Clinical trial NCT05049226: Third Dose Vaccination With AstraZeneca or Pfizer COVID-19 Vaccine Among Adults Received Sinovac COVID-19 Vaccine
Official title: A Randomized, Observer-blind Trial to Assess the Immunogenicity and Safety of Third Dose Vaccination With AstraZeneca COVID-19 Vaccine or Pfizer/BioNTech COVID-19 Vaccine Among Thai Adults Receiving Two Doses of Sinovac
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19 Infection
COVID-19 VACCINE
Keywords: COVID-19 Infection
COVID-19 Respiratory Infection
COVID-19 VACCINE
AstraZeneca COVID-19 VACCINE
AstraZeneca COVID-19 (ChAdOx1 AZD1222) vaccine
Pfizer/BioNTech COVID-19 VACCINE
Pfizer/BioNTech COVID-19 (BNT162b2) vaccine
Thai adults
full dose AstraZeneca COVID-19 VACCINE
half dose AstraZeneca COVID-19 VACCINE
full dose Pfizer/BioNTech COVID-19 VACCINE
half dose Pfizer/BioNTech COVID-19 VACCINE
Sinovac COVID-19 Vaccine
immunogenicity
safety
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: Clinixir Co., Ltd.
name: Program Management Unit-C (PMU-C), governed by Ministry of Higher Education, Science, Research and Innovation (MHESI)
First posted: 2021-09-20
Enrollment: 1250
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This prospective, multi-center, randomized, observer-blind Phase 2 study. A total of 1320 participants will be divided into 2 groups (660 each) receiving either full dose or half dose of either AZ or PF.

Each group is further stratified into 3 subgroups according to three interval duration in term of days after second dose of SV for 60 to less than 90 days, 90 to less than120 days and 120 to 180 days. Each group will be randomized to receive either AZ or PF in 1:1 ratio.

Subjects who fulfilled eligibility criteria will be randomly assigned to receive either full dose or half dose of AZ or PF in 1:1 ratio as an IM injection in the deltoid muscle at Visit 1 (V1). Subjects will be follow-up for assessing immunity at day 28 (V3), day 60 (V4) and day 90 (V5) and for safety at day 7 (V2), day 28 (V3), day 60 (V4) and day 90 (V5). At least 50% from each subgroup will be randomly selected to provide additional blood at baseline (V1, day 0) and day 28 (V3) to be used for assessment of T-cell-mediated immunity (CMI)

Detailed description: This study has been designed to assess immune response and safety of third dose vaccination with AstraZeneca ChAdOx1AZD1222 vaccine or Pfizer/BioNTech BNT162b2 vaccine among Thai subjects who have received two doses of Sinovac.

The types of vaccines provided by the government included 7.7 million doses of inactivated vaccine manufactured by Sinovac and 6.5 million doses of AstraZeneca ChAdOx1 AZD1222 vaccine.

With the limited supplies of COVID vaccines in many regions of the world especially in LMIC including Thailand and the evidences of waning immunity of especially inactivated vaccine have raised the concerns whether third dose is needed.

The third dose that available now in Thailand are AstraZeneca ChAdOx1AZD1222 vaccine (AZ)/ Pfizer/BioNTech BNT162b2 vaccine (PF) and whether this can be provided with half dose so that the vaccination coverage is going to be higher in spite of limited vaccine supplies.

A number of studies have proved that COVID-19 vaccines are effective at preventing people from getting severe COVID-19 disease. However, the vaccines do not only reduce the chance of infection, but they also help to mitigate disease severity.

Study population: Male and female adults aged equal or more than 20 years who received two doses of Inactivated COVID-19 vaccine developed by Sinovac (given at 21-28 days apart) at different intervals of 60 to less than 90 days, 90 to less than120 days and 120 to 180 days

This prospective, multi-center, randomized, observer-blind Phase 2 study, A total of 1320 participants will be divided into 2 groups (660 each) receiving either full dose or half dose of either AZ or PF.

Each group is further stratified into 3 subgroups according to three interval duration in term of days after second dose of SV for 60-less than 90 days, 90-less than120 days and 120-180 days respectively. Subjects who fulfilled eligibility criteria will be randomly assigned to receive either full dose or half dose of AZ or PF in 1:1 ratio as an IM injection in the deltoid muscle at Visit 1 (V1).

All participants will be randomized based on dose given either full dose or half dose and further stratify accordingly by Interactive web-based response system (IWRS). There will be unblinded team which consists of pharmacist and nurse who will give injection. All the safety assessment will be performed independently by clinical team.

Subjects will be follow-up for assessing immunity at day 28 (V3), day 60 (V4) and day 90 (V5) and for safety at day 7 (V2), day 28 (V3), day 60 (V4) and day 90 (V5).

