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"Vaccines Bring Us Closer, Vaccines Bring Us Closer" is the slogan of this year's World Health Organization's "World Immunization Week"
.
Since Ordos began to promote free vaccination of HPV vaccine for girls of school-age age in April, and recently, the Guangdong Provincial Health Commission has actively responded to the proposal of the National People’s Congress "recommendation of free HPV vaccination for female middle school students", which shows that the importance of HPV vaccine has gained the society.
Widely recognized by all walks of life
.
Recently, a European research team led by Professor Filipe Colaço Mariz from the German Cancer Center-Tumor Vaccine Strategy Department published the results of a long-term follow-up study after bivalent and quadrivalent HPV vaccination in the journal The Lancet-Infectious Diseases
.
They found that although the immunogenicity of the two vaccines is significantly different, the protective antibody titers induced by the HPV vaccine can still be detected 12 years after vaccination, confirming the long-term protective effect of the HPV vaccine [1]
.
Screenshot of the paper's homepage.
Bivalent, quadrivalent and even ninth-valent vaccines against cancer-causing human papillomavirus HPV have been widely used all over the world.
Pre-clinical trials have confirmed that these vaccines are highly immunogenic and can reduce the HPV infection rate to varying degrees [2 -3]
.
However, it is difficult to determine the true preventive efficacy of vaccines against HPV-related cancers because of the long time window between infection with the virus and the occurrence of cancer
.
There are currently no long-term follow-up results to reveal the long-term efficacy of vaccines, and no studies have conducted head-to-head comparisons of different types of vaccines
.
The bivalent vaccine Cervarix (for HPV16 and 18) and the quadrivalent vaccine Gardasil (for HPV6, 11, 16, and 18) were launched in Europe in 2002 and 2004 respectively in phase 3 clinical trials of PATRICIA (bivalent) [4] and FUTURE II (quadrate) test [5]
.
These two clinical trials enrolled more than 3,000 young women aged 16-17 years in Finland, and the subjects agreed to undergo health registration follow-up by the Finnish Cancer Registry
.
Most subjects in the study cohort participated in the Finnish Maternity Cohort (FMC) study
.
Since 1983, the FMC cohort has collected plasma samples from almost all Finnish pregnant women during the first trimester
.
Therefore, in the 12-year follow-up process, 2046 plasma samples after vaccination were obtained
.
The research team decided to explore the long-term effects of HPV vaccines by testing the HPV neutralizing antibodies in these plasma samples
.
Included study population and plasma sample selection process The time span of plasma samples collected during early pregnancy is 2-12 years after vaccination (each subject only collects once), of which there are 577 samples of tetravalent vaccinators
.
They divided the follow-up time into 2-4 years, 5-7 years, 8-10 years and 11-12 years after vaccination, and distinguished whether it was the first pregnancy
.
Subsequently, the researchers selected 568 matched plasma samples of bivalent vaccinators based on the follow-up time and pregnancy conditions, combined with the random number table
.
Researchers detected HPV6, 16, 18-specific neutralizing antibodies in plasma samples, as well as cross-neutralizing antibodies against non-vaccine-targeted HPV 31, 33, 45, 52, and 58
.
The final statistical analysis of the seroprevalence, average titer and geometric mean titer (GMT) of 681 first-time pregnant subjects (342 bivalent and 339 quadrivalent) were related to the preventive effect of HPV infection.
Sexual analysis
.
The detection and analysis results show that the immune response induced by the bivalent and quadrivalent HPV vaccines is significantly different
.
Neutralizing antibody levels (EC50) of HPV16 (A), HPV18 (B), HPV6 (C), HPV31 (D) induced by the bivalent HPV (red) and quadrivalent HPV (blue) vaccines over time The neutralizing antibodies of HPV 6, 16, and 18 induced by the two vaccines were still measurable 12 years after the subjects were vaccinated.
This result confirms that the neutralizing antibodies induced by the HPV vaccine are sustainable and can be used in humans.
Long-lived
.
For both HPV16 and HPV18 targeted by the two groups of vaccines, the bivalent vaccine showed better data
.
Among all 342 bivalent vaccine recipients, the seropositivity rates of HPV16 and HPV18 were 100% in each follow-up time group
.
