Real-world assessment of the immunogenicity and effectiveness of COVID-19 vaccines in Indonesia (INVITE Study)

PI: Raph Hamers

Partner PI: Dr Erni Nelwan

Collaborators

  • Dwi Utomo, Pasar Minggu Hospital
  • Robert Sinto, Pelni Hospital
  • Jakarta Health Office
  • Saraswati
  • Nunung Nuraeni
  • Winahyu Handayani

Location of activity: hospitals and primary health centers in Jakarta. 

Background

The unprecedented speed with which COVID-19 vaccines have been developed and approved represents a major scientific achievement, and vaccine-induced population immunity is a key global strategy to control the COVID-19 pandemic. There are still many “real-world” knowledge gaps on vaccine-induced immune responses, correlates of protection and temporal changes, clinical impact of breakthrough infections, effectiveness and reactogenicity of (heterologous) vaccine boosters. More research is warranted to understand vaccine-induced humoral and cellular immunity to SARS-CoV-2, defining detailed targets of humoral and cellular immune responses at the epitope level, characterising the B-cell receptor and T-cell receptor repertoire elicited by infection or vaccination, and establishing the long-term durability, and maintenance, of protective immunity after infection or vaccination. This is particularly true for the widely used inactivated whole-virus vaccines, such as Sinovac/CoronaVac and Sinopharm, being rolled out in many countries worldwide including Indonesia, a populous middle-income country and one of the COVID-19 epicenters. This research project offers a unique window of opportunity for research and learning to leverage several observational patient cohorts in Indonesian populations to conduct real-world assessments of COVID-19 vaccinations as they are rolled out, to inform optimal vaccination strategies, in the face of emerging SARS-CoV-2 variants. The aim of the study is to generate real-world essential information on the immunogenicity and effectiveness of COVID-19 vaccines (based on inactivated virus, viral vector and other) in Indonesia, in terms of immune responses, adverse reactions and SARS-CoV-2 breakthrough infections.

Primary objectives

  1. To assess humoral and cellular immune responses following primer and booster vaccine doses, in individuals with and without pre-existing immunity;
  2. To assess vaccine reactogenicity, in individuals with and without pre-existing immunity;
  3. To characterize SARS-CoV-2 breakthrough infections post-vaccination

Importance

The spread of B.1.617.2 (delta) variant threatens the success of national COVID-19 vaccine programmes, with particular concerns around the potentially reduced effectiveness of CoronaVac/SinoVac against delta infections, although it is yet unclear what will be their impact at scale. In order to address these challenges effectively, there is an urgent need to understand the biological consequences of the mutations found in these variants and the consequential impact on their susceptibility to current control measures, including vaccines, drugs and non-pharmaceutical interventions. Measuring immune correlates of vaccine-induced protection is key for understanding COVID-19 and development of next-generation vaccines.