BNT162b2 for Respiration Disorders

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Synexus SA Stanza Clinical Research Centre, Pretoria, South Africa
Respiration Disorders+6 More
BNT162b2 - Biological
Eligibility
18+
All Sexes
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Study Summary

This study is evaluating whether a third booster injection of a vaccine is safe and immunogenic.

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Eligible Conditions

  • Respiration Disorders
  • Coronavirus Disease 2019 (COVID‑19)
  • Covid19
  • SARS-CoV-2 Acute Respiratory Disease
  • Severe Acute Respiratory Syndrome (SARS)

Treatment Effectiveness

Study Objectives

This trial is evaluating whether BNT162b2 will improve 18 primary outcomes and 7 secondary outcomes in patients with Respiration Disorders. Measurement will happen over the course of up to 7 days after each dose.

1 month
Part B - GMR of B.1.1.7 NT 1 month after 2 doses of BNT162b2 (B.1.1.7 + B.1.617.2) on BNT162b2-naïve participants to the reference strain NT 1 month after 2 doses of BNT162b2 in participants from the Phase III BNT162-02 / C4591001 trial
Part B - GMR of B.1.617.2 NT 1 month after 1 dose of BNT162b2 (B.1.1.7 + B.1.617.2) on BNT162b2-experienced participants to the reference strain NT 1 month after 2 doses of BNT162b2 in participants from the Phase III BNT162-02 / C4591001 trial
Part B - GMR of B.1.617.2 NT 1 month after 1 dose of BNT162b2 (B.1.617.2) on BNT162b2-experienced participants to the reference strain NT 1 month after 2 doses of BNT162b2 in participants from the Phase III BNT162-02 / C4591001 trial
Part B - GMR of B.1.617.2 NT 1 month after 2 doses of BNT162b2 (B.1.1.7 + B.1.617.2) on BNT162b2-naïve participants to the reference strain NT 1 month after 2 doses of BNT162b2 in participants from the Phase III BNT162-02 / C4591001 trial
Part B - Geometric mean ratio (GMR) of B.1.1.7
Part B - The difference in SR to B.1.1.7 NT 1 month after 1 dose of BNT162b2 (B.1.1.7 + B.1.617.2) on BNT162b2-naïve participants to the reference strain NT 1 month after 2 doses of BNT162b2 in participants from the Phase III BNT162-02 / C4591001 trial
Part B - The difference in SR to B.1.1.7 NT 1 month after 2 doses of BNT162b2 (B.1.1.7 + B.1.617.2) on BNT162b2-naïve participants to the reference strain NT 1 month after 2 doses of BNT162b2 in participants from the Phase III BNT162-02 / C4591001 trial
Part B - The difference in SR to B.1.617.2
Part B - The difference in SR to B.1.617.2 NT 1 month after 1 dose of BNT162b2 (B.1.1.7 + B.1.617.2) on BNT162b2-naïve participants to the reference strain NT 1 month after 2 doses of BNT162b2 in participants from the Phase III BNT162-02 / C4591001 trial
Part B - The difference in SR to B.1.617.2 NT 1 month after 1 dose of BNT162b2 (B.1.617.2) on BNT162b2-experienced participants to the reference strain NT 1 month after 2 doses of BNT162b2 in participants from the Phase III BNT162-02 / C4591001 trial
Part B - The difference in SR to B.1.617.2 NT 1 month after 2 doses of BNT162b2 (B.1.1.7 + B.1.617.2) on BNT162b2-naïve participants to the reference strain NT 1 month after 2 doses of BNT162b2 in participants from the Phase III BNT162-02/C4591001 trial
Part B - The difference in Seroresponse (SR) to B.1.1.7
Part C - GMR of B.1.1.529 NT 1 month after one dose of BNT162b2 (B.1.1.529) in RNA-based COVID-19 vaccine-experienced participants with history of SARS-CoV-2 infection to those at 1 month after one dose of BNT162b2 for Cohorts 7 and 8.
Part C - The difference in SR of B.1.1.529 NT 1 month after one dose of BNT162b2 (B.1.1.529) in RNA-based COVID-19 vaccine-experienced participants with history of SARS-CoV-2 infection to those at 1 month after one dose of BNT162b2 for Cohorts 7 and 8.
Day 360
Part A - Geometric mean fold rises (GMFR) from before vaccination to each subsequent time point after vaccination
Part A - Geometric mean titer (GMT)
Part A - SR in terms of NT at each post vaccination time point
Part B - GMT - B.1.1.7 + B.1.617.2 to the reference strain
Part B - GMT - B.1.1.7 + B.1.617.2 vs BNT162b2
Part B - GMT - B.1.617.2 vs BNT162b2
Part C - GMT - B.1.1.529 or BNT162b2 or a post SARS-CoV-2 infection
Month 1
Percentage of participants reporting adverse events (AEs)
Month 6
Percentage of participants reporting serious adverse events (SAEs)
Day 7
Percentage of participants reporting local reactions at the injection site
Percentage of participants reporting systemic events

