Trial NCT04649021
Publication Hui A-M, Lancet, 2022
Dates: 2020-12-05 to 2021-01-09
Funding: Private (BioNTech ; Shanghai Fosun Pharmaceutical Development Inc.)
Conflict of interest: Yes
| Methods | |
| RCT | |
| Location :
Multicenter / China Follow-up duration (months): 6 | |
| 30 mcg BNT162b2 (n = 720) Placebo (n = 240) |
|
| Inclusion criteria | Male or female participants between the ages of 18 and 85 years, inclusive, at randomization.;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 (if required), and clinical judgment of the investigator to be eligible for inclusion in the study. Note: Healthy participants with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included.;Capable of giving personal signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and this protocol.;SARS-CoV-2 antibody test screening is negative.;Negative SARS-CoV-2 test in throat swabs by reverse transcription-polymerase chain reaction (RT-PCR) (only for the first approximately 150 subjects).;Normal in chest computed tomography (CT) scans (no imaging features of coronavirus disease 2019 (COVID-19), only for the first approximately 150 subjects). |
| 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.;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.;Immunocompromised individuals with known or suspected immunodeficiency, determined by history and/or laboratory/physical examination.;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.;If systemic corticosteroids have been administered short term (<14 days) for treatment of an acute illness, participants should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 28 days before study intervention administration. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.;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.;Have had contact with confirmed COVID-19 patients or persons tested positive for SARS-CoV-2 within the 30 days prior to Screening Visit.;Travel or live in any country or region with a high SARS-CoV-2 infection risk (as defined at Screening Visit) within the 14 days prior to Screening Visit.;Symptoms of COVID-19, e.g., respiratory symptoms, fever, cough, shortness of breath and breathing difficulties.;Fever, defined as axillary temperature ≥37.3ºC or oral temperature ≥38ºC.;History of SARS, SARS-CoV-2 or middle east respiratory syndrome (MERS) infection. Suspected SARS patients should be screened for SARS antibodies.;Investigator site staff or Fosun employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members. |
| Interventions | |
| Intervention
2 IM doses of 30 mcg BNT162b2, 21 days apart |
|
| Control
2 IM doses of saline placebo, 21 days apart | |
| Participants | |
| Randomized 960 participants | |
| Characteristics of participants Type of participants: Adults N=960 491 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: 19-84 | |
| Description of participants Healthy adults and those with a pre-existing stable condition, at 2 centers in China. | |
| Primary outcome | |
| In the register 1) SARS-CoV-2 serum neutralizing titers - Seroconversion rates (SCR) [ Time Frame: 1 Month after Dose 2 ] SCR of SARS-CoV-2 serum neutralizing titers at 1-month after dose 2. Seroconversion is defined as ≥4-fold rise from before vaccination to 1-month post dose 2 ; 2) The geometric mean titer (GMT) of SARS-CoV-2 serum neutralizing titers at 1 month after dose 2 [ Time Frame: 1 Month after Dose 2 ] | |
| In the report 1) Geometric mean titers (GMTs) against live SARS-CoV-2 and 2) the seroconversion rate (SCR), measured one month after the second dose compared to baseline. | |
| Variants description | |
Variants
| |
| Description Alpha, Beta and Delta variant. Direct evidence Assessment of immunological outcomes | |
| Documents avalaible |
Protocol Yes. In English Statistical plan Yes Data-sharing stated:
Yes, Access to data will be made available following
publication upon reasonable
request. |
| Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review |
Low |
| General comment | In addition to the pre-print article, the trial registry was used in data extraction and assessment of risk of bias. The supplementary appendices referred to in the article were not available at time of extraction. The primary and secondary outcomes in the article reflect those in the registry. The trial (n = 960) achieved its target sample size (n = 960). The trial was updated on October 27th, 2022 after publication of results at a longer follow-up. |