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Covid19Phase 2NCT04998240

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

A Phase 2 study testing BBIBP-CorV - Inactivated SARS-CoV-2 vaccine (Vero cell) and Ad26.COV2.S (Recombinant, replication-incompetent adenovirus serotype 26 (Ad26) vector encoding a full-length and stabilized SARS-CoV-2 spike protein), in people with Covid19, run by International Vaccine Institute at 2 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Covid19
What is being tested?
BBIBP-CorV - Inactivated SARS-CoV-2 vaccine (Vero cell) and Ad26.COV2.S (Recombinant, replication-incompetent adenovirus serotype 26 (Ad26) vector encoding a full-length and stabilized SARS-CoV-2 spike protein),
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
360 participants
Where
2 sitesin 2 countries
Study dates
29 Dec 2021to 28 Feb 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Individuals aged 18 to 65 years old at the time of consent.
  • Residing within the area of the study and planning to stay for the study duration.
  • HIV negative test result on the day of screening (for those who do not have a documented HIV test results in the last three months of screening).
  • Female volunteers of childbearing potential with a negative pregnancy test on the day(s) of screening and vaccination, practicing/willing to practice continuous effective contraception* recommended by the National Health System up to 12 weeks after the booster vaccination..
  • Agreement to refrain from blood donation during the course of the study.
  • Able and willing to comply with all study requirements, based on the assessment of the investigator.
  • Willingness to provide written informed consent before any trial procedure * Effective contraception is defined as follows: contraceptive medications delivered orally, intramuscularly, vaginally, or implanted underneath the skin, surgical methods (hysterectomy or bilateral tubal ligation), condoms, diaphragms, intrauterine device (IUD), and abstinence.

Who cannot join

  • Pregnancy, lactation, or intention to become pregnant during the vaccination phase through three months after the booster dose.
  • Prior receipt/ planned receipt of any vaccine other than the study intervention within 28 days before and after each study vaccination.
  • Previous participation in any COVID-19 vaccination trial or vaccination campaign.
  • Administration of immunoglobulins and/ or any blood products within the three months preceding the administration of the study vaccine.
  • Known infection with hepatitis B, C virus.
  • Known history of allergy or anaphylaxis to study vaccine components and/or excipients or other medications, or any other allergies deemed by the investigator to increase the risk of an adverse reaction.
Show all 13Show fewer
  • History of bleeding disorder (e.g., factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture.
  • Continuous use of the anticoagulants, such as coumarins and related anticoagulants.
  • Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, renal disease, liver disease, endocrine disorders, and neurological illness (mild/moderate well controlled comorbidities are allowed).
  • Any clinically significant abnormal finding on screening as judged by the investigator.
  • Confirmed SARS-CoV-2 infection at enrollment.
  • Any confirmed or suspected immunosuppressive or immunodeficient state, asplenia, recurrent severe infections and chronic use (more than 14 days) immunosuppressant medication within 3 months prior to recruitment (topical steroids are allowed).
  • Any other finding which in the opinion of the investigators would increase the risk of an adverse outcome from participation in the trial or result in incomplete or poor-quality data.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Madagascar1 site

  • Madagascar Institute for Vaccine Research (MIVR), University of Antananarivo

    Antananarivo, 101

Other trials in Madagascar

Mozambique1 site

  • Centro de Investigação e Treino em Saúde da Polana Caniço - Instituto Nacional de Saúde

    Maputo

Other trials in Mozambique

About this study

Official title: A Phase 2, Observer-blind, Randomized Study to Assess the Safety and Immunogenicity of Heterologous Prime-boost COVID-19 Vaccines Regimens in Individuals Aged 18 to 65 Years in Mozambique and Madagascar.

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.

Read the detailed description

This is a phase 2, observer-blind, randomized study to assess the safety and the immunogenicity of heterologous prime-boost COVID-19 vaccines regimens in healthy adults aged 18 to 65 years using two approved vaccines (Sinopharm / CNBG Vaccine (BBIBP-CorV) and Johnson \& Johnson Vaccine (Ad26.COV2.S)).

The study will consist of 2 cohorts, one for main immunology endpoints (N=260, 65 per study arm) and one for more detailed immunological assessment (N=100, 25 per study arm). Two doses of vaccine will be administered intramuscularly 4 week apart. All the study participants will be follow-up for 12 months from the administration of first vaccine dose.

