %;code = 37
char = ;code = 32
char = o;code = 111
char = f;code = 102
char = ;code = 32
char = w;code = 119
char = o;code = 111
char = m;code = 109
char = e;code = 101
char = n;code = 110
char = ;code = 32
char = h;code = 104
char = a;code = 97
char = v;code = 118
char = i;code = 105
char = n;code = 110
char = g;code = 103
char = ;code = 32
char = H;code = 72
char = P;code = 80
char = V;code = 86
char = ;code = 32
char = 1;code = 49
char = 6;code = 54
char = ;code = 32
char = a;code = 97
char = n;code = 110
char = d;code = 100
char = ;code = 32
char = 3;code = 51
char = .;code = 46
char = 2;code = 50
char = %;code = 37
char = ;code = 32
char = H;code = 72
char = P;code = 80
char = V;code = 86
char = ;code = 32
char = 1;code = 49
char = 8;code = 56
char = <;code = 60
char = b;code = 98
char = >;code = 62
char = ;code = 32
char = L;code = 76
char = S;code = 83
char = I;code = 73
char = L;code = 76
char = ;code = 32
char = :;code = 58
char = ;code = 32
char = <;code = 60
char = /;code = 47
char = b;code = 98
char = >;code = 62
char = w;code = 119
char = a;code = 97
char = s;code = 115
char = ;code = 32
char = d;code = 100
char = e;code = 101
char = t;code = 116
char = e;code = 101
char = c;code = 99
char = t;code = 116
char = e;code = 101
char = d;code = 100
char = ;code = 32
char = i;code = 105
char = n;code = 110
char = ;code = 32
char = 1;code = 49
char = 2;code = 50
char = .;code = 46
char = 7;code = 55
char = %;code = 37
char = ;code = 32
char = o;code = 111
char = f;code = 102
char = ;code = 32
char = w;code = 119
char = o;code = 111
char = m;code = 109
char = e;code = 101
char = n;code = 110
char = ;code = 32
char = a;code = 97
char = t;code = 116
char = ;code = 32
char = b;code = 98
char = a;code = 97
char = s;code = 115
char = e;code = 101
char = l;code = 108
char = i;code = 105
char = n;code = 110
char = e;code = 101
char = ;code = 32
char = a;code = 97
char = n;code = 110
char = d;code = 100
char = ;code = 32
char = H;code = 72
char = S;code = 83
char = I;code = 73
char = L;code = 76
char = ;code = 32
char = i;code = 105
char = n;code = 110
char = ;code = 32
char = 1;code = 49
char = .;code = 46
char = 9;code = 57
char = %;code = 37
char = .;code = 46
char = ;code = 32
char = P;code = 80
char = r;code = 114
char = e;code = 101
char = v;code = 118
char = a;code = 97
char = l;code = 108
char = e;code = 101
char = n;code = 110
char = c;code = 99
char = e;code = 101
char = ;code = 32
char = o;code = 111
char = f;code = 102
char = ;code = 32
char = C;code = 67
char = h;code = 104
char = l;code = 108
char = a;code = 97
char = m;code = 109
char = y;code = 121
char = d;code = 100
char = i;code = 105
char = a;code = 97
char = ;code = 32
char = w;code = 119
char = a;code = 97
char = s;code = 115
char = ;code = 32
char = 1;code = 49
char = 4;code = 52
char = .;code = 46
char = 2;code = 50
char = %;code = 37
char = .;code = 46
char = ;code = 32
char = T;code = 84
char = h;code = 104
char = e;code = 101
char = r;code = 114
char = e;code = 101
char = ;code = 32
char = w;code = 119
char = a;code = 97
char = s;code = 115
char = ;code = 32
char = v;code = 118
char = e;code = 101
char = r;code = 114
char = y;code = 121
char = ;code = 32
char = g;code = 103
char = o;code = 111
char = o;code = 111
char = d;code = 100
char = ;code = 32
char = a;code = 97
char = g;code = 103
char = r;code = 114
char = e;code = 101
char = e;code = 101
char = m;code = 109
char = e;code = 101
char = n;code = 110
char = t;code = 116
char = ;code = 32
char = i;code = 105
char = n;code = 110
char = ;code = 32
char = H;code = 72
char = P;code = 80
char = V;code = 86
char = ;code = 32
char = d;code = 100
char = e;code = 101
char = t;code = 116
char = e;code = 101
char = c;code = 99
char = t;code = 116
char = i;code = 105
char = o;code = 111
char = n;code = 110
char = ;code = 32
char = b;code = 98
char = e;code = 101
char = t;code = 116
char = w;code = 119
char = e;code = 101
char = e;code = 101
char = n;code = 110
char = ;code = 32
char = c;code = 99
char = l;code = 108
