Randomized trial of HPV4 vaccine assessing the response to HPV4 vaccine in two schedules among Peruvian female sex workers

Brown, Brandon; Blas, Magaly M.; Cabral, Alejandra; Cárcamo, César; Gravitt, Patti E.; Halsey, Neal A.

doi:10.1016/j.vaccine.2012.01.058

Cited by 20 publications

(21 citation statements)

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“…This is also consistent with previous studies' results observed after two or three doses of qHPV vaccine when using total IgG assay 21,27,28 which has a higher sensitivity when compared with Merck cLIA assay, especially for the detection of antibodies to HPV18. 21, As data from previous follow-up studies indicate an excellent protection even in individuals with very low or undetectable postvaccination antibodies, 29,30 the excellent persistence of antibodies in preadolescent girls vaccinated three years earlier with two doses of qHPV suggests that their protection will be retained.…”

Section: Discussionsupporting

confidence: 92%

Immunogenicity of quadrivalent HPV and combined hepatitis A and B vaccine when co-administered or administered one month apart to 9–10 year-old girls according to 0–6 month schedule

Gîlca

Sauvageau

Boulianne

et al. 2014

Human Vaccines & Immunotherapeutics

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IntroductionThe approved schedules for human papilloma virus (HPV) vaccines (qHPV (Gardasil®) and bHPV (Cervarix®)) include three doses administered at 0, 1-2 and 6 m. The first two doses given within a relatively short period of time are expected to prime the immune system and the third is expected to confer long-lasting immunity.1 When given according to this schedule to 16-45 y old females, HPV vaccines have been shown to be highly immunogenic and protect against persistent infection, anogenital warts and precancerous abnormalities.2-10 Post-licensure trials with bHPV showed that > 98% of 15-25 y old females developed antibodies to HPV 16 and HPV 18 which remain detectable up to 76 mo after a single vaccine dose.3 In addition, a significant increase in antibody titers resulted from a second dose of vaccine and high clinical efficacy was demonstrated in individuals who received less than three vaccine doses. [4][5][6] Finally, in preadolescents and adolescents, both HPV and combined HAV/HBV vaccines Background. No immunogenicity data has been reported after a single dose of the quadrivalent HPV vaccine (qHPVGardasil®) and no data are available on co-administration of this vaccine with the HAV/HBV vaccine (Twinrix-Junior®). Two pre-licensure studies reported similar anti-HPV but lower anti-HBs titers when co-administering HPV and HBV vaccines.Objectives. To assess the immunogenicity of the qHPV and HAV/HBV vaccine when co-administered (Group-co-adm) or given one month apart (Group-sep) and to measure the persistence of HPV antibodies three years post-second dose of qHPV vaccine in both study groups.Methods. 416 9-10 year-old girls were enrolled. Vaccination schedule was 0-6 months. Anti-HAV and anti-HBs were measured in all subjects 6 months post-first dose and 1 month post-second dose. Anti-HPV were measured 6 months post-first dose in Group-co-adm and in all subjects 1 and 36 months post-second dose.Results. six months post-first dose: 100% of subjects had detectable anti-HAV and 56% and 73% had detectable antiHBs in Group-co-Adm and Group-sep, respectively. In Group-co-adm 94, 100, 99 and 96% had detectable antibodies to HPV 6, 11, 16 and 18, respectively. One month post-second dose of qHPV and HAV/HBV vaccine, in both study groups 99.5-100% of subjects had an anti-HAV titer ≥ 20IU/L, 97.5-97.6% an anti-HBs level ≥ 10IU/L, and 100% had an anti-HPV titer ≥ 3LU. Thirty-six months post-second dose of qHPV all but four subjects (99%) had antibodies to HPV18 and 100% had antibodies to HPV6, 11 and 16. The great majority (97-100%) had an anti-HPV titer ≥ 3 LU. Post-second dose administration of qHPV and HAV/HBV, no meaningful difference was observed in the immune response in the two study groups to any component of vaccines.conclusions. The results indicate that qHPV and HAV/HBV can be given during the same vaccination session. Two doses of of qHPV and HAV/HBV vaccines induce a strong immune response. Three years post-second dose of qHPV, the great majority of subjects had antibodies to HPV types included in the v...

