Comparison of the safety and efficacy of Razi SARS-CoV-2 recombinant Spike protein (Razi Cov Pars) and Sinopharm vaccines

Phase 3

Conditions: Acute Respiratory Distress Syndrome due to SARS-CoV-2.
COVID-19, virus identified
U07.1

Registration Number: IRCT20201214049709N3

Lead Sponsor: Razi Vaccine and Serum Research Institute

Brief Summary: Background: We conducted a phase III, non-inferiority trial comparing safety and efficacy of RCP recombinant spike protein Covid-19 vaccine to BBIBP (Sinopharm). Methods: Adult Iranian population received RCP or BBIBP in a randomized, double blind and an additional non-randomized open labeled trial arms. Eligible participants signed a written informed consent and received two intramuscular injections three weeks apart. In the randomized arm, an intranasal dose of vaccine or adjuvant-only preparation were given to the RCP and BBIBP recipients at day 51 respectively. Participants were actively followed for up to 4 months for safety and efficacy outcomes. Primary outcome was PCR + symptomatic Covid-19 disease two weeks after the second dose. The non-inferiority margin was 10% of reported BBIBP vaccine efficacy (HR = 1.36). Results: We recruited 23,110 participants (7224 in the randomized and 15,886 in the nonrandomized arm). We observed 604 primary outcome events during 4 months of active followup including 121 and 133 in the randomized and 157 and 193 cases in the non-randomized arms among recipients of RCP and BBIBP respectively. Adjusted hazard ratios for the primary outcome in those receiving RCP compared with BBIBP interval were 0.91 (0.71–1.16) and 0.62 (0.49–0.77) in the randomized and non-randomized arms respectively. The upper boundary of 99.1% confidence interval of HR = 0.91 (0.67–1.22) remained below the margin of noninferiority in the randomized arm after observing the early stopping rules using O’Brien Fleming method. Conclusion: Our study showed that the RCP efficacy is non-inferior and its safety profile is comparable to the BBIBP.

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 41128

Inclusion Criteria

18 years of age or older;
Having access to internet and smart phone;
No current COVID-19;
No pregnancy;
No plan to have children in the next 6 months and willing to use at least one effective method of contraception;
Signed informed consent form.

Exclusion Criteria

Any current or new diagnosis of acute or chronic illness requiring continuous ongoing medical care
Breastfeeding;
History of receiving any COVID -19 vaccine;
Received blood and/or any blood products and/or immunoglobulins within three months preceding the screening day;
Long-term use of immunosuppressive drugs or systemic corticosteroids within the past 4 months;
History of allergic diseases such as angioedema or anaphylactic reactions to any drug, vaccine or food;
Recent diagnosis or treatment of cancers except basal cell carcinoma and In-situ cervical cancer
History of uncontrolled serious psychiatric illnesses;
History of blood disorders (dyscrasia, coagulopathy, platelet deficiency or disorder, or deficiency of blood clotting factors);
History of chronic neurological diseases (including seizures and epilepsy);
Current substance or alcohol abuse;
Splenectomy for any reason;
Close contact with a confirmed COVID-19 case within two weeks before the first vaccine dose;
History of diagnosis or treatment for HIV;
Chronic unstable diseases in the last 4 weeks, including hospitalization due to surgery, deterioration of one organ function, the need to add new drugs or serious dose adjustments to existing drugs.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of any symptomatic confirmed COVID-19 disease: Number and percentage of confirmed COVID-19 disease two weeks after second vaccine dose. Timepoint: Any time between the 14 days after second vaccine dose and the end of study. Method of measurement: Diagnosis of COVID-19 disease will be based on Iran's Ministry of Health's guideline and a positive PCR test.

Secondary Outcome Measures