Combination Assessment Trial of COVID-19 Vaccines (COMBAT-COVID)

NCT05162482 | Unknown Phase 2 DMC

• 1 other identifier: 6739
• Study Type: interventional
• Target: 1,680
• Locations: 1 country
• Sites: 3

Brief Summary

This is a randomized, phase II trial which will be conducted among volunteers aged 18 years and above in Karachi, Lahore and Islamabad, Pakistan. The trial will have nine arms and is an open label study. Trained persons will administer the vaccine and draw blood under strict aseptic measures. The immune responses using pseudo neutralizing antibodies against SARS-CoV-2 in COVID-19 seronegative participants receiving heterologous and homologous COVID-19 vaccines will be assessed. Anti-spike IgG antibodies by ELISA and pseudo neutralizing antibodies against SARS-CoV-2 will also be measured. The safety and reactogenicity will also be assessed by recording serious adverse events (SAE), adverse events of special interest (AESI), solicited local and systemic reactions and medically attended adverse reactions through biochemical and hematological tests or safety measures throughout the study. In most cases the adverse events are mild and self-limiting but can require medication and/or hospitalization in rare cases. Participants suffering from any adverse event causally related to the to the trial intervention will be facilitated and the cost of treatment including laboratory investigations will be provided to them. Data confidentiality will be ensured by delinking names in forms and through password protection.

Conditions

COVID 19 Vaccine

Outcome Measures

Primary Outcomes (1)

• Primary Endpoint

  Anti-spike IgG antibodies by ELISA will be measured in serum

  At weeks 14 and 38

Secondary Outcomes (18)

• Secondary Endpoint 1a

  Through study completion, an average of 2 and a half years

• Secondary Endpoint 1b

  Within 7 days post each dose

• Secondary Endpoint 1c

  Within 28 days post each dose

• Secondary Endpoint 1d

  Up to 3 months post booster dose

• Secondary Endpoint 1e:1

  From baseline to 4 weeks post each dose

Other Outcomes (5)

• Exploratory Endpoint 1a

  Within 1 week of breakthrough infection among the participants

• Exploratory Endpoint 1b

  Througout the study

• Exploratory Endpoint 1c

  Througout the study

Study Arms (9)

Heterologous 1

ACTIVE COMPARATOR

BIBP (CNBG, Sinopharm) WIV (0.5ml) at baseline CanSinoBIO (0.5ml) after 70±7 days (10 wks±2) (160 participants)

Biological: BIBP (CNBG, Sinopharm) WIV; Biological: CanSinoBIO

Heterologous 2

ACTIVE COMPARATOR

BIBP (CNBG, Sinopharm) WIV (0.5ml) at baseline AstraZeneca ChAdOx (0.5ml) after 70±7 days (10 wks±2) (160 participants)

Biological: BIBP (CNBG, Sinopharm) WIV; Biological: AstraZeneca ChAdOx

Heterologous 3

ACTIVE COMPARATOR

CanSinoBIO (0.5ml) at baseline BIBP (CNBG, Sinopharm) WIV (0.5ml) after 70±7 days (10 wks±2) (160 participants)

Biological: BIBP (CNBG, Sinopharm) WIV; Biological: CanSinoBIO

Heterologous 4

ACTIVE COMPARATOR

CanSinoBIO (0.5ml) at baseline AstraZeneca ChAdOx (0.5ml) after 70±7 days (10 wks±2) (160 participants)

Biological: CanSinoBIO; Biological: AstraZeneca ChAdOx

Heterologous 5

ACTIVE COMPARATOR

AstraZeneca ChAdOx (0.5ml) at baseline BIBP (CNBG, Sinopharm) WIV(0.5ml) after 70±7 days (10 wks±2) (160 participants)

Biological: BIBP (CNBG, Sinopharm) WIV; Biological: AstraZeneca ChAdOx

Heterologous 6

ACTIVE COMPARATOR

AstraZeneca ChAdOx (0.5ml) at baseline CanSinoBIO (0.5ml) after 70±7 days (10 wks±2) (160 participants)

Biological: CanSinoBIO; Biological: AstraZeneca ChAdOx

Homologous 7

ACTIVE COMPARATOR

BIBP (CNBG, Sinopharm) WIV (0.5ml) at baseline BIBP (CNBG, Sinopharm) WIV (0.5ml) after 70±7 days (10 wks±2) Full dose booster: 80 participants (0.5ml) 6 months after second dose Fractional dose booster: 80 participants (dose to be decided) 6 months after second dose No booster: 80 participants (240 participants)

Biological: BIBP (CNBG, Sinopharm) WIV

Homologous 8

ACTIVE COMPARATOR

CanSinoBIO (0.5ml) at baseline CanSinoBIO (0.5ml) after 70±7 days (10 wks±2) Full dose booster: 80 participants (0.5ml) 6 months after second dose Fractional dose booster: 80 participants (dose to be decided) 6 months after second dose No booster: 80 participants (240 participants)

Biological: CanSinoBIO

Homologous 9

ACTIVE COMPARATOR

AstraZeneca ChAdOx (0.5ml) at baseline AstraZeneca ChAdOx (0.5ml) after 70±7 days (10 wks±2) Full dose booster: 80 participants (0.5ml) 6 months after second dose Fractional dose booster: 80 participants (dose to be decided) 6 months after second dose No booster: 80 participants (240 participants)

Biological: AstraZeneca ChAdOx

Interventions

BIBP (CNBG, Sinopharm) WIV BIOLOGICAL

BIBP (CNBG, Sinopharm) WIV (Whole Inactivated Virus in a single dose, prefilled syringe with a storage temperature of 2-8°C)

