Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals
Purpose
This is a Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in healthy individuals. The study consists of 2 parts: Phase 1: to identify preferred vaccine candidate(s) and dose level(s); Phase 2/3: an expanded cohort and efficacy part. The study will evaluate the safety, tolerability, and immunogenicity of 2 different SARS CoV 2 RNA vaccine candidates against COVID 19 and the efficacy of 1 candidate: - As a 2-dose (separated by 21 days) schedule; - At various different dose levels in Phase 1; - In 3 age groups (Phase 1: 18 to 55 years of age, 65 to 85 years of age; Phase 2/3: ≥12 years of age [stratified as 12-15, 16-55 or >55 years of age]). The candidate selected for evaluation in Phase 2/3 is BNT162b2 (mid-dose). Participants ≥16 years of age who originally received placebo will be offered the opportunity to receive BNT162b2 at defined points as part of the study.
Conditions
- SARS-CoV-2 Infection
- COVID-19
Eligibility
- Eligible Ages
- Over 12 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Male or female participants between the ages of 18 and 55 years, inclusive, 65 and 85 years, inclusive, or ≥12 years, inclusive, at randomization (dependent upon study phase). Note that participants <18 years of age cannot be enrolled in the EU. - Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures. - Healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study. - Participants who, in the judgment of the investigator, are at risk for acquiring COVID-19. - Capable of giving personal signed informed consent
Exclusion Criteria
- Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. - Phases 1 and 2 only: Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV). - History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s). - Receipt of medications intended to prevent COVID 19. - Previous clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV-2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID 19 - Phase 1 only: Individuals at high risk for severe COVID-19, including those with any of the following risk factors: - Hypertension - Diabetes mellitus - Chronic pulmonary disease - Asthma - Current vaping or smoking - History of chronic smoking within the prior year - BMI >30 kg/m2 - Anticipating the need for immunosuppressive treatment within the next 6 months - Phase 1 only: Individuals currently working in occupations with high risk of exposure to SARS-CoV-2 (eg, healthcare worker, emergency response personnel). - Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination. - Phase 1 only: Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention. - Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. - Women who are pregnant or breastfeeding. - Previous vaccination with any coronavirus vaccine. - Individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study. - Phase 1 only: Regular receipt of inhaled/nebulized corticosteroids. - Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration or planned receipt throughout the study. - Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation. - Previous participation in other studies involving study intervention containing lipid nanoparticles. - Phase 1 only: Positive serological test for SARS-CoV-2 IgM and/or IgG antibodies at the screening visit. - Phase 1 only: Any screening hematology and/or blood chemistry laboratory value that meets the definition of a ≥ Grade 1 abnormality. - Phase 1 only: Positive test for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibodies (HBc Abs), or hepatitis C virus antibodies (HCV Abs) at the screening visit. - Phase 1 only: SARS-CoV-2 NAAT-positive nasal swab within 24 hours before receipt of study intervention. - Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
Study Design
- Phase
- Phase 2/Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Investigator)
Arm Groups
Arm | Description | Assigned Intervention |
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Experimental Low dose, 18-55 years of age (2 doses) |
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Experimental Low-mid dose, 18-55 years of age (2 doses) |
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Experimental Mid dose, 18-55 years of age (2 doses) |
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Experimental Low dose, 65-85 years of age (2 doses) |
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Experimental Low-mid dose, 65-85 years of age (2 doses) |
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Experimental Mid dose, 65-85 years of age (2 doses) |
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Experimental Mid dose, ≥12 years of age (2 doses) |
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Placebo Comparator Placebo, 18-55 years of age |
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Placebo Comparator Placebo, 65-85 years of age |
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Placebo Comparator Placebo, ≥12 years of age |
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Experimental High dose, 18-55 years of age (2 doses) |
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Other Vaccination of Placebo recipients with BNT162b2 - Stage 1 |
Participants ≥16 years of age who originally received placebo and are eligible for COVID-19 vaccination following any local or national recommendations will be offered the opportunity to receive BNT162b2 as part of the study. |
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Other Vaccination of placebo recipients with BNT162b2 - Stage 2 |
Participants ≥16 years of age who originally received placebo will be offered the opportunity to receive BNT162b2 at defined points as part of the study. |
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More Details
- Status
- Active, not recruiting
- Sponsor
- BioNTech SE