The Coalition for Epidemic Preparedness Innovations (CEPI) and the Aga Khan University (AKU) today announced a new collaboration to conduct a clinical trial of heterologous – or ‘mix-and-match’ - combinations of COVID-19 vaccines in Pakistan. CEPI will provide up to US$ 11.7 million of funding for the project to an international consortium led by AKU, comprising the National Institute of Health in Pakistan (NIH), University of Oxford, the International Vaccine Institute (IVI) and Harvard Medical School.
The clinical trial will assess the safety and immunogenicity of mix-and-match combinations of three vaccines that are currently being deployed in Pakistan, developed by AstraZeneca, Sinopharm and CanSinoBIO. Data on mix-and-match combinations of these vaccines, which are commonly used in low- and middle-income countries (LMICs), are urgently needed to contribute to the design of more flexible vaccination strategies and mitigate against shortages of vaccine at times of uncertain or fluctuating supplies. The trial will also generate valuable data on the immune response after vaccination to the different variants circulating in Pakistan. All of the data will be made available open source to inform policy makers and regulatory authorities’ recommendations on the use of COVID-19 vaccines.
The Phase 2 clinical trial will be conducted at established trial sites in the cities of Karachi, Lahore and Islamabad, Pakistan. Over 1,600 participants aged 18 years and over will be enrolled into the trial and randomised to receive either a homologous vaccine regimen (two doses of the same vaccine) or a mix-and-match combination of vaccines. All of the possible combinations of the three vaccines will be evaluated in the study. Trial participants will be followed up for two years to gather important data about the durability of immune responses and the impact of possible booster doses. The first interim results are expected to be available in the first quarter of 2022.
Dr Richard Hatchett, CEO of CEPI, said: “While multiple safe and effective COVID-19 vaccines are now in use around the world, additional R&D will help deliver the maximum public health benefit from every dose. The data generated by this clinical trial will contribute to our mission to enable equitable access by supporting the design of vaccination strategies which optimize the use of vaccines in LMICs. We are delighted to begin working with Dr. Qamar of the Aga Khan University, and the National Institute of Health in CEPI’s first partnership in Pakistan, in conjunction with our established partners at IVI and the University of Oxford.”
AKU's Dr Farah Naz Qamar, principal investigator of the clinical trial and associate professor in the University's department of paediatrics and child health, said: “Data generated from trials on mix-and-match COVID-19 vaccine combinations is important in informing effective COVID-19 vaccination policy in LMICs.”
Professor Aamer Ikram, executive director, National Institute of Health, Islamabad, Pakistan, said: “In the light of evolving requirements for COVID-19 vaccination by various countries, this study will bridge gaps in data and provide guidance about combinations of vaccines that are effective and safe.”
