To expand the access and delivery of COVID-19 Vaccines in Africa (ECOVA), theinvestigators will conduct a phase 3, individually randomized, observer-blind, controlled(influenza vaccine) trial to evaluate the safety and efficacy of the BBIBP-CorV vaccineagainst any severe acute respiratory syndrome 2 (SARS-CoV- 2) infection among adults 18years 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 NationalBiotec Group (CNBG), Sinopharm, Beijing, People's Republic of China and receivedemergency 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