Phase 3 Clinical Trial to evaluate the Immunogenicity and Safety of Covid19 Recombinant RBD Protein Vaccine (Noora Vaccine) as a Booster Vaccine after injection of existing Vaccines in IRAN

Evaluation of Immunogenicity and safety of Noora vaccine as a booster.

This clinical trial is designed as a hybrid (in the form of two separate trials) in phase 3: ّ First A randomized, double blind clinical trial with two parallel groups and a single center with a sample size of 300 people. Second A multicenter and single arm clinical trial comparing before and after injection of booster vaccine with a sample size of 10000 people.

The first part in the single center of Shahid Soleimani will be randomly double blind with parallel groups to check the immunogenicity . Blinding ratio will be 1: 2 and the volunteer, researcher and executive staff are unaware of the nature of the injection. The second ward will be in one of the 10 affiliated centers of Baqiyatallah Hospital, before and after. After injection, possible allergic reactions and other reactions will be recorded.

Inclusion criteria include: over 18 years of age, candidates who have received two identical doses of the specified approved vaccine by MOH, and at least 3 months after the second dose, fully understand the provisions of the consent form and sign it. Exclusion criteria include: COVID19 infection in the past two months, quarantine, history of certain diseases, medication received in the last 3 months, receiving immunoglobulin or blood products in the previous 3 months, pregnant women Or breastfeeding or intending to pregnancy

Including two intervention groups 1) Injection of 80 μg of recombinant RBD protein vaccine 2) Injection of a placebo dose

Primary Outcomes: Comparison of antibody levels in a sample of 300 volunteers on days 0 and 21 after injection. Cell immune response to booster dose and measurement of neutralized antibody level in 90 subgroups.

In this study, Randomization process in immunogenicity assessment section is performed one step before the onset of recruitment. For this purpose, 60 random block sequences with size 6 will be produced so that for every 4 volunteers receiving the recombinant vaccine, 2 volunteers will receive placebo. There is no randomization process in the safety assessment section which will be performed before and after.

The blinding process in the immunogenicity assessment section of this study, which will be performed on a sample size of 300 people, is performed in a double-blind manner. For this purpose, the placebo is exactly the same as the vaccine and is prepared by the manufacturer with the same volume, color and other specifications and will be labeled by an independent group based on randomization codes. Obviously, the researchers, the evaluation team of the volunteers, the vaccinators and the volunteers will be completely unaware of the type of product received. In the safety assessment section (on a sample size of 10000 people), the study will be open labeled and the blinding process will not be used.

There is not a plan to make this available

Data will be available to regulatory bodies and the ethics committee

The protocol and results will become available to the public after completion of the study.

The regulatory body and the ethics committee will have access to the study data. The monitoring team will have access to the study data during the conduct. DSMB will have access to the study data and results in predefined timelines and decides about the continuation of the study.

With the permission of the sponsor and the approval of regulatory

The study sponsor is responding to this request

Relevant applications will be provided to the requesting researcher in the form of a joint project after review and approval by the relevant authorities. Normally between 3 to 5 working days