Effectiveness Evaluation of the Sinopharm Vaccine in the Dondo District in Mozambique

Three complementary activities will be implemented:1) Baseline and repeat census of the catchment population; described in a separate protocol (IVI-ECOVA-03-WS1); 2) Enhanced surveillance for COVID-19 disease, and 3) AEFI-enhanced surveillance. The mass vaccination campaign will be conducted by the Government and is not part of this protocol.

Study Overview

• Status: Recruiting
• Conditions: Sars-CoV-2 Infection
• Intervention / Treatment: Other: Sinopharm Vaccine

• Study Type: Observational
• Enrollment (Anticipated): 3000

Contacts and Locations

• Study Contact: Name: Birkneh Tilahun Tadesse, PhD; Phone Number: +821098041348; Email: birkneh.tadesse@ivi.int
• Study Contact Backup: Name: Florian Marks, PhD; Phone Number: +821087033813; Email: fmarks@ivi.int

Study Locations

• Mozambique
  • Dondo, Mozambique, 2104
    • Recruiting
    • Dondo Health Facility
    • Contact: Ilesh Jani, PhD; Phone Number: +258825802221; Email: ilesh.jani@ins.gov.mz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study will be conducted in the Dondo District. For surveillance the catchment area will include participants from Dondo Sede and Mafambisse administrative posts. The participant will come for screening in the following health facilities; Dondo, Baptista, Mandruzi, Canhandula, Samora Machel) and in Mafambisse (Mafambisse and Bloco Nove) and at the community level, the study will involve walk-throughs for COVID-19 testing.

Description

Inclusion Criteria:

1. They resided in the study area at the time of mass immunization with the Sinopharm vaccine; and
2. They are at least 18 years of age during first round of mass vaccination.
3. Their onset of symptoms was <10 days prior to testing.
4. For each selected PCR test-positive case, we will select up to 3 test-negative controls from generally eligible subjects, matched to each case by age on the date of testing, sex, and calendar date of testing + 3 days.

Exclusion Criteria:

1. We will exclude subjects for selection as controls if they have had a positive test result within the following 21 days
2. Any Participant not matching the inclusion criteria mentioned above.

Study Plan

How is the study designed?

Design Details

• Observational Models: Ecologic or Community
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Case	Other: Sinopharm Vaccine; Sinopharm Vaccine will be administered by the Govt as part of COVID-19vaccination campaign
Test Negative Control	Other: Sinopharm Vaccine; Sinopharm Vaccine will be administered by the Govt as part of COVID-19vaccination campaign

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Protection conferred by two completed doses of Sinopharm vaccine against confirmed COVID-19 disease	Protection conferred by two completed doses of Sinopharm vaccine against RT-PCR-confirmed COVID-19 disease measured as the reduction in risk in adults who received two completed doses of the vaccine compared to those who are not vaccinated.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the effectiveness of two completed doses of the Sinopharm vaccine against severe SARS-CoV-2 infection	Evaluate the effectiveness of two completed doses of the Sinopharm vaccine against RT-PCR confirmed severe SARS-CoV-2 infection	2 years

Collaborators and Investigators

• Sponsor: International Vaccine Institute
• Collaborators: Heidelberg University; International Centre for Diarrhoeal Disease Research, Bangladesh; Harvard University; The Coalition for Epidemic Preparedness Innovations (CEPI); Instituto Nacional de Saúde (INS), Mozambique; University of Antananarivo

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2022
• Primary Completion (Anticipated): February 28, 2024
• Study Completion (Anticipated): August 30, 2024

Study Registration Dates

• First Submitted: May 2, 2022
• First Submitted That Met QC Criteria: May 2, 2022
• First Posted (Actual): May 5, 2022

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 16, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: IVI-ECOVA-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No