char = i;code = 105
char = n;code = 110
char = i;code = 105
char = c;code = 99
char = i;code = 105
char = a;code = 97
char = n;code = 110
char = -;code = 45
char = c;code = 99
char = o;code = 111
char = l;code = 108
char = l;code = 108
char = e;code = 101
char = c;code = 99
char = t;code = 116
char = e;code = 101
char = d;code = 100
char = ;code = 32
char = a;code = 97
char = n;code = 110
char = d;code = 100
char = ;code = 32
char = s;code = 115
char = e;code = 101
char = l;code = 108
char = f;code = 102
char = -;code = 45
char = ;code = 32
char = c;code = 99
char = o;code = 111
char = l;code = 108
char = l;code = 108
char = e;code = 101
char = c;code = 99
char = t;code = 116
char = e;code = 101
char = d;code = 100
char = ;code = 32
char = s;code = 115
char = p;code = 112
char = e;code = 101
char = c;code = 99
char = i;code = 105
char = m;code = 109
char = e;code = 101
char = n;code = 110
char = s;code = 115
char = ;code = 32
char = (;code = 40
char = 8;code = 56
char = 9;code = 57
char = .;code = 46
char = 4;code = 52
char = %;code = 37
char = ;code = 32
char = a;code = 97
char = g;code = 103
char = r;code = 114
char = e;code = 101
char = e;code = 101
char = m;code = 109
char = e;code = 101
char = n;code = 110
char = t;code = 116
char = ;code = 32
char = f;code = 102
char = o;code = 111
char = r;code = 114
char = ;code = 32
char = a;code = 97
char = l;code = 108
char = l;code = 108
char = ;code = 32
char = t;code = 116
char = y;code = 121
char = p;code = 112
char = e;code = 101
char = s;code = 115
char = ,;code = 44
char = ;code = 32
char = k;code = 107
char = a;code = 97
char = p;code = 112
char = p;code = 112
char = a;code = 97
char = ;code = 32
char = 0;code = 48
char = .;code = 46
char = 5;code = 53
char = 9;code = 57
char = );code = 41
char = .;code = 46
char = ;code = 32
char = F;code = 70
char = o;code = 111
char = l;code = 108
char = l;code = 108
char = o;code = 111
char = w;code = 119
char = ;code = 32
char = u;code = 117
char = p;code = 112
char = ;code = 32
char = w;code = 119
char = i;code = 105
char = l;code = 108
char = l;code = 108
char = ;code = 32
char = c;code = 99
char = o;code = 111
char = n;code = 110
char = t;code = 116
char = i;code = 105
char = n;code = 110
char = u;code = 117
char = e;code = 101
char = ;code = 32
char = w;code = 119
char = i;code = 105
char = t;code = 116
char = h;code = 104
char = ;code = 32
char = y;code = 121
char = e;code = 101
char = a;code = 97
char = r;code = 114
char = l;code = 108
char = y;code = 121
char = ;code = 32
char = o;code = 111
char = r;code = 114
char = ;code = 32
char = m;code = 109
char = o;code = 111
char = r;code = 114
char = e;code = 101
char = ;code = 32
char = f;code = 102
char = r;code = 114
char = e;code = 101
char = q;code = 113
char = u;code = 117
char = e;code = 101
char = n;code = 110
char = t;code = 116
char = ;code = 32
char = e;code = 101
char = x;code = 120
char = a;code = 97
char = m;code = 109
char = i;code = 105
char = n;code = 110
char = a;code = 97
char = t;code = 116
char = i;code = 105
char = o;code = 111
char = n;code = 110
char = s;code = 115
char = ;code = 32
char = f;code = 102
char = o;code = 111
char = r;code = 114
char = ;code = 32
char = a;code = 97
char = t;code = 116
char = ;code = 32
char = l;code = 108
char = e;code = 101
char = a;code = 97
char = s;code = 115
char = t;code = 116
char = ;code = 32
char = 4;code = 52
char = ;code = 32
char = y;code = 121
char = e;code = 101
char = a;code = 97
char = r;code = 114
char = s;code = 115
char = ;code = 32
char = f;code = 102
char = o;code = 111
char = r;code = 114
char = ;code = 32
char = e;code = 101
char = a;code = 97
char = c;code = 99
char = h;code = 104
char = ;code = 32
char = p;code = 112
char = a;code = 97
char = r;code = 114
char = t;code = 116
char = i;code = 105
char = c;code = 99
char = i;code = 105
char = p;code = 112
char = a;code = 97
char = n;code = 110
char = t;code = 116
char = .;code = 46
char = <;code = 60
char = b;code = 98
char = r;code = 114
char = /;code = 47
