This study is currently recruiting participants.
Number
001102-I
Sponsoring Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Recruitment Detail
Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 18 Max Age: 50
Referral Letter Required
No
Population Exclusion(s)
None
Keywords
Monkeypox; Dose Sparing
Recruitment Keyword(s)
Condition(s)
Monkeypox
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Biological/Vaccine: JYNNEOS (MVABN)
Supporting Site
National Institute of Allergy and Infectious Diseases
Monkeypox is an infectious disease caused by a virus. People can catch the disease after contact with infected animals. The disease can also pass from person to person. This year, an outbreak of monkeypox has spread around the world. An approved vaccine is available, but there are not enough doses for everyone who needs one. Researchers want to find the smallest vaccine dose that will protect a person against this disease.
Objective:
To compare different doses and methods of administering the monkeypox vaccine.
Eligibility:
Healthy people aged 18 to 50 years.
Design:
Participants will have 8 clinic visits in 12 months. Blood will be drawn at all visits.
Participants will be screened with a physical exam. They will answer questions about their medical history.
Participants will receive 2 injections of the monkeypox vaccine about 4 weeks apart. They will receive the injections in 1 of 2 places:
Just under the skin on the inner side of the lower arm.
Just under the skin in a fatty area of the upper arm.
Participants will stay at the clinic for at least 30 minutes after each injection.
Participants will get a daily memory aid (like a diary card), a thermometer, and a ruler. For 14 days, they will measure and record any redness or swelling at the vaccination site. They will record their temperature and any side effects. They will bring the memory aid to the clinic 14 days after each vaccination.
Participants will visit the clinic 4 more times over the remainder of the year.
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INCLUSION CRITERIA: Study inclusion criteria are similar between stages. To be eligible to participate in Stage 2, an individual must meet the following inclusion criteria: 1. Adult ages 18 to 50 years inclusive at the time of consent; OR Adolescent ages 12 to 17 years inclusive at the time of consent. 2. Adult participant is able to read the written informed consent, states willingness to comply with all study procedures and is anticipated to be available for all study visits; OR Parent(s)/Legal Authorized Representative (LAR)(s) of the participating adolescent is able to read and provides written informed permission and participating adolescent provides assent as appropriate for age or development and approved by IRB. Adolescent states willingness to comply with all study procedures and is anticipated to be available for all study visits. 3. Adult participant is able to understand and agrees to adhere to Lifestyle Considerations during the study; OR Parent(s)/LAR(s) of the participating adolescent is able to understand and states willingness to comply with Lifestyle Considerations. 4. Females of reproductive potential who have sexual intercourse with male partners must be using highly effective contraception for at least 1 month prior to signing ICF and agrees to use acceptable method of contraception through Day 57. Note: See MOP for definitions and list of acceptable method of contraception 5. In good general health as evidenced by medical history, physical examination, and clinical judgement of the investigator to be in stable state of health. Note: Participants with pre-existing stable chronic medical conditions defined as conditions not requiring significant change in therapy or hospitalization for worsening disease in the 4 weeks prior to enrollment can be included at the discretion of the investigator. This includes stable, well-controlled HIV positive individuals. 6. Individuals with HIV must be on suppressive ART for at least 6 months, report a CD4 count of greater than 350 cells/microL and no AIDS-defining illness in the last year. EXCLUSION CRITERIA: For Stage 2 of the study, an individual who meets any of the following criteria will be excluded from participation in this study. Of note, the only differences between exclusion criteria in Stage 1 and Stage 2 is criterion 8 and the addition of criterion 13: 1. Ever received a licensed or an investigational smallpox or mpox vaccine. Note: this includes Dryvax, Acam2000, LC 16 m8, MVA-based vaccine candidate or licensed vaccines, and Jynneos, Imvamune or Imvanex) 2. Any history of mpox, cowpox, or vaccinia infection. 3. Close contact of anyone known to have mpox in the 3 weeks prior to signing ICF 4. Immunocompromised as determined by the investigator 5. Recent or current use of any immunosuppressing medications in the 4 weeks prior to signing ICF. Note: topical, ophthalmic, inhaled, intranasal and intraarticular corticosteroids are acceptable, but receipt of >=20 mg/day of prednisone or equivalent for >=14 consecutive days in the 4 weeks prior to signing ICF is exclusionary. 6. Pregnant or breast feeding. 7. Received or plans to receive a live vaccine or any COVID-19 vaccine in the 4 weeks before or after each study vaccination. 8. Received or plans to receive any other vaccine in the one week before or after each study vaccination. 9. Received experimental therapeutic agent or vaccine in the 3 months prior to signing ICF. 10. Has known allergy or history of anaphylaxis or other serious adverse reaction to a vaccine or vaccine products. Note: this includes individuals with history of severe allergic reaction to gentamicin, ciprofloxacin, chicken or egg protein. 11. Has tattoos, scars, or other marks which would, in the opinion of the investigator, interfere with assessment of the vaccination site. 12. Has any medical disease or condition that, in the opinion of the participating site PI or appropriate sub-investigator, precludes study participation. Note: this includes acute, subacute, intermittent, or chronic medical disease or condition that would place the participant at an unacceptable risk of injury, render the participant unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the participant s successful completion of this trial. 13. Adolescent or adult participant has a history of myocarditis/pericarditis or a history of structural congenital heart defect/cardiac dysrhythmia that, in the opinion of the investigator, poses increased risk to the participant. 14. Adolescent or adult participant has a history of COVID-19 (with positive test for SARSCoV-2) in the 4 weeks prior to receipt of the first study vaccination. Note: This includes positive rapid antigen test, polymerase chain reaction (PCR) assay,or other nucleic acid amplification (NAAT) test including those performed by the participant at home.
