Trial NCT04860739, EudraCT2021-001978-37
Publication Borobia A M, Lancet, 2021
Dates: 2021-04-24 to 2021-04-30
Funding: Public/non profit (Instituto de Salud Carlos III (ISCIII), European Union ́s Horizon 2020 Research and Innovation Programme)
Conflict of interest: Yes
| Methods | |
| RCT | |
| Location :
Multicenter / Spain Follow-up duration (months): 0.5 | |
| • BNT162b2 (n = 450) • No vaccine (n = 226) |
|
| Inclusion criteria | Healthy, or clinically stable, adults (aged ≥18 and ≤60) ; received a prime ChAdOx1-S vaccination between 8 and 12 weeks before the screening visit. |
| Exclusion criteria | Clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature ≥38.0ºC within 24 hours prior to the planned dose of study vaccine ; known or suspected allergy or history of anaphylaxis or other serious adverse reactions to COMIRNATY excipients ; any contraindication to the administration of COMIRNATY, included pregnancy ; prior documented COVID19 since VAXZEVRIA vaccination ; symptoms or signs compatible with COVID19 ; participating in a clinical trial in the last three months ; vaccinated with any other vaccine since the prime dose; any condition or situation precluding or interfering the compliance with the protocol. |
| Interventions | |
| Intervention
1 IM dose 30 mcg/0.3mL BNT162b2 8-12 weeks after 1 dose ChAdOx1-S |
|
| Control
No second vaccine dose 8-12 weeks after 1 dose of ChAdOx1-S | |
| Participants | |
| Randomized 676 participants | |
| Characteristics of participants Type of participants: Healthy volunteers N=676 294 males Children: 0 Pregnant women: 0 Mean age: Age range: NR | |
| Description of participants Healthy, or clinically stable, adults (aged ≥18 and ≤60) that were SARS-COV-2 infection free and who had received a prime ChAdOx1-S vaccination between 8 and 12 weeks before the screening visit in 5 centers in Spain. | |
| Primary outcome | |
| In the register 1) Serological response to vaccination (antibodies against SARS-Cov2 spike protein) as measured by immunoassay, 14 days after the boost dose. (NCT and EudraCT) 2) Solicited local and systemic adverse events (AEs) for 7 days after vaccine. (EudraCT) 3) Unsolicited local and systemic adverse events (AEs) for 28 days after vaccine.( EudraCT) 4) Serious adverse events (SAEs) throughout the study (from randomization until end of the study). (EudraCT ) 5) Medically-attended adverse events (MAAEs) from the day of vaccination until 6 months after the last vaccination. (EudraCT) | |
| In the report Reactogenicity and immunological response to vaccination as per antibodies against SARS-CoV-2 spike protein titres measured by immunoassay 14 days after the BNT162b2 dose. | |
| Variants description | |
| Variants | |
| Description | |
| Documents avalaible |
Protocol Yes. In English Statistical plan Yes Data-sharing stated:
Yes, When the trial is complete, upon requests directed to the corresponding authors; after approval of a proposal. |
| 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 pre-print article, the trials registries were used in data extraction and assessment of risk of bias. (EudraCT2021-001978-37 posted May 6 2021; NCT04860739 posted April 27 2021, but submitted April 22, prior to recruitment start.) The protocol, statistical analysis plan and supplementary appendices were not available at time of extraction. Inclusion criteria in the registries have no upper age limit, but reported as ≤60 years in the article. There is no change from the trial registration in the intervention and control treatments. Safety outcomes were described as primary outcomes in EudraCT, but as secondary outcomes in NCT and the article. The study achieved the target sample size registered prospectively in EudraCT. Given that the pre-print reports interim data, outcomes with longer follow-up durations are not reported. This trial was updated on July 6th 2021 after study publication. |