char = >;code = 62
result sql = We report the rationale, design, methods and details of participation of a community-based, double-blind, randomized clinical trial of an HPV 16 and 18 vaccine conducted in two provinces of Costa Rica to investigate the efficacy and population impact of the vaccine in the prevention of cervical cancer precursors. More than 24,000 women between 18 and 25 years of age were invited to participate and pre-screened for eligibility, with recruitment of 7466 women (30% of those pre-screened, 59% of those eligible) who were randomized to receive 3 doses of the HPV vaccine or hepatitis A vaccine as control. A complex protocol of data and specimen collection was applied, including an interview, pelvic exam for sexually active women, blood for serology and cell-mediated immunity, cervical secretions for local immunity and cells for HPV, Chlamydia trachomatis and gonorrhea testing. Eighty percent of the women received three doses, 12.4% two doses and 7.4% one dose. At visits, compliance with data and specimen collection was close to 100%. Baseline characteristics and age-specific prevalence of HPV and cervical neoplasia are reported. Overall prevalence of HPV was high (50%), with 8.3% of women having HPV 16 and 3.2% HPV 18 LSIL : was detected in 12.7% of women at baseline and HSIL in 1.9%. Prevalence of Chlamydia was 14.2%. There was very good agreement in HPV detection between clinician-collected and self- collected specimens (89.4% agreement for all types, kappa 0.59). Follow up will continue with yearly or more frequent examinations for at least 4 years for each participant.

Publication: Vaccine 2008 Sep 2 ;26(37)::4795-808. :doi: 10.1016/j.vaccine.2008.07.002.
Publication Date: 2008 Sep 2
Study Author(s): Herrero, Rolando;Hildesheim, Allan;Rodríguez, Ana C;Wacholder, Sholom;Bratti, Concepción;Solomon, Diane;González, Paula;Porras, Carolina;Jiménez, Silvia;Guillen, Diego;Morales, Jorge;Alfaro, Mario;Cyr, Jean;Morrisey, Kerrygrace;Estrada, Yenory;Cortés, Bernal;Morera, Lidia Ana;Freer, Enrique;Schussler, John;Schiller, John;Lowy, Douglas;Schiffman, Mark;Costa Rica Vaccine Trial (CVT) Group;
Institution: Proyecto Epidemiológico Guanacaste, Fundación INCIENSA, Torre La Sabana, 300 Oeste del ICE, Piso 7, Sabana Norte, San José, Costa Rica. [email protected]
Shortcut link to this study:
We report the rationale, design, methods and details of participation of a community-based, double-blind, randomized clinical trial of an HPV 16 and 18 vaccine conducted in two provinces of Costa Rica to investigate the efficacy and population impact of the vaccine in the prevention of cervical cancer precursors. More than 24,000 women between 18 and 25 years of age were invited to participate and pre-screened for eligibility, with recruitment of 7466 women (30% of those pre-screened, 59% of those eligible) who were randomized to receive 3 doses of the HPV vaccine or hepatitis A vaccine as control. A complex protocol of data and specimen collection was applied, including an interview, pelvic exam for sexually active women, blood for serology and cell-mediated immunity, cervical secretions for local immunity and cells for HPV, Chlamydia trachomatis and gonorrhea testing. Eighty percent of the women received three doses, 12.4% two doses and 7.4% one dose. At visits, compliance with data and specimen collection was close to 100%. Baseline characteristics and age-specific prevalence of HPV and cervical neoplasia are reported. Overall prevalence of HPV was high (50%), with 8.3% of women having HPV 16 and 3.2% HPV 18 LSIL : was detected in 12.7% of women at baseline and HSIL in 1.9%. Prevalence of Chlamydia was 14.2%. There was very good agreement in HPV detection between clinician-collected and self- collected specimens (89.4% agreement for all types, kappa 0.59). Follow up will continue with yearly or more frequent examinations for at least 4 years for each participant.
PMID: 18640170

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