JYNNEOS Vaccine for Monkeypox

Recruiting at 47 trial locations

Overseen By 22-0020 Central Contact

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Must be taking: Suppressive ART

Must not be taking: Immunosuppressants, Prednisone

Disqualifiers: Smallpox vaccine, Monkeypox history, Immunocompromised, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

450 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is a Phase 2 open-label, non-placebo controlled, multi-site clinical trial that will evaluate the standard SC regimen in adolescents ages 12 through 17 years, inclusive, and compared to the standard subcutaneous regimen in adults ages 18 to 50, inclusive. Approximately 135 healthy, vaccinia-naïve adults will be enrolled in a comparator arm (Arm 4) and will be given the standard, licensed regimen of 1x10\^8 TCID50 MVA-BN administered SC on Day 1 and 29. These adults (Arm 4) will be combined with the 76 healthy, vaccinia-naïve adults that received the standard SC regimen in Stage 1 (Arm 3). Together, this will be the comparator group for non-inferiority testing for the primary endpoint. Approximately 315 healthy, vaccinia-naïve adolescents will be enrolled and given 1x10\^8 TCID50 MVA-BN administered SC on Days 1 and 29 (Arm 5). The study will have a set target enrollment of at least 25% adolescents ages 12 to 14 years, inclusive, to ensure that adequate numbers of younger adolescents are enrolled. The primary objectives are 1.) to determine if peak (Day 43) humoral immune responses in adolescents ages 12 to 17 years following administration of a 2-dose 1 x 10\^8 TCID50 MVA-BN regimen administered SC are non-inferior to the response in adults ages 18 to 50 years who received the licensed 2-dose SC regimen of 1 x 10\^8 TCID50 MVA-BN ; and 2.) to describe safety of a 2-dose 1 x 10\^8 TCID50 MVA-BN regimen administered SC in adolescents ages 12 to 17 years.

Eligibility Criteria

This trial is for healthy adults aged 18-50 and adolescents 12-17 who have never had a smallpox or monkeypox vaccine, no history of certain pox infections, not immunocompromised, and not on recent immunosuppressing meds. Women must agree to use effective contraception. Participants with stable chronic conditions including well-controlled HIV can join.

Inclusion Criteria

I can read and agree to follow the study's procedures and attend all visits.

I have HIV, on ART for 6+ months, CD4 count >350, no AIDS illness last year.

In good general health as evidenced by medical history, physical examination, and clinical judgement of the investigator to be in stable state of health.

Exclusion Criteria

You have a heart condition that makes participating in the study risky, such as a history of inflammation of the heart or a structural heart defect.

I have received a smallpox vaccine.

Any history of monkeypox, cowpox, or vaccinia infection.

Treatment Details

Interventions

• JYNNEOS

Trial Overview The study tests two different dosages of the MVA-BN vaccine given intradermally (ID) against the standard dose given subcutaneously (SC) in adults. It aims to see if the immune response with lower ID doses is just as good as the standard SC dose. Adolescents will receive the standard SC regimen for comparison.

Participant Groups

Group I: 5 Experimental Treatment 1 Intervention

0.5 mL of 1 x 10\^8 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered subcutaneously on adolescents ages 12-17 years on Days 1 and 29. N=315

Group II: 4 Active Control 1 Intervention

0.5 mL of 1 x 10\^8 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered subcutaneously on adults ages 18-50 years on Days 1 and 29. N=135

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+