Post-Authorization Safety Study of Papilloguard (A Domestically Manufactured Bivalent (16,18) HPV Vaccine in Iran.

Q2 Medicine

Asian Pacific Journal of Cancer Prevention Pub Date : 2026-09-01 DOI:10.31557/APJCP.2026.27.9.3161

Mojgan Karimi Zarchi, Mina Ebrahimi

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引用次数: 0

Abstract

Background: In recent years, various vaccines, including Papilloguard, have been introduced to prevent transmission of this virus. This vaccine has shown good immunogenicity and efficacy profile in phase III study; however, its safety remains controversial. This study aimed to investigate the complications and adverse events associated with the Papilloguard vaccine in the Iranian population.

Methods: In this survey study, 1,028 volunteers (690 (67.1%) female and 338 (32.9%) males, mean age 33.8±7.01), who had received the Papilloguard vaccine and whose basic information was recorded in the Papilloguard vaccine registration system by call center team of Arta Pharmed Company (Tehran, Iran) were examined. Cumulative vaccine-related complications were assessed and recorded by Arta Pharmed Company's call center team 7 days, 1 month, and 6 months after receiving each dose of vaccine during the 6 months following vaccination. Patient evaluations were conducted over the phone. Any complication leading to hospitalization or requiring medical interventions was defined as a serious complication.

Result: The cumulative incidence of at least one complication immediately after injection, 7 days, 1 month, and 6 months after injection was reported in 272 (26.5%), 101 (9.8%), 74 (7.2%), and 29 (2.8%) of the participants, respectively. Post-injection pain was the most common complication after vaccination, 227 (22.1%). The cumulative incidence of injection site pain 7 days, 1 month, and 6 months after injection was 8.4%, 5.7%, and 0.7%, respectively. In terms of severity of complications, complications were reported as mild in 253 (24.6%), moderate in 15 (1.5%), and severe in 4 (0.4%) recipients. Only 0.4% of recipients experienced severe complications.

Conclusion: In a mid-term follow-up, in the Iranian population, Papilloguard vaccine had few side effects and was well tolerated. Papilloguard vaccine can be included in national vaccination guidelines for the prevention of HPV and its consequences.

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伊朗国产二价（16,18）HPV疫苗Papilloguard获批后安全性研究

背景：近年来，包括Papilloguard在内的各种疫苗已被引入以预防该病毒的传播。该疫苗在III期研究中显示出良好的免疫原性和有效性；然而，它的安全性仍然存在争议。本研究旨在调查伊朗人群中与Papilloguard疫苗相关的并发症和不良事件。方法：选取1028名接受过Papilloguard疫苗接种的志愿者，其中女性690人（67.1%），男性338人（32.9%），平均年龄33.8±7.01岁，基本信息登记在伊朗德黑兰阿尔塔制药公司呼叫中心团队的Papilloguard疫苗登记系统中。在接种疫苗后6个月内，Arta Pharmed Company的呼叫中心团队在接种每剂疫苗后7天、1个月和6个月评估和记录累积疫苗相关并发症。病人的评估是通过电话进行的。任何导致住院或需要医疗干预的并发症都被定义为严重并发症。结果：注射后立即、7天、1个月和6个月至少有一种并发症的累积发生率分别为272例（26.5%）、101例（9.8%）、74例（7.2%）和29例（2.8%）。注射后疼痛是接种疫苗后最常见的并发症，227例（22.1%）。注射后7天、1个月、6个月注射部位疼痛累积发生率分别为8.4%、5.7%、0.7%。在并发症严重程度方面，253例（24.6%）患者报告了轻度并发症，15例（1.5%）患者报告了中度并发症，4例（0.4%）患者报告了重度并发症。只有0.4%的接受者出现了严重的并发症。结论：在中期随访中，在伊朗人群中，Papilloguard疫苗副作用少，耐受性好。乳头状瘤病毒防护疫苗可列入预防HPV及其后果的国家疫苗接种指南。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Asian Pacific Journal of Cancer Prevention 医学-肿瘤学

CiteScore

2.80

自引率

0.00%

发文量

779

审稿时长

3 months

期刊介绍： Cancer is a very complex disease. While many aspects of carcinoge-nesis and oncogenesis are known, cancer control and prevention at the community level is however still in its infancy. Much more work needs to be done and many more steps need to be taken before effective strategies are developed. The multidisciplinary approaches and efforts to understand and control cancer in an effective and efficient manner, require highly trained scientists in all branches of the cancer sciences, from cellular and molecular aspects to patient care and palliation. The Asia Pacific Organization for Cancer Prevention (APOCP) and its official publication, the Asia Pacific Journal of Cancer Prevention (APJCP), have served the community of cancer scientists very well and intends to continue to serve in this capacity to the best of its abilities. One of the objectives of the APOCP is to provide all relevant and current scientific information on the whole spectrum of cancer sciences. They aim to do this by providing a forum for communication and propagation of original and innovative research findings that have relevance to understanding the etiology, progression, treatment, and survival of patients, through their journal. The APJCP with its distinguished, diverse, and Asia-wide team of editors, reviewers, and readers, ensure the highest standards of research communication within the cancer sciences community across Asia as well as globally. The APJCP publishes original research results under the following categories: -Epidemiology, detection and screening. -Cellular research and bio-markers. -Identification of bio-targets and agents with novel mechanisms of action. -Optimal clinical use of existing anti-cancer agents, including combination therapies. -Radiation and surgery. -Palliative care. -Patient adherence, quality of life, satisfaction. -Health economic evaluations.