Study inclusion criteria are similar between stages. To be eligible to participate in Stage 2, an individual must meet the following inclusion criteria:
1. Adult ages 18 to 50 years inclusive at the time of consent; OR
Adolescent ages 12 to 17 years inclusive at the time of consent.
2. Adult participant is able to read the written informed consent, states willingness to comply with all study procedures and is anticipated to be available for all study visits; OR
Parent(s)/Legal Authorized Representative (LAR)(s) of the participating adolescent is able to read and provides written informed permission and participating adolescent provides assent as appropriate for age or development and approved by IRB. Adolescent states willingness to comply with all study procedures and is anticipated to be available for all study visits.
3. Adult participant is able to understand and agrees to adhere to Lifestyle Considerations during the study; OR
Parent(s)/LAR(s) of the participating adolescent is able to understand and states willingness to comply with Lifestyle Considerations.
4. Females of reproductive potential who have sexual intercourse with male partners must be using highly effective contraception for at least 1 month prior to signing ICF and agrees to use acceptable method of contraception through Day 57.
Note: See MOP for definitions and list of acceptable method of contraception
5. In good general health as evidenced by medical history, physical examination, and clinical judgement of the investigator to be in stable state of health.
Note: Participants with pre-existing stable chronic medical conditions defined as conditions not requiring significant change in therapy or hospitalization for worsening disease in the 4 weeks prior to enrollment can be included at the discretion of the investigator. This includes stable, well-controlled HIV positive individuals.
6. Individuals with HIV must be on suppressive ART for at least 6 months, report a CD4 count of greater than 350 cells/microL and no AIDS-defining illness in the last year.
EXCLUSION CRITERIA:
For Stage 2 of the study, an individual who meets any of the following criteria will be excluded from participation in this study. Of note, the only differences between exclusion criteria in Stage 1 and Stage 2 is criterion 8 and the addition of criterion 13:
1. Ever received a licensed or an investigational smallpox or mpox vaccine.
Note: this includes Dryvax, Acam2000, LC 16 m8, MVA-based vaccine candidate or licensed vaccines, and Jynneos, Imvamune or Imvanex)
2. Any history of mpox, cowpox, or vaccinia infection.
3. Close contact of anyone known to have mpox in the 3 weeks prior to signing ICF
4. Immunocompromised as determined by the investigator
5. Recent or current use of any immunosuppressing medications in the 4 weeks prior to signing ICF.
Note: topical, ophthalmic, inhaled, intranasal and intraarticular corticosteroids are acceptable, but receipt of >=20 mg/day of prednisone or equivalent for >=14 consecutive days in the 4 weeks prior to signing ICF is exclusionary.
6. Pregnant or breast feeding.
7. Received or plans to receive a live vaccine or any COVID-19 vaccine in the 4 weeks before or after each study vaccination.
8. Received or plans to receive any other vaccine in the one week before or after each study vaccination.
9. Received experimental therapeutic agent or vaccine in the 3 months prior to signing ICF.
10. Has known allergy or history of anaphylaxis or other serious adverse reaction to a vaccine or vaccine products.
Note: this includes individuals with history of severe allergic reaction to gentamicin, ciprofloxacin, chicken or egg protein.
11. Has tattoos, scars, or other marks which would, in the opinion of the investigator, interfere with assessment of the vaccination site.
12. Has any medical disease or condition that, in the opinion of the participating site PI or appropriate sub-investigator, precludes study participation.
Note: this includes acute, subacute, intermittent, or chronic medical disease or condition that would place the participant at an unacceptable risk of injury, render the participant unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the participant s successful completion of this trial.
13. Adolescent or adult participant has a history of myocarditis/pericarditis or a history of structural congenital heart defect/cardiac dysrhythmia that, in the opinion of the investigator, poses increased risk to the participant.
14. Adolescent or adult participant has a history of COVID-19 (with positive test for SARSCoV-2) in the 4 weeks prior to receipt of the first study vaccination.
Note: This includes positive rapid antigen test, polymerase chain reaction (PCR) assay,or other nucleic acid amplification (NAAT) test including those performed by the participant at home.
Principal Investigator
Referral Contact
For more information: