Risk of miscarriage with bivalent vaccine against human papillomavirus (HPV) types 16 and 18: Pooled analysis of two randomised controlled trials

Sholom Wacholder, Bingshu Eric Chen, Allen Wilcox, George Macones, Paula Gonzalez, Brian Befano, Allan Hildesheim, Ana Cecilia Rodríguez, Diane Solomon, Rolando Herrero, Mark Schiffman

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Abstract

Objective: To assess whether vaccination against human papillomavirus (HPV) increases the risk of miscarriage. Design: Pooled analysis of two multicentre, phase three masked randomised controlled trials Setting: Multicentre trials in several continents and in Costa Rica. Participants: 26 130 women aged 15-25 at enrolment; 3599 pregnancies eligible for analysis. Interventions: Participants were randomly assigned to receive three doses of bivalent HPV 16/18 VLP vaccine with AS04 adjuvant (n=13 075) or hepatitis A vaccine as control (n=13 055) over six months. Main outcome measures: Miscarriage and other pregnancy outcomes. Results: The estimated rate of miscarriage was 11.5% in pregnancies in women in the HPV arm and 10.2% in the control arm. The one sided P value for the primary analysis was 0.16; thus, overall, there was no significant increase in miscarriage among women assigned to the HPV vaccine arm. In secondary descriptive analyses, miscarriage rates were 14.7% in the HPV vaccine arm and 9.1% in the control arm in pregnancies that began within three months after nearest vaccination. Conclusion: There is no evidence overall for an association between HPV vaccination and risk of miscarriage. Trial registration: Clinical Trials NCT00128661 and NCT00122681.

Original languageEnglish
Article numberc712
Number of pages1
JournalBMJ (Online)
Volume340
Issue number7748
DOIs
StatePublished - Mar 27 2010

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    Wacholder, S., Chen, B. E., Wilcox, A., Macones, G., Gonzalez, P., Befano, B., Hildesheim, A., Rodríguez, A. C., Solomon, D., Herrero, R., & Schiffman, M. (2010). Risk of miscarriage with bivalent vaccine against human papillomavirus (HPV) types 16 and 18: Pooled analysis of two randomised controlled trials. BMJ (Online), 340(7748), [c712]. https://doi.org/10.1136/bmj.c712