JMIR Publications

ABSTRACT

Background:

The coronavirus disease 2019 (COVID-19) pandemic has caused devastating morbidity and mortality globally and poses an unprecedented threat to economic growth. The global rollout of vaccines has met with social‒economic disparities impeding the global effort in infection prevention and severity reduction. The development and evaluation of candidate vaccines against COVID-19 that overcome logistical, social and economic challenges are highly needed. Here, we present a trial protocol to assess the safety, tolerability and immunogenicity of the TANCoV-1.3.20 SARS-CoV-2 vaccine among healthy participants who were SARS-CoV-2 negative in Tanzania.

Objective:

To assess the safety, tolerability and immunogenicity of the TANCoV-1.3.20 SARS-CoV-2 vaccine candidate among healthy participants in Dar es Salaam and Mbeya regions of Tanzania

Methods:

TANCoV-1 is a phase 1/2a double-blinded randomized controlled trial conducted in Dar es Salaam and Mbeya regions of Tanzania. A total of 169 healthy participants will be recruited and randomized at a 1:1:1 ratio to a TANCoV-1.3.20 vaccination dose of 100 µL with a booster or without a booster or 200 µL without a booster. A total of 127 participants will be assigned to the experimental arm, and another 42 participants will be assigned to the standard arm. Participant recruitment is expected to take six months and follow-up for six months post vaccination. The trial has two primary end points: safety, as ascertained by the incidence of adverse events, and immunogenicity, which involves local, humoral, and cellular immune responses. The trial has enrolled healthy individuals aged between 18 and 45 years, who provided written informed consent and meet all the inclusion criteria as per protocol. The data will be analysed via Stata. Findings will be reported according to the Consolidated Standards of Reporting Trials (CONSORT) guidelines.

Results:

As of manuscript submission, recruitment has been completed, laboratory tests and data analysis are ongoing

Conclusions:

This randomized clinical trial in an African context, will provide valuable data that can be utilized to ensure future availability of safe, cost effective and environmentally accustomed effective vaccines. Furthermore, findings of this trial will help in increasing public awareness and acceptance of COVID-19 vaccines, contributing to efforts to combat the COVID-19 pandemic. Clinical Trial: PACTR202107612488277