Pregnancy Outcomes From the Pregnancy Registry of a Human Papillomavirus Type6/11/16/18 Vaccine

Dana, Adrian; Buchanan, Karyn M.; Goss, Mary Ann; Seminack, Margaret M.; Shields, Kristine E.; Korn, Scott; Cunningham, Michael L.; Haupt, Richard M.

doi:10.1097/aog.0b013e3181c2a122

Cited by 72 publications

(19 citation statements)

References 9 publications

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“…The congenital abnormalities observed were diverse and consistent with those generally seen in young women. Several post-licensure safety studies have been conducted or are ongoing [43–45]. To date, the findings are consistent with those of the clinical trials.…”

Section: Safetysupporting

confidence: 73%

A Review of Clinical Trials of Human Papillomavirus Prophylactic Vaccines

Schiller

Castellsagué

Garland

2012

Vaccine

635

532

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End of study analyses of the phase III trials of prophylactic human papillomavirus (HPV) virus-like particle (VLP) vaccines in young women are now largely completed. Two distinct vaccines were evaluated, Gardasil® (Merck & Co., Whitehouse Station, NJ USA) a quadrivalent vaccine containing VLPs of types 6, 11, 16 and 18 and Cervarix® (GlaxoSmithKline Biologicals, Rixensart, Belgium), a bivalent vaccine containing VLPs of types 16 and 18. Both vaccines exhibited excellent safety and immunogenicity profiles. The vaccines also demonstrated remarkably high and similar efficacy against the vaccine-targeted types for a range of cervical endpoints from persistent infection to cervical intraepithelial neoplasia grade 3 (CIN3) in women naïve to the corresponding type at the time of vaccination. However, protection from incident infection or disease from non-vaccine types was restricted, and the vaccines had no effect on prevalent infection or disease. Gardasil® also demonstrated strong protection against genital warts and vulvar/vaginal neoplasia associated with the vaccine types. In other trials, Gardasil® protected mid-adult women from incident infection and CIN caused by the vaccine types and protected men for incident infection, genital warts and anal intraepithelial neoplasia by the vaccine types. Cervarix® protected against vaccine-targeted anal infections in women in an end of study evaluation. For practical reasons, efficacy studies have not been conducted in the primary target populations of current vaccination programs, adolescent girls and boys. However, immunogenicity bridging studies demonstrating excellent safety and strong immune responses in adolescence, coupled with the documentation of durable antibody responses and protection in young adults, leads to an optimistic projection of the effectiveness of the vaccines in adolescent vaccination programs. Taken together, the excellent clinical trial results strongly support the potential of the vaccines as high value public health interventions and justify their widespread implementation to prevent anogenital HPV infections and their associated neoplasia. This article forms part of a special supplement entitled “Opportunities for comprehensive control of HPV infections and related diseases” Vaccine Volume 30, Supplement X, 2012.

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Section: Safetysupporting

confidence: 73%

A Review of Clinical Trials of Human Papillomavirus Prophylactic Vaccines

Schiller

Castellsagué

Garland

2012

Vaccine

635

532

View full text Add to dashboard Cite

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“…Voluntary reporting is known for underreporting of congenital anomalies if not detected at birth, and over-reporting bias for anomalies is common with the use of retrospective reports. The manufacturer-supported registries have therefore only used prospective inadvertent vaccine exposure reports for the calculation of the congenital anomaly rates [54]. The manufacturer-sponsored registries observed overall rates of major congenital malformations that were consistent with the background rates in the populations [5 of 189 live born infants (2.6%) and 37 of 1527 live born infants (2.4%), respectively in the 2vHPV and 4vHPV registries] [55], [56].…”

Section: Preamblementioning

confidence: 91%

Congenital anomalies: Case definition and guidelines for data collection, analysis, and presentation of immunization safety data

DeSilva

Muñoz

McMillan

et al. 2016

Vaccine

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“…During this long period HPV virions and immunity against these virions could influence fertility. Only a limited number of studies have analyzed the clinical impact of HPV infections on fertility outcomes [12,13,14,15,16]. We retrospectively investigated the relationship between a cervical virion-productive HPV infection and intrauterine insemination (IUI) outcome, as well as the relationship with coexistent CT and TV infections.…”

Section: Introductionmentioning

confidence: 99%

Human Papillomavirus Positivity in Women Undergoing Intrauterine Insemination Has a Negative Effect on Pregnancy Rates

Depuydt¹,

Verstraete²,

Berth³

et al. 2015

Gynecol Obstet Invest

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Background: Sexually transmitted infections are a major cause of infertility. Human papillomavirus (HPV) infection is one of the most common viral infections of the female genital tract. Only a limited number of studies have investigated the influence of HPV on fertility and its impact remains controversial. Objective: We investigated the relationship between cervical HPV infection and pregnancy outcome after intrauterine insemination (IUI). Since other sexually transmitted infections could also influence outcome, we also analyzed the influence of Trichomonas vaginalis (TV) and Chlamydia trachomatis (CT) on pregnancy outcome. Methods: We performed a retrospective analysis of 590 women who underwent 1,529 IUI cycles at AML between 2010 and 2014. Positivity of 18 different HPV types (6, 11, 16, 18, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 67, 68) and TV was assessed by PCR in cervical cytology specimens. CT status was ascertained by detection of IgA/IgG antibodies on serum samples or by PCR on cervical swabs. Results: The HPV prevalence per IUI cycle was 11.0 and 6.9% for CT; none of the women tested positive for TV. HPV-positive women were six times less likely to become pregnant after IUI (1.87 vs. 11.36%; p = 0.0041). There was no significant difference in pregnancy rates between women with or without a history of CT (8.51 vs. 11.10%; p > 0.05). Conclusion: Detection of HPV is associated with a negative IUI outcome.

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Pregnancy Outcomes From the Pregnancy Registry of a Human Papillomavirus Type6/11/16/18 Vaccine

Abstract: III.

Cited by 72 publications

References 9 publications

A Review of Clinical Trials of Human Papillomavirus Prophylactic Vaccines

A Review of Clinical Trials of Human Papillomavirus Prophylactic Vaccines

Congenital anomalies: Case definition and guidelines for data collection, analysis, and presentation of immunization safety data

Human Papillomavirus Positivity in Women Undergoing Intrauterine Insemination Has a Negative Effect on Pregnancy Rates

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