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Effectiveness of Covid-19 Vaccination in Eswatini Against SARS-CoV-2 Associated Hospitalization and Death

CompletedPhase 4

Sponsor: Shabir Madhi

Conditions: COVID-19, Pneumonia, Viral

Interventions: AZD1222

Countries: Eswatini

Since late December 2019, the novel human coronavirus (SARS-CoV-2) first reported in China, has spread worldwide. Vaccines to prevent SARS-CoV-2 infections have been developed in record time and several candidate vaccines have completed Phase 2a/b and Phase 3 clinical trials. Coronaviruses (CoVs) are spherical, enveloped viruses with positive-sense single-stranded RNA genomes. One fourth of their genome is responsible for coding structural proteins, such as the Spike (S) glycoprotein, envelope, membrane, and nucleocapsid proteins. Envelope, membrane, and nucleocapsid proteins are mainly responsible for virion assembly whilst the S protein is involved in receptor binding, mediating virus entry into host cells during CoVs infection via different receptors. SARS-CoV-2 belongs to the phylogenetic lineage B of the genus Betacoronavirus and it recognizes the ACE2 as the entry receptor. It is the seventh CoV known to cause human infections and the third known to cause severe disease after SARS-CoV and MERS-CoV. AZD1222 is a recombinant replication-defective chimpanzee adenovirus vaccine expressing the SARS-CoV-2 S surface glycoprotein. Development of AZD1222, previously referred to as ChAdOx1 nCoV-19, was initiated by the University of Oxford, UK, with subsequent transfer of development activities to AstraZeneca. The ChAdOx1 platform has been used in 14 clinical studies sponsored by the University of Oxford with immunogens from multiple pathogens such as influenza, tuberculosis, malaria, chikungunya, Zika, MERS-CoV, and Meningitis B. Over 360 healthy adult participants have received ChAdOx1-vectored vaccines in these studies. These vaccines demonstrated robust immunogenicity after a single dose and favourable safety profiles, with no vaccine-related serious adverse events (SAEs).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Any individual aged 18 and older eligible to receive AZ1222 vaccine following the national immunization recommendations.
* Willing and able to provide informed consent.

Exclusion Criteria:

* Any significant acute or chronic medical condition that in the opinion of the vaccinator makes the participant unsuitable for participation in the study or jeopardises the safety of the participant.
* Participant reports being pregnant.
* History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine.

Test negative vaccine effectiveness case-control study

The study population consists of individuals presenting at the participating hospitals and health centres during the study period, who:

Either

* Are hospitalized (or died) for an illness consistent with possible COVID-19. Or (in case of other hospital controls)
* Presented to the emergency department (ED) for reasons other than a COVID-19 like illness (e.g. trauma or elective surgery).

And

* Meet the inclusion criteria.

Inclusion criteria:

* Ever eligible to receive AZ1222 vaccine following the national immunization recommendations prior to hospital admission.

And

* Willing and able to provide informed consent.

Exclusion criteria:

* None

Locations (1)

Mbabane, Eswatini