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- Title
Immunogenicity of 2-Dose HPV Vaccine Series for Postpartum Women: An Open-Label, Nonrandomized, Noninferiority Trial.
- Authors
Moss, Chailee F.; Wang, Runzhi; Sao, Saumya; Chou, Betty; Perin, Jamie; Lander, Megan E.; Thaker, Sejal M.; Mann, Melindia; Coleman, Jenell S.
- Abstract
Key Points: Question: Is a 2-dose human papillomavirus (HPV) nonavalent vaccine series administered to women immediately post partum noninferior to a 3-dose vaccine series administered to historical controls? Findings: In this open-label, noninferiority, nonrandomized clinical trial, the HPV-16 geometric mean titer ratio for postpartum women aged 15 to 45 years receiving a 2-dose HPV nonavalent vaccine series was 2.29 relative to that for historical controls who received a 3-dose vaccine series. Meaning: This study suggests that postpartum women receiving a 2-dose nonavalent HPV vaccine series had noninferior immunogenicity compared with historical controls who received a 3-dose regimen. Importance: Postpartum human papillomavirus (HPV) vaccination is a promising strategy to increase HPV vaccination uptake in the US, particularly for reaching vaccine-naive women and those who lack health insurance beyond the pregnancy period. However, completion of the 3-dose vaccine regimen is challenging. Objective: To evaluate the immunogenicity of a 2-dose postpartum HPV vaccination regimen (0 and 6 months) and assess whether it is noninferior to a 3-dose postpartum HPV vaccination regimen (0, 1-2, and 6 months) administered to historical controls. Design, Setting, and Participants: A noninferiority, open-label, nonrandomized immunogenicity trial was conducted from August 4, 2020, to June 23, 2022, of postpartum patients aged 15 to 45 years who delivered at 2 hospitals in Baltimore, Maryland. Historical controls were adolescents and young women aged 16 to 26 years. Intervention: Two doses of the nonavalent HPV vaccine administered 6 months apart. Main Outcomes and Measures: The primary outcome was noninferiority (90% CI, lower bound >0.67) of the geometric mean titer (GMT) ratio for HPV-16 among postpartum women compared with historical controls. Secondary outcomes were noninferiority of GMT ratios for the other 8 HPV types and percentage seroconversion for each HPV type. As a noninferiority trial, the primary analysis used the per-protocol analysis. Results: Of 225 enrolled participants, the mean (SD) age at baseline was 29.9 (6.8) years, and 171 (76.0%) were HPV-16 seronegative at baseline. Of these 171 participants, 129 (75.4%) received a second vaccine dose and completed the subsequent 4-week serologic measurements. Relative to historical controls, the HPV-16 GMT ratio was 2.29 (90% CI, 2.03-2.58). At month 7, HPV-16 GMT was higher after the 2-dose regimen (7213.1 mMU/mL [90% CI, 6245.0-8331.4 mMU/mL]) than among historic controls after the 3-dose regimen (3154.0 mMU/mL [90% CI, 2860.2-3478.0 mMU/mL]). Similarly, the lower bound of the 90% CI of the GMT ratio was above 1 for the 8 HPV types 6, 11, 18, 31, 33, 45, 52, and 58. A total of 118 of 134 women (88.1%) seroconverted for HPV-16 after the first dose; 4 weeks after the second dose, the seroconversion rate was 99% or greater for all HPV types. Conclusions and Relevance: This study suggests that immunogenicity of a 2-dose HPV vaccination regimen given 6 months apart among postpartum women was noninferior to a 3-dose regimen among young historical controls. Most women seroconverted after the first dose of the 2-dose regimen. These results demonstrate that postpartum vaccination using a reduced schedule may be a promising strategy to increase HPV vaccine series completion. Trial Registration: ClinicalTrials.gov Identifier: NCT04274153 This nonrandomized equivalence and noninferiority trial evaluates the immunogenicity of a 2-dose postpartum human papillomavirus vaccination (HPV) regimen and assesses whether it is noninferior to a 3-dose postpartum human papillomavirus vaccination regimen administered to historical controls.
- Subjects
MARYLAND; EXPERIMENTAL design; CONFIDENCE intervals; VACCINE immunogenicity; SEROCONVERSION; IMMUNOSUPPRESSION; INFECTION control; HUMAN papillomavirus vaccines; DESCRIPTIVE statistics; CHI-squared test; PAPILLOMAVIRUS diseases; RESEARCH funding; POSTNATAL care; DATA analysis software; WOMEN'S health
- Publication
JAMA Network Open, 2024, Vol 7, Issue 1, pe2352996
- ISSN
2574-3805
- Publication type
Article
- DOI
10.1001/jamanetworkopen.2023.52996