5 for Monkeypox

Brigham and Women's Hospital - Infectious Diseases, Boston, MA
MonkeypoxJYNNEOS - Biological
Eligibility
12 - 50
All Sexes

Study Summary

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

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Study Objectives

6 Primary · 13 Secondary · Reporting Duration: Day 1 through Day 394

Day 181
Frequency of withdrawals or discontinuation of vaccination
Occurrence of Medically Attended Events (MAAE) in each study arm
Occurrence of Serious Adverse Events (SAE) in each study arm
Day 210
Occurrence of Adverse Events of Special Interest (AESI).
Occurrence of Medically Attended Events (MAAE)
Day 29
Occurrence of solicited Adverse Events (AE) for 7 days after each vaccination in study arms 4-5
Day 36
Occurrence of solicited Adverse Events (AE).
Day 365
Change from baseline in peak Geometric Mean Titers (GMT)
Vaccinia virus specific plaque reduction neutralizing antibody (PRNT) half-life (t ½)
Day 394
Change from baseline in Vaccinia virus specific plaque reduction neutralizing antibody (PRNT) Geometric Mean Titers (GMT)
Occurrence of Adverse Events (AE)
Occurrence of Serious Adverse Events (SAE) in adolescent and adult study arms
Occurrence of Serious Adverse Events (SAEs)
Occurrence of withdrawals and discontinuations of vaccination.
Day 43
Occurrence of solicited Adverse Events (AE) for 14 days after each vaccination in study arms 1-3
Day 57
Occurrence of unsolicited Adverse Events (AE)
Day 210
Occurrence of Adverse Event of Special Interest
Occurrence of Medically Attended Events (MAAE) in adolescent and adult study arms
Day 43
Change from baseline Vaccinia virus specific plaque reduction neutralizing antibody (PRNT) Geometric Mean Titers (GMT)

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Side Effects for

Group 4
3%Upper respiratory tract infection
1%Oropharyngeal pain
This histogram enumerates side effects from a completed 2014 Phase 3 trial (NCT01144637) in the Group 4 ARM group. Side effects include: Upper respiratory tract infection with 3%, Oropharyngeal pain with 1%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

4
1 of 2
5
1 of 2

Active Control

Experimental Treatment

400 Total Participants · 2 Treatment Groups

Primary Treatment: 5 · No Placebo Group · Phase 2

5
Biological
Experimental Group · 1 Intervention: JYNNEOS · Intervention Types: Biological
4
Biological
ActiveComparator Group · 1 Intervention: JYNNEOS · Intervention Types: Biological

Trial Logistics

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: 13 Months
Reporting: day 1 through day 394

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,186 Previous Clinical Trials
4,981,709 Total Patients Enrolled
4 Trials studying Monkeypox
1,709 Patients Enrolled for Monkeypox

Eligibility Criteria

Age 12 - 50 · All Participants · 0 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Who else is applying?

What state do they live in?
Texas60.0%
Maryland20.0%
Washington20.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria80.0%
Met criteria20.0%
What site did they apply to?
University of Texas Medical Branch - Division of Infectious Disease25.0%
University of Texas Medical Branch25.0%
Kaiser Permanente Washington Health Research Institute25.0%
Other25.0%
Why did patients apply to this trial?
  • "I am interested in helping medical advancement"
  • "I am involved with different types of studies through the years. Trying to have some extra cash"
  • "I saw the opportunity to sign up for these trials and I really want to help if I can to advance medicine. I also could use the extra income."
How many prior treatments have patients received?
033.3%
133.3%
3+33.3%

Frequently Asked Questions

Is this research endeavor open to elderly individuals over eighty-five years of age?

"Participants must be between 12 and 50 years of age to qualify for this clinical trial." - Anonymous Online Contributor

Unverified Answer

Could I be a viable participant in this experiment?

"This trial is searching for 400 volunteers between the ages of 12 and 50 who are currently living with monkeypox. Qualified patients must meet these criteria in order to participate." - Anonymous Online Contributor

Unverified Answer

Are there any available vacancies in this trial for participants?

"As indicated on clinicaltrials.gov, this medical study is not presently accepting participants. Initially posted in March 15th2023 and last updated February 13th 2023, the trial has yet to begin recruiting patients. However there are 12 other trials that are actively seeking enrolment at the present moment." - Anonymous Online Contributor

Unverified Answer

How many medical sites are currently administering this research trial within the state?

"A number of medical centres are taking part in this trial, including The George Washington University Medical Faculty Associates - Infectious Diseases located in the District Of Columbia and National Institutes of Health's Clinical Centre as well as their Laboratory Of Immunoregulation. In addition, Brigham and Women's Hospital is accepting participants for this clinical research study. Altogether there are 13 sites recruiting patients." - Anonymous Online Contributor

Unverified Answer

What potential risks and side effects are associated with the use of 5?

"A score of 2 was attributed to the safety profile of compound 5, as it is presently being tested in a Phase 2 clinical trial. That said, there does exist data that supports its security but no evidence yet for its efficacy." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.