Efficacy, Immunogenicity, and Safety of a 9-Valent Human Papillomavirus Vaccine: Subgroup Analysis of Participants From Asian Countries

Garland, Suzanne M.; Pitisuttithum, Punnee; Ngan, Hextan Y.S.; Cho, C. H.; Lee, C. Y.; Chen, Chi-An; Yang, Yuh Cheng; Chu, Tang-Yuan; Twu, Nae Fang; Samakoses, Rudiwilai; Takeuchi, Yuzuru; Cheung, Tak Hong; Kim, S. C.; Huang, Li‐Min; Kim, B. G.; Kim, Y. T.; Kim, K. H.; Song, Yong Sang; Lalwani, Sanjay; Kang, Jin Han; Sakamoto, Masaru; Ryu, Hee Sug; Bhatla, Neerja; Yoshikawa, Hiroyuki; Ellison, Misoo C.; Han, Shi Rong; Moeller, Erin; Murata, Shinichi; Ritter, Michael; Sawata, Miyuki; Shields, Christine; Walia, Anuj; Pérez, Gonzalo; Luxembourg, Alain

doi:10.1093/infdis/jiy133

Cited by 34 publications

(18 citation statements)

References 44 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…In previous 4vHPV vaccine clinical trials, rates of injection-site AEs were 64% and 60% in Japanese boys and men, respectively, while geometric mean titer ratios (boys versus men) for anti-HPV6/11/16/18 antibodies were 1.25–3.05 [ 30 , 31 ]. Similar results were observed in studies of the 9vHPV vaccine in Japanese girls and women [ 32 , 33 ]. Most injection-site AEs were mild and moderate in both girls and young women in Study 027 and 028, and participants recovered within 5 days; these results were also consistent with the severity and duration of reactions observed in Japanese boys and men receiving the 4vHPV vaccine, as well as Japanese girls and women given the 9vHPV vaccine [ [30] , [31] , [32] , [33] ].…”

Section: Discussionsupporting

confidence: 89%

“…Similar results were observed in studies of the 9vHPV vaccine in Japanese girls and women [ 32 , 33 ]. Most injection-site AEs were mild and moderate in both girls and young women in Study 027 and 028, and participants recovered within 5 days; these results were also consistent with the severity and duration of reactions observed in Japanese boys and men receiving the 4vHPV vaccine, as well as Japanese girls and women given the 9vHPV vaccine [ [30] , [31] , [32] , [33] ]. An early onset of injection-site AEs was also observed in the placebo group, with most AEs occurring on the day of vaccination.…”

Section: Discussionsupporting

confidence: 89%

See 1 more Smart Citation

Post-hoc analysis of injection-site reactions following vaccination with quadrivalent human papillomavirus vaccine in Japanese female clinical trial participants

Murata

Shirakawa

Sugawara

et al. 2020

Papillomavirus Research

View full text Add to dashboard Cite

Aim The quadrivalent human papillomavirus (4vHPV) vaccine has demonstrated efficacy and immunogenicity and was generally well tolerated in clinical trials conducted in Japan. We report a detailed safety analysis of injection-site reactions in female Japanese 4vHPV clinical trial participants. Methods This post-hoc analysis included data from 2 double-blind, placebo-controlled phase II clinical trials of a 3-dose (Day 1, Month 2, Month 6) regimen of 4vHPV vaccine in Japanese young women aged 18–26 years (N = 1021; NCT00378560) and girls aged 9–17 years (N = 107; NCT00411749). Injection-site and systemic adverse events (AEs) were monitored using vaccination report cards for 15 days after each vaccine dose; serious AEs were reported throughout the trials. Post-hoc analyses of data from these trials were performed to examine details of injection-site AEs, including day of onset, time from onset to resolution, and maximum intensity. Results Injection-site AEs were reported by 85.6% of 4vHPV vaccine recipients and 72.4% of placebo recipients, most commonly erythema, pain, pruritus, and swelling (each >5% of 4vHPV vaccine recipients). The majority of injection-site AEs had an onset within 3 days of vaccination and were mild to moderate in intensity; few 4vHPV vaccine recipients reported severe injection-site AEs (2.0% overall). All injection-site AEs resolved, and most (4vHPV: 87.5%; placebo: 92.7%) resolved within 5 days of onset. Conclusions Most injection-site reactions are mild or moderate in intensity and of short duration. The 3-dose regimen of 4vHPV vaccine is well tolerated in Japanese female clinical trial participants based on this post-hoc analysis. These results will further support safety communication between healthcare providers and vaccine recipients regarding the HPV vaccine. Trial registration Clinicaltrials. gov: NCT00378560 and NCT00411749.

show abstract

Section: Discussionsupporting

confidence: 89%

Section: Discussionsupporting

confidence: 89%

Post-hoc analysis of injection-site reactions following vaccination with quadrivalent human papillomavirus vaccine in Japanese female clinical trial participants

Murata

Shirakawa

Sugawara

et al. 2020

Papillomavirus Research

View full text Add to dashboard Cite

show abstract

“…The currently available HPV vaccines are estimated to prevent 70–90% of cervical cancer cases [ 49 ]. The nonavalent HPV vaccine has been highly effective in preventing HPV infection and cancer diseases, with efficacies ranging between 90% and 100% [ 15 , 50 , 51 , 52 ]. A study reported by Garland and colleagues (2018) in Asian women showed that nonavalent significantly decreased the risk of persistent infection, abnormal cytology, and diseases caused by specific HPV types targeted by this vaccine [ 50 ].…”