Among the quadrivalent vaccinators, 4% (14/339) and 15% (51/339) of the subjects did not detect HPV16 and HPV18 neutralizing antibodies
.
The HPV18 antibody seropositivity rate of bivalent vaccine vaccinators was higher than that of quadrivalent vaccinators in each follow-up time group, and the antibody titer level was also higher
.
Among the HPV16 seropositive quadrivalent vaccinators, compared with the antibody level 2-4 years after vaccination, the geometric mean antibody titer (GMT) was almost halved in 5-7 years after vaccination (2-4 years GMT 6642, 5-7 years GMT 3679), the antibody level was maintained thereafter, but the same halving effect was not observed in bivalent vaccine vaccinators
.
5-12 years after vaccination, the neutralizing antibody GMT of HPV16 and HPV18 in bivalent vaccinators is 5.
7 and 12.
4 times that of quadrivalent vaccinators, respectively
.
For HPV6 targeted by the quadrivalent vaccine, neutralizing antibodies can be detected in all quadrivalent vaccinators
.
86% (294/342) of bivalent vaccinators had HPV6 cross-neutralizing antibodies in their plasma
.
The median titre of HPV6 neutralizing antibodies induced by the quadrivalent vaccine is 44-45 times that of the bivalent vaccine, and the GMT is 19 times that of the bivalent vaccine
.
The seroprevalence, median titers and geometric mean titers of HPV6, 16, 18 neutralizing antibodies in patients with bivalent and tetravalent vaccines at different follow-up times.
The team also tested non-vaccine-targeted HPV 31, 33, 45, 52 and 58 cross-neutralizing antibodies to verify the cross-protection effect of HPV vaccine
.
They found that the seroprevalence of these types of cross-neutralizing antibodies was higher among bivalent vaccinators, but the antibody titer levels of seropositive individuals were similar
.
Similarly, the presence of cross-neutralizing antibodies can still be detected 12 years after vaccination
.
In order to further explore the relationship between the existence of neutralizing antibodies and the effectiveness of vaccines to prevent HPV infection, the researchers calculated the cohort of persistent HPV infection prevention and analyzed the correlation with the levels of various types of neutralizing antibodies
.
The results showed that among the bivalent vaccinators, the seroprevalence of HPV16, 31, 33, 52, 58 antibodies was significantly related to the efficacy of anti-HPV infection (p=0.
037), but no correlation was observed in the quadrivalent cohort Sex (p=0·27)
.
The cross-neutralizing antibody seroprevalence, median titer and geometric mean titer of bivalent and tetravalent vaccine vaccinators at different follow-up times.
The results of this study reveal significant differences in the immunogenicity of the two vaccines, which are crossed with different vaccines.
The difference in protection effectiveness is the same
.
However, more studies are still needed to verify which is better for bivalent and tetravalent vaccines
.
More importantly, these data confirm the long-term sustainability of the protective antibody titers induced by HPV vaccines, and add solid and reliable evidence-based medical evidence for the promotion of HPV vaccines
.
However, regular HPV screening is still required after vaccination to maximize the prevention of cervical cancer
.
We still need to continue to work hard to promote HPV vaccination, cervical HPV screening, and the popularization of related medical knowledge in order to create a world without cervical cancer
.
References: [1].
Mariz FC, Gray P, Bender N, et al.
Sustainability of neutralising antibodies induced by bivalent or quadrivalent HPV vaccines and correlation with efficacy: a combined follow-up analysis of data from two randomised, double-blind , multicentre, phase 3 trials [published online ahead of print, 2021 May 28].
Lancet Infect Dis.
2021;S1473-3099(20)30873-2.
doi:10.
1016/S1473-3099(20)30873-2[2] Luostarinen T, Apter D, Dillner J, et al.
Vaccination protects against invasive HPV-associated cancers.
Int J Cancer.
2018;142(10):2186-2187.
doi:10.
1002/ijc.
31231[3].
Einstein MH , Takacs P, Chatterjee A, et al.
Comparison of long-term immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine and HPV-6/11/16/18 vaccine in healthy women aged 18-45 years: end-of-study analysis of a Phase III randomized trial.
Hum Vaccin Immunother.
2014;10(12):3435-3445.
doi:10.
