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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Number (and percentage) of participants with at least one solicited local reaction (pain, erythema/redness, induration/swelling) [Срок оценки: 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) [Срок оценки: For up to 7 days following each dose]
• Number (and percentage) of participants with at least one use of antipyretics/analgesics [Срок оценки: For up to 7 days following each dose]
• Number (and percentage) of participants with at least one unsolicited adverse event (AE) (post-Dose 1) [Срок оценки: From Dose 1 to 28 days post-Dose 1]
• Number (and percentage) of participants with at least one unsolicited AE (post-Dose 2) [Срок оценки: From Dose 2 to 28 days post-Dose 2]
• Number (and percentage) of participants with at least one serious adverse event [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: From Dose 1 until the end of study, i.e., up to ~14 months]

Вторичные конечные точки (6)

• Geometric mean titers (GMT) of BNT166a antigen-specific (A35, B6, H3, and M1) binding antibody titers [Срок оценки: 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 [Срок оценки: At 1 month post-Dose 1 and 1 month post-Dose 2]
• GMT of MPXV-specific neutralizing antibody titers [Срок оценки: At baseline, 1 month post-Dose 1, and 1 month post-Dose 2]
• GMFR of MPXV-specific neutralizing antibody titers [Срок оценки: At 1 month post-Dose 1 and 1 month post-Dose 2]
• GMT of vaccinia virus (VACV)-specific neutralizing antibody titers [Срок оценки: At baseline, 1 month post-Dose 1, and 1 month post-Dose 2]
• GMFR of VACV-specific neutralizing antibody titers [Срок оценки: At 1 month post-Dose 1 and 1 month post-Dose 2]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Профилактика

Центры проведения

ЮАР · 4 центра

• 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 центра

• University of Kinshasa UNIKIN — Kinshasa
• Institute National de Recherche Biomedicale — Kinshasa

Идентификаторы

NCT: NCT07379580 · BNT166-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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