Abstract
We previously reported higher anti-HPV-16 and -18 immune responses induced by HPV-16/18 vaccine compared with HPV-6/11/16/18 vaccine at Month 7 (one month after completion of full vaccination series) in women aged 18-45 y in an observer-blind study NCT00423046; the differences of immune response magnitudes were maintained up to Month 24. Here we report follow-up data through Month 48. At Month 48, in according-to-protocol cohort for immunogenicity (seronegative and DNA-negative for HPV type analyzed at baseline), geometric mean titers of serum neutralizing antibodies were 2.0- to 5.2-fold higher (HPV-16) and 8.6- to 12.8-fold higher (HPV-18) in HPV-16/18 vaccine group than in HPV-6/11/16/18 vaccine group. The majority of women in both vaccine groups remained seropositive for HPV-16. The same trend was observed for HPV-18 in HPV-16/18 vaccine group; however, seropositivity rates in HPV-6/11/16/18 vaccine group decreased considerably, particularly in the older age groups. In the total vaccinated cohort (regardless of baseline serological and HPV-DNA status), anti-HPV-16 and -18 neutralizing antibody levels induced by HPV-16/18 vaccine were higher than those induced by HPV-6/11/16/18 vaccine. CD4+ T-cell response for HPV-16 and HPV-18 was higher in HPV-16/18 vaccine group than in HPV-6/11/16/18 vaccine group. Memory B-cell responses appeared similar between vaccine groups. Both vaccines were generally well tolerated. Overall, the higher immune response observed with the HPV-16/18 vaccine was maintained up to Month 48. A head-to-head study incorporating clinical endpoints would be required to confirm whether the observed differences in immune response between the vaccines influence the duration of protection they provided.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 3455-3465 |
| Number of pages | 11 |
| Journal | Human Vaccines and Immunotherapeutics |
| Volume | 10 |
| Issue number | 12 |
| DOIs | |
| State | Published - Dec 1 2014 |
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Keywords
- Cervarix®
- Gardasil®
- Human papillomavirus
- Immunogenicity
- Safety
ASJC Scopus subject areas
- Immunology and Allergy
- Immunology
- Pharmacology
Cite this
Comparative humoral and cellular immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine and HPV-6/11/16/18 vaccine in healthy women aged 18-45 years : Follow-up through Month 48 in a Phase III randomized study. / Einstein, Mark H.; Levin, Myron J.; Chatterjee, Archana; Chakhtoura, Nahida; Takacs, Peter; Catteau, Grégory; Dessy, Francis J.; Moris, Philippe; Lin, Lan; Struyf, Frank; Dubin, Gary; Blatter, Mark; Chambers, Christopher V.; Fernandez, Marina; Fox, Bradley; Fried, David L.; Funk, Sidney A.; Hansen, Cheryl A.; Hedrick, James A.; Hoffman, Bethany; Klein, Terry D.; Lalezari, Jacob; Noss, Michael J.; Silverblatt, James H.; Sperling, Rhoda S.; Swenson, Karen G.; Thompson, Troy; Turner, Mark; Warren, Michael W.; Yoachim, Robert.
In: Human Vaccines and Immunotherapeutics, Vol. 10, No. 12, 01.12.2014, p. 3455-3465.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Comparative humoral and cellular immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine and HPV-6/11/16/18 vaccine in healthy women aged 18-45 years
T2 - Follow-up through Month 48 in a Phase III randomized study
AU - Einstein, Mark H.
AU - Levin, Myron J.
AU - Chatterjee, Archana
AU - Chakhtoura, Nahida
AU - Takacs, Peter
AU - Catteau, Grégory
AU - Dessy, Francis J.
AU - Moris, Philippe
AU - Lin, Lan
AU - Struyf, Frank
AU - Dubin, Gary
AU - Blatter, Mark
AU - Chambers, Christopher V.
AU - Fernandez, Marina
AU - Fox, Bradley
AU - Fried, David L.
AU - Funk, Sidney A.
AU - Hansen, Cheryl A.
AU - Hedrick, James A.
AU - Hoffman, Bethany
AU - Klein, Terry D.
AU - Lalezari, Jacob
AU - Noss, Michael J.
AU - Silverblatt, James H.
AU - Sperling, Rhoda S.
AU - Swenson, Karen G.
AU - Thompson, Troy
AU - Turner, Mark
AU - Warren, Michael W.
AU - Yoachim, Robert
PY - 2014/12/1
Y1 - 2014/12/1
N2 - We previously reported higher anti-HPV-16 and -18 immune responses induced by HPV-16/18 vaccine compared with HPV-6/11/16/18 vaccine at Month 7 (one month after completion of full vaccination series) in women aged 18-45 y in an observer-blind study NCT00423046; the differences of immune response magnitudes were maintained up to Month 24. Here we report follow-up data through Month 48. At Month 48, in according-to-protocol cohort for immunogenicity (seronegative and DNA-negative for HPV type analyzed at baseline), geometric mean titers of serum neutralizing antibodies were 2.0- to 5.2-fold higher (HPV-16) and 8.6- to 12.8-fold higher (HPV-18) in HPV-16/18 vaccine group than in HPV-6/11/16/18 vaccine group. The majority of women in both vaccine groups remained seropositive for HPV-16. The same trend was observed for HPV-18 in HPV-16/18 vaccine group; however, seropositivity rates in HPV-6/11/16/18 vaccine group decreased considerably, particularly in the older age groups. In the total vaccinated cohort (regardless of baseline serological and HPV-DNA status), anti-HPV-16 and -18 neutralizing antibody levels induced by HPV-16/18 vaccine were higher than those induced by HPV-6/11/16/18 vaccine. CD4+ T-cell response for HPV-16 and HPV-18 was higher in HPV-16/18 vaccine group than in HPV-6/11/16/18 vaccine group. Memory B-cell responses appeared similar between vaccine groups. Both vaccines were generally well tolerated. Overall, the higher immune response observed with the HPV-16/18 vaccine was maintained up to Month 48. A head-to-head study incorporating clinical endpoints would be required to confirm whether the observed differences in immune response between the vaccines influence the duration of protection they provided.
AB - We previously reported higher anti-HPV-16 and -18 immune responses induced by HPV-16/18 vaccine compared with HPV-6/11/16/18 vaccine at Month 7 (one month after completion of full vaccination series) in women aged 18-45 y in an observer-blind study NCT00423046; the differences of immune response magnitudes were maintained up to Month 24. Here we report follow-up data through Month 48. At Month 48, in according-to-protocol cohort for immunogenicity (seronegative and DNA-negative for HPV type analyzed at baseline), geometric mean titers of serum neutralizing antibodies were 2.0- to 5.2-fold higher (HPV-16) and 8.6- to 12.8-fold higher (HPV-18) in HPV-16/18 vaccine group than in HPV-6/11/16/18 vaccine group. The majority of women in both vaccine groups remained seropositive for HPV-16. The same trend was observed for HPV-18 in HPV-16/18 vaccine group; however, seropositivity rates in HPV-6/11/16/18 vaccine group decreased considerably, particularly in the older age groups. In the total vaccinated cohort (regardless of baseline serological and HPV-DNA status), anti-HPV-16 and -18 neutralizing antibody levels induced by HPV-16/18 vaccine were higher than those induced by HPV-6/11/16/18 vaccine. CD4+ T-cell response for HPV-16 and HPV-18 was higher in HPV-16/18 vaccine group than in HPV-6/11/16/18 vaccine group. Memory B-cell responses appeared similar between vaccine groups. Both vaccines were generally well tolerated. Overall, the higher immune response observed with the HPV-16/18 vaccine was maintained up to Month 48. A head-to-head study incorporating clinical endpoints would be required to confirm whether the observed differences in immune response between the vaccines influence the duration of protection they provided.
KW - Cervarix®
KW - Gardasil®
KW - Human papillomavirus
KW - Immunogenicity
KW - Safety
UR - http://www.scopus.com/inward/record.url?scp=84922588675&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84922588675&partnerID=8YFLogxK
U2 - 10.4161/hv.36117
DO - 10.4161/hv.36117
M3 - Article
VL - 10
SP - 3455
EP - 3465
JO - Human Vaccines and Immunotherapeutics
JF - Human Vaccines and Immunotherapeutics
SN - 2164-5515
IS - 12
ER -