Studies immune response to a low-dose mpox vaccine in people with and without HIV

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who have received or plan to receive the mpox vaccine, or who recently had mpox. People with and without HIV can take part.

Age

18 to 100 years

Sex

All sexes

Disease stage

People who recently had mpox must be out of isolation, at least 30 days after symptoms began.

Earlier treatment

Must have received the mpox vaccine, or plan to receive it in the next 30 days. People with recent mpox infection can also join.

Main reasons for not taking part

• Known significant anemia (Hb below 10 g/dL)
• A reason that makes blood draws unsafe, such as blood thinners with past blood draw problems or low platelets
• Any condition that makes taking part unsafe or would interfere with the study goals

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 18 and 100 years old?YesNo

What the trial wants to find out

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.

The 11 groups in the trial

• HIV-negative, SQ-SQ, short interval

  HIV-negative patients who received two subcutaneous mpox vaccinations with an interval of \<7 weeks between primer and booster doses.

• HIV-positive, SQ-SQ, short interval

  HIV-positive patients who received two subcutaneous mpox vaccinations with an interval of \<7 weeks between primer and booster doses.

• HIV-negative, ID-ID, short interval

  HIV-negative patients who received two intradermal mpox vaccinations with an interval of \<7 weeks between primer and booster doses.

• HIV-positive, ID-ID, short interval

  HIV-positive patients who received two intradermal mpox vaccinations with an interval of \<7 weeks between primer and booster doses.

• HIV-negative, SQ-SQ, SQ-ID, ID-SQ or ID-ID, long interval

  HIV-negative patients who received either: 1. subcutaneous primer and booster mpox vaccinations, OR 2. intradermal primer and booster mpox vaccinations, OR 3. subcutaneous primer followed by intradermal booster mpox vaccination OR 4. intradermal primer followed by subcutaneous booster mpox vaccination with the booster dose being taken after an interval of ≥7 weeks.

• HIV-positive, SQ-SQ, SQ-ID, ID-SQ or ID-ID, long interval

  HIV-positive patients who received either: 1. subcutaneous primer and booster mpox vaccinations, OR 2. intradermal primer and booster mpox vaccinations, OR 3. subcutaneous primer followed by intradermal booster mpox vaccination OR 4. intradermal primer followed by subcutaneous booster mpox vaccination with the booster dose being taken after an interval of ≥7 weeks.

• SQ-ID or ID-SQ, short interval

  1. subcutaneous primer and intradermal booster mpox vaccinations, OR 2. intradermal primer and subcutaneous booster mpox vaccinations with the booster dose being taken after an interval of \<7 weeks.

• 1st Dose Only

  Participants who receive a 1st dose of the mpox vaccination but elect not to take 2nd dose.

• Convalescent, No Vaccination

  Participants who are convalescent from mpox infection who do not receive mpox vaccination.

• Convalescent, Vaccination Post-Infection

  Participants who are convalescent from mpox infection who receive mpox vaccination after infection.

• BT after Vaccinations

  Participants who experienced breakthrough (BT) mpox infections following mpox vaccination.