96 Participants Needed

Investigational Monkeypox Vaccines for Monkeypox

Recruiting at 7 trial locations
Bc
Overseen ByBioNTech clinical trials patient information
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This is a dose-escalation, Phase I/II study evaluating the safety, tolerability, reactogenicity and immunogenicity of the investigational RNA-based multivalent vaccine candidate BNT166a for active immunization against monkeypox (mpox). This study started with substudy A (SSA) and substudy B (SSB) for which recruitment has been completed. A Substudy C (SSC) was planned, but the sponsor decided not to conduct it. This study will therefore continue with substudy D (SSD). In SSA and SSB, dosing started with an initial sentinel group, followed by the expansion cohort. This study was initially planned to investigate two vaccine candidates (the quadrivalent BNT166a and the trivalent BNT166c). The sponsor decided to not activate the groups with BNT166c.

Will I have to stop taking my current medications?

The trial protocol mentions that certain medications are prohibited, but it does not specify which ones. It is best to discuss your current medications with the study team to see if any adjustments are needed.

Will I have to stop taking my current medications?

The trial protocol mentions that certain medications are prohibited during the study, but it does not specify which ones. It is best to discuss your current medications with the study team to determine if any changes are needed.

What data supports the effectiveness of the treatment BNT166a, BNT166a, BNT166c, BNT166c, BNT166c for monkeypox?

Research shows that a similar vaccine, MVA-BN, is effective in reducing the risk of monkeypox infection by 86% after a single dose in high-risk groups. Additionally, another vaccine, LC16m8, has been shown to protect monkeys from monkeypox, suggesting potential effectiveness in humans.12345

What data supports the effectiveness of the drug BNT166a, BNT166a, BNT166c, BNT166c, BNT166c for monkeypox?

The research does not provide direct evidence for the effectiveness of BNT166a or BNT166c for monkeypox, but it mentions that a similar vaccine, MVA-BN, showed an 86% effectiveness in reducing monkeypox infections in a high-risk group.12345

What safety data exists for investigational monkeypox vaccines like BNT166a and BNT166c?

The BNT162b2 vaccine, which is similar to BNT166a and BNT166c, has been shown to be generally safe in humans, with most adverse events being mild and temporary, such as pain or fatigue. Serious reactions like anaphylaxis (a severe allergic reaction) are very rare.678910

How does the drug BNT166a, BNT166c differ from other treatments for monkeypox?

The investigational drug BNT166a, BNT166c is unique because it is being specifically developed for monkeypox, whereas existing vaccines like JYNNEOS and LC16m8 were originally designed for smallpox and adapted for monkeypox. This drug may offer a novel approach by potentially targeting specific components of the monkeypox virus, unlike the broader smallpox vaccines.1241112

Research Team

BR

BioNTech Responsible Person

Principal Investigator

BioNTech SE

Eligibility Criteria

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.

Inclusion Criteria

Negative Hepatitis B surface antigen test result and negative anti Hepatitis C virus antibodies (anti-HCV), or negative Hepatitis C virus (HCV) polymerase chain reaction (PCR) test result if the anti-HCV is positive at Visit 0
Agree not to enroll in another trial with an IMP starting from Visit 0 and until the end of this trial (Visit 12)
I am between 18 and 45 years old.
See 9 more

Exclusion Criteria

I have been vaccinated against mpox or vaccinia virus.
I have or had type 1 or type 2 diabetes, even if it's diet-controlled.
History of mpox, smallpox or vaccinia infection based on volunteer-reported medical history
See 31 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the investigational RNA-based multivalent vaccine candidate BNT166a in a dose-escalation manner

4 weeks
Multiple visits for dosing and monitoring

Follow-up

Participants are monitored for safety, reactogenicity, and immunogenicity after receiving the vaccine

14 months

Treatment Details

Interventions

  • BNT166a
  • BNT166c
Trial OverviewThe 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.
Participant Groups
5Treatment groups
Experimental Treatment
Group I: SSD - BNT166aExperimental Treatment1 Intervention
One dose level based on SSA and SSB data
Group II: SSB - BNT166a DL2Experimental Treatment1 Intervention
One dose level
Group III: SSA - BNT166a Dose Level (DL)1Experimental Treatment1 Intervention
One dose level
Group IV: SSA - BNT166a DL3Experimental Treatment1 Intervention
One dose level
Group V: SSA - BNT166a DL2Experimental Treatment1 Intervention
One dose level

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Who Is Running the Clinical Trial?

