Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04612972 |
| Other study ID # |
UPeruanaCH |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
September 9, 2020 |
| Est. completion date |
April 3, 2023 |
Study information
| Verified date |
April 2023 |
| Source |
Universidad Peruana Cayetano Heredia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This is a multicenter, randomized, double blind, parallel placebo controlled, phase 3
clinical trial to evaluate the protective efficacy, safety and immunogenicity of inactivated
SARS-CoV-2 vaccines in healthy population 18 years old and above.
Description:
Product characteristics:
WIBP:
The inactivated SARS CoV 2 Vaccine (Vero cell) is prepared by inoculating Verda Reno cells
(Vero cell) with SARS CoV 2 WIV04 strain, culturing, harvesting, inactivating, clarifying,
concentrating, second inactivating, purifying and adding aluminum hydroxide adjuvant BIBP:
The inactivated SARS CoV 2 Vaccine (Vero cell) is prepared by inoculating Verda Reno cells
(Vero cell) with SARS CoV 2 HB02 strain, culturing, harvesting, inactivating, clarifying,
concentrating, purifying and adding aluminum hydroxide adjuvant. After vaccination, the body
can produce immune response to prevent diseases caused by SARS CoV 2.
Primary objective To evaluate the protective efficacy of inactivated SARS CoV 2 Vaccine (Vero
Cell) after full course of immunization in preventing diseases caused by the SARS CoV 2 in
healthy subjects aged 18 years old and above.
Study design:
This clinical trial is conducted in randomized, blind, placebo-controlled design. Total
sample size is 12,000, which are randomly allocated into investigational vaccine 1,
investigational vaccine 2 and placebo control group. Subjects with compatible symptoms, will
be excluded.
Immunization schedule: 2-doses of investigational vaccine or placebo are inoculated to the
deltoid muscle of the upper arm according to the Day 0 and day 21 (window for both days + 7
days), immunization schedule.
Safety observation After each dose of vaccination, the subject is observed for 30 minutes on
site, and local and systemic adverse events are collected. Within 0-30 21/28 days, the local
and systemic reactions of the subjects are actively followed up and recorded on the.
telephone follow-up contact form. Serious adverse events (SAE) will be daily monitored within
12 months after vaccination, and followed up, recorded and reported as required.
Observation of efficacy After the subjects are enrolled in the group, the monitoring of
SARS-CoV-2 infection cases will begin Planned and active follow-up is carried out on the
subjects, and a monitoring network is established in local medical and health institutions to
monitor SARS-CoV-2 infection-like cases in the subjects. Those diagnosed as suspected cases
by clinicians will be studied as epidemiological case, including nasopharyngeal swabs, sputum
and/or other lower respiratory secretions, venous blood in acute and convalescent stages are
collected. SARS-CoV-2 nucleic acid will be tested by RT-PCR method, and/or viral gene
sequencing. Subjects with positive nucleic acid, or/and convalescent serum antibodies
increased 4 fold or more than acute phase serum are confirmed cases of COVID-19. (refer to
case monitoring operation manual).
The incidence of confirmed SARS-CoV-2 disease in the three groups of study samples is
calculated and the epidemiological protection rate and confidence interval of SARS-CoV-2
inactivated vaccines against SARS-CoV-2 disease are analyzed.
Immunogenicity observation:
Immunogenicity (antibody response to inactivated SARS-CoV-2 vaccine / placebo) will be
evaluated in subjects V00001-V12000 on 14 days after 2nd dose (day 35) and 360 days after 2nd
dose (day 381). Subgroups of 1200 participants will be registered on 28 days after 2nd dose
(days 49), 180 days after 2nd dose ( day 201), to better precise the peak of neutralizing
antibodies
Case definition:
Cases will be further classified as:
Asymptomatic cases: No symptoms developed for 14 consecutive days after positive PCR testing.
Confirmed cases: On the basis of the clarification of the suspected case, the COVID-19 PCR
diagnosis is positive, or IgG antibodies in convalescent sera four times higher than
baseline.
Confirmed mild COVID-19 cases: The clinical symptoms were mild, and there was no sign of
pneumonia on imaging.
Confirmed moderate COVID-19 cases: Showing fever and respiratory symptoms with radiological
findings of pneumonia.
Confirmed severe COVID-19 cases: Confirmed COVID-19 case meeting any one of the following
criteria:
- Respiratory distress (RR≥30 breaths/min);
- Oxygen saturation≤93% at rest;
- Arterial partial pressure of oxygen (PaO2)/ fraction of inspired oxygen (FiO2)≦300mmHg
(1mmHg=0.133kPa);
- The clinical symptoms progressively worsened, and the chest imaging showed >50% obvious
lesion progression within 24-48 hours.
Confirmed Critical COVID-19 cases: Confirmed COVID-19 case meeting any one of the following
criteria:
- Respiratory failure and requiring mechanical ventilation;
- Shock;
- With other organ failure that requires ICU care;
- Death
