Mix and Match Heterologous Prime-Boost Study Using Approved COVID-19 Vaccines

Summary

This is an observer-blind, randomized study which aims to assess the immune response and the safety of two different approved vaccines for first and second dose in healthy adults.

Conditions

• Covid19

Interventions

BIOLOGICAL

BBIBP-CorV - Inactivated SARS-CoV-2 vaccine (Vero cell)

The Inactivated SARS-CoV-2 vaccine (Vero cell)- BBIBP-CorV manufactured by Beijing Institute of Biological Products (BIBP), China National Biotec Group (CNBG), Sinopharm, Beijing, People's Republic of China Dose formulation: A liquid formulation containing 4μg total protein with aluminum hydroxide adjuvant (0·45 mg/mL) per 0·5 mL (2-dose schedule followed by a booster dose). Mode of Administration: Intramuscular Storage Conditions: 2°C to 8°C

BIOLOGICAL

Ad26.COV2.S (Recombinant, replication-incompetent adenovirus serotype 26 (Ad26) vector encoding a full-length and stabilized SARS-CoV-2 spike protein),

Ad26.COV2.S (Recombinant, replication-incompetent adenovirus serotype 26 (Ad26) vector encoding a full-length and stabilized SARS-CoV-2 spike protein), manufactured by Johnson and Johnson in the United States of America. Dose formulation: One dose (0.5 ml) contains contains 5 x 10 10 virus particles Mode of administration: Intramuscular Storage Conditions: 2°C to 8°C

BIOLOGICAL

Placebo - Normal saline (0.9% sodium chloride solution)

Placebo - Normal saline (0.9% sodium chloride solution) Dose formulation: Not Applicable Mode of administration: Intramuscular Storage conditions: 15°C to 30°C

Sponsors & Collaborators

• The Coalition for Epidemic Preparedness Innovations (CEPI)

  collaborator UNKNOWN

• Instituto Nacional de Saúde, Mozambique

  collaborator OTHER_GOV

• University of Antananarivo

  collaborator UNKNOWN

• International Centre for Diarrhoeal Disease Research, Bangladesh

  collaborator OTHER

• Harvard University

  collaborator OTHER

• Heidelberg University

  collaborator OTHER

• International Vaccine Institute

  lead OTHER

Principal Investigators

• Florian Marks, PhD · International Vaccine Institute

• Ilesh Jani, PhD · Instituto Nacional de Saúde, Mozambique

• Raphael Rakotozandrindrainy, MD · Madagascar Institute for Vaccine Research (MIVR), University of Antananarivo

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-12-29

Primary Completion

2022-09-26

Completion

2024-02-28

Countries

• Madagascar
• Mozambique

Study Locations