View clinical trials related to Human Papilloma Virus Vaccine.
Filter by:People living with HIV (PLWH) are 28 times more likely to be diagnosed with Human Papillomavirus (HPV) - associated anal cancer than the general population. The HPV vaccine is an effective and safe approach to prevent and reduce the risk of HPV-related disease among PLWH. HPV vaccine programs tailored and implemented in the HIV population are lagging for this high-risk group. The CDC's 4 Pillars Transformation Program is a multi-level, evidence-based intervention that has been successfully used to increase HPV vaccination in the general population and is ready to be tested in the high-risk HIV population, particularly PLWH in the rural South. This program offers providers and clinic staff evidence-based strategies to increase HPV vaccination uptake via training and educational resources. This study proposes to tailor and refine the 4 Pillars Program and do this project in three HIV clinics in Georgia (AID Atlanta, AID Newnan, and Albany Model Rural HIV Clinic) and enroll n=365 PLWH who are age 18-45 years from those clinics.
This is a randomized, double-blind, active-controlled, phaseI/II clinical trial to enroll 200 healthy female including 80 healthy adult aged 19 to 26 years and 120 adolescents aged 9 to 13 years to assess the safety and immunogenicity of NBP615 in comparison with Gardasil. In order to confirm the safety, 80 healthy adult should be enrolled first, and the safety of the test product (NBP615) will be confirmed by 2nd vaccination in adults. After that, enrolled of 120 adolescents proceeds. participants who previously agreed to participate in the study will be screened and only those participants who met the inclusion/exclusion criteria will be randomized in to 1:1 to receive test product (NBP615) or reference product (Gardasil pre-filled syringe). Three/ Two doses of 0.5 ml IM injection will be given and two blood sample, pre vaccine and post vaccine 4 weeks after completion of vaccine will be collected to assess the immunogenicity of NBP615 and Gardasil, comparator HPV vaccine. Solicited adverse events occurring up to 7 days after each dose of the investigational product will be collected in the diary card. Unsolicited adverse events occurring up to 28 days after each dose of the investigational product will be collated in the diary card. Serious adverse events will be collected during the entire study period. In addition to this safety data will be collected through the study period by active contact with the study participants by doing home visit or by telephone contact.