Health Trials

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

ConditionsMpox (Monkeypox)SmallpoxOrthopoxvirus Infection
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-64
SponsorBioNTech SE

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • BNT166a

    Biological/Vaccine

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

  • Placebo

    Other intervention

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

Treatment groups

310 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Cohort 1 - BNT166a Dose Level (DL) 1 (Orthopoxvirus-naïve participants, aged 18-45 years)Experimental treatment 1 intervention
Group B: Cohort 1 - BNT166a DL 2 (Orthopoxvirus-naïve participants, aged 18-45 years)Experimental treatment 1 intervention
Group C: Cohort 1 - Placebo (Orthopoxvirus-naïve participants, aged 18-45 years)Placebo comparator 1 intervention
Group D: Cohort 2 - BNT166a DL 1 (Orthopoxvirus-experienced participants, aged 18-64 years)Experimental treatment 1 intervention
Group E: Cohort 2 - BNT166a DL 2 (Orthopoxvirus-experienced participants, aged 18-64 years)Experimental treatment 1 intervention
Group F: Cohort 2 - Placebo (Orthopoxvirus-experienced participants, aged 18-64 years)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number (and percentage) of participants with at least one solicited local reaction (pain, erythema/redness, induration/swelling)

At each dose level of BNT166a in Orthopoxvirus-naïve (Cohort 1) and Orthopoxvirus-experienced (Cohort 2) adults.

Time frame
For up to 7 days following each dose
2

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)

At each dose level of BNT166a in Orthopoxvirus-naïve (Cohort 1) and Orthopoxvirus-experienced (Cohort 2) adults.

Time frame
For up to 7 days following each dose
3

Number (and percentage) of participants with at least one use of antipyretics/analgesics

At each dose level of BNT166a in Orthopoxvirus-naïve (Cohort 1) and Orthopoxvirus-experienced (Cohort 2) adults.

Time frame
For up to 7 days following each dose
4

Number (and percentage) of participants with at least one unsolicited adverse event (AE) (post-Dose 1)

At each dose level of BNT166a in Orthopoxvirus-naïve (Cohort 1) and Orthopoxvirus-experienced (Cohort 2) adults.

Time frame
From Dose 1 to 28 days post-Dose 1

Secondary outcomes

1

Geometric mean titers (GMT) of BNT166a antigen-specific (A35, B6, H3, and M1) binding antibody titers

At each dose level of BNT166a in Orthopoxvirus-naïve (Cohort 1) and Orthopoxvirus-experienced (Cohort 2) adults, at the defined timepoints.

Time frame
At baseline, 1 month post-Dose 1, and 1 month post- Dose 2
2

Geometric mean fold rise (GMFR) of BNT166a antigen-specific (A35, B6, H3, and M1) binding antibody titers

At each dose level of BNT166a in Orthopoxvirus-naïve (Cohort 1) and Orthopoxvirus-experienced (Cohort 2) adults. Ratio post-baseline/baseline at the defined timepoints.

Time frame
At 1 month post-Dose 1 and 1 month post-Dose 2
3

GMT of MPXV-specific neutralizing antibody titers

At each dose level of BNT166a in Orthopoxvirus-naïve (Cohort 1) and Orthopoxvirus-experienced (Cohort 2) adults, at the defined timepoints.

Time frame
At baseline, 1 month post-Dose 1, and 1 month post-Dose 2
4

GMFR of MPXV-specific neutralizing antibody titers

At each dose level of BNT166a in Orthopoxvirus-naïve (Cohort 1) and Orthopoxvirus-experienced (Cohort 2) adults. Ratio post-baseline/baseline at the defined timepoints.

Time frame
At 1 month post-Dose 1 and 1 month post-Dose 2

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

BioNTech SE

Lead sponsor

Coalition for Epidemic Preparedness Innovations

Collaborator

Source ClinicalTrials.gov
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