Immunogenicity of bivalent HPV vaccine among partially vaccinated young adolescent girls in Uganda

LaMontagne, D. Scott; Mugisha, Emmanuel; Pan, Yuanji; Kumakech, Edward; Ssemaganda, Aloysius; Kemp, Troy J.; Cover, Jane; Pinto, Lígia A.; Safaeian, Mahboobeh

doi:10.1016/j.vaccine.2014.08.071

Cited by 24 publications

(29 citation statements)

References 41 publications

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“…There was no evidence of a reduction in HPV-16 or HPV-18 GMT at Month 7 or Month 12 follow-up visits among participants with helminths or malaria.LaMontagne et al (2013) [28]Vietnam girls 11–13 year n = 903Quadrivalent HPV vaccineOpen-label, cluster randomized, noninferiority study3 doses of quadrivalent HPV vaccine on a standard dosing schedule (at 0, 2, and 6 months) and 3 alternative dosing schedules (at 0, 3, and 9 months; at 0, 6, and 12 months; or at 0, 12, and 24 months.>2 years follow upcLIAGeometric mean anti-HPV-6, 11,16 and −18 antibody titres.HPV vaccine dose- timing, and extended schedules do not produce inferior immune responses. In addition, 2 doses of HPV vaccine delivered at 0 and 12 months might afford similar protectionNakalembe et al (2014) [21]Ugandan girls 10–16 yearsHPV-16/18 AS04-adjuvanted vaccineCross-sectional study follow up on girls vaccinated in 2010 in an HPV demonstration project0,1 and 6 months18 months post vaccinationMultiplex HPV serologyMedian Flourescent intenstityThe AS04-Adjuvanted HPV-16/18 vaccinated girls showed a higher level of antibodies to HPV-16/18(HPV-16 4691 95 % CI: 4438–4958 among the vaccinated compared to 218 95 % CI: 190–252 among the unvaccinated girls; HPV-18 1326 95 % CI: 1470–1776 among the vaccinated compared to 103 95 % CI: 88–121) among unvaccinated girls) and other non-vaccine hrHPV types compared to the unvaccinated girls.( n = 404)LaMontagne et al (2014) [29]Ugandan girls 10–17 yearsHPV-16/18 AS04-adjuvanted vaccineCross-sectional follow-up study. Girls vaccinated in a government-run HPV vaccination demonstration program0,1 and 6 monthsAt month 36 post vaccinationVLP ELISAGeometric mean anti-HPV-16 and −18 antibody titresThe immunogenicity with less than three doses did not meet a priori non-inferiority thresholds.…”

Section: Resultsmentioning

confidence: 99%

Vaccines against human papillomavirus in low and middle income countries: a review of safety, immunogenicity and efficacy

Nakalembe

Mirembe

Banura

2015

Infect Agents Cancer

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Currently, there is limited data on the immunogenicity and efficacy of human papillomavirus vaccines in Low and Middle income countries (LMIC). The review aims to summarize the current status from published HPV vaccine safety, immunogenicity and efficacy studies in low and middle income countries (LMIC). Electronic databases (PubMed/MEDLINE and HINARI) were searched for peer reviewed English language articles on HPV vaccination in LMIC that have so far been published from 1st January 2006 up to 30th January 2015. Eligible studies were included if they had used the bivalent (bHPV) or quadrivalent HPV (qHPV) vaccines in a LMIC and investigated safety, immunogenicity and/or efficacy. The main findings were extracted and summarized. A total of fourteen HPV vaccine studies assessing safety, Immunogenicity and efficacy of the bivalent or quadrivalent vaccines in LMIC were included. There are only ten published clinical trials where a LMIC has participated. There was no published study so far that assessed efficacy of the HPV vaccines in Sub-Saharan Africa. From these studies, vaccine induced immune response was comparable to that from results of HICs for all age groups. Studies assessing HPV vaccine efficacy of the bivalent or quadrivalent vaccine within LMIC were largely missing. Only three studies were found where a LMIC was part of a multi center clinical trial. In all the studies, there were no vaccine related serious adverse events. The findings from the only study that investigated less than three doses of the bivalent HPV-16/18 vaccine suggest that even with less than three doses, antibody levels were still comparable with older women where efficacy has been proven. The few studies from LMIC in this review had comparable safety, Immunogenicity and efficacy profiles like in HIC. Overall, the LMIC of Africa where immune compromising/modulating situations are prevalent, there is need for long term immunogenicity as well as surveillance studies for long term clinical effectiveness after two and three dose regimens.