Conditions
Covid19
Being tested
BBIBP-CorV - Inactivated SARS-CoV-2 vaccine (Vero cell), Ad26.COV2.S (Recombinant, replication-incompetent adenovirus serotype 26 (Ad26) vector encoding a full-length and stabilized SARS-CoV-2 spike protein),, Placebo - Normal saline (0.9% sodium chloride solution)
Keywords
SARS-CoV-2, Vaccines, Mix and Match Trial
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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

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

    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

  • Placebo - Normal saline (0.9% sodium chloride solution)Biological

    Placebo - Normal saline (0.9% sodium chloride solution)

    Dose formulation: Not Applicable

    Mode of administration: Intramuscular

    Storage conditions: 15°C to 30°C

Study groups in NCT04998240
Study groupRoleWhat they receive
Prime BBIBP-CorV, Boost Ad26.COV2.S (A1)ExperimentalThe randomized study participants will receive Prime BBIBP-CorV vaccine followed by Booster dose of Ad26.COV2.S vaccine (A1).
Receives: Biological: BBIBP-CorV - Inactivated SARS-CoV-2 vaccine (Vero cell); Biological: Ad26.COV2.S (Recombinant, replication-incompetent adenovirus serotype 26 (Ad26) vector encoding a full-length and stabilized SARS-CoV-2 spike protein),
Prime BBIBP-CorV, Boost BBIBP-CorV (A2)ExperimentalThe randomized study participants will receive Prime BBIBP-CorV vaccine followed by Booster dose of BBIBP-CorV vaccine (A2).
Receives: Biological: BBIBP-CorV - Inactivated SARS-CoV-2 vaccine (Vero cell)
Prime Ad26.COV2.S, Boost BBIBP-CorV (B1)ExperimentalThe randomized study participants will receive Prime Ad26.COV2.S vaccine followed by Booster dose of BBIBP-CorV vaccine (B1).
Receives: Biological: BBIBP-CorV - Inactivated SARS-CoV-2 vaccine (Vero cell); Biological: Ad26.COV2.S (Recombinant, replication-incompetent adenovirus serotype 26 (Ad26) vector encoding a full-length and stabilized SARS-CoV-2 spike protein),
Prime Placebo, Boost Ad26.COV2.S (B2)ExperimentalThe randomized study participants will receive Prime Placebo vaccine followed by Booster dose of Ad26.COV2.S (B2).
Receives: Biological: Ad26.COV2.S (Recombinant, replication-incompetent adenovirus serotype 26 (Ad26) vector encoding a full-length and stabilized SARS-CoV-2 spike protein),; Biological: Placebo - Normal saline (0.9% sodium chloride solution)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Geometric Mean Titers (GMTs) of anti-SARS-CoV-2 neutralizing antibodies

    Geometric Mean Titers (GMTs) of anti-SARS-CoV-2 neutralizing antibodies using a neutralization assay four weeks after the second dose, in COVID-19 seronegative participants following immunization with heterologous and homologous prime-boost COVID-19 vaccines regimens.

    Measured: Four Weeks after second dose

  2. Incidence of SAEs and AESI observed at any time point during the entire study period

    Incidence of SAEs and AESI observed at any time point during the entire study period, among all study participants of heterologous and homologous prime-boost COVID-19 vaccines regimens

    Measured: Till 12 months follow-up visit

  3. Incidence of solicited reactions within 7 days (local reactions) and 14 days (systemic reactions)

    Incidence of solicited reactions within 7 days (local reactions) and 14 days (systemic reactions) following each vaccination in all study participants of heterologous and homologous prime-boost COVID-19 vaccines regimens.

    Measured: Within 7 days (local reactions) and 14 days (systemic reactions) following each vaccination

  4. Incidence of unsolicited adverse events that are within 28 days after each vaccination

    Incidence of unsolicited adverse events that are within 28 days after each vaccination in all study participants of heterologous and homologous prime-boost COVID-19 vaccines regimens.