4161/hv.
36121[4].
Lehtinen M, Paavonen J, Wheeler CM, et al.
Overall efficacy of HPV-16/18 AS04-adjuvanted vaccine against grade 3 or greater cervical intraepithelial neoplasia: 4-year end-of-study analysis of the randomised, double-blind PATRICIA trial [published correction appears in Lancet Oncol.
2012 Jan;13(1):e1].
Lancet Oncol.
2012 ;13(1):89-99.
doi:10.
1016/S1470-2045(11)70286-8[5].
FUTURE II Study Group.
Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions.
N Engl J Med.
2007;356(19):1915-1927.
doi:10.
1056/NEJMoa061741 Chief EditorBioTalkerOverall efficacy of HPV-16/18 AS04-adjuvanted vaccine against grade 3 or greater cervical intraepithelial neoplasia: 4-year end-of-study analysis of the randomised, double-blind PATRICIA trial [published correction appears in Lancet Oncol.
2012 Jan; 13(1):e1].
Lancet Oncol.
2012;13(1):89-99.
doi:10.
1016/S1470-2045(11)70286-8[5].
FUTURE II Study Group.
Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions.
N Engl J Med.
2007;356(19):1915-1927.
doi:10.
1056/NEJMoa061741 Editor in chargeBioTalkerOverall efficacy of HPV-16/18 AS04-adjuvanted vaccine against grade 3 or greater cervical intraepithelial neoplasia: 4-year end-of-study analysis of the randomised, double-blind PATRICIA trial [published correction appears in Lancet Oncol.
2012 Jan; 13(1):e1].
Lancet Oncol.
2012;13(1):89-99.
doi:10.
1016/S1470-2045(11)70286-8[5].
FUTURE II Study Group.
Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions.
N Engl J Med.
2007;356(19):1915-1927.
doi:10.
1056/NEJMoa061741 Editor in chargeBioTalkerQuadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions.
N Engl J Med.
2007;356(19):1915-1927.
doi:10.
1056/NEJMoa061741 Responsible editorBioTalkerQuadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions.
N Engl J Med.
2007;356(19):1915-1927.
doi:10.
1056/NEJMoa061741 Responsible editorBioTalker
.
Since Ordos began to promote free vaccination of HPV vaccine for girls of school-age age in April, and recently, the Guangdong Provincial Health Commission has actively responded to the proposal of the National People’s Congress "recommendation of free HPV vaccination for female middle school students", which shows that the importance of HPV vaccine has gained the society.
Widely recognized by all walks of life
.
Recently, a European research team led by Professor Filipe Colaço Mariz from the German Cancer Center-Tumor Vaccine Strategy Department published the results of a long-term follow-up study after bivalent and quadrivalent HPV vaccination in the journal The Lancet-Infectious Diseases
.
They found that although the immunogenicity of the two vaccines is significantly different, the protective antibody titers induced by the HPV vaccine can still be detected 12 years after vaccination, confirming the long-term protective effect of the HPV vaccine [1]
.
Screenshot of the paper's homepage.
Bivalent, quadrivalent and even ninth-valent vaccines against cancer-causing human papillomavirus HPV have been widely used all over the world.
Pre-clinical trials have confirmed that these vaccines are highly immunogenic and can reduce the HPV infection rate to varying degrees [2 -3]
.
However, it is difficult to determine the true preventive efficacy of vaccines against HPV-related cancers because of the long time window between infection with the virus and the occurrence of cancer
.
There are currently no long-term follow-up results to reveal the long-term efficacy of vaccines, and no studies have conducted head-to-head comparisons of different types of vaccines
.
The bivalent vaccine Cervarix (for HPV16 and 18) and the quadrivalent vaccine Gardasil (for HPV6, 11, 16, and 18) were launched in Europe in 2002 and 2004 respectively in phase 3 clinical trials of PATRICIA (bivalent) [4] and FUTURE II (quadrate) test [5]
.
These two clinical trials enrolled more than 3,000 young women aged 16-17 years in Finland, and the subjects agreed to undergo health registration follow-up by the Finnish Cancer Registry
.
Most subjects in the study cohort participated in the Finnish Maternity Cohort (FMC) study
.
