The goal of this study is to assess the immune response, tolerance, and safety of the low-dose intradermal (forearm) mpox vaccine in people who are HIV+ compared to people who are HIV-, and compared to the standard-dose subcutaneous (upper arm) vaccine. The resulting data will fill knowledge gaps, inform public health practices, and address community concerns about the absence of data for low-dose intradermal mpox vaccinations in people living with HIV.
Study Type
OBSERVATIONAL
Enrollment
174
NYU Langone Health
New York, New York, United States
Geometric Mean Titer (GMT) of Serum Neutralization of Mpox Virus approximately 14 Days After Second Vaccination
Measured using live-virus mpox neutralization assay, plaque reduction neutralization assay (PRNT).
Time frame: Day 14 Post-Second Vaccination
Number of Solicited Adverse Events through Day 14 Post-Vaccinations
Participants will complete a 14-day diary recording solicited adverse events following each vaccination.
Time frame: Day 14 Post-Vaccination
Number of Adverse Events that Occur within 28 Days After Final Vaccination
Time frame: Day 28 Post-Final Vaccination
GMT of Mpox Virus-Specific Serum Immunoglobulin approximately 28 Days After First Vaccination
Measured using enzyme-linked immunosorbent assay (ELISA).
Time frame: Day 28 Post-First Vaccination
GMT of Mpox Virus-Specific Serum Immunoglobulin approximately 56 Days After First Vaccination
Measured using enzyme-linked immunosorbent assay (ELISA).
Time frame: Day 56 Post-First Vaccination
GMT of Mpox Virus-Specific Serum Immunoglobulin approximately 14 Days After Second Vaccination
Measured using enzyme-linked immunosorbent assay (ELISA).
Time frame: Day 56 Post-Second Vaccination
GMT of Serum Neutralization of Mpox Virus approximately 28 Days After First Vaccination
Measured using live-virus mpox neutralization assay, plaque reduction neutralization assay (PRNT).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Day 28 Post-First Vaccination
GMT of Serum Neutralization of Mpox Virus approximately 56 Days After First Vaccination
Measured using live-virus mpox neutralization assay, plaque reduction neutralization assay (PRNT).
Time frame: Day 56 Post-First Vaccination