Immunization of early adolescent females with human papillomavirus type 16 and 18 L1 virus-like particle vaccine containing AS04 adjuvant.
OBJECTIVE
In female individuals 15-25-years of age, the AS04-containing human papillomavirus (HPV)-16/18 vaccine is highly immunogenic and provides up to 100% protection against HPV-16/18 persistent infection and associated cervical lesions up to 4.5 years. Optimal cervical cancer prevention will require prophylactic vaccination against oncogenic HPV 16 and 18 before the onset of sexual activity in early adolescent girls. To establish the feasibility of vaccination in girls 10-14 years of age, we compared the immunogenicity and safety in early adolescent female individuals to those 15-25 years in whom vaccine efficacy has been demonstrated.


METHODS
We enrolled 773 female participants aged 10-14 years and 15-25 years to receive the HPV-16/18 L1 VLP AS04 vaccine, which was administered at months 0, 1, and 6. Serum samples were collected at months 0 and 7; antibodies to HPV 16 and 18 VLPs were measured by enzyme-linked immunosorbent assay. Vaccine safety was assessed at 7 or 30 days after each dose; serious adverse events were recorded during the entire study period.


RESULTS
Both age groups achieved 100% seroconversion for HPV 16 and 18. Participants in the group aged 10-14 years were not only noninferior to those 15-25 years in terms of HPV 16 and 18 seroconversion rates but also had approximately twice as high geometric mean titers. The vaccine was generally safe and well tolerated.


CONCLUSIONS
These findings suggest that HPV vaccination during early adolescence is generally safe, well tolerated, and highly immunogenic. The observed higher antibody titers in the group 10-14 years of age are likely to result in longer antibody persistence. Overall, these data support the implementation of prophylactic HPV vaccination in this age group.
Pedersen
Court
C
Odense University Hospital, Odense, Denmark.
Petaja
Tiina
T
Strauss
Gitte
G
Rumke
Hans C
HC
Poder
Airi
A
Richardus
Jan Hendrik
JH
Spiessens
Bart
B
Descamps
Dominique
D
Hardt
Karin
K
Lehtinen
Matti
M
Dubin
Gary
G
D000293:Adolescent; D016497:Adolescent Health Services; D000328:Adult; D000367:Age Factors; D000914:Antibodies, Viral; D036022:Capsid Proteins / Q000276:immunology*; D002648:Child; D004341:Drug Evaluation; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D006801:Humans; D009856:Oncogene Proteins, Viral / Q000276:immunology*; D030361:Papillomavirus Infections / Q000517:prevention & control* / Q000821:virology; D053918:Papillomavirus Vaccines / Q000008:administration & dosage*; D002583:Uterine Cervical Neoplasms / Q000453:epidemiology / Q000517:prevention & control* / Q000821:virology; D014764:Viral Proteins / Q000276:immunology*
D000914:Antibodies, Viral; D036022:Capsid Proteins; D009856:Oncogene Proteins, Viral; D053918:Papillomavirus Vaccines; D014764:Viral Proteins; C063317:L1 protein, Human papillomavirus type 16; C480565:L1 protein, Human papillomavirus type 18