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Investigational Vvax001 Vaccine Shows Significant Potential in Reducing Precancerous Cervical Lesions
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Key Takeaways
- Vvax001 demonstrated a 50% histopathological complete response rate in HPV16-positive CIN3 patients, with 94% experiencing lesion size reduction.
- The vaccine induced potent anti-E6 and -E7 cytotoxic T-cell responses, achieving 63% HPV16 clearance.
The therapeutic vaccine could provide patients with a non-surgical alternative to traditional treatment approaches.
Vvax001 (Vicinivax) demonstrated safety, feasibility, and preliminary clinical effectiveness in patients with newly diagnosed human papillomavirus 16-positive (HPV16+) cervical intraepithelial neoplasia grade 3 (CIN3), according to data from a phase 2 trial (EudraCT201900405029) conducted by researchers from the University Medical Centre Groningen in the Netherlands.1
Microscopic rendering of cervical lesions | Image Credit: © CreativeBro - stock.adobe.com
Cervical cancer is one of the most common causes of cancer-related death and is estimated to affect over 4000 women in the United States in 2025. Treatment advances have greatly improved overall survival outcomes for patients with cervical cancer, but prevention, such as the pivotal HPV vaccine, and early detection remain essential.2
HPV infection is a known risk factor for cervical cancers and premalignant lesions. Infection with HPV is common, and typically the body’s immune system can naturally clear the infection from the body. However, it cannot be cured with medication, meaning patients whose immune system’s do not clear out the infection can develop chronic HPV infection. Patients with chronic infection need ongoing monitoring and management to reduce their risk of developing HPV-related cancers. Early detection through Pap smears and HPV testing has had a significant impact, allowing health care professionals to identify cellular changes and remove precancerous lesions before they progress.3
HPV16, a high-risk subtype of HPV, is a major driver of cervical cancer development. When the infection persists, it can lead to CIN3, the most advanced precancerous stage before invasive cancer. Research shows that individuals with HPV16 have a 47.4% risk of developing CIN3 within 12 years.4
HPV16+ CIN3 refers to a severe precancerous lesion caused by persistent HPV16 infection. Without treatment, CIN3 has a high likelihood of progressing to cervical cancer, emphasizing the need for early detection through Pap smears, HPV testing, and timely medical intervention, such as cryotherapy, laser therapy, loop electrosurgical procedure, or cone biopsy to remove or destroy the abnormal tissue. In a phase 2 study, the investigational therapeutic vaccine Vvax001 showed promising potential as an alternative to more invasive interventions.5
Vvax001 is a replication-incompetent Semliki Forest virus (SFV) vaccine encoding HPV type HPV16, E6, and E7 that has demonstrated capabilities in inducing potent anti-E6 and -E7 cytotoxic T-cell responses to prevent lesion growth. Prior studies of therapeutic immunizations have shown promise but only yielded regression rates ranging from 22% to 52% in 1 to 6 months. In the phase 2 study, treatment with Vvax001 resulted in a far greater regression rate of 50%.5,6
"To the best of our knowledge, Vvax001 is one of the most effective therapeutic vaccines for HPV16-associated CIN3 lesions thus far," wrote the authors.5
The study included 18 patients with newly diagnosed HPV16-positive CIN3 who received 3 immunizations of Vvax001 (5x107 infectious particles) at a 3-week interval. They were monitored for CIN3 regression by colposcopy up to 19 weeks after the immunizations. The researchers’ measurements included histopathologic response rates, HPV16 clearance, treatment-related adverse events (trAEs), and vaccine-induced immune responses.6
The data showed that Vvax001 was associated with a reduction in CIN3 lesion size in 94% of patients, and 50% had a histopathological complete response (regression to CIN1 or no dysplasia). HPV16 clearance was reported in 63%; however, Vvax001 did not induce clearance of other HPV subtypes.6
As of the publishing of the study results, there have been no recurrences, and the median, longest progression-free survival was 20 months for patients with a histopathological complete response and 30 months in those with HPV16 clearance.6
These findings highlight the potential of Vvax001 as a promising therapeutic vaccine for HPV16-positive CIN3, offering a less invasive alternative to current surgical treatments. Although further studies are needed to confirm its long-term efficacy and safety, the phase 2 results suggest that Vvax001 could play a crucial role in reducing the burden of HPV-related cervical disease, improving outcomes, and reducing the risk of cervical cancer progression.