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Section: Resultsmentioning

confidence: 99%

Vaccines against human papillomavirus in low and middle income countries: a review of safety, immunogenicity and efficacy

Nakalembe

Mirembe

Banura

2015

Infect Agents Cancer

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“…In an observational study, girls (10 years old) who received either one or two doses of 2vHPV were compared with girls who received three doses also observed lower HPV 16-and 18-antibody levels, 24 months following the last dose of the vaccine [44]. Whether this inferior response will affect long-term protection in girls receiving reduced dose HPV schedules remains to be determined.…”

Section: Evidence Of Non-inferior Antibody Responses In Reduced Dose mentioning

confidence: 99%

Reduced dose human papillomavirus vaccination: An update of the current state-of-the-art

Toh

Licciardi

Fong

et al. 2015

Vaccine

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“…Website for each company: Clontech (http://www.clontech.com/US/Products/Fluorescent_Proteins_and_Reporters/Chemiluminescent_Reporters/ Secreted_Alkaline_Phosphatase); Roche (http://www.roche-applied-science.com/shop/products/seap-reporter-gene-assay-chemiluminescent#tab-0); Life Technologies (http://www.lifetechnologies.com/us/en/home/life-science/protein-expression-and-analysis/enzymes-and-protein-activity-assays/epaassaysmisc/novabrightchemiluminescent-reporter-gene-assays/novabright-chemiluminescent-seap-reporter-gene-assays.html); and Jaden Bioscience (http://www.jadenbio.com/assays/protein/ziva-seap.html) Uganda Immunogenicity Study. 36 Anti-HPV16 and -HPV18 antibody titers were determined using randomly selected sera from those who received 1 (n D 25), 2 (n D 24), or 3 doses (n D 23) of the vaccine.…”

Section: Hpv-specific Antibody Titers Measured By Ziva Correlate Withmentioning

confidence: 99%

“…Information on the study population and the assays The neutralization/SEAP assays were conducted as part of the Uganda Immunogenicity Study, 36 which was a follow-up vaccination study of Cervarix Ò among 10-11 y old girls who were vaccinated as part of a government-run HPV vaccination demonstration program in Uganda. The program was designed to provide the recommended 3 doses of the vaccine; however, some of the participants received less than 3 doses because of absenteeism from school by these girls.…”

Section: Tt Infectivity Assaymentioning

confidence: 99%

“…In the Uganda Immunogenicity Study, 36 our laboratory performed the anti-HPV16 and HPV18 ELISAs, and 293TT cellbased neutralization/SEAP assays on randomly selected subset of the samples from each vaccine dose group. This enabled us to examine the titers obtained from the ELISAs correlated with those from the SEAP assays, as we have done in our previous study.…”

Section: Tt Infectivity Assaymentioning

confidence: 99%

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A comparative study of two different assay kits for the detection of secreted alkaline phosphatase in HPV antibody neutralization assays

Kemp¹,

Matsui

Shelton

et al. 2015

Human Vaccines & Immunotherapeutics

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TM SEAP Chemiluminescence Kit 2.0; ELISA, enzyme-linked immunosorbent assay; GFP, green fluorescent protein; L1 and L2, late 1 and late 2 proteins; RLU, relative-light-unitTo assess immunogenicity and development of antibodies in the context of vaccination, it is critical to quantify titers of neutralizing antibodies. We have been employing the 293TT cell-based neutralization assay system to quantify anti-HPV neutralizing antibodies. In this system, human papillomavirus (HPV) pseudovirion (PsV) particles encapsidating secreted alkaline phosphatase (SEAP) gene are used to measure infection of 293TT cells in 72-hr cell-culture supernatants. SEAP has traditionally been measured by Great EscAPe TM SEAP Chemiluminescence Kit 2.0 (GE). To reduce the cost, and to potentially increase efficiency, we sought a cheaper kit with better detection capability. Performance characteristics of the newer chemiluminescence kit, ZiVa Ò Ultra SEAP Plus Assay (Ziva) and GE were compared using the 293TT system. Dose titration of HPV PsV 16 or 18 showed that signal-to-noise ratios at 48 and 72 hr post-infection were higher for ZiVa at nearly all doses. ZiVa was superior to GE as it was able to detect SEAP at 48 hr, as well as when lower numbers of 293TT cells were used. The ability of ZiVa to quantitate HPV-16 and -18 neutralizing antibody titers was tested using sera from Cervarix Ò immunized individuals. Spearman rank correlational analyses showed excellent correlations between the titers obtained with ZiVa and GE for anti-HPV16 (r D 0.9822, p < 0.0001) and anti-HPV18 (r D 0.9832, p < 0.0001) antibodies. We concluded that ZiVa is superior to GE in detecting SEAP, and the antibody titers in sera of vaccinated individuals were similar to those obtained with GE. Thus, Ziva is a suitable alternative to GE.

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Immunogenicity of bivalent HPV vaccine among partially vaccinated young adolescent girls in Uganda

Cited by 24 publications

References 41 publications

Vaccines against human papillomavirus in low and middle income countries: a review of safety, immunogenicity and efficacy

Vaccines against human papillomavirus in low and middle income countries: a review of safety, immunogenicity and efficacy

Reduced dose human papillomavirus vaccination: An update of the current state-of-the-art

A comparative study of two different assay kits for the detection of secreted alkaline phosphatase in HPV antibody neutralization assays

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