Immunogenicity and safety of co-administered Escherichia coli-produced bivalent HPV-16/18 vaccine and hepatitis E vaccine

Resumo original em inglês

O que aconteceu

Human papillomavirus (HPV) and Hepatitis E virus (HEV) infections are major health concerns for women of reproductive age. Administration of HPV and HEV vaccines serves as primary prevention strategies. Our study aimed to demonstrate the immunogenicity and safety of co-administering Escherichia coli-produced bivalent HPV-16/18 vaccine and HEV vaccine compared to HPV-alone/HEV-alone.

This randomized, multicenter, open-label trial was conducted at 4 clinical study sites in Zhejiang Province, China. Participants were enrolled and randomly assigned into three groups to receive bivalent HPV vaccine co-administered with HEV vaccine, HPV vaccine alone and HEV vaccine alone following a 0, 1, 6-month vaccination schedule. The geometric mean concentrations (GMC) and seroconversion rates were measured at months 0 and 7 to evaluate immunogenicity. Non-inferiority was met if the lower bound of the two-sided 95% CI for the seroconversion rate difference exceeded -5%, or that for the GMC ratio exceeded 0.5. Safety outcomes were assessed post-vaccination.

O que encontraram

Of the 480 women aged 18-25 years enrolled, 462 (96.3%) completed the full vaccination regimen and follow-up and were included in the per-protocol set (PPS), whereas all 480 participants (100%) were included in the safety set (SS). The GMC ratio for HPV-16 (HPV+HEV group vs. HPV-alone group) was 0.82 (95% CI 0.68-0.98), with corresponding GMCs of 433.16 IU/mL and 529.20 IU/mL, respectively. For HPV-18, the GMC ratio (HPV+HEV vs. HPV-alone) was 0.78 (95% CI 0.64-0.96), based on concentrations of 318.30 and 407.54 IU/mL, respectively. HEV GMCs were 10.51 WU/mL for the co-administration group and 11.18 WU/mL for the HEV-alone group (ratio 0.94; 95% CI 0.81-1.09). All groups achieved 100% seroconversion. Most adverse reactions were Grade 1, and no vaccine-related serious adverse events (SAEs) occurred.

Por que isso importa

Co-administration of HPV vaccine and HEV vaccine elicited high seroconversion rates and met non-inferiority criteria compared to administration of each vaccine alone, with a similar safety profile, supporting the feasibility of concomitant vaccination.

Resumo publicado sob licença CC BY. A tradução para o português ainda não chegou a este estudo.