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Section: Discussionsupporting

confidence: 92%

Immunogenicity of quadrivalent HPV and combined hepatitis A and B vaccine when co-administered or administered one month apart to 9–10 year-old girls according to 0–6 month schedule

Gîlca

Sauvageau

Boulianne

et al. 2014

Human Vaccines & Immunotherapeutics

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“…This is especially true in groups with high HPV exposure, including female sex workers (FSWs; Brown et al, 2012; Brown, Carcamo, Blas, Valderrama, & Halsey, 2010; Brown, Blas, Heidari, Carcamo, & Halsey, 2013). Knowledge of HPV as a risk factor for cervical cancer varies widely, and people often confuse HPV with other sexually transmitted infections (Brown et al, 2010; Klug, Hukelmann, & Blettner, 2008; Malta et al, 2007; Tarimo et al, 2011).…”

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confidence: 99%

Peruvian Female Sex Workers’ Ethical Perspectives on Their Participation in an HPV Vaccine Clinical Trial

2014

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This study examined female sex workers’ evaluation of ethically relevant experiences of participating in an HPV4 vaccine clinical trial conducted in Lima, Peru (the Sunflower Study). The Sunflower Study provided all participants with HPV testing, treatment for those testing positive, and access to the vaccine for all testing negative. Themes that emerged from content analysis of interviews with 16 former participants included the importance of respectful treatment and access to healthcare not otherwise available and concerns about privacy protections, the potential for HIV stigma, and poststudy abandonment.

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“…Although less than half (44.2%) had heard of HPV, after receiving information regarding the infection and its association with cancer, almost all (97.5%) wanted to receive the vaccine. This group also demonstrated a 92% completion rate of the 3-dose HPV vaccine in this population in a trial comparing two dosing schedules (29). As in this study, FSWs in Thailand also demonstrated low knowledge levels regarding HPV despite the high rates of cervical cancer in the region.…”

Section: Discussionmentioning

confidence: 92%

Human papillomavirus knowledge, vaccine acceptance, and vaccine series completion among female entertainment and sex workers in Phnom Penh, Cambodia: the Young Women’s Health Study

et al. 2014

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Human papillomavirus (HPV) is a common sexually transmitted infection (STI) and the causative agent for cervical cancer, a frequently occurring malignant disease among women in developing countries. We assessed HPV awareness prior to the delivery of a brief information and education intervention, and HPV vaccine provision to female entertainment and sex workers (N=220). At baseline, only 23.6% of women had heard of HPV. Following the educational intervention, 90% answered all the HPV knowledge questions correctly. Of 192 participants attending the first quarterly cohort visit where vaccine was offered, 149 (78%) were eligible for vaccination; HIV-positive (n=32) and pregnant (n=11) women were excluded. Acceptance of vaccine among eligible women was universal, and 79.2% completed the three-dose vaccination series. Women who reported use of amphetamine type stimulants (ATS) had significantly and independently lower odds of vaccine completion (Adjusted OR 0.24; 95% CI 0.08, 0.69). New pregnancies also had an impact on vaccine completion: 5.4% (8/149 5.4%) who started the series had to stop due to new pregnancy. Results demonstrate the effectiveness of a simple education intervention designed to increase HPV knowledge and the feasibility of successful HPV vaccine in a population that is often difficult to engage in preventive health care.

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Randomized trial of HPV4 vaccine assessing the response to HPV4 vaccine in two schedules among Peruvian female sex workers

Cited by 20 publications

References 20 publications

Immunogenicity of quadrivalent HPV and combined hepatitis A and B vaccine when co-administered or administered one month apart to 9–10 year-old girls according to 0–6 month schedule

Immunogenicity of quadrivalent HPV and combined hepatitis A and B vaccine when co-administered or administered one month apart to 9–10 year-old girls according to 0–6 month schedule

Peruvian Female Sex Workers’ Ethical Perspectives on Their Participation in an HPV Vaccine Clinical Trial

Human papillomavirus knowledge, vaccine acceptance, and vaccine series completion among female entertainment and sex workers in Phnom Penh, Cambodia: the Young Women’s Health Study

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