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Cancer Vaccine

Investigational Monkeypox Vaccines for Monkeypox

Phase 1
Recruiting
Research Sponsored by BioNTech SE
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 7 day after each imp dose
Awards & highlights

Study Summary

This trial tests a vaccine for monkeypox, to see if it is safe, tolerable, and effective.

Who is the study for?
This trial is for healthy adults with a BMI between 18.5 and 30 kg/m^2, weighing at least 50 kg, without prior smallpox vaccination (ages 18-45) or with past vaccination before 1980 (ages 50-65). Participants must not have immune deficiencies, uncontrolled diseases, recent vaccinations outside the study, or be pregnant. They should agree to use effective contraception.Check my eligibility
What is being tested?
The trial tests two RNA-based monkeypox vaccines: BNT166a for those who've never had a smallpox vaccine and BNT166c for those vaccinated before 1980. It's randomized and partially observer-blind to assess safety and immune response starting with low doses that increase over time.See study design
What are the potential side effects?
Possible side effects of the vaccines may include reactions at the injection site like pain or swelling, general feelings of discomfort such as fatigue or headaches, muscle pain, feverish symptoms, and potentially other mild to moderate responses typical of vaccines.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 day after each imp dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 day after each imp dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
SSA and SSB - Proportion (%) of participants reporting solicited local reactions at the injection site (pain, erythema/redness, induration/swelling) up to 7 days after each investigational medicinal product (IMP) dose for each group
SSA and SSB - Proportion (%) of participants reporting solicited systemic events (vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, and fever) up to 7 days after each IMP dose for each group
SSA and SSB - Proportion (%) of participants with at least one serious adverse event (SAE) occurring from Dose 1 to 24 weeks after Dose 2
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: SSB - BNT166aExperimental Treatment1 Intervention
One dose level
Group II: SSA - BNT166aExperimental Treatment1 Intervention
Escalating dose levels

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

BioNTech SELead Sponsor
64 Previous Clinical Trials
107,634 Total Patients Enrolled
BioNTech Responsible PersonStudy DirectorBioNTech SE
33 Previous Clinical Trials
9,720 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any age restrictions for this research protocol?

"As outlined in the requirements for participation, individuals must be between 18 and 65 years old to qualify."

Answered by AI

Is this research study actively seeking new participants?

"According to the information in clinicaltrials.gov, this research is currently looking for participants. It was initially posted on September 21st 2023 and recently revised on October 24th 2023."

Answered by AI

What risks do individuals face when using SSA - BNT166a?

"The safety of SSA-BNT166a is rated at a 1 due to the limited clinical research data regarding both its efficacy and overall security."

Answered by AI

What is the overall number of individuals involved in this medical investigation?

"Affirmative. Clinicaltrials.gov displays evidence that this medical investigation, which initially debuted on September 21st 2023, is still in search of participants. The trial requires 96 people to be recruited from two distinct sites."

Answered by AI

Is there an opportunity to take part in this medical experiment?

"This medical trial is seeking to recruit 96 individuals with monkeypox aged 18-65. To qualify for the study, candidates must consent in writing and meet other conditions such as being of a certain age range (18-45 or 50-65 depending on group), demonstrate good health based on reported history and tests, agree not to enrol in another trial during this one, have an appropriate BMI between 18.5–30kg/m^2 and weigh at least 50 kg, either be previously vaccinated against smallpox before 1980 if over 45 years old or remain unvaccinated if under 46 years old, and finally pass HIV1/HIV"

Answered by AI
~27 spots leftby Oct 2024