Since 1983, the FMC cohort has collected plasma samples from almost all Finnish pregnant women during the first trimester
.
Therefore, in the 12-year follow-up process, 2046 plasma samples after vaccination were obtained
.
The research team decided to explore the long-term effects of HPV vaccines by testing the HPV neutralizing antibodies in these plasma samples
.
Included study population and plasma sample selection process The time span of plasma samples collected during early pregnancy is 2-12 years after vaccination (each subject only collects once), of which there are 577 samples of tetravalent vaccinators
.
They divided the follow-up time into 2-4 years, 5-7 years, 8-10 years and 11-12 years after vaccination, and distinguished whether it was the first pregnancy
.
Subsequently, the researchers selected 568 matched plasma samples of bivalent vaccinators based on the follow-up time and pregnancy conditions, combined with the random number table
.
Researchers detected HPV6, 16, 18-specific neutralizing antibodies in plasma samples, as well as cross-neutralizing antibodies against non-vaccine-targeted HPV 31, 33, 45, 52, and 58
.
The final statistical analysis of the seroprevalence, average titer and geometric mean titer (GMT) of 681 first-time pregnant subjects (342 bivalent and 339 quadrivalent) were related to the preventive effect of HPV infection.
Sexual analysis
.
The detection and analysis results show that the immune response induced by the bivalent and quadrivalent HPV vaccines is significantly different
.
Neutralizing antibody levels (EC50) of HPV16 (A), HPV18 (B), HPV6 (C), HPV31 (D) induced by the bivalent HPV (red) and quadrivalent HPV (blue) vaccines over time The neutralizing antibodies of HPV 6, 16, and 18 induced by the two vaccines were still measurable 12 years after the subjects were vaccinated.
This result confirms that the neutralizing antibodies induced by the HPV vaccine are sustainable and can be used in humans.
Long-lived
.
For both HPV16 and HPV18 targeted by the two groups of vaccines, the bivalent vaccine showed better data
.
Among all 342 bivalent vaccine recipients, the seropositivity rates of HPV16 and HPV18 were 100% in each follow-up time group
.
Among the quadrivalent vaccinators, 4% (14/339) and 15% (51/339) of the subjects did not detect HPV16 and HPV18 neutralizing antibodies
.
The HPV18 antibody seropositivity rate of bivalent vaccine vaccinators was higher than that of quadrivalent vaccinators in each follow-up time group, and the antibody titer level was also higher
.
Among the HPV16 seropositive quadrivalent vaccinators, compared with the antibody level 2-4 years after vaccination, the geometric mean antibody titer (GMT) was almost halved in 5-7 years after vaccination (2-4 years GMT 6642, 5-7 years GMT 3679), the antibody level was maintained thereafter, but the same halving effect was not observed in bivalent vaccine vaccinators
.
5-12 years after vaccination, the neutralizing antibody GMT of HPV16 and HPV18 in bivalent vaccinators is 5.
7 and 12.
4 times that of quadrivalent vaccinators, respectively
.
For HPV6 targeted by the quadrivalent vaccine, neutralizing antibodies can be detected in all quadrivalent vaccinators
.
86% (294/342) of bivalent vaccinators had HPV6 cross-neutralizing antibodies in their plasma
.
The median titre of HPV6 neutralizing antibodies induced by the quadrivalent vaccine is 44-45 times that of the bivalent vaccine, and the GMT is 19 times that of the bivalent vaccine
.
The seroprevalence, median titers and geometric mean titers of HPV6, 16, 18 neutralizing antibodies in patients with bivalent and tetravalent vaccines at different follow-up times.
The team also tested non-vaccine-targeted HPV 31, 33, 45, 52 and 58 cross-neutralizing antibodies to verify the cross-protection effect of HPV vaccine
.
They found that the seroprevalence of these types of cross-neutralizing antibodies was higher among bivalent vaccinators, but the antibody titer levels of seropositive individuals were similar
.
Similarly, the presence of cross-neutralizing antibodies can still be detected 12 years after vaccination
.
In order to further explore the relationship between the existence of neutralizing antibodies and the effectiveness of vaccines to prevent HPV infection, the researchers calculated the cohort of persistent HPV infection prevention and analyzed the correlation with the levels of various types of neutralizing antibodies
.