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

11 Treatment Groups

Part B - Cohort 4: 18 to 85 years of age
1 of 11
Part A - Cohort 4: 18 to 55 years of age
1 of 11
Part C - Cohort 7: 18 to 85 years of age
1 of 11
Part A - Cohort 2: 18 to 55 years of age
1 of 11
Part C - Cohort 8: 18 to 85 years of age
1 of 11
Part B - Cohort 1: 18 to 85 years of age
1 of 11
Part A - Cohort 3: 18 to 55 years of age
1 of 11
Part B - Cohort 6: 18 to 85 years of age
1 of 11
Part A - Cohort 1: 18 to 55 years of age
1 of 11
Part A - Cohort 6: 18 to 55 years of age
1 of 11
Part A - Cohort 5: 18 to 55 years of age
1 of 11
Experimental Treatment

This trial requires 1655 total participants across 11 different treatment groups

This trial involves 11 different treatments. BNT162b2 is the primary treatment being studied. Participants will be divided into 11 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Part B - Cohort 4: 18 to 85 years of age
Biological
Participants will receive 1 dose of BNT162b2 (B.1.617.2) of 30 µg.
Part A - Cohort 4: 18 to 55 years of age
Biological
Participants will receive 1 dose of BNT162b2 (B.1.617.2) of 30 µg.
Part C - Cohort 7: 18 to 85 years of age
Biological
Participants will receive 1 dose of BNT162b2 (B.1.1.529) of 30 µg.
Part A - Cohort 2: 18 to 55 years of age
Biological
Participants will receive 2 doses of BNT162b2 (B.1.1.7 + B.1.617.2) of 30 µg.
Part C - Cohort 8: 18 to 85 years of age
Biological
Participants will receive 1 dose of BNT162b2 of 30 µg.
Part B - Cohort 1: 18 to 85 years of age
Biological
Participants will receive 1 dose of BNT162b2 (B.1.1.7 + B.1.617.2) of 30 µg.
Part A - Cohort 3: 18 to 55 years of age
Biological
Participants will receive 1 dose of BNT162b2 (B.1.1.7) of 30 µg.
Part B - Cohort 6: 18 to 85 years of age
Biological
Participants will receive 3 doses of BNT162b2 (B.1.1.7 + B.1.617.2) of 30 µg.
Part A - Cohort 1: 18 to 55 years of age
Biological
Participants will receive 1 dose of BNT162b2 (B.1.1.7 + B.1.617.2) of 30 µg.
Part A - Cohort 6: 18 to 55 years of age
Biological
Participants will receive 3 doses of BNT162b2 (B.1.1.7 + B.1.617.2) of 30 µg.
Part A - Cohort 5: 18 to 55 years of age
Biological
Participants will receive 1 dose of BNT162b2 of 30 µg.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pfizer-BioNTech COVID-19 Vaccine
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: dose 1 to 1 month after the last dose
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly dose 1 to 1 month after the last dose for reporting.

Closest Location

California Research Foundation - San Diego, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
You have given informed consent before initiation of any trial-specific procedures. show original
Part A: 18 to 55 years old.
Part B and Part C: 18 to 85 years old (~60% should be 18 to 55 years old and ~40% 56 to 85 years old).
For Cohorts 1 to 5: In Part A, who have received BNT162b2 vaccine (30 µg, two-dose regimen) in either a clinical trial or as part of the governmental vaccination programs at least 6 months before Visit 0. Participants who are currently enrolled in the Phase III BNT162-02 / C4591001 trial, have already been unblinded, and have previously received two doses of BNT162b2 at least 6 months earlier can be included (for Cohorts 1 and 4 in Part B, prior enrollment and dosing in the BNT162-02 / C4591001 trial is mandatory). At enrollment into Part B of this trial, their participation in the BNT162-02 / C4591001 trial will be terminated. Participants should have not experienced COVID-19 based on medical history.
For Cohort 6: Are COVID-19 vaccine-naïve and have not experienced COVID-19 based on their medical history.
Are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other trial procedures.
Are overall healthy at Visit 0 in the clinical judgment of the investigator based on the medical history, clinical assessment (including physical examination, vital signs, blood and urine clinical laboratory tests, 12-lead electrocardiogram (ECG), and oral swab for Nucleic Acid Amplification-based Test (NAAT)-based Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) testing).
Note: Healthy volunteers with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 12 weeks before Visit 0, can be included.
Note: Volunteers who had hepatitis C (HCV) infection, but have completed curative treatment based on the medical history can be included. Volunteers who had or have hepatitis B (HBV) or human immunodeficiency virus (HIV) based on the medical history cannot be included.
You agree not to enroll in another trial of an IMP, starting after Visit 0 and continuously until the last planned visit in this trial. show original

Patient Q&A Section

What is covid-19?

