New NIH Study on RNA Vaccine Candidates Against COVID-19
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 3 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;
- As a booster;
- 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 efficacy evaluation in Phase 2/3 is BNT162b2 at a dose of 30 µg. Participants who originally received placebo will be offered the opportunity to receive BNT162b2 at defined points as part of the study. In order to describe the boostability of BNT162, and potential heterologous protection against emerging SARS-CoV-2 VOCs, an additional dose of BNT162b2 at 30 µg will be given to Phase 1 participants approximately 6 to 12 months after their second dose of BNT162b1 or BNT162b2. This will provide an early assessment of the safety of a third dose of BNT162, as well as its immunogenic
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| SARS-CoV-2 InfectionCOVID-19 | Biological: BNT162b1Biological: BNT162b2Other: PlaceboBiological: BNT162b2SA | Phase 2Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 43998 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Prevention |
| Official Title: | A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS |
| Actual Study Start Date : | April 29, 2020 |
| Estimated Primary Completion Date : | May 2, 2023 |
| Estimated Study Completion Date : | May 2, 2023 |
The assessment of boostability will be further expanded in a subset of Phase 3 participants at selected sites in the US who will receive a third dose of BNT162b2 at 30 µg or a third and potentially a fourth dose of prototype BNT162b2VOC at 30 µg (BNT162b2s01, based upon the South African variant and hereafter referred to as BNT162b2SA). A further subset of Phase 3 participants will receive a third, lower, dose of BNT162b2 at 5 or 10 µg.
To further describe potential homologous and heterologous protection against emerging SARS-CoV-2 VOCs, a new cohort of participants will be enrolled who are COVID-19 vaccine-naïve (ie, BNT162b2-naïve) and have not experienced COVID-19. They will receive BNT162b2SA given as a 2-dose series, separated by 21 days.
Read the rest here: clinicaltrials.gov
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Garzog
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Participants who originally received placebo will be offered the opportunity to receive BNT162b2 at defined points as part of the study
And there’s the control group gone out the window!
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W
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Had it, cured it, no pharmaceuticals or vaccines necessary.
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Lunatictoctarian
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Had what?
Someone just arbitrarily classified your health status as “covid”.
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Tom
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Who doesn’t think that this study will be fake and yet be used to further big pharma’s injection parade of death? Trials, safety, efficacy and informed consent mean nothing and are not part of the mRNA injection fantasy. Profits at all costs is the only thing big pharma cares about.
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