HIV, Monkeypox, Mpox
Conditions
Keywords
Vaccine, Immunity, Intradermal
Brief summary
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.
Interventions
None listed
Sponsors
NYU Langone Health
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
1. Must be able to understand and sign the Informed Consent Form (ICF) 2. ≥18 years of age a. Including breastfeeding and pregnant people 3. Must have one or the other of criteria a and b, or can have both: 1. Planning receipt of (in the next 30 days) or have received the mpox vaccine, and/or 2. people with recent mpox infection who are out of isolation (≥30 days after symptom onset) 4. Willingness and ability to participate in all study procedures
Exclusion criteria
1. Known clinically significant anemia (i.e., Hb \< 10 g/dL) 2. Contraindication to phlebotomy based on investigator judgement; e.g., anti-coagulation therapy with history of phlebotomy complications, or clinically significant thrombocytopenia 3. Any condition that, in the opinion of the Investigator, would make study participation unsafe for the individual or would interfere with the objectives of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titer (GMT) of Serum Neutralization of Mpox Virus approximately 14 Days After Second Vaccination | Day 14 Post-Second Vaccination | Measured using live-virus mpox neutralization assay, plaque reduction neutralization assay (PRNT). |
| Number of Solicited Adverse Events through Day 14 Post-Vaccinations | Day 14 Post-Vaccination | Participants will complete a 14-day diary recording solicited adverse events following each vaccination. |
| Number of Adverse Events that Occur within 28 Days After Final Vaccination | Day 28 Post-Final Vaccination | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GMT of Mpox Virus-Specific Serum Immunoglobulin approximately 28 Days After First Vaccination | Day 28 Post-First Vaccination | Measured using enzyme-linked immunosorbent assay (ELISA). |
| GMT of Mpox Virus-Specific Serum Immunoglobulin approximately 56 Days After First Vaccination | Day 56 Post-First Vaccination | Measured using enzyme-linked immunosorbent assay (ELISA). |
| GMT of Mpox Virus-Specific Serum Immunoglobulin approximately 14 Days After Second Vaccination | Day 56 Post-Second Vaccination | Measured using enzyme-linked immunosorbent assay (ELISA). |
| GMT of Serum Neutralization of Mpox Virus approximately 28 Days After First Vaccination | Day 28 Post-First Vaccination | Measured using live-virus mpox neutralization assay, plaque reduction neutralization assay (PRNT). |
| GMT of Serum Neutralization of Mpox Virus approximately 56 Days After First Vaccination | Day 56 Post-First Vaccination | Measured using live-virus mpox neutralization assay, plaque reduction neutralization assay (PRNT). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAngelica Kottkamp, MD
NYU Langone Health
Outcome results
None listed