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

NCT05362682 | Unknown

• 1 other identifier: IVI-ECOVA-03
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sars-CoV-2 Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evaluate the effectiveness of two completed doses of the Sinopharm vaccine against severe SARS-CoV-2 infection

  2 years

Study Arms (2)

Case

Other: Sinopharm Vaccine

Test Negative Control

Other: Sinopharm Vaccine

Interventions

Sinopharm Vaccine OTHER

Sinopharm Vaccine will be administered by the Govt as part of COVID-19vaccination campaign

Case; Test Negative Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• They resided in the study area at the time of mass immunization with the Sinopharm vaccine; and
• They are at least 18 years of age during first round of mass vaccination.
• Their onset of symptoms was \<10 days prior to testing.
• 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.

You may not qualify if:

• We will exclude subjects for selection as controls if they have had a positive test result within the following 21 days

Sponsors & Collaborators

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

Study Sites (1)

Dondo Health Facility

Dondo, 2104, Mozambique

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Florian Marks, PhD

CONTACT

+821087033813; fmarks@ivi.int

Birkneh Tilahun Tadesse, PhD

CONTACT

+821098041348; birkneh.tadesse@ivi.int

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2022
• First Posted: May 5, 2022
• Study Start: February 24, 2022
• Primary Completion: February 28, 2024
• Study Completion: August 30, 2024
• Last Updated: April 19, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

MO (1)