To expand the access and delivery of COVID-19 Vaccines in Africa (ECOVA), the investigators will conduct a phase 3, individually randomized, observer-blind, controlled (influenza vaccine) trial to evaluate the safety and efficacy of the BBIBP-CorV vaccine against any severe acute respiratory syndrome 2 (SARS-CoV- 2) infection among adults 18 years and older. The BBIBP-CorV vaccine is an inactivated SARS-CoV-2 vaccine (Vero cell) manufactured by the Beijing Institute of Biological Products (BIBP), China National Biotec Group (CNBG), Sinopharm, Beijing, People's Republic of China and received emergency use authorization (EUA) from World Health Organization (WHO).
The investigators will conduct a randomized, observer-blind, controlled, phase 3 trial will
be conducted to assess the safety, immunogenicity and efficacy of two doses of intramuscular
BBIBP-CorV vaccine, followed by a booster dose, in adults 18 years of age and older. . Study
Arms 1 and 2 will have two groups: group 1 - HIV-uninfected receiving BBIBP-CorV or Flu
Quadrivalent; group 2 - HIV-infected receiving BBIBP-CorV or Flu Quadrivalent. Arm 3 will
have 1 group - HIV-uninfected co-administration group receiving both vaccines. The
randomization will be stratified by HIV status. Active surveillance for covid-19 will be
carried out and immunogenicity will be assessed for a subset of population.
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 to 8 degree Celsius
Biological: influenza season quadrivalent Influenza Vaccine (Flu Quadrivalent)
The southern hemisphere for the 2021 influenza season quadrivalent Influenza Vaccine (Flu Quadrivalent)
Dose formulation: Purified Inactivated Influenza Virus Antigen H1N1, H3N2, Yamagata and Victoria (single dose, 0.5ml for adults)
Mode of Administration: Intramuscular
Storage Conditions: 2 to 8 degree Celsius
Inclusion Criteria:
- Female and male adults aged 18 years and older (Arm 1-Group 1 and Arm 2-Group 1) and
18-65 years (Arm 1 - Group 2, Arm 2-Group 2 and Arm3-Group1) at the time of consent.
- Residing within the Beira and Maputo health region and planning to stay for the study
duration.
- HIV-negative test result at the day of screening for participants in Group 1, in Arms
1, 2 and 3
- HIV-positive and on anti-retroviral treatment for at least six months for participants
in Group 2, in Arms 1 and 2
- 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 four weeks
after the third vaccination.
- Able and willing to comply with all study requirements, based on the assessment of the
investigator.
- Provide written informed consent before any trial procedure.
Exclusion Criteria:
- Pregnant, lactating, or with intention to become pregnant during the study.
- Planned receipt of any investigational vaccine than the study intervention within 28
days before and after each study vaccination.
- Active COVID-19 infection at the time of enrollment
- History of allergic reactions or anaphylaxis to previous immunization or allergies to
any components of the vaccines.
- History of bleeding disorder, or prior history of significant bleeding or bruising
following intramuscular injections or venipuncture (for the immunogenicity subset and
HIV infected participants).
- 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.
Florian Marks, PhD
+ 821087033813
fmarks@ivi.int
Birkneh Tilahun Tadesse, PhD
+821098041348
birkneh.tadesse@ivi.int
Florian Marks, PhD, Principal Investigator
International Vaccine Institute