RESUMEN
BACKGROUND: Human papillomavirus (HPV) vaccines are indicated for the prevention of cancers and genital warts caused by vaccine-covered HPV types. Although the standard regimen requires a two or three-dose vaccine series, there is emerging data suggesting that a single dose of the bivalent or quadrivalent HPV vaccine generates persistently positive antibody titers. No similar data is yet available for the nonavalent HPV vaccine, currently the only HPV vaccine available in the United States. The overall objective of our study is to assess the stability and kinetics of antibody titers for 24 months following a single dose of the nonavalent HPV vaccine among preteen girls and boys. METHODS: This is a prospective, single-arm, open-label, non-randomized, Phase IIa trial among 9-11 year-old girls and boys to determine the immunogenicity after a single dose of the nonavalent HPV vaccine (GARDASIL® 9) over 24 months, with a deferred booster dose at 24 months and an optional booster at 30 months after the first dose. Participants provide blood specimens at 6, 12, 18, 24, and 30 months after the first dose. Serologic geometric mean titers (GMT) of the nine vaccine types (HPV 16/18/ 6/11/31/33/45/52/58) will be measured at each time point. The primary objective is to determine the stability of type-specific serologic GMT of HPV16 and HPV18 between the 6- vs. 12-month, 12- vs. 18-month, and 18- vs. 24-month visits. Secondary objectives are to determine the stability of type-specific serologic GMT of the other HPV types (HPV 6/11/31/33/45/52/58) between the visits and to assess safety and reactogenicity after each vaccine dose. DISCUSSION: Single dose HPV vaccination could simplify the logistics and reduce costs of HPV vaccination in the US and across the world. This study will contribute important immunogenicity data on the stability and kinetics of type-specific antibody titers and inform feasibility of the single dose HPV vaccination paradigm. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02568566 . Registered on October 6, 2015.
Asunto(s)
Infecciones por Papillomavirus/prevención & control , Vacunas contra Papillomavirus/inmunología , Anticuerpos Antivirales , Niño , Femenino , Humanos , Esquemas de Inmunización , Inmunogenicidad Vacunal , Masculino , Infecciones por Papillomavirus/inmunología , Vacunas contra Papillomavirus/uso terapéutico , Estudios Prospectivos , Resultado del TratamientoRESUMEN
BACKGROUND: The Interactive Systems Framework (ISF), a guide for translational research, encourages the balancing of traditional research and community-based participatory research (CBPR) approaches. OBJECTIVES: This paper focuses on the challenges, solutions, and lessons learned in applying the ISF to our translational research project. METHODS: A community-campus partnership translated evidence-based screening guidelines on sexually transmitted infections (STIs) and depression into culturally relevant educational materials. Community health workers (CHWs) disseminated the information through a cross-over design to Hispanic women in Pima County, Arizona. Challenges, solutions, and lessons learned were identified throughout this process. LESSONS LEARNED: We identified challenges in the areas of research design, and in the ISF systems of prevention synthesis and translation, prevention support, and prevention delivery. We successfully negotiate solutions between the scientific and local community that resulted in acceptable compromises for both groups. CONCLUSIONS: The model presented by the ISF is difficult to achieve, but we offer concrete solutions to community members and scientists to move toward that ideal.