Eligibility criteria: Inclusion Criteria:

1. Adult male or female age equal or more than 20 years with Thai ID cards
2. Received two doses (21-28 days apart) of Sinovac inactivated COVID-19 vaccine who will be divided according to their intervals 60-less than 90 days, 90-less than120 days and 120-180 days
3. Has provided written informed consent prior to performance of any study-specific procedure
4. No history of fever or PUI symptoms within 7 days

Exclusion Criteria:

1. Any confirmed or suspected immunosuppressive or immunodeficient state.
2. Contraindication to AZ or PF according to labelling of the products
3. History of COVID infection within 3 months period
4. Pregnancy

Primary outcomes:
measure: GMT Anti-S IgG at baseline and after vaccination
timeFrame: Day 0, Day 28, Day 60 and Day 90
measure: GMFR changed from baseline in anti-S IgG GMT after vaccination
timeFrame: Day 28, Day 60 and Day 90
measure: Anti-S IgG Seroresponses changed from baseline after vaccination
timeFrame: Day 28, Day 60 and Day 90
measure: GMT against SARS-Cov-2 pseudovirus (PVNT) Neutralizing antibody titer 50 at baseline and after vaccination
timeFrame: Day 0, Day 28 and Day 90
measure: GMFR changed from baseline in NT50 against SARS-CoV-2 pseudovirus after vaccination
timeFrame: Day 28 and Day 90
measure: Frequency of solicited reportable local adverse event after vaccination
timeFrame: Day 0 through Day 7
measure: Frequency of solicited reportable systemic adverse event after vaccination
timeFrame: Day 0 through Day 7
measure: Frequency of all unsolicited AEs
timeFrame: Day 0 through Day 28
measure: Frequency of SAEs
timeFrame: Day 0 through Day 90
Secondary outcomes:
measure: NT50 GMT against SARS-Cov-2 by micro neutralization assay at baseline and day 28 and day 90 after vaccination
timeFrame: Day 0, Day 28 and Day 90
measure: GMFR changed from baseline in NT50 against SARS-CoV-2 (micro NT Delta/WT NA) at 28 and 90 days after vaccination among those positives by PNT assay
timeFrame: Day 28 and Day 90
measure: NT50 seroresponses against SARS-CoV-2 using micro NT changed from baseline at 28 and 90 days after vaccination among those positive by PVNT assay
timeFrame: Day 28 and Day 90
Other outcomes:
measure: S protein-specific T cells response at baseline, 28 days after vaccination given at different intervals
timeFrame: Day 28
measure: Seroresponse against SARS-CoV-2 pseudovirus towards Omicron strains at baseline, 28 and 90 days after vaccination
timeFrame: Day 0, 28 and 90
measure: NT50 GMT against SARS-Cov-2 pseudovirus (pVNT) Omicrron strain at baseline 28 and 90 days after vaccination
timeFrame: Day 0, 28 and 90
measure: GMFR changed from baseline in NT50 against SARS-CoV-2 pseudovirus (pVNT), Omicron strain at 28 and 90 days after vaccination
timeFrame: Day 28, 90
Locations:
city: Bangkok Noi
country: Thailand
facility: Faculty of Medicine Siriraj Hospital, Mahidol University
state: Bangkok
city: Pathum Wan
country: Thailand
facility: Faculty of Medicine Chulalongkorn University
state: Bangkok
city: Khlong Luang
country: Thailand
facility: Faculty of Medicine Thammasat University
state: Pathum Thani
city: Bang Phli
country: Thailand
facility: Chakri Naruebodindra Medical Institute, Faculty of Medicine Ramathibodi hospital, Mahidol University
state: Samut Prakan
city: Hat Yai
country: Thailand
facility: Faculty of Medicine, Prince of Songkla University
state: Songkla
city: Chiang Mai
country: Thailand
facility: Faculty of Medicine, Chiang Mai University
city: Khon Kaen
country: Thailand
facility: Faculty of Medicine, Khon Kaen University
Study officials:
affiliation: Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University
name: Punnee Pitisuttithum, MD
role: STUDY_CHAIR
affiliation: Faculty of Medicine, Khon Kaen University
name: Atibordee Meesing, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Medicine, Chiang Mai University
name: Romanee Chaiwarith, MD,MHS
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Medicine, Prince of Songkla University
name: Sarunyou Chusri, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Medicine, Thammasat University
name: Sira Nanthapisal, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chakri Naruebodindra Medical Institute, Faculty of Medicine Ramathibodi hospital,Mahidol University
name: Suppachok Kirdlarp, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mahidol University
name: Suvimol Niyomnaitham, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chulalongkorn University
name: Sarawut Siwamogsatham, MD
role: PRINCIPAL_INVESTIGATOR
References: