mRNA Booster Vaccine(SW-BIC-213) Compared With Pfizer andSinopharm Against Emerging VOCs

NCT05686161 | Unknown Phase 3 DMC

• 1 other identifier: SWC310-1
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

Primary#Objectives #Immunogenicity:To demonstrate the non-inferiority of binding antibody response in terms of geometric mean titers (GMT) of mRNA vaccine compare with mRNA COVID-19 vaccine(Pfizer) 14 days post dose. Secondary#Immunogenicity:

1. 1.To describe binding antibody profile at D01, D29 and D181 of each study group.
2. 2.To describe the neutralizing antibody profile at D15, D29 and D181 of each study intervention group.

Conditions

Immunogenicity; Safety; Efficacy

Keywords

new generation mRNA vaccine

Outcome Measures

Primary Outcomes (1)

• Immunogenicity

  GMT of Anti-Spike IgG antibody titers will be measured with the ELISA assay on day1 , day 15

  day1, day15

Study Arms (3)

A single 25 μg dose mRNA vaccine SW-BIC-213

EXPERIMENTAL

Intervention Name :COVID-19 mRNA vaccine Type :Investigational Vaccine Dose :Formulation mRNA Unit Dose Strength(s) :0.5ml; Dosage Level(s) :0.25ml; Route of Administration: injection Intramuscular

Biological: SW-BIC-213;SARS-Cov-2.

A third dose of COVID-19 Inactivated vaccine

ACTIVE COMPARATOR

Intervention Name: COVID-19 Inactivated Vaccine Type : Control Vaccine Dose :Inactive Unit Dose Strength(s) : 0.5ml; Route of Administration: injection Intramuscular

Biological: Sinopharm (BIBP);SARS-Cov-2.

A single 30μg dose mRNA vaccine Pfizer(BNT162b2)

ACTIVE COMPARATOR

Type :mRNA COVID -19 vaccine - Pfizer(BNT162b2) Dose :Formulation mRNA Unit Dose Strength(s) :30ug; Dosage Level(s) :0.3ml; Route of Administration: injection Intramuscular

Biological: Pfizer(BNT162b2);SARS-Cov-2.

Interventions

SW-BIC-213;SARS-Cov-2. BIOLOGICAL

The study will be performed in people receiving two doses of Sinopharm vaccine over 180 days (± 30 days) after the second dose prior to enrollment. The three study groups who will receive the booster dose will be assigned as follows: Subjects (N≈600) Group 1: (N≈200) - Stemirna(SW-BIC-213) Group 2: (N≈200) - Pfizer(BNT162b2) Group 3: (N≈200) -Sinopharm (BIBP) Study groups: There will be three study groups. Study Group Assignment: Randomization (1:1:1) will be applied for subjects to account for the different number of doses per vial for different vaccines and short shelf life.

A single 25 μg dose mRNA vaccine SW-BIC-213

Sinopharm (BIBP);SARS-Cov-2. BIOLOGICAL

The study will be performed in people receiving two doses of Sinopharm vaccine over 180 days (± 30 days) after the second dose prior to enrollment. The three study groups who will receive the booster dose will be assigned as follows: Subjects (N≈600) Group 1: (N≈200) - Stemirna(SW-BIC-213) Group 2: (N≈200) - Pfizer(BNT162b2) Group 3: (N≈200) -Sinopharm (BIBP) Study groups: There will be three study groups. Study Group Assignment: Randomization (1:1:1) will be applied for subjects to account for the different number of doses per vial for different vaccines and short shelf life.

A third dose of COVID-19 Inactivated vaccine

Pfizer(BNT162b2);SARS-Cov-2. BIOLOGICAL

The study will be performed in people receiving two doses of Sinopharm vaccine over 180 days (± 30 days) after the second dose prior to enrollment. The three study groups who will receive the booster dose will be assigned as follows: Subjects (N≈600) Group 1: (N≈200) - Stemirna(SW-BIC-213) Group 2: (N≈200) - Pfizer(BNT162b2) Group 3: (N≈200) -Sinopharm (BIBP) Study groups: There will be three study groups. Study Group Assignment: Randomization (1:1:1) will be applied for subjects to account for the different number of doses per vial for different vaccines and short shelf life.

A single 30μg dose mRNA vaccine Pfizer(BNT162b2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is willing and able to give written informed consent for participation in the study.
• Male or Female, aged 18 years or above and in good health as determined by study clinician.
• Female participants of childbearing potential must be willing to ensure that they or their partner use effective contraception from 1 month prior to first immunization continuously until 3months after boost immunization.
• In the Investigator's opinion, is able and willing to comply with all trial requirements.
• Subjects had completed the 2-dose series vaccination of COVID-19 inactivated vaccine(Sinopharm) at least 24 weeks with the completed the 2-dose Series as the primary vaccination according to the product label.

You may not qualify if:

• The participant may not enter the study if ANY of the following apply:
• Confirmed cases, suspected cases or asymptomatic cases of COVID-19;
• Self-reported history of SARS and MERS infection;
• Receipt of live attenuated vaccine within one month prior to vaccination and other vaccines within 14 days prior to vaccination;
• Receipt of any SARS-COV-2 vaccine after last dose of primary vaccination
• Participants who are pregnant at enrolment or planning to become pregnant during the first 3 months following vaccination
• Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccines
• History of allergic disease or reactions likely to be exacerbated by any component of study vaccines
• Any history of anaphylaxis to any component of vaccine.
• Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or continuous use of anticoagulants (warfarin, apixaban, rivaroxaban, dabigatran, edoxaban), or prior history of significant bleeding or bruising following IM injections or venipuncture
• Suspected or known current alcohol or drug dependency
• Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data
• Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, and neurological illness (mild/moderate well controlled comorbidities are allowed)
• Scheduled elective surgery during the trial
• Other reasons investigators did not consider it appropriate to refer to clinical trials

Sponsors & Collaborators

• Stemirna Therapeutics: lead

Study Sites (1)

Savannakhét Provincial hospital

Savannakhet, Sava, Laos

Location

Study Officials

• Mayfong Mayxay, doctor

  National Ethics Committee for Health Research(NECHR)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This study uses an observer-blinded design, and the investigators and participants will all remain blinded before unblinding and do not know which group the participant belongs to.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: a randomized observer-blinded parallel controlled trial#Experimental group#mRNA vaccine# and positive control group#inactive vaccine#

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: January 17, 2023
• Study Start: October 19, 2022
• Primary Completion: December 7, 2022
• Study Completion: June 27, 2023
• Last Updated: January 17, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

LA (1)