Comparison of long-term 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: End-of-study analysis of a Phase III randomized trial

Einstein, Mark H.; Takács, Péter; Chatterjee, Archana; Sperling, Rhoda; Chakhtoura, Nahida; Blatter, Mark M.; Lalezari, Jacob; David, Marie-Pierre; Lin, Lan; Struyf, Frank; Dubin, Gary

doi:10.4161/hv.36121

Cited by 106 publications

(87 citation statements)

References 16 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Combing the content of antigen and other control standard to detect the different lots vaccine of ED 50 , which could received the consistency data of vaccines quality. [42][43][44] In our paper we calculated the ED 50 of the EV71 VLPs and the anti-EV71 serum. It may predict the protective efficacy in humans when compared with future clinical trial results and could be instructive to determine the dosage used in future clinical trials.…”

Section: Discussionmentioning

confidence: 99%

Immunogenicity and protective efficacy of an EV71 virus-like particle vaccine against lethal challenge in newborn mice

Sun

Gao

Mao

et al. 2015

Human Vaccines & Immunotherapeutics

View full text Add to dashboard Cite

Section: Discussionmentioning

confidence: 99%

Immunogenicity and protective efficacy of an EV71 virus-like particle vaccine against lethal challenge in newborn mice

Sun

Gao

Mao

et al. 2015

Human Vaccines & Immunotherapeutics

View full text Add to dashboard Cite

“…Follow-up data to Month 60 are complete and are reported along with data modeling long-term persistence of antibody responses. 23 …”

Section: Discussionmentioning

confidence: 99%

“…Follow-up data to Month 60 are complete and disclosed. 23 Blood samples for assessment of serological humoral responses (measured by ELISA 24,25 and PBNA…”

Section: Methodsmentioning

confidence: 99%

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

Levin

Chatterjee

et al. 2014

Human Vaccines & Immunotherapeutics

Self Cite

View full text Add to dashboard Cite

Abbreviations: ANOVA, analysis of variance; AS04, Adjuvant System containing 3-O-desacyl-4'-monophosphoryl lipid A (MPL; 50 mg) adsorbed on aluminum salt (500 mg Al(OH) 3 ); ATP, according-to-protocol; CI, confidence interval; CMI, cell-mediated immune; CVS, cervicovaginal secretion; ED 50 , effective dose producing 50% response; ELISA, enzyme-linked immunosorbent assay; GM, geometric mean; GMR, geometric mean (titer) ratio; GMT, geometric mean titer; HPA, Health Protection Agency; HPV, human papillomavirus; IgG, immunoglobulin G; MSC, medically significant condition; nAb(s), neutralizing antibody(ies); NOAD, new onset autoimmune disease; NOCD, new onset chronic disease; PBMC, peripheral blood mononuclear cells; PBNA, pseudovirion-based neutralization assay; SAE, serious adverse event; TVC, total vaccinated cohort; VLP, virus-like particle.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. CD4C 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.

show abstract

“…18-21 The kinetics of antibody response to qHPV vaccine show a peak one month after the third vaccine shot and a decrease in level to a plateau at 18 months, with high GMTs maintained at 5 years post vaccine. 18 , 20-22 There are some studies assessing immunogenicity in immunosuppressed populations with most showing immunogenicity with slightly lower GMTs post vaccine than in normal individuals. In those infected with human immunodeficiency virus (HIV), qHPV vaccine is highly immunogenic but induces lower GMTs which correlates with lower CD4 counts (<200) and with highly active anti-retroviral therapy (HAART) therapy improving response.…”

Section: Discussionmentioning

confidence: 99%

The effect of history of abnormal pap smear or preceding HPV infection on the humoral immune response to Quadrivalent Human Papilloma virus (qHPV) vaccine in women with systemic lupus erythematosus

Dhar

Essenmacher

Dhar

et al. 2018

Human Vaccines & Immunotherapeutics

View full text Add to dashboard Cite

Objective : To determine if natural human papillomavirus (HPV) infection would induce an anamnestic response to quadrivalent (qHPV) vaccine in women with Systemic Lupus Erythematosus (SLE). Methods: Thirty four women (19-50 years) with mild to moderate and minimally active or inactive SLE received standard qHPV vaccine. Neutralizing antibody titers to HPV 6, 11, 16 and18 were evaluated pre- and post- vaccine using HPV competitive Luminex Immunoassay. For each HPV type, logistic regressions were performed to explore the relationship between a positive titer at baseline with their final geometric mean titer and with the rise in titer. Fisher's Exact Test was used to assess the association of at least one positive HPV antibody test at baseline and history of abnormal pap. Results: History of abnormal pap smear/cervical neoplasia occurred in 52.9%. Baseline anti HPV antibody titers: 21% = negative for all 4 HPV types, 79% = positive for ≥1 of the HPV types. Statistical analysis showed: those with a history of abnormal pap smear/cervical neoplasia were likely to have a positive anti-HPV antibody result pre-vaccine to ≥ 1 of the 4 types, p = 0.035 Fisher's Exact Test. In general, HPV exposed women showed higher post vaccine GMTs than HPV unexposed women with higher point estimates. However, when examining the rise in titers using logistic regression, there was no evidence of an anamnestic response. Conclusion: Prior HPV infection and cervical neoplasia in SLE are linked with no anamnestic response to HPV vaccine. This supports not checking HPV-antibodies pre-vaccine. Women with SLE should be vaccinated for HPV.

show abstract

Comparison of long-term 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: End-of-study analysis of a Phase III randomized trial

Cited by 106 publications

References 16 publications

Immunogenicity and protective efficacy of an EV71 virus-like particle vaccine against lethal challenge in newborn mice

Immunogenicity and protective efficacy of an EV71 virus-like particle vaccine against lethal challenge in newborn mice

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

The effect of history of abnormal pap smear or preceding HPV infection on the humoral immune response to Quadrivalent Human Papilloma virus (qHPV) vaccine in women with systemic lupus erythematosus

Contact Info

Product

Resources

About