Comparison of the immunogenicity and reactogenicity of a prophylactic quadrivalent human papillomavirus (types 6, 11, 16, and 18) L1 virus-like particle vaccine in male and female adolescents and young adult women
Prophylactic vaccination of 16- to 23-year-old females with a quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like particle vaccine has been shown to prevent type-specific human papillomavirus infection and associated clinical disease. We conducted a noninferiority immunogenicity st...
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Published in | Pediatrics (Evanston) Vol. 118; no. 5; p. 2135 |
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Main Authors | , , , , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
United States
01.11.2006
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Subjects | |
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Abstract | Prophylactic vaccination of 16- to 23-year-old females with a quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like particle vaccine has been shown to prevent type-specific human papillomavirus infection and associated clinical disease. We conducted a noninferiority immunogenicity study to bridge the efficacy findings in young women to preadolescent and adolescent girls and boys, who represent a primary target for human papillomavirus vaccination.
We enrolled 506 girls and 510 boys (10-15 years of age) and 513 females (16-23 years of age). Participants were vaccinated on day 1, at month 2, and at month 6, and serology testing was performed on day 1 and at months 3 and 7 on blinded samples. Neutralizing antibody concentrations were determined using type-specific immunoassays and summarized as geometric mean titers and seroconversion rates. Vaccine tolerability also was assessed.
By month 7, seroconversion rates were > or = 99% for all 4 human papillomavirus types in each group. By month 7, compared with women, anti-human papilloma virus geometric mean titers in girls or boys were noninferior and were 1.7- to 2.7-fold higher. Most (> 97%) injection-site adverse events were mild to moderate in intensity. Significantly more boys (13.8%) and girls (12.8%) than women (7.3%) reported fevers > or = 37.8 degrees C within 5 days of vaccination. Most (96.4%) fevers were mild (< 39 degrees C).
Noninferior immunogenic responses to all 4 human papillomavirus types in the quadrivalent vaccine permit the bridging of efficacy data that were generated in young women to girls. The results in boys lend support for the implementation of gender-neutral human papillomavirus vaccination programs. This vaccine generally was well tolerated. |
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AbstractList | Prophylactic vaccination of 16- to 23-year-old females with a quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like particle vaccine has been shown to prevent type-specific human papillomavirus infection and associated clinical disease. We conducted a noninferiority immunogenicity study to bridge the efficacy findings in young women to preadolescent and adolescent girls and boys, who represent a primary target for human papillomavirus vaccination.
We enrolled 506 girls and 510 boys (10-15 years of age) and 513 females (16-23 years of age). Participants were vaccinated on day 1, at month 2, and at month 6, and serology testing was performed on day 1 and at months 3 and 7 on blinded samples. Neutralizing antibody concentrations were determined using type-specific immunoassays and summarized as geometric mean titers and seroconversion rates. Vaccine tolerability also was assessed.
By month 7, seroconversion rates were > or = 99% for all 4 human papillomavirus types in each group. By month 7, compared with women, anti-human papilloma virus geometric mean titers in girls or boys were noninferior and were 1.7- to 2.7-fold higher. Most (> 97%) injection-site adverse events were mild to moderate in intensity. Significantly more boys (13.8%) and girls (12.8%) than women (7.3%) reported fevers > or = 37.8 degrees C within 5 days of vaccination. Most (96.4%) fevers were mild (< 39 degrees C).
Noninferior immunogenic responses to all 4 human papillomavirus types in the quadrivalent vaccine permit the bridging of efficacy data that were generated in young women to girls. The results in boys lend support for the implementation of gender-neutral human papillomavirus vaccination programs. This vaccine generally was well tolerated. |
Author | Barr, Eliav Castellsagué, Xavier Cavanaugh, Jr, Paul F Reisinger, Keith S Marchant, Colin D Lukac, Suzanne Block, Stan L Rusche, Steven A Nolan, Terry Giacoletti, Katherine E D Sattler, Carlos Bryan, Janine T |
Author_xml | – sequence: 1 givenname: Stan L surname: Block fullname: Block, Stan L email: slblock@pol.net organization: Kentucky Pediatric Research, Inc, 201 S 5th St, Bardstown, KY 40004, USA. slblock@pol.net – sequence: 2 givenname: Terry surname: Nolan fullname: Nolan, Terry – sequence: 3 givenname: Carlos surname: Sattler fullname: Sattler, Carlos – sequence: 4 givenname: Eliav surname: Barr fullname: Barr, Eliav – sequence: 5 givenname: Katherine E D surname: Giacoletti fullname: Giacoletti, Katherine E D – sequence: 6 givenname: Colin D surname: Marchant fullname: Marchant, Colin D – sequence: 7 givenname: Xavier surname: Castellsagué fullname: Castellsagué, Xavier – sequence: 8 givenname: Steven A surname: Rusche fullname: Rusche, Steven A – sequence: 9 givenname: Suzanne surname: Lukac fullname: Lukac, Suzanne – sequence: 10 givenname: Janine T surname: Bryan fullname: Bryan, Janine T – sequence: 11 givenname: Paul F surname: Cavanaugh, Jr fullname: Cavanaugh, Jr, Paul F – sequence: 12 givenname: Keith S surname: Reisinger fullname: Reisinger, Keith S |
BackLink | https://www.ncbi.nlm.nih.gov/pubmed/17079588$$D View this record in MEDLINE/PubMed |
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PublicationTitle | Pediatrics (Evanston) |
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Snippet | Prophylactic vaccination of 16- to 23-year-old females with a quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like particle vaccine has been... |
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SubjectTerms | Adolescent Adult Age Factors Antibodies, Viral - blood Child Female Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 Humans Male Papillomaviridae - immunology Papillomavirus Vaccines Viral Vaccines - immunology |
Title | Comparison of the immunogenicity and reactogenicity of a prophylactic quadrivalent human papillomavirus (types 6, 11, 16, and 18) L1 virus-like particle vaccine in male and female adolescents and young adult women |
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