BioNTech SE

Lead Sponsor

Trials
84
Recruited
120,000+

Prof. Dr. Ugur Sahin

BioNTech SE

Chief Executive Officer since 2008

MD from University of Cologne

Prof. Özlem Türeci

BioNTech SE

Chief Medical Officer since 2018

MD from Saarland University

Findings from Research

The study involved 745 participants and demonstrated that the MVA-BN vaccine significantly boosts neutralizing antibody levels after both primary vaccination and a booster, indicating strong immunological memory.
No safety concerns were reported, suggesting that MVA-BN is a safe option for smallpox and monkeypox prevention, with effective long-term immune responses.
One- and Two-Dose Vaccinations With Modified Vaccinia Ankara-Bavarian Nordic Induce Durable B-Cell Memory Responses Comparable to Replicating Smallpox Vaccines.Ilchmann, H., Samy, N., Reichhardt, D., et al.[2023]
The LC16m8 strain of the vaccinia virus vaccine effectively induced protective immunity against monkeypox in nonhuman primates, showing no symptoms after exposure, while nonimmunized controls exhibited typical disease symptoms.
Both LC16m8 and the parental Lister strain provided protection against monkeypox, indicating that LC16m8 could be a valuable vaccine option for preventing both monkeypox and smallpox, especially given its safety profile with only mild side effects.
LC16m8, a highly attenuated vaccinia virus vaccine lacking expression of the membrane protein B5R, protects monkeys from monkeypox.Saijo, M., Ami, Y., Suzaki, Y., et al.[2023]
In a study of 2,054 eligible male individuals, a single subcutaneous dose of the MVA-BN vaccine showed an impressive 86% effectiveness in reducing the risk of monkeypox (mpox) infection after at least 90 days of follow-up.
The study found that only 5 infections occurred in vaccinated individuals compared to 16 in unvaccinated individuals, highlighting the vaccine's significant protective effect in a high-risk population.
Real-world effectiveness of a single dose of mpox vaccine in males.Wolff Sagy, Y., Zucker, R., Hammerman, A., et al.[2023]

References

One- and Two-Dose Vaccinations With Modified Vaccinia Ankara-Bavarian Nordic Induce Durable B-Cell Memory Responses Comparable to Replicating Smallpox Vaccines. [2023]
LC16m8, a highly attenuated vaccinia virus vaccine lacking expression of the membrane protein B5R, protects monkeys from monkeypox. [2023]
Real-world effectiveness of a single dose of mpox vaccine in males. [2023]
Vaccines against monkeypox. [2023]
[Vaccines against monkeypox]. [2023]
Early Adverse Events between mRNA and Adenovirus-Vectored COVID-19 Vaccines in Healthcare Workers. [2021]
Myocarditis following COVID-19 mRNA vaccination. [2022]
Pfizer/BioNtech BNT162b2: adverse events and insights from an Australian mass vaccination clinic for COVID-19. [2022]
Decline of antibody titres 3 months after two doses of BNT162b2 in non-immunocompromised adults. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Safety of COVID-19 Pfizer-BioNtech (BNT162b2) mRNA vaccination in adolescents aged 12-17 years: A systematic review and meta-analysis. [2022]
Identification of B and T Cell Epitopes to Design an Epitope-Based Peptide Vaccine against the Cell Surface Binding Protein of Monkeypox Virus: An Immunoinformatics Study. [2023]
12.United Statespubmed.ncbi.nlm.nih.gov
Incidence of Monkeypox Among Unvaccinated Persons Compared with Persons Receiving ≥1 JYNNEOS Vaccine Dose - 32 U.S. Jurisdictions, July 31-September 3, 2022. [2023]