Heterologous 1; Heterologous 2; Heterologous 3; Heterologous 5; Homologous 7

CanSinoBIO BIOLOGICAL

CanSinoBIO (Viral Vector in a single dose, prefilled syringe with a storage temperature of 2-8°C)

Heterologous 1; Heterologous 3; Heterologous 4; Heterologous 6; Homologous 8

AstraZeneca ChAdOx BIOLOGICAL

AstraZeneca ChAdOx (Viral Vector in a multi-dose vial consisting of 10 doses with a storage temperature of 2-8°C)

Heterologous 2; Heterologous 4; Heterologous 5; Heterologous 6; Homologous 9

Eligibility Criteria

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

You may qualify if:

• \- Adult male and female volunteers aged 18 years and above and volunteers with well controlled mild or moderate comorbidities will be enrolled to participate in trial.
• Participant is willing and able to give written informed consent for participation in the trial.
• Male or Female aged 18 years or above and in good health as determined by a trial clinician. Participants may have well controlled mild-moderate comorbidity.
• In the Investigator's opinion, is able and willing to comply with all trial requirements.
• Residing in the study areas.

You may not qualify if:

• The participant may not enter in the trial if ANY of the following apply:
• Pregnant women or those who are planning to conceive within next 70 days.
• Women who are breast feeding
• Already received any COVID-19 vaccine or any other vaccine likely to impact on interpretation of the trial data (e.g., Adenovirus vectored vaccines).
• Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccines.
• Any confirmed or suspected immunosuppressive or immunodeficient state; asplenia; recurrent severe infections and use of immunosuppressant medication within the past 6 months, except topical steroids or short-term oral steroids (course lasting ≤14 days)
• History of allergic disease or reactions likely to be exacerbated by any component of study vaccines (e.g., hypersensitivity to the active substance of the COVID-19 vaccines included in the study groups
• Any history of anaphylaxis.
• Current diagnosis of or treatment for cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
• Bleeding disorder (e.g., factor deficiency, coagulopathy, or platelet disorder), or prior history of thrombotic events and/or significant bleeding or bruising following IM injections or venipuncture.
• Continuous use of anticoagulants, such as coumarins and related anticoagulants (i.e., warfarin)
• 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)
• History of laboratory confirmed COVID-19 within 6 months prior to enrolment (history of SARS-CoV-2 detection by PCR or antibody to SARS-CoV-2).
• Scheduled elective surgery during the trial.

Sponsors & Collaborators

• Aga Khan University Hospital, Pakistan: lead
• Coalition for Epidemic Preparedness Innovations: collaborator
• University of Oxford: collaborator
• International Vaccine Institute: collaborator
• Harvard Medical School (HMS and HSDM): collaborator
• Chughtai Lab: collaborator
• National Institute of Health, Pakistan: collaborator

Study Sites (3)

National Institute of Health

Islamabad, Punjab Province, Pakistan

Location

Chughtai Lab

Lahore, Punjab Province, Pakistan

Location

Aga Khan University

Karachi, Sindh, Pakistan

Location

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Related Links

• Patel D. Poverty in Pakistan: Numerous efforts, many numbers, not enough results 2015

Study Officials

• Farah Qamar

  Aga Khan University Hospital, Pakistan (AKU)

  PRINCIPAL INVESTIGATOR

• Tahir Yousafzai

  Aga Khan University Hospital, Pakistan (AKU)

  STUDY DIRECTOR

• Zahra Hassan

  Aga Khan University Hospital, Pakistan (AKU)

  STUDY DIRECTOR

• Junaid Iqbal

  Aga Khan University Hospital, Pakistan (AKU)

  STUDY DIRECTOR

• Kiran Iqbal

  Aga Khan University Hospital, Pakistan (AKU)

  STUDY DIRECTOR

• Sonia Qureshi

  Aga Khan University Hospital, Pakistan (AKU)

  STUDY DIRECTOR

• Maria Fletcher

  Aga Khan University Hospital, Pakistan (AKU)

  STUDY DIRECTOR

• Najeeha Iqbal

  Aga Khan University Hospital, Pakistan (AKU)

  STUDY DIRECTOR

• Momin Kazi

  Aga Khan University Hospital, Pakistan (AKU)

  STUDY DIRECTOR

• Shazia Sultana

  Aga Khan University Hospital, Pakistan (AKU)

  STUDY DIRECTOR

• Andrew Pollard

  University of Oxford

  STUDY DIRECTOR

• Matthew Snape

  University of Oxford

  STUDY DIRECTOR

• Teresa Lambe

  University of Oxford

  STUDY DIRECTOR

• Xinxue Liu

  University of Oxford

  STUDY DIRECTOR

• Anh Wartel

  International Vaccine Institute (IVI), Korea

  STUDY DIRECTOR

• Jean-Louis Excler

  International Vaccine Institute (IVI), Korea

  STUDY DIRECTOR

• Deok-Ryun Kim

  International Vaccine Institute (IVI), Korea

  STUDY DIRECTOR

• Galit Alter

  Ragon Institute, Harvard School of Medicine, USA

  STUDY DIRECTOR

• Aamir Ikram

  National Institute of Health (NIH) Pakistan

  STUDY DIRECTOR

• Ghazala Parveen

  National Institute of Health (NIH) Pakistan

  STUDY DIRECTOR

• Firdous Nawaz Khan

  National Institute of Health (NIH) Pakistan

  STUDY DIRECTOR

• Omera Naseer

  National Institute of Health (NIH) Pakistan

  STUDY DIRECTOR

Central Study Contacts

Farah Qamar

CONTACT

02134865035; farah.qamar@aku.edu

Tahir Yousafzai

CONTACT

02134864031; tahir.yousafzai@aku.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: December 17, 2021
• Study Start: March 1, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: February 18, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (3)