Purpose: To evaluate the safety, immunogenicity and efficacy of a therapeutic DNA vaccine VB10.16, using a unique modular vaccine technology that is based on linking antigens to CCL3L1 targeting module, in women with HPV16-positive high-grade cervical intraepithelial neoplasia (CIN). Patients and Methods: We conducted a first-in-human, open-label, phase I/IIa clinical trial of VB10.16 in subjects with confirmed HPV16-positive CIN 2/3. The primary endpoint was the proportion of participants with adverse events, including dose-limiting toxicities. Secondary outcome measures included measuring the E6/E7-specific cellular immune response. In the Expansion cohort HPV16 clearance, regression of CIN lesion size and grading were assessed during a 12-month follow-up period. Results: A total of 34 women were enrolled: 16 in two dose cohorts and 18 in the expansion cohort. No serious adverse events or dose-limiting toxicities were observed, and none of the subjects discontinued treatment with VB10.16 due to an adverse event. Mild to moderate injection site reactions were the most commonly reported adverse event (79%). HPV16-specific T-cell responses were observed after vaccination in the majority of the subjects. In the expansion cohort, HPV16 clearance was seen in 8 of 17 evaluable subjects (47%). Reductions in lesion size were seen in 16 subjects (94%) and 10 subjects (59%) had regression to CIN 0/1. Correlation between strong IFNγ T-cell responses and lesion size reduction was statistically significant (P < 0.001) Conclusions: The novel therapeutic DNA vaccine VB10.16 was well tolerated and showed promising evidence of efficacy and strong HPV16-specific T-cell responses in subjects with high-grade CIN.

Purpose: The PODCAD study aimed at assessing the degree of psychological stress that women experience due to notification of an abnormal Papanicolaou (Pap) smear finding or a positive human papillomavirus (HPV) test result. Methods: We designed a survey to address the question of psychological burden due to abnormal Pap smear results and/or positive HPV tests. In this online campaign approach, we aimed to reach > 2000 women all over Germany irrespective of kind and number of abnormal screening findings. We asked for different kinds of anxiety, distress and uncertainty regarding both, Pap and HPV status. Results: A total of 3753 women completed the survey at least partially, and almost 2300 fully completed the survey. Of these, more than 50% were affected already since more than 1 year, and almost half of them had experienced at least three Pap smears in follow-up examinations. Almost 70% of the women were afraid of developing cancer. Intriguingly, almost half of the women with abnormal findings were not aware of their stage of the Pap smear. Furthermore, almost 30% of the women displayed signs of a post-traumatic stress disorder. Conclusion: Abnormal results in cervical cancer screening have an impact on patients’ psychology, irrespective of the knowledge and severity of the findings. Better information concerning risks and benefits of cervical cancer screening and about the meaning of the outcome of its procedures are required to decrease this anxiety.

Introduction: Artificial intelligence (AI) is revolutionizing medical workflows, with self-learning systems like ChatGPT showing promise in therapy recommendations. Our study evaluated ChatGPT’s performance in suggesting treatments for 30 breast cancer cases. AI’s role in healthcare is expanding, particularly with tools like ChatGPT becoming accessible. However, understanding its limitations is vital for safe implementation. Material and Methods: We used 30 breast cancer cases from our medical board, assessing ChatGPT’s suggestions. The input was standardized, incorporating relevant patient details and treatment options. ChatGPT’s output was evaluated by oncologists based on a given questionnaire. Results: Treatment recommendations by ChatGPT were overall rated sufficient with minor limitations by the oncologists. The HER2 treatment category was the best-rated therapy option, with the most accurate recommendations. Primary cases received more accurate recommendations, especially regarding chemotherapy. Conclusions: While ChatGPT demonstrated potential, difficulties were shown in intricate cases and postoperative scenarios. Challenges arose in offering chronological treatment sequences and partially lacked precision. Refining inputs, addressing ethical intricacies, and ensuring chronological treatment suggestions are essential. Ongoing research is vital to improving AI’s accuracy, balancing AI-driven suggestions with expert insights and ensuring safe and reliable AI integration into patient care.