This study will evaluate the immunogenicity of the 9-valent HPV vaccine in post-partum women age 16-45.
Women age 16-45 who are pregnant or who have just delivered will be eligible to participate in a study involving the 9-valent HPV vaccine. For clarification, women who are pregnant are eligible to sign consent, but the first vaccine will not occur until after delivery. Vaccine # 1 must occur within seven days of delivery. The main objective of the study is to determine the immunogenicity of the vaccine in postpartum women. The immunogenicity results will be compared to that of non-postpartum women of the same age, 16-45. Women will participate for approximately 12 months and will complete a total of 4 visits during that time frame.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
100
9-valent HPV vaccine
Geometric mean titer
immunogenicity testing using 9-plex competitive Luminex Immuno Assay (9-plex cLIA)
Time frame: Day 0, Month 7 and Month 12
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