Efficacy of the HPV-16/18 AS04-adjuvanted vaccine against low-risk HPV types (PATRICIA randomized trial): an unexpected observation.

Abstract

BACKGROUND:

Public Health England has reported a decrease of up to 20.8% in new diagnoses of external genital warts (GWs) among women aged <19 years since the national vaccination program with the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine began in 2008. A post hoc analysis of the phase III PATRICIA (PApilloma TRIal against Cancer In young Adults) trial (NCT00122681) was performed to ascertain whether protection against low-risk HPV types was apparent.

METHODS:

Vaccine efficacy (VE) at 48 months was assessed against 6-month persistent infection (6MPI) with low-risk HPV types in the total vaccinated cohort (TVC) and in the TVC naive (for 25 HPV types tested) populations.

RESULTS:

In the TVC naive cohort, VE against 6MPI (95% confidence interval) was 34.5% (11.3 to 51.8) for HPV-6/11, 34.9% (9.1 to 53.7) for HPV-6, 30.3% (-45.0 to 67.5) for HPV-11, and 49.5% (21.0 to 68.3) for HPV-74.

CONCLUSIONS:

The HPV-16/18 AS04-adjuvanted vaccine appears to have moderate efficacy against persistent infections with a number of low-risk HPV types (HPV-6/11/74), which are responsible for the majority of external GWs, and recently, antibody and cell-mediated immune response to HPV-6/11 have been observed. These findings may help to explain the decrease in external GW diagnoses seen in England.

• Authors: Anne Szarewski, S Rachel Skinner, Suzanne M Garland, Barbara Romanowski, Tino F Schwarz, Dan Apter, Song-Nan Chow, Jorma Paavonen, M Rowena Del Rosario-Raymundo, Julio C Teixeira, Newton S De Carvalho, Maria Castro-Sanchez, Xavier Castellsagué, Willy A J Poppe, Philippe De Sutter, Warner Huh, Archana Chatterjee, Wiebren A Tjalma, Ronald T Ackerman, Mark Martens, Kim A Papp, Jose Bajo-Arenas, Diane M Harper, Aureli Torné, Marie-Pierre David, Frank Struyf, Matti Lehtinen, Gary Dubin
• Journal: The Journal of infectious diseases (J Infect Dis) Vol. 208 Issue 9 Pg. 1391-6 (Nov 01 2013) ISSN: 1537-6613 [Electronic] United States
• PMID: 24092907 (Publication Type: Journal Article)

Chemical References

• ASO4 mixture
• Adjuvants, Immunologic
• Lipid A
• Papillomavirus Vaccines
• Aluminum Hydroxide

Topics

• Adjuvants, Immunologic (administration & dosage)
• Aluminum Hydroxide (administration & dosage)
• Clinical Trials, Phase III as Topic
• Condylomata Acuminata (epidemiology, immunology, prevention & control)
• Double-Blind Method
• Female
• Human papillomavirus 16 (immunology)
• Human papillomavirus 18 (immunology)
• Human papillomavirus 6 (immunology)
• Humans
• Incidence
• Incidental Findings
• Lipid A (administration & dosage, analogs & derivatives)
• Multicenter Studies as Topic
• Papillomavirus Vaccines
• Randomized Controlled Trials as Topic
• Treatment Outcome
• Vaccination