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Recruiting NCT07379580

A Randomized Clinical Trial Investigating the Safety, Reactogenicity, and Immunogenicity After Immunization With an mRNA-based Mpox Vaccine Candidate in Africa

Phase II Interventional Mpox (Monkeypox) Smallpox Orthopoxvirus Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BNT166a, Placebo.
Who it may be relevant to
Registry conditions: Mpox (Monkeypox), Smallpox, Orthopoxvirus Infection. Basic parameters: 18 years — 64 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Democratic Republic of the Congo, South Africa
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Safety, Reactogenicity, and Immunogenicity of an Mpox mRNA Vaccine Candidate, BNT166a, in Healthy Participants Aged 18 Years and Older in African Countries: A Randomized, Double-blind, Placebo-controlled Phase II Trial

Overview

This is a randomized, double-blind, placebo-controlled study which aims to assess the safety, reactogenicity, and immunogenicity after one and two doses of BNT166a or placebo in healthy participants.

Detailed description

This study will include the following cohorts:

* Cohort 1: healthy adults aged 18 to 45 years inclusive who are Orthopoxvirus-naïve. * Cohort 2: healthy adults aged 18 to 64 years inclusive who are Orthopoxvirus-experienced.

All participants will receive two doses of BNT166a or placebo at least 28 days apart.

The planned study duration per participant is \~14 months.

Interventions

  • Biological BNT166a
    Intramuscular injection. Injections should be given in the deltoid muscle, using the same non-dominant arm for all IMP doses.
  • Other Placebo
    Intramuscular injection. Injections should be given in the deltoid muscle, using the same non-dominant arm for all IMP doses.

Primary outcome measures

  • Number (and percentage) of participants with at least one solicited local reaction (pain, erythema/redness, induration/swelling) [Time frame: For up to 7 days following each dose]
  • Number (and percentage) of participants with at least one solicited systemic reaction (fever, headache, fatigue/tiredness, muscle pain/myalgia, joint pain/arthralgia, chills, diarrhea, vomiting) [Time frame: For up to 7 days following each dose]
  • Number (and percentage) of participants with at least one use of antipyretics/analgesics [Time frame: For up to 7 days following each dose]
  • Number (and percentage) of participants with at least one unsolicited adverse event (AE) (post-Dose 1) [Time frame: From Dose 1 to 28 days post-Dose 1]
  • Number (and percentage) of participants with at least one unsolicited AE (post-Dose 2) [Time frame: From Dose 2 to 28 days post-Dose 2]
  • Number (and percentage) of participants with at least one serious adverse event [Time frame: From Dose 1 until the end of study, i.e., up to ~14 months]
  • Number (and percentage) of participants with at least one AE of special interest [Time frame: From Dose 1 until the end of study, i.e., up to ~14 months]
  • Number (and percentage) of participants with at least one medically attended AE [Time frame: From Dose 1 until the end of study, i.e., up to ~14 months]
  • Number (and percentage) of participants with at least one AE leading to a participant's withdrawal from the study [Time frame: From Dose 1 until the end of study, i.e., up to ~14 months]
Secondary outcome measures (6)
  • Geometric mean titers (GMT) of BNT166a antigen-specific (A35, B6, H3, and M1) binding antibody titers [Time frame: At baseline, 1 month post-Dose 1, and 1 month post- Dose 2]
  • Geometric mean fold rise (GMFR) of BNT166a antigen-specific (A35, B6, H3, and M1) binding antibody titers [Time frame: At 1 month post-Dose 1 and 1 month post-Dose 2]
  • GMT of MPXV-specific neutralizing antibody titers [Time frame: At baseline, 1 month post-Dose 1, and 1 month post-Dose 2]
  • GMFR of MPXV-specific neutralizing antibody titers [Time frame: At 1 month post-Dose 1 and 1 month post-Dose 2]
  • GMT of vaccinia virus (VACV)-specific neutralizing antibody titers [Time frame: At baseline, 1 month post-Dose 1, and 1 month post-Dose 2]
  • GMFR of VACV-specific neutralizing antibody titers [Time frame: At 1 month post-Dose 1 and 1 month post-Dose 2]

Eligibility criteria

Key Inclusion Criteria (applicable to all participants unless otherwise specified):

  • Are male or female individuals ≥18 years of age at the time of giving informed consent:
  • Cohort 1: ≥18 to ≤45 years of age
  • Cohort 2: ≥18 to ≤64 years of age
  • Cohort 1: Participants must be Orthopoxvirus-naïve (have no history of smallpox or mpox vaccination or mpox infection).
  • Cohort 2: Participants must be Orthopoxvirus-experienced (have evidence of mpox or smallpox vaccination or mpox infection at least 2 years prior to consent).

Key Exclusion Criteria (applicable to all participants unless otherwise specified):

  • Have had recent exposure to mpox (defined as close contact with a probable or confirmed case of mpox within the past 28 days, or have evidence of mpox infection or mpox vaccination within 2 years prior to consent).
  • Have a contraindication, warning and/or precaution to vaccination with a messenger ribonucleic acid (mRNA) Coronavirus disease 2019 (COVID-19) vaccine as specified in the Summary of Product Characteristics for BNT162b2 (COMIRNATY United States Prescribing Information/European Union Summary of Product Characteristics) and BNT166 Investigator Brochure.
  • Have a history of allergies, hypersensitivities, or intolerance to the study treatments including any excipients thereof.
  • Have a current or history of cardiovascular diseases, e.g., myocarditis, pericarditis, myocardial infarction, congestive heart failure, cardiomyopathy, or clinically significant arrhythmias.
  • Have any known bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
  • Have a body mass index ≤18.5 kg/m\^2 or ≥35 kg/m\^2.

NOTE: Other protocol defined Inclusion/Exclusion criteria apply.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

South Africa · 4 centers
  • TASK Applied Science — Cape Town
  • TREAD Research Pty Ltd — Cape Town
  • Desmond Tutu Health Foundation Masiphumelele Clinic — Cape Town
  • Perinatal HIV Research Unit — Johannesburg
Democratic Republic of the Congo · 2 centers
  • University of Kinshasa UNIKIN — Kinshasa
  • Institute National de Recherche Biomedicale — Kinshasa

Identifiers

NCT: NCT07379580 · BNT166-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