    Measured: Within 28 days after each vaccination

  5. Incidence of changes in laboratory safety measures from baseline to day 28 after each vaccination

    Incidence of changes in laboratory safety measures from baseline to day 28 after each vaccination, in all study participants of heterologous and homologous prime-boost COVID-19 vaccines regimens

    Measured: Within 28 days after each vaccination

Secondary outcomes (2)

  1. Geometric Mean Titers (GMTs) and Geometric Mean Fold Rise (GMFR)

    • GMTs of anti-SARS-CoV-2 neutralizing antibodies as measured by neutralization assay at Day 0, Day 28, Day 196, Day 364
    • GMFR from baseline of anti-SARS-CoV-2 neutralizing antibodies as measured by neutralization assay at Day 0, Day 28, Day 196, Day 364
    • Percentage of participants achieving 4-fold or more rise from baseline of anti-SARS-CoV-2 neutralizing antibodies as measured by neutralization assay at Day 0, Day 28, Day 196, Day 364

    Measured: Till 12 months follow-up visit

  2. Geometric Mean Titers (GMTs) and Geometric Mean Fold Rise (GMFR)

    • GMTs of anti-SARS-CoV-2 anti-spike IgG as measured by immunoassay, anti-SARS-CoV-2 pseudoneutralizing antibodies as measured by pseudo-neutralization assay, and anti-SARS-CoV-2 anti-nucleocapsid IgG at Day 0, Day 28, Day 56, Day 196, Day 364
    • GMFR from baseline of anti-SARS-CoV-2 anti-spike IgG as measured by immunoassay, anti-SARS-CoV-2 pseudo-neutralizing antibodies as measured by pseudo-neutralization assay, and anti-SARS-CoV-2 anti-nucleocapsid IgG at Day 0, Day 28, Day 56, Day 196, Day 364
    • Percentage of participants achieving 4-fold or more rise from baseline for anti-SARS-CoV-2 anti-spike IgG as measured by immunoassay, anti-SARS-CoV-2 pseudoneutralizing antibodies as measured by pseudo-neutralization assay, and anti-SARS-CoV-2 anti-nucleocapsid IgG at Day 0, Day 28, Day 56, Day 196, Day 364

    Measured: Till 12 months follow-up visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2021
  2. Study start29 Dec 2021
  3. Primary completion26 Sep 2022
  4. Study completion28 Feb 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
The primary analysis of this study will be a non-inferiority comparison between heterologous versus homologous boost arms 4 weeks after second vaccination within each group of the studied COVID-19 vaccines, i.e., the A1 arm (BBIBP-CorV, Ad26.COV2.S) will be compared with the A2 arm (BBIBP-CorV, BBIBP-CorV), and the B1 arm (Ad26.COV2.S, BBIBP-CorV) will be compared with the B2 arm (Placebo, Ad26.COV2.S). All 360 participants will be used for the primary analysis and the secondary analysis.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
360 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04998240
Sponsor's protocol ID
IVI-ECOVA-02
Status last verified
Apr 2023
First submitted
29 Jul 2021
Last updated
19 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Ramgi P, Siribie M, Rakotozandrindrainy N, Bule O, Shrivastava H, Chambule L, Park EL, Fernando C, Boque J, Macuiana R, Razafimanantsoa R, Rakotozandrindrainy N, Razafindrabe TJL, Rakotoarisoa AN, Raminosoa TM, Derandrainy HL, Rakotoson MM, de Silva CSS, Mutombene M, Massinga C, Langa JP, Guarnacci T, Kang SSY, Jo SK, Jeon HJ, Excler JL, Yang Y, Wang S, Sugimoto JD, Yang JS, Shim BS, Binger T, Capitine IU, Aziz AB, Park JY, Kim DR, Rakotozandrindrainy R, Jani IV, Tadesse BT, Marks F. Immunogenicity and Safety of Heterologous Versus Homologous Prime-Boost Regimens With BBIBP-CorV and Ad26.COV2.S COVID-19 Vaccines: A Multicentric, Randomized, Observer-Blinded Non-inferiority Trial in Madagascar and Mozambique. Clin Infect Dis. 2025 Jul 22;80(12 Suppl 2):S37-S46. doi: 10.1093/cid/ciaf130.

    PubMed 40694514

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BBIBP-CorV - Inactivated SARS-CoV-2 vaccine (Vero cell) and Ad26.COV2.S (Recombinant, replication-incompetent adenovirus serotype 26 (Ad26) vector encoding a full-length and stabilized SARS-CoV-2 spike protein), in people with Covid19, run by International Vaccine Institute at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Madagascar, Mozambique. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Geometric Mean Titers (GMTs) of anti-SARS-CoV-2 neutralizing antibodies (time frame: Four Weeks after second dose). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04998240, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2023.

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