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Ad26.COV2.S as a Heterologous Booster in Adults After Single- or Two-Dose of Inactivated COVID-19 Vaccine

NCT05109559 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 690

Last updated 2022-09-13

No results posted yet for this study

Summary

This study aims to address evidence gaps regarding the safety, reactogenicity and immune responses of a heterologous boost of a single dose of Ad26.COV2.S (half or full dose) at pre-specified time intervals in recipients who are documented to have received either 1-dose or 2-doses (primary series completion) of inactivated COVID-19 vaccines, Sinovac and/or Sinopharm.

Conditions

Interventions

BIOLOGICAL

Full dose of Ad26.COV2. 5x10^10vp

A booster dose (3rd dose) of Ad26.COV2.S as an IM injection in the deltoid muscle in adults.

BIOLOGICAL

Half dose of Ad26.COV2. 2.5x10^10vp

A booster dose (3rd dose) of Ad26.COV2.S as an IM injection in the deltoid muscle in adults.

BIOLOGICAL

Full dose of Ad26.COV2. 5x10^10vp

A booster dose (2nd dose) of Ad26.COV2.S as an IM injection in the deltoid muscle in adults.

Sponsors & Collaborators

  • National Vaccine Institute, Thailand

    collaborator OTHER

  • International Vaccine Institute

    collaborator OTHER

  • Janssen Pharmaceuticals

    collaborator INDUSTRY

  • Mahidol University

    lead OTHER

Principal Investigators

  • Punnee Pitisuttithum, MD · Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-20
Primary Completion
2023-12-31
Completion
2024-12-31
FDA Drug
Yes

Countries

  • Thailand

Study Locations

More Related Trials

Entities

Diseases

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 NCT05109559 on ClinicalTrials.gov