Inconclusive evidence for non-inferior immunogenicity of two- compared with three-dose HPV immunization schedules in preadolescent girls: A systematic review and meta-analysis - 04/06/15
Summary |
Background |
The European Medicines Agency (EMA) recently approved two-dose immunization schedules for bivalent (HPV 16/18) and quadrivalent (HPV 6/11/16/18) human papillomavirus (HPV) vaccines in nine to fourteen and thirteen year-old-girls, respectively. Registration was based on trials comparing immunogenicity of two-dose schedules in girls 9–14 years to three-dose schedules in young women 15–26 years. We evaluate comparability of antibody levels between and within age groups and discuss potential implications for monitoring the effectiveness of HPV vaccination.
Methods |
A systematic literature search was performed for studies comparing immunogenicity of two- to three-dose schedules of HPV vaccination. We compared geometric mean concentrations (GMCs) of vaccine-type antibodies between different dosing schedules across different age groups. Meta-analysis was used to estimate pooled GMC ratios (bivalent vaccine) of two- compared with three-dose schedules within girls.
Findings |
For both vaccines, two-dose immunization of girls yielded non-inferior GMCs relative to a three-dose schedule in young women up to respectively 36 and 48 months follow-up. Pooled GMC ratios for the bivalent vaccine within girls showed the two-dose schedule becoming inferior to the three-dose schedule in girls for HPV 16 at approximately two years after the first dose. For the quadrivalent vaccine, antibody responses for HPV-18 became inferior from 18 months follow-up onwards when comparing the two-dose schedule with the three-dose schedule within girls.
Implications |
Two-dose immunization of girls has non-inferior immunogenicity compared to a three-dose schedule among young women. However, non-inferior immunogenicity of two- compared with three-dose schedules within girls has not been shown at all time points. Due to this inconclusive evidence, implementation of two-dose HPV vaccination needs to be monitored closely.
Le texte complet de cet article est disponible en PDF.Highlights |
• | Antibody levels of 2- (young girls) compared to 3-dose (adult women) schedules are non-inferior. |
• | Non-inferiority has not been proved comparing 2- with 3-dose schedules within the same age group. |
• | Monitoring antibody levels alongside introduction of a 2-dose schedule is essential. |
Keywords : Human papillomavirus 16, Human papillomavirus 18, Human papillomavirus vaccine L1, type 6,11,16,18, Human papillomavirus vaccine L1, type 16,18, Vaccination, Immunization schedule, Antibodies, Non-inferiority
Plan
Vol 71 - N° 1
P. 61-73 - juillet 2015 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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