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

• Sponsor: International Vaccine Institute (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05362682
• Collaborator: The Coalition for Epidemic Preparedness Innovations (CEPI) (Other), Instituto Nacional de Saúde (INS), Mozambique (Other), University of Antananarivo (Other), International Centre for Diarrhoeal Disease Research, Bangladesh (Other), Harvard University (Other), Heidelberg University (Other)
• Enrollment: 3,000
• Location: 1
• Anticipated Duration (Months): 30.2
• Patients Per Site Per Month: 99.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Effectiveness Evaluation of the Sinopharm Vaccine in Mozambique	Other: Sinopharm Vaccine

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 3000 participants
• Observational Model: Ecologic or Community
• Time Perspective: Prospective
• Official Title: Effectiveness Evaluation of the Sinopharm Vaccine in the Dondo District in Mozambique
• Actual Study Start Date: Feb 24, 2022
• Anticipated Primary Completion Date: Feb 28, 2024
• Anticipated Study Completion Date: Aug 30, 2024

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Protection conferred by two completed doses of Sinopharm vaccine against confirmed COVID-19 disease [2 years]

   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.

Secondary Outcome Measures

1. Evaluate the effectiveness of two completed doses of the Sinopharm vaccine against severe SARS-CoV-2 infection [2 years]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dondo Health Facility	Dondo		Mozambique	2104

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: International Vaccine Institute
• ClinicalTrials.gov Identifier: NCT05362682
• Other Study ID Numbers: IVI-ECOVA-03
• First Posted: May 5, 2022
• Last Update Posted: May 5, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of May 5, 2022