Trial NCT04552366
Publication Wu S, Lancet, 2021
Dates: 2020-09-28 to 2020-09-30
Funding: Public/non profit (National Key Research and Development Programme of China and National Science and Technology Major Project.)
Conflict of interest: Yes
| Methods | |
| RCT | |
| Location :
Single center / China Follow-up duration (months): 2 | |
| 0.2 mL nebulized 2 doses (n = 26) 0.1 mL nebulized 2 doses (n = 26) 0.5 mL IM + 0.2 mL nebulized (n = 26) 0.5 mL IM (n = 26) 1.0 mL IM (n = 26) | |
| Inclusion criteria | Aged 18 years and older; HIV-negative; no previous SARS-CoV-2 infection (determined by the detection of SARS-CoV-2-specific IgG and IgM antibodies); axillary temperature of 37·0°C or less; in general good health. |
| Exclusion criteria | Pregnant or breastfeeding women; psychiatric disorders; history of any allergies; serious cardiovascular disease; other major chronic illnesses, or abnormal laboratory tests (blood counts, alanine aminotransferase, aspartate aminotransferase, total bilirubin, fasting blood glucose, and creatinine were measured before each vaccination); clinically significant abnormalities (as judged by the investigators). Participants with severe allergic reactions or other severe adverse events related to the first vaccination were excluded before booster vaccination. |
| Interventions | |
| Intervention
2 nasal 0.2 mL (2 × 10^10 vp) doses 28 days apart 2 nasal 0.1 mL (2 × 10^10 vp) doses 28 days apart 1 IM 0.5 mL (5 × 10^10 vp) dose + 1 nasal 0.2 mL (2 × 10^10 vp) dose 28 days apart 1 IM 0.5 mL (5 × 10^10 vp) dose once-off |
|
| Control
2 IM 0.5 mL (5 × 10^10 vp) doses once-off | |
| Participants | |
| Randomized 130 participants | |
| Characteristics of participants Type of participants: Healthy adult volunteers N=130 65 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: NR | |
| Description of participants Adults who were HIV-negative and seronegative for SARS-CoV-2 at a single center in China | |
| Primary outcome | |
| In the register 1) Incidence of the AE in all groups [ Time Frame: 0-7 days after each vaccination ] 2) Seroconversion rate of the IgG antibody against SARS-CoV-2 [ Time Frame: Day 28 after last vaccination ] 3) Geomean titers of the IgG antibody against SARS-CoV-2 [ Time Frame: Day 28 after last vaccination ] 4) Seroconversion rate of the neutralizing antibody against SARS-CoV-2 [ Time Frame: Day 28 after last vaccination ] 5) Geomean titers of the neutralizing antibody against SARS-CoV-2 [ Time Frame: Day 28 after last vaccination ] | |
| In the report 1) Occurrence of adverse events within 7 days after each vaccination. 2) Anti-SARS-CoV-2 spike receptor IgG antibody and SARS-CoV-2 neutralising antibody geometric mean concentrations and titres at day 28 after last vaccination. | |
| Variants description | |
| Variants | |
| Description * | |
| Documents avalaible |
Protocol Yes. In English Statistical plan Yes Data-sharing stated:
Yes, All data will be made available for a minimum of 5 years from the end of the trial. |
| 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 |
Some concerns |
| General comment | In addition to the published article, the prospective trial registry, protocol (with statistical analysis plan and supplementary materials were used in data extraction and assessment of risk of bias. There were no substantive differences in outcomes between the published article and the registry and protocol. The number of participants enrolled in the trial differs between registry and report (149/130 respectively). There were 2 arms described in the first version of the registry that were not included in the trial or report. Results for local and systemic adverse events were pooled. Quote: "Local or systemic adverse events were not differentiated because of the influence of aerosolised vaccination on the respiratory system." |