← Back to Search

Virus Therapy

JYNNEOS Vaccine for Monkeypox

Phase 2

Waitlist Available

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Individuals 18 - 50 years of age inclusive at the time of consent; OR Adolescent ages 12 to 17 years inclusive at the time of consent.

Individuals with HIV must be on suppressive ART for at least 6 months, report a CD4 count of greater than 350 cells/µL and no AIDS-defining illness in the last year.

Must not have

Ever received a licensed or an investigational smallpox or monkeypox vaccine.

*This includes Dryvax, Acam2000, LC 16 m8, MVA-based vaccine candidate or licensed vaccines, and Jynneos, Imvamune or Imvanex)

Timeline

Screening 1 day

Treatment 13 months

Follow Up day 1 through day 394

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare two vaccine regimens to the standard in adults and adolescents to see which one is better.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, vaccines like JYNNEOS may cause reactions at injection site such as pain and redness, muscle aches, headache, fatigue, nausea or mild fever. Serious allergic reactions are rare but possible.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 12 and 50 years old.

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been vaccinated against smallpox or monkeypox.

Select...

I have received a smallpox vaccine.

Select...

I haven't taken any immunosuppressing drugs in the last 4 weeks.

Select...

I haven't taken more than 20 mg/day of prednisone or its equivalent for 2 weeks in the last month.

Timeline

Screening ~ 1 day0 visits

Treatment ~ 13 months8 visits

Follow Up ~ day 1 through day 394

Screening ~ 1 day

Treatment ~ 13 months

Follow Up ~day 1 through day 394

This trial's timeline: 1 day for screening, 13 months for treatment, and day 1 through day 394 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline Vaccinia virus specific plaque reduction neutralizing antibody (PRNT) Geometric Mean Titers (GMT)

Occurrence of Adverse Events of Special Interest (AESI).

Occurrence of Medically Attended Events (MAAE)

+3 more

Secondary study objectives

Change from baseline in Vaccinia virus specific plaque reduction neutralizing antibody (PRNT) Geometric Mean Titers (GMT)

Change from baseline in peak Geometric Mean Titers (GMT)

Frequency of withdrawals or discontinuation of vaccination

+10 more

Side effects data

From 2023 Phase 2 trial • 229 Patients • NCT05512949

85%

Injection site pruritus

83%

Injection site erythema

77%

Injection site discolouration

68%

Injection site nodule

65%

Injection site pain

57%

Fatigue

49%

Injection site induration

48%

Headache

32%

Myalgia

24%

Arthralgia

23%

Nausea

20%

Chills

15%

Appetite disorder

12%

Injection site exfoliation

Upper respiratory tract infection

100%

80%

60%

40%

20%

Study treatment Arm

2 x 10^7 ID MVA-BN

1 x 10^8 SC MVA-BN

1 x 10^7 ID MVA-BN

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: 5Experimental Treatment1 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: 4Active Control1 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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

JYNNEOS

2022

Completed Phase 2

~230

0 / 6Eligibility criteria met