Effizienz

Meta-Studie zur Erfassung der Effizienz der HPV-Impfung

(Nur in Englisch verfügbar)

Abstract

BACKGROUND:

The investigational 9-valent viruslike particle vaccine against human papillomavirus (HPV) includes the HPV types in the quadrivalent HPV (qHPV) vaccine (6, 11, 16, and 18) and five additional oncogenic types (31, 33, 45, 52, and 58). Here we present the results of a study of the efficacy and immunogenicity of the 9vHPV vaccine in women 16 to 26 years of age.

METHODS:

We performed a randomized, international, double-blind, phase 2b-3 study of the 9vHPV vaccine in 14,215 women. Participants received the 9vHPV vaccine or the qHPV vaccine in a series of three intramuscular injections on day 1 and at months 2 and 6. Serum was collected for analysis of antibody responses. Swabs of labial, vulvar, perineal, perianal, endocervical, and ectocervical tissue were obtained and used for HPV DNA testing, and liquid-based cytologic testing (Papanicolaou testing) was performed regularly. Tissue obtained by means of biopsy or as part of definitive therapy (including a loop electrosurgical excision procedure and conization) was tested for HPV.

RESULTS:

The rate of high-grade cervical, vulvar, or vaginal disease irrespective of HPV type (i.e., disease caused by HPV types included in the 9vHPV vaccine and those not included) in the modified intention-to-treat population (which included participants with and those without prevalent infection or disease) was 14.0 per 1000 person-years in both vaccine groups. The rate of high-grade cervical, vulvar, or vaginal disease related to HPV-31, 33, 45, 52, and 58 in a prespecified per-protocol efficacy population (susceptible population) was 0.1 per 1000 person-years in the 9vHPV group and 1.6 per 1000 person-years in the qHPV group (efficacy of the 9vHPV vaccine, 96.7%; 95% confidence interval, 80.9 to 99.8). Antibody responses to HPV-6, 11, 16, and 18 were noninferior to those generated by the qHPV vaccine. Adverse events related to injection site were more common in the 9vHPV group than in the qHPV group.

CONCLUSIONS:

The 9vHPV vaccine prevented infection and disease related to HPV-31, 33, 45, 52, and 58 in a susceptible population and generated an antibody response to HPV-6, 11, 16, and 18 that was noninferior to that generated by the qHPV vaccine. The 9vHPV vaccine did not prevent infection and disease related to HPV types beyond the nine types covered by the vaccine. (Funded by Merck; ClinicalTrials.gov number, NCT00543543 http://clinicaltrials.gov/show/NCT00543543).

Comment in

– HPV « coverage » http://www.ncbi.nlm.nih.gov/pubmed/25693018

[N Engl J Med. 2015]

http://www.ncbi.nlm.nih.gov/pubmed/25693011

Die einzelnen Studien:

Joura EA
http://www.ncbi.nlm.nih.gov/pubmed/?term=Joura%20EA%5BAuthor%5D&cauthor=true&cauthor_uid=25693011

Giuliano AR
http://www.ncbi.nlm.nih.gov/pubmed/?term=Giuliano%20AR%5BAuthor%5D&cauthor=true&cauthor_uid=25693011

Iversen OE
http://www.ncbi.nlm.nih.gov/pubmed/?term=Iversen%20OE%5BAuthor%5D&cauthor=true&cauthor_uid=25693011

Bouchard C
http://www.ncbi.nlm.nih.gov/pubmed/?term=Bouchard%20C%5BAuthor%5D&cauthor=true&cauthor_uid=25693011

Mao C
http://www.ncbi.nlm.nih.gov/pubmed/?term=Mao%20C%5BAuthor%5D&cauthor=true&cauthor_uid=25693011

Mehlsen J
http://www.ncbi.nlm.nih.gov/pubmed/?term=Mehlsen%20J%5BAuthor%5D&cauthor=true&cauthor_uid=25693011

Moreira ED Jr
http://www.ncbi.nlm.nih.gov/pubmed/?term=Moreira%20ED%20Jr%5BAuthor%5D&cauthor=true&cauthor_uid=25693011

