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.
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.
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
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Madagascar Institute for Vaccine Research (MIVR), University of Antananarivo
Antananarivo, Madagascar
Centro de Investigação e Treino em Saúde da Polana Caniço - Instituto Nacional de Saúde
Maputo, Mozambique