Effects of varying antigens and adjuvant systems on the immunogenicity and safety of investigational tetravalent human oncogenic papillomavirus vaccines: Results from two randomized trials.

Van Damme, Pierre; Leroux-Roels, Geert; Simon, Philippe; Foidart, Jean-Michel; Donders, Gilbert; Hoppenbrouwers, Karel; Levin, Myron; Tibaldi, Fabian; Poncelet, Sylviane; Moris, Philippe; Dessy, Francis; Giannini, Sandra L.; Descamps, Dominique; Dubin, Gary

doi:10.1016/j.vaccine.2014.03.040

Article (Scientific journals)

Effects of varying antigens and adjuvant systems on the immunogenicity and safety of investigational tetravalent human oncogenic papillomavirus vaccines: Results from two randomized trials.

Van Damme, Pierre; Leroux-Roels, Geert; Simon, Philippe et al.

2014 • In Vaccine

Peer Reviewed verified by ORBi

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https://hdl.handle.net/2268/165704

DOI
10.1016/j.vaccine.2014.03.040

PubMed
24674663

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Keywords :

Bivalent vaccine; Human papillomavirus vaccine; Immune interference; Immunogenicity; Safety; Tetravalent vaccine

Abstract :

[en] BACKGROUND: A prophylactic human papillomavirus (HPV) vaccine targeting oncogenic HPV types in addition to HPV-16 and -18 may broaden protection against cervical cancer. Two Phase I/II, randomized, controlled studies were conducted to compare the immunogenicity and safety of investigational tetravalent HPV L1 virus-like particle (VLP) vaccines, containing VLPs from two additional oncogenic genotypes, with the licensed HPV-16/18 AS04-adjuvanted vaccine (control) in healthy 18-25 year-old women. METHODS: In one trial (NCT00231413), subjects received control or one of 6 tetravalent HPV-16/18/31/45 AS04 vaccine formulations at months (M) 0,1,6. In a second trial (NCT00478621), subjects received control or one of 5 tetravalent HPV-16/18/33/58 vaccines formulated with different adjuvant systems (AS04, AS01 or AS02), administered on different schedules (M0,1,6 or M0,3 or M0,6). RESULTS: One month after the third injection (Month 7), there was a consistent trend for lower anti-HPV-16 and -18 geometric mean antibody titers (GMTs) for tetravalent AS04-adjuvanted vaccines compared with control. GMTs were statistically significantly lower for an HPV-16/18/31/45 AS04 vaccine containing 20/20/10/10mug VLPs for both anti-HPV-16 and anti-HPV-18 antibodies, and for an HPV-16/18/33/58 AS04 vaccine containing 20/20/20/20mug VLPs for anti-HPV-16 antibodies. There was also a trend for lower HPV-16 and -18-specific memory B-cell responses for tetravalent AS04 vaccines versus control. No such trends were observed for CD4+ T-cell responses. Immune interference could not always be overcome by increasing the dose of HPV-16/18 L1 VLPs or by using a different adjuvant system. All formulations had acceptable reactogenicity and safety profiles. Reactogenicity in the 7-day post-vaccination period tended to increase with the introduction of additional VLPs, especially for formulations containing AS01. CONCLUSIONS: HPV-16 and -18 antibody responses were lower when additional HPV L1 VLPs were added to the HPV-16/18 AS04-adjuvanted vaccine. Immune interference is a complex phenomenon that cannot always be overcome by changing the antigen dose or adjuvant system.

Disciplines :

Reproductive medicine (gynecology, andrology, obstetrics)

Author, co-author :

Van Damme, Pierre

Leroux-Roels, Geert

Simon, Philippe

Foidart, Jean-Michel ; Université de Liège - ULiège > Département des sciences cliniques > Gynécologie - Obstétrique

Donders, Gilbert

Hoppenbrouwers, Karel

Levin, Myron

Tibaldi, Fabian

Poncelet, Sylviane

Moris, Philippe

More authors (4 more)

Language :

English

Title :

Effects of varying antigens and adjuvant systems on the immunogenicity and safety of investigational tetravalent human oncogenic papillomavirus vaccines: Results from two randomized trials.

Publication date :

2014

Journal title :

Vaccine

ISSN :

0264-410X

eISSN :

1873-2518

Publisher :

Elsevier Science, Amsterdam, Netherlands

Peer reviewed :

Peer Reviewed verified by ORBi

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since 16 April 2014

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