Trial NCT04566770
Publication Zhu F , Clin. Infect. Dis., 2021
Dates: 2020-09-24 to 2020-11-28
Funding: Mixed (National Key R&D Program of China, CanSino Biologics, and Beijing Institute of Biotechnology.)
Conflict of interest: Yes

Methods
RCT
Location : Single center / China
Follow-up duration (months): 8
3x10^10 vp Ad5-nCoV or 5x10^10 vp Ad5-nCoV (n = 100)
Placebo (n = 50)
Inclusion criteria
  • Aged 6-17 years
  • Able to understand the content of informed consent and willing to sign the informed consent
  • Able and willing to complete all the secluded study process during the whole 6 months study follow-up period
  • Negative in HIV diagnostic test
  • Negative in serum antibodies (IgG and IgM) screening of COVID-19
  • Axillary temperature ≤37.0°C
  • General good health as established by medical history and physical examination.
Exclusion criteria
  • Laboratory abnormalities of clinical significance, including white blood cell count, lymphocyte count, neutrophils, platelets, hemoglobin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, fasting blood glucose, and creatinine. Only apply to the sentinel participants in each cohort (the first 30 subjects)
  • Family history of seizure, epilepsy, brain or mental disease
  • Subject allergic to any component of the investigational vaccine, or a more severe allergic reaction and history of allergies in the past
  • Woman who is pregnant, breast-feeding or positive in β-HCG (human chorionic gonadotropin) pregnancy test (urine) on day of enrollment, or become pregnant during the next 6 months
  • Any acute fever disease or infections
  • History of SARS
  • Major congenital defects or not well-controlled chronic illness, such as asthma, diabetes, or thyroid disease
  • Serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension without controllable drugs, etc.
  • Hereditary angioneurotic edema or acquired angioneurotic edema Urticaria in last one year
  • No spleen or functional spleen
  • Platelet disorder or other bleeding disorder may cause injection contraindication
  • Faint at the sight of needles
  • Prior administration of immunodepressant or corticosteroids, antianaphylaxis treatment, cytotoxic treatment within last 6 months
  • Prior administration of blood products within last 4 months
  • Prior administration of other research medicines within last 1 month
  • Prior administration of attenuated vaccine within last 1 month
  • Prior administration of inactivated vaccine within last 14 days
  • Current anti-tuberculosis prophylaxis or therapy
  • Various medical, psychological, social or other conditions which could affect the subjects to sign informed consent according to the judgement of investigator.
Interventions
Intervention
2 IM doses of 3×10¹⁰ vp (or 20% received 5×10¹⁰ vp), 56 days apart
Control
2 IM doses of placebo, 56 days apart
Participants
Randomized
150 participants
Characteristics of participants
Type of participants: Healthy children and adolescents
N=150
79 males
Children: 150
Pregnant women: 0
Immunocompromized patients: 0
Mean age:
Age range: NR
Description of participants
Healthy children and adolescents aged 6-17 years that were HIV-negative and SARS-CoV-2 infection-free in a single centre in China.
Primary outcome
In the register
1. Safety indexes of adverse reactions [Time Frame: within 14 days post each vaccination]: Occurrence of adverse reactions post vaccination. 2. Immunogencity indexes of GMT [Time Frame: Day 28 post the second vaccination]: Evaluate the Geometric mean titer (GMT) of IgG antibody. 3. Immunogencity indexes of neutralizing antibody [Time Frame: Day 28 post the second vaccination]: Evaluate the Geometric mean titer (GMT) of neutralizing antibody.
In the report
1. Incidence of adverse reactions within 14 days after each vaccination. 2. GMT of RBD-specific ELISA antibodies on day 28 after boost vaccination. 3. GMT of pseudovirus neutralising antibodies on day 28 after boost vaccination.
Documents
available

Protocol

NR

Statistical plan

*

Data-sharing stated: No
Data accessibility: Corresponding author: Wei Chen, cw0226@foxmail.com
Risk of bias
Overall
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
Low
General comment In addition to the published article, the supplementary materials and study registry were used in data extraction and risk of bias assessment. Neither protocol nor statistical analysis plan was available at the time of data extraction. Enrolment was in stages and after grade 2 fever and headache reactions in the first stage participants, the 5x10^10 vp dose was lowered to 3x10^10 vp to increase tolerability. 20 children received a dose of 5×10¹⁰ vp, while 80 children received 3×10¹⁰ vp. Serious adverse events were not reported per arm, as had been pre-specified. There were no other important differences between registry and published report in population, procedures or interventions. The overall target sample size specified in the registry was achieved. This phase 2b trial included 3 cohorts [children (n=150), younger adults (n=30), and older adults (n=250)] with different intervention arms for each cohort. Here we present data and risk of bias assessments for the cohort aged 6-17 years.