Evaluation of Full Versus Fractional Dose of COVID-19 Vaccine Given as a Booster for the Prevention of COVID-19 in Adults in Mongolia.

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

601 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-27

Study Completion Date

2024-11-06

Brief Summary

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This clinical trial is a single-blind, randomised study to determine the reactogenicity and immunogenicity of severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) vaccine (Pfizer-BioNTech) as booster dose in adults, who have previously received either Sinopharm (BBIBP-CorV®), AstraZeneca (ChAdOx1-S, or Vaxzevria®) or Sputnik V (Gam-COVID-Vac®) as their primary doses 6 to 9 months earlier. Both standard and fractional doses will be tested.

Participants are healthy adults aged 18 years or older, with no upper age limit. Procedures will be implemented to ensure participants of all ages (aged 18 and above) are included and that there is an even age distribution (\<50 and ≥50 years) in each group. There will be a total of 6 groups (Sinopharm-standard dose Pfizer, Sinopharm-fractional dose Pfizer, AstraZeneca-standard dose Pfizer, AstraZeneca-fractional dose Pfizer, Sputnik - standard dose Pfizer, Sputnik - fractional dose Pfizer), with 200 participants per group for Sinopharm and 100 for AstraZeneca and Sputnik.

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Detailed Description

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As per brief summary

Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Study participants who have received two doses of either Sinopharm, AstraZeneca or Sputnik vaccine as their primary vaccine will be randomised into one of two groups. The two groups consist of a standard or fractional dose of Pfizer vaccine.

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The participants and those evaluating reactogenicity will be blinded to the vaccine allocation for the first 28 days following vaccination. After that, both clinical investigators and participants will be aware of their investigational product allocation. Laboratory staff will remain blinded to the investigational product allocation during the immunology testing.

Study Groups

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Standard Pfizer-BioNTech booster group

Biological/Vaccine: Tozinameran - Standard Dose

Other Names:

BNT162b2 Comirnaty Pfizer Covid-19 vaccine

Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.

Group Type ACTIVE_COMPARATOR

Tozinameran - Standard Dose

Intervention Type BIOLOGICAL

Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.

Fractional Pfizer-BioNTech booster group

Biological/Vaccine: Tozinameran - Standard Dose

Other Names:

BNT162b2 Comirnaty Pfizer Covid-19 vaccine

Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Dose - 15 µg in 0.3 ml. Liquid for injection. Single dose.

Group Type EXPERIMENTAL

Tozinameran - Fractional Dose

Intervention Type BIOLOGICAL

Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.

Interventions

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Tozinameran - Standard Dose

Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.

Intervention Type BIOLOGICAL

Tozinameran - Fractional Dose

Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.

Intervention Type BIOLOGICAL

Other Intervention Names

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BNT162b2 Comirnaty Pfizer Covid-19 vaccine BNT162b2 Comirnaty Pfizer Covid-19 vaccine

Eligibility Criteria

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Inclusion Criteria

1. Have completed two doses of Sinopharm, AstraZeneca or Sputnik vaccines with the recommended schedule 6 months prior to the date of enrolment
2. Willing and able to give written informed consent
3. Aged 18 years or above
4. Willing to complete the follow-up requirements of the study

Exclusion Criteria

1. Received 3 doses of COVID-19 vaccine
2. Received 2 doses of COVID-19 less than 6 months prior to the start of the trial
3. Currently on immunosuppressive medication or anti-cancer chemotherapy
4. HIV infection
5. Congenital immune deficiency syndrome
6. Has received immunoglobulin or other blood products in the 3 months prior to vaccination
7. Study staff and their relatives
8. Have a history of a severe allergic reaction to any COVID-19 vaccines or have a medical exception to receiving further COVID-19 vaccines

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes