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Immunogenicity and Safety of Fractional Booster Dose of COVID-19 Vaccines Available for Use in Pakistan/Brazil: A Phase 4 Dose-optimizing Trial

NCT05343871 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2354

Last updated 2024-01-30

No results posted yet for this study

Summary

Since the emergence of the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pathogen in late 2019, millions of people around the world have fallen ill and died from coronavirus disease 2019 (COVID-19), with variant-fueled case spikes causing repeated cycles of morbidity and mortality. The rapid development and emergency use authorization of vaccines against SARS-CoV-2 presents an enormous opportunity to protect populations, but bottlenecks in production have led to demand for vaccines that far outpaces supply. This project will investigate the immunogenicity of fractional doses of SARS-CoV-2 vaccines given a minimum of six months following an initial two-dose schedule or following natural immunity via documented infection. The consortium of research partners from the Sabin Vaccine Institute, Aga Khan University, Fundação Oswaldo Cruz (Fiocruz), and Stanford University will recruit volunteers to receive a full or fractional booster dose of BNT162b2, AZD1222 or Sinovac following receipt of their primary vaccination series or PCR-confirmed natural infection in Pakistan. The research team will follow participants for six months from boosting, with blood draws at baseline, 28 days, 3 months and 6 months, and measure sero-response rate (SRR) by anti-Spike immunoglobulin G (IgG) binding enzyme-linked immunosorbent assay (ELISA) with the ultimate aim of identifying whether fractional doses provide a similar immune response compared to full doses of vaccine.

Conditions

Interventions

BIOLOGICAL

Sinovac

Sinovac inactivated COVID-19 vaccine: ● Full dose (0.5 ml)

BIOLOGICAL

AZD1222

AstraZeneca ChAdOx1-S recombinant AZD1222 vaccine: * Full dose (0.5 ml) * Half dose (0.25 ml)

BIOLOGICAL

BNT162b2

Pfizer/BioNTech BNT162b2 mRNA vaccine: * Full dose (30 micrograms) * Half dose (15 micrograms) * One-third dose (10 micrograms)

Sponsors & Collaborators

  • Aga Khan University

    collaborator OTHER

  • Oswaldo Cruz Foundation

    collaborator OTHER

  • Stanford University

    collaborator OTHER

  • Albert B. Sabin Vaccine Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-05
Primary Completion
2023-07-28
Completion
2024-01-11

Countries

  • Brazil
  • Pakistan

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05343871 on ClinicalTrials.gov