Ngan Y
http://www.ncbi.nlm.nih.gov/pubmed/?term=Ngan%20Y%5BAuthor%5D&cauthor=true&cauthor_uid=25693011

Petersen LK
http://www.ncbi.nlm.nih.gov/pubmed/?term=Petersen%20LK%5BAuthor%5D&cauthor=true&cauthor_uid=25693011

Lazcano-Ponce E
http://www.ncbi.nlm.nih.gov/pubmed/?term=Lazcano-Ponce%20E%5BAuthor%5D&cauthor=true&cauthor_uid=25693011

Pitisuttithum P
http://www.ncbi.nlm.nih.gov/pubmed/?term=Pitisuttithum%20P%5BAuthor%5D&cauthor=true&cauthor_uid=25693011

Restrepo JA
http://www.ncbi.nlm.nih.gov/pubmed/?term=Restrepo%20JA%5BAuthor%5D&cauthor=true&cauthor_uid=25693011

Stuart G
<http://www.ncbi.nlm.nih.gov/pubmed/?term=Stuart%20G%5BAuthor%5D&cauthor=true&cauthor_uid=25693011

Woelber L
http://www.ncbi.nlm.nih.gov/pubmed/?term=Woelber%20L%5BAuthor%5D&cauthor=true&cauthor_uid=25693011

Yang YC
http://www.ncbi.nlm.nih.gov/pubmed/?term=Yang%20YC%5BAuthor%5D&cauthor=true&cauthor_uid=25693011

Cuzick J
http://www.ncbi.nlm.nih.gov/pubmed/?term=Cuzick%20J%5BAuthor%5D&cauthor=true&cauthor_uid=25693011

Garland SM
http://www.ncbi.nlm.nih.gov/pubmed/?term=Garland%20SM%5BAuthor%5D&cauthor=true&cauthor_uid=25693011

Huh W
http://www.ncbi.nlm.nih.gov/pubmed/?term=Huh%20W%5BAuthor%5D&cauthor=true&cauthor_uid=25693011

Kjaer SK
http://www.ncbi.nlm.nih.gov/pubmed/?term=Kjaer%20SK%5BAuthor%5D&cauthor=true&cauthor_uid=25693011

Bautista OM
http://www.ncbi.nlm.nih.gov/pubmed/?term=Bautista%20OM%5BAuthor%5D&cauthor=true&cauthor_uid=25693011

Chan IS
http://www.ncbi.nlm.nih.gov/pubmed/?term=Chan%20IS%5BAuthor%5D&cauthor=true&cauthor_uid=25693011

Chen J
http://www.ncbi.nlm.nih.gov/pubmed/?term=Chen%20J%5BAuthor%5D&cauthor=true&cauthor_uid=25693011

Gesser R
http://www.ncbi.nlm.nih.gov/pubmed/?term=Gesser%20R%5BAuthor%5D&cauthor=true&cauthor_uid=25693011

Moeller E
http://www.ncbi.nlm.nih.gov/pubmed/?term=Moeller%20E%5BAuthor%5D&cauthor=true&cauthor_uid=25693011

Ritter M
http://www.ncbi.nlm.nih.gov/pubmed/?term=Ritter%20M%5BAuthor%5D&cauthor=true&cauthor_uid=25693011

Vuocolo S
http://www.ncbi.nlm.nih.gov/pubmed/?term=Vuocolo%20S%5BAuthor%5D&cauthor=true&cauthor_uid=25693011

Luxembourg A
http://www.ncbi.nlm.nih.gov/pubmed/?term=Luxembourg%20A%5BAuthor%5D&cauthor=true&cauthor_uid=25693011

Broad Spectrum HPV Vaccine Study
http://www.ncbi.nlm.nih.gov/pubmed/?term=Broad%20Spectrum%20HPV%20Vaccine%20Study%5BCorporate%20Author%5D

Collaborators (227)
http://www.ncbi.nlm.nih.gov/pubmed/25693011#

Author information
http://www.ncbi.nlm.nih.gov/pubmed/25693011#