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Efficacy of Different COVID-19 Vaccine Combinations in Inducing Long-term Humoral Immunity [PRIBIVAC]

NCT05142319 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 326

Last updated 2024-10-15

No results posted yet for this study

Summary

PRIBIVAC will assess a heterologous prime-boost-boost strategy in comparison with a homologous regimen in order to compare short and long-term immunogenicity of different COVID-19 vaccine combinations against the ancestral SARS-CoV-2 as well as different variants of concern (VOCs). Initial phases of the study (Phases A-C) have studied homologous versus heterologous vaccines at the first booster, later phases (Phase D) will study these as the second booster.

Hypothesis: One or more heterologous prime-boost-boost COVID-19 vaccine combinations will produce humoral and cellular immunity that is non-inferior to an homologous prime-boost-boost vaccination against wildtype SARS-CoV-2 and/or 1≥ VOC. In Phases A-C of the study the primary 2 dose mRNA vaccine series was defined as 'Prime-boost'. For phase D we will define these 2 doses as 'Prime' and the 3rd vaccine dose as 'Boost'.

Conditions

Interventions

BIOLOGICAL

Homologous mRNA booster vaccine

Single intradermal injection. The vaccine dose will be according to manufacturer's instructions.

BIOLOGICAL

Heterologous mRNA booster vaccine

Single intradermal injection. The vaccine dose will be according to manufacturer's instructions.

BIOLOGICAL

COVAXIN

Single intradermal injection at 6ug (0.5ml) per dose.

BIOLOGICAL

Nuvaxovid

Single intradermal injection at 5mcg (0.5mL) per dose.

Sponsors & Collaborators

  • A*Star

    collaborator OTHER

  • KK Women's and Children's Hospital

    collaborator OTHER_GOV

  • Duke-NUS Graduate Medical School

    collaborator OTHER

  • Tan Tock Seng Hospital

    lead OTHER

Principal Investigators

  • Barnaby Young, A/Prof · National Centre for Infectious Diseases

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-12
Primary Completion
2023-06-01
Completion
2024-05-07
FDA Drug
Yes

Countries

  • Singapore

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 NCT05142319 on ClinicalTrials.gov