The results showed that among the bivalent vaccinators, the seroprevalence of HPV16, 31, 33, 52, 58 antibodies was significantly related to the efficacy of anti-HPV infection (p=0.
037), but no correlation was observed in the quadrivalent cohort Sex (p=0·27)
.
The cross-neutralizing antibody seroprevalence, median titer and geometric mean titer of bivalent and tetravalent vaccine vaccinators at different follow-up times.
The results of this study reveal significant differences in the immunogenicity of the two vaccines, which are crossed with different vaccines.
The difference in protection effectiveness is the same
.
However, more studies are still needed to verify which is better for bivalent and tetravalent vaccines
.
More importantly, these data confirm the long-term sustainability of the protective antibody titers induced by HPV vaccines, and add solid and reliable evidence-based medical evidence for the promotion of HPV vaccines
.
However, regular HPV screening is still required after vaccination to maximize the prevention of cervical cancer
.
We still need to continue to work hard to promote HPV vaccination, cervical HPV screening, and the popularization of related medical knowledge in order to create a world without cervical cancer
.
References: [1].
Mariz FC, Gray P, Bender N, et al.
Sustainability of neutralising antibodies induced by bivalent or quadrivalent HPV vaccines and correlation with efficacy: a combined follow-up analysis of data from two randomised, double-blind , multicentre, phase 3 trials [published online ahead of print, 2021 May 28].
Lancet Infect Dis.
2021;S1473-3099(20)30873-2.
doi:10.
1016/S1473-3099(20)30873-2[2] Luostarinen T, Apter D, Dillner J, et al.
Vaccination protects against invasive HPV-associated cancers.
Int J Cancer.
2018;142(10):2186-2187.
doi:10.
1002/ijc.
31231[3].
Einstein MH , Takacs P, Chatterjee A, et al.
Comparison of long-term immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine and HPV-6/11/16/18 vaccine in healthy women aged 18-45 years: end-of-study analysis of a Phase III randomized trial.
Hum Vaccin Immunother.
2014;10(12):3435-3445.
doi:10.
4161/hv.
36121[4].
Lehtinen M, Paavonen J, Wheeler CM, et al.
Overall efficacy of HPV-16/18 AS04-adjuvanted vaccine against grade 3 or greater cervical intraepithelial neoplasia: 4-year end-of-study analysis of the randomised, double-blind PATRICIA trial [published correction appears in Lancet Oncol.
2012 Jan;13(1):e1].
Lancet Oncol.
2012 ;13(1):89-99.
doi:10.
1016/S1470-2045(11)70286-8[5].
FUTURE II Study Group.
Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions.
N Engl J Med.
2007;356(19):1915-1927.
doi:10.
1056/NEJMoa061741 Chief EditorBioTalkerOverall efficacy of HPV-16/18 AS04-adjuvanted vaccine against grade 3 or greater cervical intraepithelial neoplasia: 4-year end-of-study analysis of the randomised, double-blind PATRICIA trial [published correction appears in Lancet Oncol.
2012 Jan; 13(1):e1].
Lancet Oncol.
2012;13(1):89-99.
doi:10.
1016/S1470-2045(11)70286-8[5].
FUTURE II Study Group.
Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions.
N Engl J Med.
2007;356(19):1915-1927.
doi:10.
1056/NEJMoa061741 Editor in chargeBioTalkerOverall efficacy of HPV-16/18 AS04-adjuvanted vaccine against grade 3 or greater cervical intraepithelial neoplasia: 4-year end-of-study analysis of the randomised, double-blind PATRICIA trial [published correction appears in Lancet Oncol.
2012 Jan; 13(1):e1].
Lancet Oncol.
2012;13(1):89-99.
doi:10.
1016/S1470-2045(11)70286-8[5].
FUTURE II Study Group.
Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions.
N Engl J Med.
2007;356(19):1915-1927.
doi:10.
1056/NEJMoa061741 Editor in chargeBioTalkerQuadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions.
N Engl J Med.
2007;356(19):1915-1927.
doi:10.
1056/NEJMoa061741 Responsible editorBioTalkerQuadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions.
N Engl J Med.
2007;356(19):1915-1927.
doi:10.
1056/NEJMoa061741 Responsible editorBioTalker
