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

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

Interventions

BIOLOGICAL

BIBP (CNBG, Sinopharm) WIV

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

BIOLOGICAL

CanSinoBIO

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

BIOLOGICAL

AstraZeneca ChAdOx

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

Sponsors & Collaborators

• Coalition for Epidemic Preparedness Innovations

  collaborator OTHER

• University of Oxford

  collaborator OTHER

• International Vaccine Institute

  collaborator OTHER

• Harvard Medical School (HMS and HSDM)

  collaborator OTHER

• Chughtai Lab

  collaborator UNKNOWN

• National Institute of Health, Pakistan

  collaborator UNKNOWN

• Aga Khan University Hospital, Pakistan

  lead OTHER

Principal Investigators

• Farah Qamar · Aga Khan University Hospital, Pakistan (AKU)

• Tahir Yousafzai · Aga Khan University Hospital, Pakistan (AKU)

• Zahra Hassan · Aga Khan University Hospital, Pakistan (AKU)

• Junaid Iqbal · Aga Khan University Hospital, Pakistan (AKU)

• Kiran Iqbal · Aga Khan University Hospital, Pakistan (AKU)

• Sonia Qureshi · Aga Khan University Hospital, Pakistan (AKU)

• Maria Fletcher · Aga Khan University Hospital, Pakistan (AKU)

• Najeeha Iqbal · Aga Khan University Hospital, Pakistan (AKU)

• Momin Kazi · Aga Khan University Hospital, Pakistan (AKU)

• Shazia Sultana · Aga Khan University Hospital, Pakistan (AKU)

• Andrew Pollard · University of Oxford

• Matthew Snape · University of Oxford

• Teresa Lambe · University of Oxford

• Xinxue Liu · University of Oxford

• Anh Wartel · International Vaccine Institute (IVI), Korea

• Jean-Louis Excler · International Vaccine Institute (IVI), Korea

• Deok-Ryun Kim · International Vaccine Institute (IVI), Korea

• Galit Alter · Ragon Institute, Harvard School of Medicine, USA

• Aamir Ikram · National Institute of Health (NIH) Pakistan

• Ghazala Parveen · National Institute of Health (NIH) Pakistan

• Firdous Nawaz Khan · National Institute of Health (NIH) Pakistan

• Omera Naseer · National Institute of Health (NIH) Pakistan

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-03-01

Primary Completion

2024-06-30

Completion

2024-06-30

Countries

• Pakistan

Study Locations