"Given the current coronavirus outbreak, we discuss here the relevance of coronavirus to the public health of the world, and the urgency to use appropriate communication methods. Our present review further examines the viral transmission characteristics of the SARS-CoV-2 virus, which shed light on the pathogenesis of the viral disease epidemic." - Anonymous Online Contributor

Unverified Answer

How many people get covid-19 a year in the United States?

"There is no currently available evidence suggesting that people with a recent history of or current COVID-19 infection are more likely to develop symptoms of COVID-19, to develop severe or life-threatening complications of COVID-19, or to be hospitalized with COVID-19. A small subset of adults may experience transient or asymptomatic infection; individuals who develop acute symptoms of COVID-19 should receive adequate follow-up as usual. There was an asymptomatic but substantial proportion of reported COVID-19 infections among healthy adults who were neither required to treat or evaluated." - Anonymous Online Contributor

Unverified Answer

What are the signs of covid-19?

"Patients with COVID-19 present with symptoms or signs which can be suggestive of any of the illnesses they have had contact with previously, including: fever, cough, muscle pain, fatigue and myalgia, headache, vomiting, diarrhea, pneumonia, and abdominal pain and tenderness or bloating. There is a high rate of coexisting illnesses which should be considered in diagnosing patients with confirmed COVID-19 or suspicion of COVID-19 infections." - Anonymous Online Contributor

Unverified Answer

Can covid-19 be cured?

"Covid-19 can be cured. In light of the ongoing coronavirus outbreak, a new type of infectious disease might be encountered, and a disease-sorting strategy might be necessary, if we could eradicate it from the human population by vaccines or drugs." - Anonymous Online Contributor

Unverified Answer

What are common treatments for covid-19?

"Findings from a recent study demonstrated that the prevalence of cough has significantly increased in the outpatient department during the 2019-20 coronavirus epidemic, and the most commonly prescribed medications were Oseltamivir, Paracetamol, and Ipratropium." - Anonymous Online Contributor

Unverified Answer

What causes covid-19?

"Many animals, including cattle, camels, wild and domestic animals, wild and domesticated pigs, waterfowls, monkeys, bats and some other animals are susceptible to the disease. Other than human infections (e.g. direct droplet or close contact transmission), the virus can also be transmitted between humans through direct contact with any of the previously infected mammals and it has the potential to spread from human to human in a manner similar to HIV/AIDS.\n\n- "

"Erythranol palmitate\n\nErythranol palmitate is a member of the stanol series of carotenoids." - Anonymous Online Contributor

Unverified Answer

Has bnt162b2 proven to be more effective than a placebo?

"Results from a recent clinical trial show for the first time an overall superiority against a placebo group of the investigational drug bnt162b2 in comparison to current standard care. Both studies underscore the potential for a low toxicity safety profile and highlight the importance of patient selection based on clinical manifestations." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of covid-19?

"(a) The H7N9 epidemic began at the end of January 2019 when the Ministry of Health advised travelers to the Hubei Province and started quarantining those coming from Hubei within 4 days, and (b) as of 28 December, more than 10 years after it became human, it has turned out to be the primary cause of this epidemic among human beings, with the Hubei virus being the main one in the primary human-to-human transmissions." - Anonymous Online Contributor

Unverified Answer

Is bnt162b2 safe for people?

"Bnt162b2 was well tolerated and safe when administered across multiple dosages by intravenous, intramuscular, or subcutaneous routes, and no evidence of pharmacokinetic interaction or safety concern was observed for the Bnt162b2 drug." - Anonymous Online Contributor

Unverified Answer

How serious can covid-19 be?

"Based on the numbers reported in the literature, approximately 1 in 4 of those who develop symptomatic infection will have a fatal outcome. Given the complexity of diagnosing the disease, and the fact that many infected people are asymptomatic, it is possible that this number is an underestimate, indicating the possible seriousness of the disease. At this time, there is no evidence that it is more likely to become serious in those with other underlying diseases. More work is urgently required to find effective treatments and to improve diagnostics." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in bnt162b2 for therapeutic use?

"The bnRNA bnt162b2 is a novel and efficacious anti-HCV agent which has the potential to offer a novel therapeutic lead and a new therapeutic strategy for HCV infection." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for covid-19?

"Most patients and medical providers will not pursue a clinical trial for the coronavirus, and even those who would consider it will be slow to consider it. Thus, clinical trials may not be the answer, and clinical trial participation should be made widely available in all settings to ensure equitable access for those who want to participate." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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