Safety and Effectiveness of HPV Vaccine CIGB-228 in Women with High-Grade Cervical Lesions
Author Information
Author(s): Ana M. Solares, Idania Baladron, Thelvia Ramos, Carmen Valenzuela, Zaida Borbon, Sonia Fanjull, Leonardo Gonzalez, Dagnelia Castillo, Julio Esmir, Milaid Granadillo, Aileen Batte, Alberto Cintado, Mayte Ale, Maria E. Fernandez de Cossio, Annia Ferrer, Isis Torrens, Pedro Lopez-Saura
Primary Institution: Gyneco-obstetric Hospital Ramon Gonzalez Coro, Havana, Cuba
Hypothesis
The CIGB-228 vaccine will be safe and effective in inducing immune responses and regression of high-grade cervical intraepithelial neoplasia (CIN).
Conclusion
The CIGB-228 vaccine was well tolerated and showed promising results in inducing immune responses and regression of lesions in women with high-grade CIN.
Supporting Evidence
- Five of seven women had complete and partial regression of lesions.
- Cellular immune response was observed in all patients.
- HPV was cleared in three patients with complete response.
Takeaway
This study tested a new vaccine to help women with serious cervical problems, and it seemed to work well without causing major side effects.
Methodology
Seven HLA-A2 positive women with biopsy-proven high-grade CIN were vaccinated with CIGB-228 for four weeks, followed by LEEP, and monitored for one year.
Potential Biases
Potential bias due to the open-label design and lack of randomization.
Limitations
The small sample size and lack of a control group limit the ability to draw definitive conclusions about the vaccine's effectiveness.
Participant Demographics
All participants were women aged 24 to 43, with high-grade CIN and HPV16 positivity.
Digital Object Identifier (DOI)
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