Phase 4
N=225
HPV Vaccination Study in Postpartum Women
HPV · Immunization · Human Papilloma Virus
Bottom Line
View on ClinicalTrials.gov: NCT04274153 ↗Enrolled (actual)
225
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcome: Primary: Immunogenicity of a Two-dose 9-valent HPV Vaccination as Assessed by Antibody Titer — 7177.6 mMU/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Gardasil9 (Biological)
- Age
- Pediatric, Adult · 15+ yrs
- Sex
- Female
- Sponsor
- Johns Hopkins University
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Immunogenicity of a Two-dose 9-valent HPV Vaccination as Assessed by Antibody Titer |
7177.6 | — |
| SECONDARY Antibody Response to the Other 8 HPV Types |
2187.2; 1492.1; 1589.8; 1077.5; 792.8; 323.2 | — |
| SECONDARY Seropositivity for HPV 16 After 1-dose |
118 | — |
| SECONDARY Seropositivity for HPV 16 After 2-doses |
128 | — |
| SECONDARY Percentage of Participants With Baseline Titers Suggestive of Natural Inoculation or Prior Vaccination to HPV 16 |
91 | — |
| SECONDARY Percentage of Participants Who Complete 2-dose Vaccination |
174 | — |
Summary
The human papillomavirus (HPV) is the most common sexually transmitted infection (STI) in the United States (U.S.) and is responsible for a wide range of conditions, including cancers within the anogenital tract and the oropharynx. In just the U.S. alone, it's estimated that HPV causes 330,000 cases of precancerous cervical dysplasia and 12,000 cases of cervical cancer. The investigators propose a 2-dose HPV vaccination study in women seeking postpartum care at Johns Hopkins University. The investigators will measure the immunogenicity and acceptability of the vaccine in the postpartum setting.
Eligibility Criteria
Inclusion Criteria
- Participants biologically born as females between the ages of 15 through 45 who have delivered a live born baby within the past 72 hours.
Exclusion Criteria
- Pregnancy
- Severe allergic reaction to vaccine components
- Prior receipt of an HPV vaccine dose
- Fetal demise or stillbirth
- Allergy to latex or yeast
- Moderate or severe acute illness (deemed by the investigator to exclude)
- Immunosuppression (e.g., HIV, solid organ transplant).
Data sourced from ClinicalTrials.gov (NCT04274153). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.