Section: Discussionmentioning

confidence: 99%

“…The nonavalent HPV vaccine has been highly effective in preventing HPV infection and cancer diseases, with efficacies ranging between 90% and 100% [ 15 , 50 , 51 , 52 ]. A study reported by Garland and colleagues (2018) in Asian women showed that nonavalent significantly decreased the risk of persistent infection, abnormal cytology, and diseases caused by specific HPV types targeted by this vaccine [ 50 ]. In the present study, HPV vaccines could protect 20–69.0% of CIN2/3 cases in women with or without HIV infection.…”

Section: Discussionmentioning

confidence: 99%

Distribution of Human Papillomavirus (HPV) Genotypes in HIV-Negative and HIV-Positive Women with Cervical Intraepithelial Lesions in the Eastern Cape Province, South Africa

Taku

Mbulawa

Phohlo

et al. 2021

Viruses

View full text Add to dashboard Cite

South African women have a high rate of cervical cancer cases, but there are limited data on human papillomavirus (HPV) genotypes in cervical intraepithelial neoplasia (CIN) in the Eastern Cape province, South Africa. A total of 193 cervical specimens with confirmed CIN from women aged 18 years or older, recruited from a referral hospital, were tested for HPV infection. The cervical specimens, smeared onto FTA cards, were screened for 36 HPV types using an HPV direct flow kit. HPV prevalence was 93.5% (43/46) in CIN2 and 96.6% (142/147) in CIN3. HIV-positive women had a significantly higher HPV prevalence than HIV-negative women (98.0% vs. 89.1%, p = 0.012). The prevalence of multiple types was significantly higher in HIV-positive than HIV-negative women (p = 0.034). The frequently detected genotypes were HPV35 (23.9%), HPV58 (23.9%), HPV45 (19.6%), and HPV16 (17.3%) in CIN2 cases, while in CIN3, HPV35 (22.5%), HPV16 (21.8%), HPV33 (15.6%), and HPV58 (14.3%) were the most common identified HPV types, independent of HIV status. The prevalence of HPV types targeted by the nonavalent HPV vaccine was 60.9% and 68.7% among women with CIN2 and CIN3, respectively, indicating that vaccination would have an impact both in HIV-negative and HIV-positive South African women, although it will not provide full protection in preventing HPV infection and cervical cancer lesions.

show abstract

“…The burden of cervical cancer and risk is different across populations around the world. Subgroup analyses from two Phase III double-blind randomized controlled trials were performed among Asian and Latin American participants to determine the population-specific vaccine efficacy 44,45. Similar high vaccine efficacy (>96%) against any grade of cervical, vulvar, and vaginal diseases, as well as greater than 93% against six-month persistent HPV infection, were found for both ethnic populations in individuals who were not infected with HPV.…”

Section: Vaccine Efficacy Of 9vhpvmentioning

confidence: 98%

<p>Recombinant human papillomavirus nonavalent vaccine in the prevention of cancers caused by human papillomavirus</p>

Toh¹,

Kosasih²,

Russell³

et al. 2019

IDR

View full text Add to dashboard Cite

Human papillomavirus (HPV) types 16 and 18 cause 70% of cervical cancer cases globally. The nonavalent HPV vaccine (9vHPV) was licensed in 2014 and protects against the next five most common cancer-causing HPV types (HPV 31/33/45/52/58) after HPV 16/18. Phase III clinical studies have demonstrated high vaccine efficacy (>90%) against cervical, vulvar, and vaginal precancers caused by these additional types, and have shown comparable immunogenicity to the shared genotypes to quadrivalent HPV vaccine (4vHPV). Vaccine efficacy and antibody responses for 9vHPV are found to persist for at least five years while longer-term observational studies are ongoing to monitor long-term vaccine effectiveness. The implementation of 9vHPV has the potential to prevent up to 93% of cervical cancer cases, as well as a significant proportion of other HPV-related anogenital cancers. This review article summarizes the current evidence for 9vHPV in terms of vaccine efficacy against HPV infection and related anogenital precancers, safety, and immunogenicity, as well as discussing the potential impact of this vaccine on the cervical cancer burden globally.

show abstract

Efficacy, Immunogenicity, and Safety of a 9-Valent Human Papillomavirus Vaccine: Subgroup Analysis of Participants From Asian Countries

Abstract: The 9vHPV vaccine was efficacious, immunogenic, and well-tolerated in Asian participants from 2 international, randomized clinical trials. Data support 9vHPV vaccination programs in Asia.

Cited by 34 publications

References 44 publications

Post-hoc analysis of injection-site reactions following vaccination with quadrivalent human papillomavirus vaccine in Japanese female clinical trial participants

Post-hoc analysis of injection-site reactions following vaccination with quadrivalent human papillomavirus vaccine in Japanese female clinical trial participants

Distribution of Human Papillomavirus (HPV) Genotypes in HIV-Negative and HIV-Positive Women with Cervical Intraepithelial Lesions in the Eastern Cape Province, South Africa

<p>Recombinant human papillomavirus nonavalent vaccine in the prevention of cancers caused by human papillomavirus</p>

Contact Info

Product

Resources

About